Roche from A to Z Serving health

Roche from A to Z 

Serving health


Serving health

© 2007 

F. Hoffmann-La Roche Ltd 

Corporate Communications 

4070 Basel, Switzerland 

http://www.roche.com 

All trademarks mentioned in this publication are protected by law. 

Eighth, revised edition 

7 000 782

For over 110 years now, Roche has been a pioneer in the discovery, development, 

production and marketing of novel healthcare solutions. Roche is one of the 

world’s leading research-focused healthcare groups in the fields of pharmaceuticals 

and diagnostics. As the world’s biggest biotech company and an innovator 

of products and services for the early detection, prevention, diagnosis and treatment 

of diseases, the Group contributes on a broad range of fronts to improving 

people’s health and quality of life. Roche is the world leader in in-vitro diagnostics 

and drugs for cancer and transplantation, a market leader in virology and 

active in other major therapeutic areas such as autoimmune diseases, inflammation, 

metabolic disorders and diseases of the central nervous system. 

Every day tens of thousands of innovative, dedicated and highly professional 

people team their efforts for the continued success of our Group. It is only right, 

then, that this reference guide should be concerned primarily with people, 

methods, products and services. Since it was first published over thirty years ago, 

the Corporate Publication Roche from A to Z serving health has become something 

of an institution. It provides readers with wide-ranging, yet in-depth 

information on different aspects of our Group. Written in simple language, 

it guides readers through the Roche world, providing insights into our many and 

varied activities. 

The success of the book speaks for itself. Now in its eighth, revised edition, 

the book has gone through printings totalling over 800,000 copies in German, 

English, French and Spanish. Like its predecessors, this new edition can offer no 

more than a snapshot of our Group at a particular moment in time. For Roche is 

constantly evolving as we rise to the challenges posed by new technologies and 

discoveries and by a changing business environment. 

Roche’s history is one of change and progress – in short, of innovation. And 

these are the very things that are the bedrock of our success. This reference guide 

is thus offered as a source of facts and background information about a Group 

striving to better serve health. 


Franz B. Humer 

Editorial 

Chairman and 

Chief Executive Officer 

3

ACE inhibitors. Angiotensin-converting 

enzyme inhibitors. Blood pressure-lowering 

agents that inhibit 

the conversion of angiotensin, a tissue 

hormone produced by the body, from 

its inactive to its active form. In its active 

form angiotensin increases blood 

pressure by causing blood vessels to 

constrict and reducing salt excretion 

via the kidneys (→cardiovascular). 

Agonist. A drug producing a pharmacological 

effect, analogous to that of a 

naturally occurring ligand, by occupying 

a specific biologically active binding 

site (receptor) on the surface of a 

cell (→antagonist). 

AIDS. Abbreviation for acquired immunodeficiency 

syndrome. AIDS is an 

extremely serious infectious disease 

caused by the human immunodeficiency 

virus (HIV). HIV is transmitted 

via the blood (transfusions, blood 

products, transplants, injections, injuries) 

and by unprotected sexual 

activity. The →virus primarily attacks 

the →immune system and parts of the 

central nervous system. 

Current evidence indicates that HIV 

replication begins immediately after 

infection with the virus. Up to 100 billion 

new viruses are produced daily in 

helper T cells, a vitally important population 

of →blood cells which serve as 

hosts for the virus. As the virus replicates, 

these helper cells are damaged 

and destroyed. Eventually, the body’s 

4 

ACE inhibitors 

A 

Model of an AIDS virus (HIV). 

immune defences break down, leaving 

patients susceptible to life-threatening 

infections with pathogens that are 

normally relatively harmless. These 

opportunistic infections, as they are 

called, can affect the lungs, brain, liver, 

esophagus, bowel and other organs. 

The incidence of various cancers, such 

as Kaposi’s sarcoma and lymphomas, 

is also increased in HIV patients. 

This clinical picture of full-blown 

immunodeficiency disease is known as 

AIDS. 

Because of the high replication and 

mutation rate of HIV, drug resistance 

emerges relatively quickly. For this 

reason patients are now treated with 

a combination of agents belonging 

to different pharmacological classes. 

By combining agents with different 

mechanisms of action, multidrug regimens 

can greatly retard the development 

of resistant viruses. Numerous 

studies are underway to establish 

which combination of currently available 

antiviral medications is best. 

One focus of AIDS research at 

Roche is to develop novel additions to 

existing classes of anti-HIV medication 

that will be effective against

strains of the virus which have become 

resistant to currently available drugs. 

The Group also continues its search 

for innovative medicines that will 

block viral replication via completely 

new mechanisms of action. One approach 

is to inhibit the chemokine 

coreceptors (→receptors) present on 

the surface of helper T cells, thus preventing 

HIV from entering these cells. 

Fuzeon is the first in a new class of 

drugs (known as fusion inhibitors) 

which act in this way. It received 

→FDA approval in the United States, 

its first market, in March 2003. 

Intensive work is being done on 

developing new diagnostic tests for 

HIV and hepatitis. The →Diagnostics 

Division offers increasingly automated 

tests based on real-time PCR technology 

to detect active infections. These 

tests enable direct qualitative or quantitative 

detection of the viruses for 

diagnosis as well as viral load monitoring, 

an indication of patient response 

to drug therapy. Conventional tests, 

by contrast, provide only indirect evidence 

of infection, without distinction 

between past or active infection, by 

detecting →antibodies produced by 

the immune system to fight the virus. 

Coinfection (simultaneous infection) 

with HIV and hepatitis is a significant 

problem that requires special care. In 

the case of mother-to-child transmission 

of HIV during birth, DNA tests 

are the only reliable indicator of infection 

in infants, since mothers pass 

their antibodies to the infants during 

gestation and breast feeding. 


Air pollution, control of 

In addition, Roche also supplies 

medicines for the clinical complications 

of HIV infection such as 

Cymevene/Cytovene for CMV infections 

(→antimicrobials). 

AIDS Walk. A sponsored walk by 

Roche employees worldwide held on 

World AIDS Day, 1 December, in order 

to raise money for children in Malawi 

who have been impacted by HIV and 

AIDS. Funds collected by employees 

are matched by Roche. Partner organisations 

use the money from Roche to 

support centres in which these children 

are given food, clothing and basic 

healthcare. Malawi is one of the poorest 

countries in the world. Twenty percent 

of its 11 million inhabitants are 

HIV positive; half a million children 

have lost one or both parents to AIDS 

(→social responsibility). 

Air pollution, control of. Air pollution 

has become a problem of global 

proportions, as reflected by broad 

public concern about the greenhouse 

effect, ozone holes, summer smog and 

acid rain. Roche endeavours to protect 

the environment from harmful and 

unpleasant air pollution. 

5

At Roche it is mainly production 

and laboratory facilities that generate 

air emissions. The principal air pollutants 

in exhaust air from production 

facilities are volatile organic compounds 

(VOCs) from the organic solvents 

often used in chemical reactions 

and purification steps. In the last few 

years Roche has significantly reduced 

VOC emissions groupwide by installing 

engineering controls such as 

gas scrubbers, vapour recovery lines, 

filters, low-temperature condensers 

and thermal oxidation systems for 

waste gases. 

The burning of natural gas, fuel oil 

and waste solvents to produce power 

and steam results in emissions containing 

carbon dioxide, oxides of 

nitrogen and sulphur, hydrochloric 

acid or soot. Over the last few years 

progressive conversion of facilities 

from heavy fuel oil to natural gas and 

“extralight” heating oil has significantly 

reduced carbon dioxide and 

sulphur dioxide emissions per unit of 

energy produced. Installation of gas 

scrubbers and electrostatic precipitators 

has largely eliminated gaseous 

pollutants such as hydrogen chloride 

and soot particles from flue gases. 

Airol. A wound-healing powder containing 

bismuth and iodine. Developed 

in 1894, it was the first product to 

come out of the laboratories of Hoffmann, 

Traub & Co., the forerunner of 

F. Hoffmann-La Roche & Co. Ltd. At 

the time German patent law allowed a 

maximum of three years’ protection 

6 

Airol 

for products made outside Germany. 

This restriction led to the establishment 

of Hoffmann-La Roche Aktiengesellschaft, 

Roche’s first production 

site outside Switzerland. In 1897 Fritz 

→Hoffmann-La Roche purchased 

property in →Grenzach for a German 

factory in order to qualify Airol for a 

patent extension by manufacturing it 

domestically (→patents). 

The Airol →trademark was reintroduced 

in some countries in 1973 as the 

name of a retinoid product used for 

the topical treatment of acne. 

Alarm centre. A Group-wide telephone 

centre operated by Safety and 

Environmental Protection in Basel for 

international calls in the event of incidents 

or accidents and for information 

regarding product safety (toxicity, environmental 

toxicity, etc.). It provides 

around-the-clock assistance, receives 

site-specific alarms from automatic 

surveillance and process monitoring 

systems and passes on reports of malfunctions 

to the responsible units. 

Alternatives to animal testing. Techniques 

designed to supplement or 

replace testing in animals, through 

the use of cell, tissue or organ cultures 

(→in vitro), isolated organs, lower organisms 

(bacteria or worms) or computer 

simulations. Alternative methods 

need to supply results equally as 

good as those from animal tests. There 

is no lack of interest in such methods, 

particularly in industry. For a number 

of years now Roche has been spending

several million CHF annually on projects 

in this area. 

Alternative testing methods provide 

in-depth insights into events at the cellular 

and subcellular levels – the very 

events which often give rise to disease, 

and which effective remedies need to 

target. Whether such findings are clinically 

useful, however, can often only 

be established by studying the complex 

interplay of biological processes in an 

intact living animal, for animals and 

people are more than the sum of their 

parts. 

In vitro tests are particularly helpful 

for screening drugs that might be 

effective. They reduce the number of 

tests that have to be done in animals 

since only promising compounds are 

investigated further. 

The case is different in toxicity testing 

(→toxicology) and the evaluation 

of side effects. The toxicity tests that 

have to be done before a drug can be 

tried in man or before it can be marketed 

are prescribed by the regulatory 

authorities. Alternatives to toxicity 

testing in animals are not yet advanced 

enough to be fully acceptable to health 

regulators. 

In short, alternative methods are a 

valuable adjunct to animal testing. 

They cannot replace it entirely but do 

help reduce the number of animals 

needed. 

Alzheimer’s disease. A degenerative 

brain disease named after the Munich 

neurologist and psychiatrist Alois 

Alzheimer (1864–1915), the cause of 


Amino acids 

which is still unknown. Alzheimer’s 

disease usually strikes after the age of 

65 and is characterised by the gradual 

death and disappearance of nerve cells 

in the cerebral cortex. Early clinical 

signs include marked forgetfulness 

and episodes of mental confusion. In 

advanced stages, memory is almost 

completely obliterated, and the disabling 

effects of the disease are so severe 

that patients require institutional 

care. There is a good deal of evidence 

to suggest that genetic factors play a 

role in Alzheimer’s disease. For example, 

carriers of what is termed the 

ApoE-e4 allele are more likely to suffer 

from Alzheimer’s, and →mutations in 

certain genes can lead to an earlier 

onset of the disease. Roche researchers 

in Basel are using transgenic mice to 

investigate potential causes of the disease 

and explore ways of developing 

drugs to treat it. The brains of these 

mice display some of the characteristic 

features of Alzheimer’s disease (→research, 

→research expenditure). 

Amino acids. The basic structural 

units of →proteins; organic molecules 

capable of undergoing a wide range of 

biochemical reactions, most notably 

reactions in which they bind to each 

other to form long chains. Despite 

their tremendous diversity, proteins 

(also called polypeptides) are all composed 

of roughly 20 amino acids 

found in nature. The sequence in 

which amino acids are arranged in a 

protein molecule is determined by 

→genes. Ten of the naturally occurring 

7

amino acids, known as essential amino 

acids, cannot be made by the human 

body in adequate amounts or at all, 

and therefore have to be obtained from 

dietary protein. 

AmpliCare programme. This programme 

is a contribution by Roche 

Diagnostics to the improved management 

of HIV/AIDS patients where the 

need is greatest – in sub-Saharan 

countries in Africa and in other countries 

defined by the United Nations as 

belonging to the least developed nations. 

In this programme, which was 

initiated in 2002, Roche supplies tests 

for measuring HI viral load at greatly 

reduced prices. Roche also assists with 

the patient monitoring programme 

and is involved in the basic and advanced 

training of doctors and nurses. 

Roche always endeavours to adapt its 

involvement to local needs. For example, 

the company works with laboratories 

and hospitals to identify, where 

feasible, those services or technical 

support operations that are best suited 

to the local environment and then to 

develop a customised solution. Roche 

Diagnostics intends to extend the programme 

to other countries, primarily 

those defined by the UN as having 

a low income. In this context, Roche 

has already initiated talks in Eastern 

Europe, Latin America and other Asian 

countries (→sustainability, →social 

responsibility). 

AmpliChip CYP450 Test. Based on 

DNA chip technology, this test analy- 

8 

AmpliCare programme 

ses the genotype of the cytochrome 

P450 2D6 and 2C19 genes in the 

genomic DNA of patients’ blood samples. 

The test results enable doctors 

to take account of patients’ specific 

genetic information when selecting 

drugs and establishing the best dosage 

for the treatment of various common 

illnesses such as heart disease, pain 

syndromes and cancer. This new test 

will give doctors access to information 

that could prove useful both in avoiding 

harmful drug interactions and in 

the using drugs to maximum effect. 

Side effects of drugs are responsible 

for a very large number of hospital 

referrals. Thanks to this new test it 

will also be possible, in certain cases, 

to avoid the selection of a less suitable, 

or even harmful, drug treatment. It is 

very important for patients to know 

whether painkillers or narcotics will 

work differently, or even at all, in their 

own case. The effect of drugs can last 

for much longer in patients who 

metabolise them poorly or slowly. 

Patients who are aware of such things

can then ask for other, better tolerated, 

drugs (→DNA chips, →tests, diagnostic, 

→gene chip). 

Analysis. In chemistry, the determination 

of the identity and amounts of 

the constituents of a chemical compound 

or mixture. The chemical analyst’s 

job is to answer questions about 

the structure and composition of samples 

sent to the laboratory for analysis. 

Which methods he or she employs will 

depend on the properties of a given 

sample. Generally, chemical, physicochemical, 

biochemical and biological 

methods are used. Modern technologies 

have made it possible to penetrate 

the infinitesimal realm of atomic bonds. 

In research and chemical manufacturing, 

chemists use analytical methods 

to elucidate the sequence of events 

in a chemical reaction, to identify the 

molecular structure of a compound 

or to determine its purity. Control of 

large-scale chemical and pharmaceutical 

manufacturing processes involves 

automatic monitoring and evaluation 

of analytical data. 

Biological systems are employed to 

test the efficacy or toxicity of substances. 

Such systems make it possible 

to assess the activity or harmfulness 

(→toxicology) of an active drug ingredient 

and to establish its “fate” in the 

body. For example, it is possible to 

determine how much of a dose reaches 

the bloodstream (bioavailability) and 

how much is excreted by the body in 

unchanged form. Equally important 

questions concern the drug meta- 


Analytical systems 

bolites formed in the body and how, 

and to what extent, they are excreted. 

Until just a few years ago, measuring 

blood levels of an agent like acetylsalicylic 

acid posed almost insurmountable 

difficulties, even though it is taken 

in doses of up to 500 mg. Today agents 

administered in amounts as small as 

a millionth of a milligram can be 

tracked in the blood despite the significant 

dilution that occurs once a drug 

enters the circulation. To measure 

quantities of an agent too small to be 

detected by chemical procedures, microbiologists 

also use microorganisms. 

Analysis plays a pivotal role in many 

operational areas at Roche (→quality 

control, →product safety). →Occupational 

hygiene and →environmental 

protection are no exceptions; activities 

in these areas are likewise based ultimately 

on analytical findings. 

Analytical systems. Instruments supplying 

reliable, precise and cost-effective 

diagnostic information; they help 

increase laboratory efficiency and 

often contribute to major treatment 

decisions. The →Diagnostics Division’s 

→Professional Diagnostics business 

area supplies fully automated, computer-aided 

analytical systems under 

the →Cobas trademark and the →Elecsys 

and Modular Analytics lines of 

laboratory diagnostic systems. Roche 

can provide customers with a coordinated 

system of analysers and reagents 

tailored to their specific needs. Clinical 

chemistry test methods are based on 

proven analytical measuring techno- 

9

Anemia 

logies, including absorbance photometry, 

turbidimetry, fluorescence polarisation 

and ion selective electrode 

potentiometry. The wide range of 

immunoassays are measured by electrochemiluminescence 

technology. 

Thanks to our comprehensive service 

portfolio, customers are able to use 

our innovative diagnostic products in 

a simple, safe and efficient manner. 

Software solutions and comprehensive 

data management tools provided by 

Roche link centralised and decentralised 

diagnostic systems, allowing 

the customer to view laboratory data, 

measurements and comprehensive 

patient information at a glance. The 

broad range of analytical systems for 

→clinical chemistry and immunology 

can also be combined on one platform 

(modular concept). These systems 

relieve laboratory staff of much of the 

workload of routine analysis, freeing 

them up to concentrate on specific 

operations. 

Anemia. A condition characterised by 

a decrease in the number of red blood 

cells (erythrocytes) or by an abnormally 

low concentration of the oxy- 

10 

gen-carrying red pigment hemoglobin 

in the blood. Anemia can have any of 

a wide variety of causes. When kidney 

function is impaired (after a severe 

kidney infection, for example, or as a 

complication of →diabetes), the body 

produces too little or no →erythropoietin 

(EPO); this →cytokine stimulates 

the production of erythrocytes from 

precursor cells derived from →stem 

cells in the bone marrow. Today recombinant 

human EPO (→NeoRecormon) 

(epoetin beta) is available to 

treat this form of acquired anemia. 

Anemia can also result from malnutrition, 

particularly if a person’s dietary 

intake of iron or vitamin B 12 is too low. 

In some African and Mediterranean 

countries there is an increased incidence 

of congenital, hereditary abnormalities 

in hemoglobin structure, such 

as sickle cell anemia and various forms 

of thalassemia. Anemia is also common 

in cancer patients undergoing 

chemotherapy who, while already 

compromised by their primary disease, 

have also to cope with low hemoglobin 

levels. This leads to fatigue and 

lack of concentration, rated as one of 

the most debilitating of all cancer side 

effects (→C.E.R.A.). 

Angiogenesis. The physiological process 

involving the growth of new blood 

vessels from pre-existing vessels, facilitating 

enhanced oxygen and nutrient 

delivery to the tissues. Under normal 

cellular conditions angiogenesis is 

essential for human growth, wound 

repair and embryonic development.

It continues from birth to death and 

plays a fundamental role in the body’s 

healthy development. Angiogenesis 

also forms an essential component of 

tumour maturation. In cancer patients 

a protein called VEGF (Vascular Endothelial 

Growth Factor) is released by 

the tumour, initiating the growth of 

new blood vessels. This in turns results 

in increased oxygen and nutrient delivery 

to the tumour, allowing it to 

grow and ultimately spread through 

the body (known as metastasis). Due 

to its importance to tumour development, 

angiogenesis is a valid therapeutic 

target for many cancers. →Avastin 

is the first anticancer agent that acts by 

binding to circulating VEGF, thereby 

preventing the formation of immature 

blood vessels proximal to the tumour. 

Animal experiments. Preliminary experiments 

on animals are absolutely 

essential if we are to determine the 

possible effects and side effects of 

chemical compounds or biological 

therapeutic agents in humans. They 

provide invaluable information on the 

desired action, distribution and biotransformation 

of substances in individual 

organs and, in particular, on 

their possible harmful effects. It would 

be irresponsible to test a substance in 

human beings without first testing it 

in carefully designed animal experiments. 

The scientists who carry out these 

experiments are aware of the limitations 

of animals as models, as their 

bodies and metabolic processes do not 


Animal experiments 

correspond exactly to those of humans. 

This fact has given rise to the 

fallacy prevalent in animal rights circles, 

and even among some doctors, 

that animal experiments are pointless 

and that the results of such experiments 

can never be applied to man. 

This is only partly true. Experiments 

must often be conducted on several 

animal species and the findings subjected 

to careful evaluation and interpretation. 

Some laboratory animals are used 

for identifying the effects of substances 

that might prove useful in a 

particular treatment. Research is increasingly 

directed towards identifying 

and correcting defective biochemical 

processes that cause illness in humans. 

Such individual reactions are more 

easily observed outside the living organism 

(→in vitro) than in the intact 

body, where they occur alongside numerous 

other reactions. Such in vitro 

investigations (→alternatives to animal 

testing,) are gaining in importance, 

and only those compounds that 

appear promising are now tested in 

animals. This largely explains why animal 

experiments cannot be dispensed 

with altogether. 

Nowadays, laboratory animals also 

have to be used for identifying and 

eliminating the adverse effects of 

drugs or new compounds. These animal 

experiments are essential for an 

evaluation of risks and benefits prior 

to human trials, because the reaction 

of a complete organism to the substance 

must be determined. Not only 

11

Antagonist 

are these investigations a prerequisite 

for subsequent tests on healthy volunteers 

and patients, they are also required 

by law for drug registration 

purposes (→toxicology). 

Roche also works with organisations 

dedicated to reducing the use of 

animals. In Switzerland Roche actively 

supports the 3R Research Foundation. 

This body provides funding to develop 

new or improved methods based 

on what is known as the 3R strategy: 

Reduce – Improve existing methods 

so that fewer laboratory animals are 

required. Refine – Refine existing 

methods so that animals are exposed 

to as little discomfort and distress as 

possible. Replace – Use alternatives to 

animal testing wherever possible. 

Antagonist. An agent that nullifies 

or counteracts the pharmacological 

action of another agent (called the 

→agonist). An example is Anexate, a 

benzodiazepine antagonist developed 

by Roche and used in anesthesia and 

emergency medicine. 

Antibodies. Vast spectrum of special 

→proteins formed by the →immune 

systems of higher animals in response 

to invading →antigens; antibodies are 

also called immunoglobulins. In Paris 

Louis Pasteur did the first systematic 

→animal experiments exploiting antigen-antibody 

reactions to induce immunity 

– work which resulted in 

a rabies vaccine that saved the life of 

a young boy in 1885. A few years 

later the German physician Emil von 

12 

Behring (Nobel Prize, 1901) and his 

Japanese assistant Shibasaburo Kitasato 

recognised the presence of antibodies 

in blood serum and became the 

first to successfully use such polyclonal 

antibodies (antibodies produced by 

many different B cells) from the blood 

of immunised animals as antitoxins 

for diphtheria and tetanus. The first 

theory of antibody structure and 

activity was proposed a decade later 

by Paul Ehrlich (Nobel Prize, 1908), 

but it was not until more recently that 

immunologists began to gain a clearer 

understanding of the complexities 

involved. For example, the number of 

lymphocytes (white blood cells) circulating 

in the human body is now 

known to be immense (over 10 10 to 

10 12 ), and to include millions of cells 

capable of producing antibodies. 

Another major figure in research on 

the antibody system was Niels Kaj 

Jerne (→Nobel Prize, 1984). Working 

with Albert Nordin in the United 

States in the early 1960s, Jerne devised 

a simple, visual test for measuring the 

number of cells producing antibodies 

to a given antigen. Known as the Jerne 

plaque assay, this test has played an 

important role in the development of 

modern immunology, and particularly 

of cellular immunology. In 1969, while 

the former Basel Institute for Immunology 

was still in its infancy, Jerne, 

the institute’s first director, proposed 

a theory based on molecular genetics 

to explain the tremendous diversity of 

specific antibodies in each individual. 

Jerne’s work culminated in his theory,

also developed in Basel, of the immune 

system as a self-regulating network of 

cells and antibodies which is kept in 

balance by highly specific mechanisms. 

Jerne not only made pioneering 

discoveries of his own, but provided 

the impetus for new experimental 

work by younger researchers with his 

stimulating ideas. Among the scientists 

whose work he influenced were 

Georges Köhler and César Milstein, 

who shared the 1984 Nobel Prize with 

Jerne for their discovery of a method 

of producing monoclonal →antibodies. 

Working at the former Basel Institute 

for Immunology in the late 1970s, 

Susumu Tonegawa (Nobel Prize, 1987) 

elucidated the genetic basis of antibody 

diversity. He showed that the 

enormous structural variety of antibodies 

results from genetic rearrangements 

and numerous chance →mutations 

in specific gene sequences during 

the earliest stage of an organism’s 

development; at the same time his 

discoveries confirmed Jerne’s theory 

of antibody diversity. 

Antibodies, humanised. Antibodies 

produced with the help of genetic engineering 

techniques by grafting the 

respective DNA regions of →antigenbinding 

sites from animal (usually 

mouse) immunoglobulin onto the 

framework of a human immunoglobulin. 

Humanised antibodies are recognised 

as foreign and neutralised by the 

human immune system (reduced immunogenicity) 

less frequently than 

antibodies of mouse or rat origin. 


Antigen 

Antibodies, monoclonal. Identical 

antibodies formed by a single cell line; 

they can be produced artificially in 

large quantities and in highly pure 

form for use in research, diagnostic 

testing and therapy. Monoclonal antibodies 

are produced using hybridomas, 

cultures of hybrid cells obtained 

by fusing cells from two different 

mammalian cell lines. Georges Köhler 

and César Milstein were awarded a 

→Nobel Prize in 1984 for developing 

the hybridoma technique (→oncology) 

(see diagramme on page 14). 

Antibodies, polyclonal. Antibodies 

produced by a multitude of different 

→B-lymphocyte clones (in contrast 

to monoclonal →antibodies), and 

which therefore differ in molecular 

structure in the binding site for the 

→antigen. 

Antigen. Term denoting any substance 

recognised as foreign by the →immune 

system and which provokes a defensive 

reaction by the body (immune response). 

Immune responses may be 

directed against →bacteria, →viruses 

or parasites, but also include allergic 

reactions and rejection reactions to 

tissues transplanted from other persons 

(→organ transplantation). Proteins, 

such as the surface proteins on 

microbial pathogens or natural toxins 

(snake and bee venom), comprise the 

main group of antigens. In principle, 

though, any relatively large molecule 

can act as an antigen. Ordinarily the 

body’s own components are not at- 

13

tacked by the immune system, unless 

an individual has an →autoimmune 

disease. The term “antigen” has nothing 

to do with →genes. 

Antimicrobials. Chemotherapeutic 

agents produced chemically or by a 

biotechnological process and which 

14 

Antimicrobials 

Monoclonal antibodies from hybridoma cells 

Antigen 

Tumour cells 

Fusion 

Spleen cells 

Hybridoma cells 

Spleen 

Selection of hybridomas with antibody reactivity, 

expansion of cell lines (clones) from positive cell cultures 

Blood 

Conventional 

serum containing 

polyclonal 

antibodies 

Monoclonal antibodies 

Genetically identical cell lines (clones) of hybridomas are obtained by fusing 

short-lived antibody-producing spleen cells from the mouse with continuously 

dividing, “immortal” tumour cells. These hybrid cells can be grown indefinitely 

in culture, with each cell line producing a single uniform type of antibody. 

Because of their extremely high specificity, such monoclonal antibodies (MAbs) 

are indispensable tools in research and diagnostics; humanised MAbs serve as 

novel, highly effective medicines. 

are used to treat infectious diseases 

caused by →bacteria, fungi, parasites 

or →viruses. Highly effective drugs 

against these pathogens have been 

available since the advent of the sulfonamides 

in the 1930s and the penicillins 

and other antibiotics somewhat 

later.

Pegasys, the drug developed by Roche for 

the treatment of chronic hepatitis C. 

The blue-violet chains are branched 

polyethylene glycol (PEG) molecules 

that surround the active ingredient interferon 

alfa-2a (a protein). This is 

known as pegylation. The PEG molecules 

protect the interferon against excessively 

rapid breakdown in the body. 

They thus increase the stability of the 

protein and improve the therapeutic 

effect significantly compared to nonpegylated 

interferon alfa-2a. 

Roche has developed numerous 

drugs for the treatment of viral illnesses, 

for instance Fuzeon →Invirase, 

and Viracept for the treatment of 

→AIDS, and Cymevene/Cytovene and 

Valcyte for cytomegalovirus infections. 

If left untreated, cytomegalovirus 

infection can lead to blindness 

and death. The development of the 

first antiviral drugs represented an 

important milestone. The assumption 

that vaccination was the only suitable 

weapon against viruses had to be revised. 

Research and development work 


Antimicrobials 

at Roche has resulted in groundbreaking 

therapeutic approaches with 

innovative drugs and diagnostic tests. 

Completely new avenues have been 

opened up to patients and doctors by 

Roche drugs for HIV, such as Invirase 

and Fuzeon, and increasingly by automated 

diagnostic tests such as qualitative 

PCR for the detection of HIV and 

quantitative real-time PCR for the 

monitoring of viral load. 

Roferon A, based on the natural 

protein called interferon, was one of 

the first treatments for hepatitis C. 

Pegasys, the world’s best-selling 

treatment for →hepatitis C, contains 

pegylated interferon alfa 2a (40KD). 

Pegasys is specifically designed to stay 

in the body longer fighting the virus. 

Patients are given Pegasys as an injection 

just once a week and many have 

an excellent chance of being cured of 

their disease. Pegasys is approved for 

a broad range of patients with hepatitis 

C, including those patients who 

have cirrhosis, are coinfected with HIV 

or who have “normal” ALT levels. In 

addition, Pegasys is the only pegylated 

interferon approved for the treatment 

of patients with chronic hepatitis B. 

Copegus (ribavirin) is given in 

combination with Pegasys and substantially 

increases a patient’s chances 

of being cured. Copegus tablets are 

taken once a day for the duration of 

treatment with Pegasys. This combination 

is now considered to be the gold 

standard. Since the introduction of 

new diagnostic tests based on →PCR 

and real-time PCR technology, it is 

15

Antiparkinsonian agents 

now possible to obtain better and 

more detailed results in the diagnosis 

of this viral disease and the monitoring 

of the response to treatment. 

Approval of the antiflu drug 

→Tamiflu has made it possible to treat 

→influenza by targeting the virus that 

causes it. Introduced by Roche in 1999, 

Tamiflu and a test for detecting 

influenza infection are an extremely 

effective pair of tools for diagnosing 

and treating the illness. The flu outbreaks 

that occur regularly can place a 

considerable burden on public health 

systems and claim many lives as a result 

of complications. 

Another Roche antimicrobial that 

deserves to be mentioned is the antibiotic 

→Rocephin. 

Antiparkinsonian agents. Medicines 

for the treatment of Parkinson’s disease 

(also called paralysis agitans and 

shaking palsy), which is characterised 

by trembling (tremor), rigidity (rigor), 

slowness and poverty of movements 

(akinesia) and other physical and mental 

symptoms. The first detailed description 

of the disease was published 

by James Parkinson in 1817. The incidence 

of Parkinson’s disease increases 

dramatically from age 55 on. 

In the 1960s Prof. Walther Birkmayer 

of Vienna and others discovered 

that certain regions of the brain in 

parkinsonian patients produced too 

little of a chemical messenger (→neurotransmitter) 

called dopamine. Close 

collaboration between Birkmayer and 

Alfred Pletscher, Roche’s head of re- 

16 

search at the time, led to the development 

of levodopa (Markus →Guggenheim) 

as the first effective treatment 

for Parkinson’s disease. Levodopa 

(dihydroxyphenylalanine, l-dopa, also 

known by its trade name Larodopa) is 

the precursor of the depleted neurotransmitter 

dopamine; the body is able 

to convert it to dopamine. Unfortunately, 

a satisfactory response can only 

be achieved with high doses and correspondingly 

marked adverse events. 

The discovery that adverse events 

could be suppressed by concomitantly 

administering benserazide, an enzyme 

inhibitor, led to the development of 

Madopar, a medicine combining 

levodopa and benserazide. Madopar is 

significantly more effective and has a 

significantly better tolerability profile 

than Larodopa; the benefits it provides 

to patients with Parkinson’s disease 

have yet to be surpassed by any other 

medicine. 

Apothecary jars, historical. Albarelli, 

syrup jugs and flasks from Italy, Spain 

and other European countries. Roche 

owns a valuable collection of approximately 

400 apothecary jars, on display 

in exhibit cases in various buildings 

in Basel and Grenzach. The collection 

comprises pieces from the early 16th to 

the 19th century. A scientific catalogue 

makes the collection accessible to researchers. 

Applied Science. Business area of the 

→Diagnostics Division. With over half 

a century of experience in its field,

An especially beautiful piece from 

Roche’s collection of apothecary ceramics. 

An ornamental majolica vase from 

Talavera, Spain, circa 1710 (48 cm high). 

Applied Science is one of the world’s 

leading producers of reagents and 

systems for life science research. Applied 

Science develops and markets 

components for medical and biotechnological 

research, focusing especially 

on →genomics and →proteomics. This 

business area also supplies reagents 

MagNA Pure LC Instrument – a highly 

flexible instrument for isolating DNA 

and RNA from a wide range of sample 

materials; it is an ideal complement to 

the LightCycler system. 


Apprenticeships 

LightCycler 2.0 Instrument – a system 

for fully automated PCR that not only 

reduces PCR cycles to a fraction of the 

usual time (32 PCR cycles in less than 

20 minutes), but also simultaneously 

monitors PCR reaction kinetics online 

and in real time. A system for highthroughput 

PCR is also now available 

in the form of the LightCycler 480 

Instrument. 

and consumables for the pharmaceutical 

and diagnostics industry. 

Apprenticeships. Roche has trained 

apprentices since the 1950s. Every year 

in Basel, for example, some 300 young 

people are prepared for a technical or 

commercial career or receive training 

in a trade. Similar programmes that 

operate in line with local training 

practices are in place at Roche companies 

in other countries. 

17

Besides offering apprenticeships for 

chemical and laboratory technicians 

– occupations typically in demand in 

the pharmaceuticals industry – Roche 

also trains apprentices for technical 

careers in mechanical engineering, 

electronics, automation, mechanical 

design and fitting, draughting, IT and 

logistics, and the company even has 

training programmes for animal 

keepers, medical practice assistants 

and clerical employees. 

In Basel apprentices are trained for 

three or four years by instructors in 

the workplace, while also attending 

the Roche works school and sectorspecific 

industrial training colleges or 

the city’s commercial college, where 

they take both vocational and general 

education courses. The knowledge 

acquired on the job and in the college 

classroom is consolidated and expanded 

at the works school, with its 

apprentice labs and workshops, a 

modern training factory for chemical 

technicians opened in 1996 and a computer 

training centre, under the expert 

guidance of Roche’s own training staff. 

This ensures that apprentices receive 

highly practical, hands-on training. 

The results achieved year after year in 

the final trades examinations in Basel 

are just one example of the success 

of the Roche apprentice training system. 

Architecture. In 1971 the Basel conservation 

society awarded Roche a 

prize for its well-designed industrial 

buildings and the harmonious way in 

18 

Architecture 

Top: Executive office building in Basel, 

built in 1935–36. Bottom: The building’s 

sweeping spiral staircase, one of 

the hallmarks of architect Otto R. 

Salvisberg’s designs. A similar staircase 

can be found in the original Roche 

building in Welwyn Garden City. 

which they fit in with the surrounding 

townscape. 

The company’s building policies 

were shaped in part by the association 

of architect Otto R. Salvisberg (a professor 

at Zurich’s Federal Institute of 

Technology) and the then head of 

Roche, Dr Emil C. →Barell. And they 

are also a reflection of the interest of 

the founder families represented on 

the →Board of Directors in the visual

→arts and architecture. Salvisberg’s 

first building for Barell was a private 

residence. Following this successful 

“trial run”, Barell commissioned him 

to design a new executive office building 

in Basel. To this day it stands out 

as an exceptional piece of industrial 

architecture. Salvisberg subsequently 

drew up a master development plan 

for the entire Roche site in Basel. 

Despite numerous modifications, it 

was retained essentially intact and 

largely determined the present appearance 

of the site. After Salvisberg’s 

death Dr Roland Rohn took over his 

teacher’s studio and commissions, including 

the Basel site development 

project. It was under Rohn’s direction 

that the most visible and striking parts 

of the complex were built: the office 

highrise, the staff amenities building 

and the buildings along the Rhine and 

those abutting the Wettsteinallee. 

Rohn’s plans for an office building on 

the last vacant plot fell victim to objections 

by the city’s conservation society, 

and Rohn died while the project was 

still under study. 

The guiding idea in developing the 

Basel campus was to create a “buffer 

zone” around the production facilities 

so as to protect neighbouring residential 

areas as much as possible from 

industrial emissions. The strips along 

the Rhine and Wettsteinallee were accordingly 

used for research buildings; 

the staff amenities building, a warehouse 

and production facilities solely 

for pharmaceuticals were sited along 

the eastern edge of the campus; and 


Art 

administration buildings along its 

western edge. What little chemical 

production is still done in Basel is 

located at the centre of the complex. 

Most chemical manufacturing activities 

have been relocated to other sites 

for lack of space and for economic reasons. 

The style of industrial architecture 

promoted in Basel, with its emphasis 

on quality and functionality, has been 

retained in more recent projects, such 

as the pharmaceutical research laboratory 

building designed by the architectural 

firm Herzog & de Meuron 

completed in 2000 and the newest 

building, the →Avastin production 

centre. This style has also been 

adopted by the other companies in the 

Roche Group, though each of them has 

adapted the basic stylistic elements to 

suit local needs. Copies, in the strict 

sense, of Salvisberg buildings can be 

found at the →Nutley site in New 

Jersey (United States). Salvisberg 

personally designed the original complex 

in Welwyn Garden City (Great 

Britain), which unfortunately has 

undergone substantial changes in the 

meantime. The notable buildings in 

Istanbul and Kamakura (Japan), on 

the other hand, were designed by 

members of the planning and building 

department at Roche Basel. 

Art. Also has its place in the world of 

work and science. Countless works 

of art, usually by contemporary local 

artists, decorate the walls of work and 

recreation areas and corridors in 

19

Roche buildings all over the world. As 

an experiment, seven painted panels 

and sculptures were put up in the main 

Basel workshops in 1969. These works 

of art were created especially for these 

surroundings by young artists. 

Other works of art are also accessible 

to visitors or the general public, 

among them the following sculptures 

on display at corporate headquarters 

in Basel: 

– Concrete sculpture on the east front 

of the staff amenities building, by 

Ödön Koch (1906–1979). 

– Eyecatching red iron sculpture outside 

the staff amenities building, 

visible from afar, by Bernhard Luginbühl 

(*1929). 

– Oyarek II, iron sculpture in the 

foyer of the large auditorium, by 

Eduardo Chillida (1924–2002). 

20 

Arthritis, rheumatoid 

Sculpture by Hans Arp on the Roche 

site in Basel. 

– Interlocking Two Pieces Sculpture, 

stone sculpture in the garden between 

the old administration building 

and the office highrise, by Henry 

Moore (1898–1986). 

– Pépin-Géant, in the garden in front 

of the foyer of Building 71, by Hans 

Arp (1887–1966). 

Arthritis, rheumatoid. →Autoimmune 

disease whose cause remains 

unknown. Typical symptoms of this 

disorder include symmetrical joint inflammation 

on both sides of the body, 

with destruction of the joint lining 

and, in the rapidly progressive form, 

destruction of the adjacent bone and 

cartilage. The condition is generally 

chronic and progressive with acute 

disease flares leading to painful joint 

swelling. Rheumatoid arthritis is a 

generalised inflammatory disease that 

is not limited to the joints, but one that 

can also lead to systemic effects such as 

→anemia, chronic fatigue, →osteoporosis, 

and ultimately to a shortened 

life span. Even if treated with classical 

anti-inflammatory drugs, rheumatoid 

arthritis (RA) can still lead to gradual 

destruction of the joints and loss of 

function. Over 21 million people 

worldwide suffer from the disease. 

MabThera/Rituxan (rituximab) is currently 

approved for the treatment of 

active rheumatoid arthritis in patients 

who have an inadequate response or 

who are intolerant to one or more tumour 

necrosis factor inhibitor therapies 

and is in development for further 

use in rheumatoid arthritis.

Rheumatoid arthritis particularly 

affects the small joints and the hands 

and feet. 

At the beginning of 2003 Roche and 

→Chugai announced their intention 

to jointly develop and market the 

Chugai molecule tocilizumab. Tocilizumab 

is a humanised monoclonal 

→antibody which selectively targets 

interleukin-6 (IL-6), one of several 

cytokines involved in the activation of 

autoantibodies, and other mediators 

of inflammatory mechanisms. With 

its novel mechanism of action, tocilizumab 

could represent a new, effective 

approach to the treatment of rheumatoid 

arthritis. A Phase III clinical 

development programme is underway 

globally with more than 4,000 patients 

enrolled in 41 countries including 

countries in Europe and the USA. 

Tocilizumab has one of the largest 

clinical development programmes 

within Roche. 

Autoimmune diseases. Any of numerous 

disorders, most of them serious, 

resulting from an inappropriate 


Autoimmune diseases 

or excessive response by components 

of the →immune system. The cause is a 

breakdown in the mechanisms controlling 

immunological tolerance to 

the body’s own tissues; as a result, 

→antibodies or certain →T lymphocytes 

(white →blood cells) attack the 

body’s own →proteins or healthy cells. 

T lymphocyte precursors learn selftolerance 

– which also means learning 

to discriminate between “self” and 

“nonself” – in a kind of training school 

in the thymus gland (hence the name 

“T lymphocytes”) through exposure to 

cell surface proteins that are unique 

to each individual. The mature T lymphocytes 

that emerge from the selection 

process in the thymus normally 

do not bind to these self-proteins. As 

killer T cells, mature T lymphocytes 

are directly involved in cellular immunity, 

mounting attacks against any 

cells expressing foreign antigens – 

foreign cells in tissue or organ transplants 

(→organ transplantation), for 

example, or virus-infected or cancer 

cells. Other T lymphocytes mature 

into helper T cells, which control the 

activity of antibody-producing B lymphocytes 

through various complex 

reactions. When errors occur in the 

“training” of T lymphocytes, the result 

may be an appropriate immune response 

(say, to a microbial pathogen) 

which is too weak, or the immune 

system may recognise self as nonself 

and run amok against the body’s own 

constituents. 

A long list of clinical entities are 

now recognised as autoimmune dis- 

21

Avastin 

eases. These include multiple sclerosis, 

certain types of →diabetes and 

rheumatoid →arthritis. The discovery 

of the mechanisms involved in the development 

of “naive” T cell precursors 

into mature, fully immunocompetent 

T cell families was largely the work of 

an international team of researchers 

at the former Basel Institute for 

Immunology in the late 1980s. For 

Roche’s immunologists, findings from 

→basic research are the cornerstone of 

the quest for novel, highly specific 

medicines aimed as closely as possible 

at the root causes of autoimmune diseases 

and rejection reactions following 

→organ transplantation. 

Avastin. The first anticancer drug that 

inhibits →angiogenesis, i.e. the growth 

of a network of blood vessels that supply 

nutrients and oxygen to cancerous 

tissues. Avastin (active ingredient bevacizumab) 

is a monoclonal →antibody 

currently being codeveloped by 

Roche and →Genentech for use in a 

number of cancer types. Avastin was 

launched in 2004 for the first-line 

treatment of patients with advanced 

colorectal cancer. It was also approved 

in 2006 for the treatment of non-small 

cell lung cancer. Avastin is the only 

antiangiogenic agent that has consistently 

demonstrated an overall and/or 

progression-free survival benefit in the 

three most common tumour types: 

colorectal cancer, →breast cancer and 

non-small cell lung cancer. Avastin 

possesses a novel mode of action and 

works by targeting and binding to 

22 

a naturally occurring protein called 

VEGF (vascular endothelial growth 

factor), a key mediator of angiogenesis, 

thereby choking off the blood 

supply that is essential for the growth 

of the tumour and its spread throughout 

the body. Due to its mode of action 

Avastin has the potential to become 

the backbone of cancer treatment. As 

such, Roche and Genentech are pursuing 

a comprehensive clinical programme, 

the largest ever undertaken 

for an anticancer agent, which is expected 

to include over 40,000 patients, 

investigating Avastin’s use in many 

tumour types including colorectal, 

breast, lung, pancreatic, ovarian, renal 

and many other kinds of cancer (→oncology).

Bacteria. Ubiquitous single-cell microorganisms. 

Some bacteria are pathogens, 

causing diseases that can be 

treated with antibiotics and other 

→antimicrobials. Far from being 

harmful, most bacteria are actually 

Salmonella typhimurium. 

Streptococcus pyogenes. 

Klebsiella pneumoniae. 


B 

Barell, Emil Christoph 

indispensable to plant and animal life. 

Bacteria and other single-cell organisms 

are responsible for a vast range of 

natural processes such as humus formation 

and the breakdown of organic 

wastes in sewage. The human body 

also harbours bacteria as permanent 

residents, notably the coli bacteria 

(Escherichia coli) which are part of the 

normal intestinal flora. 

In →biotechnology, naturally occurring 

bacterial strains are used for 

fermentation, a centuries-old technique. 

High-performance strains produced 

by continuous selection are 

used in today’s biotechnological production 

processes. Bacteria with special 

properties can also be produced 

by genetic recombination for use in 

biotechnology and →genetic engineering. 

Escherichia coli K12 is frequently 

employed for such applications. This 

non-pathogenic strain of E. coli resulted 

from spontaneous mutation in 

the laboratory and is scarcely viable in 

nature. 

Barell, Emil Christoph (1874–1953). 

Chemist, member of the →Board of 

Directors, chairman and delegate of 

the Board and an instrumental figure 

in Roche’s expansion into an international 

company. Barell was born and 

raised in the canton of Schaffhausen, 

of which he later became a citizen. His 

father was from Gressoney-Saint-Jean 

in Piedmont, Italy; his mother was 

Swiss. 

He earned his PhD in chemistry in 

Bern. In 1896 he joined Roche, becom- 

23

ing Fritz →Hoffmann’s right-hand 

man. World War I and the upheavals in 

revolutionary and post-revolutionary 

Russia dealt a serious blow to the company’s 

fortunes, and as Hoffmann’s 

health failed, Barell assumed responsibility 

for managing Roche. In the early 

1920s he reorganised the company 

with almost draconian harshness, 

stamping his own highly personal style 

on its organisational structure and way 

of doing business. 

Barell had actually joined Roche as 

a plant chemist, but quickly expanded 

his duties while the fledgling company 

was still relatively small. As the chemist 

responsible for supervising production 

he insisted on scrupulous cost 

accounting for every stage of manufacture. 

It was Barell who enlisted the first 

chemical and medical researchers, 

many of whom collaborated with 

Roche as external consultants. He was 

24 

Barell, Emil Christoph 

Emil Christoph Barell, 1874 –1953. 

unequalled in his mastery of product 

promotion and medical communications 

– activities vital to the branded 

pharmaceuticals business – and as a 

born financier he was the company’s 

undisputed head. The anecdotes about 

Barell’s frugalness are legion. Realising 

that people, not rules, are the main 

thing, he was his own personnel manager. 

Roche’s international expansion 

after the First World War was due 

mainly to Barell. He also saw to it that 

buildings and production facilities 

were built in a unified style. →Architecture 

fascinated him as an expression 

of the human creative impulse. 

Barell was elected to the Board of 

Directors in 1933, and in 1939 became 

chairman and delegate of the Board. At 

the outbreak of World War II, when it 

looked as if headquarters was about to 

be cut off from its affiliates and offices 

abroad, Barell decided to move to 

→Nutley with a small staff and manage 

the Group from there. At the end of the 

war he immediately returned to Basel, 

assuming control of the →parent company 

and the entire Group. He was 

now over 70 years old; and when he fell 

ill in 1952, it was clear that the Barell 

era, which had shaped Roche so profoundly, 

was drawing to a close. “It is a 

fortunate man”, he remarked in one of 

his last interviews, “who can spend his 

whole working life with the same employer. 

Some never find the right job, 

others have to change jobs. I’m thankful 

for the privilege of having been able 

to work for the same company for 

nearly 57 years.”

Basel. →Parent company. 

Basic research. Research whose goal 

is an understanding of the causes and 

effects of fundamental natural phenomena. 

The boundaries between 

basic and applied research are fluid. 

Often a very simple distinction is 

drawn: the scientific work done by academia 

is basic research; what industry 

does is applied research. But matters 

are not quite that simple. 

Time and again industrial researchers 

encounter the limitations of 

current scientific knowledge and find 

that they must therefore tackle fundamental 

problems. Such work is then 

usually undertaken in collaboration 

with research groups at universities, 

independent institutes or biotech companies 

(→Nobel Prize, →research). 

Basilisk. Greek for little king. Originally 

a legendary serpent reputed to be 

able to kill by its mere look; ancient 

references to it include a passage in the 

Bible (Isaiah 59:5). The name is also 

applied to a tropical American lizard. 

Probably because of its similar sounding 

name, the basilisk was adopted as 

the symbol of Basel. It is usually depicted 

as the shield bearer of the Basel 


Benzodiazepines 

coat of arms. For this reason it formed 

part of the first Roche brand mark 

(→trademarks), representing pharmacy’s 

deep roots in Basel. 

Benzodiazepines. →Psychotropic 

drugs characterised by anxiety-relieving, 

sedative/sleep-inducing, anticonvulsant 

and muscle-relaxant effects. 

They are accordingly indicated for 

the treatment of anxiety disorders, 

sleep disturbances (→hypnotics) and 

epileptic seizures. Benzodiazepines are 

indispensable in anesthesiology and 

intensive care medicine, where they 

are used as premedication before general 

anesthesia and as sedatives in the 

intensive care unit and before procedures 

performed under local or regional 

anesthesia. 

Development of the benzodiazepines 

was pioneered in the 1950s by 

chemist Leo H. →Sternbach and pharmacologist 

Lowell Randall, working at 

Roche in Nutley. The world’s first 

commercially available drug of this 

class, Librium, was launched by Roche 

in 1960, followed in 1963 by Valium 

Roche. These two products marked a 

watershed in Roche’s history and 

sparked intense efforts (both at Roche 

and in other companies) to explain 

how the benzodiazepines work. One of 

the high points of this research was the 

discovery of the benzodiazepine receptor 

in certain regions of the brain. 

Two further benzodiazepine preparations, 

Lexotan for anxiety and Rivotril 

for epilepsy, were launched on the 

market in 1973. Rivotril subsequently 

25

Biologics 

came to be used to treat anxiety as 

well. Of the many benzodiazepines 

that have since been developed and 

marketed, the benzodiazepine receptor 

→antagonist Anexate deserves special 

mention. This compound binds 

to benzodiazepine receptors without 

stimulating them. As a result, the effects 

of benzodiazepine →agonists are attenuated 

or completely reversed. Anexate 

is used in anesthesiology to terminate 

general anesthesia and in intensive 

care medicine for the management of 

benzodiazepine overdose. 

Biologics. Biologics, or biopharmaceuticals 

are much more complex than 

the chemically clearly defined small 

→molecules that still make up the 

majority of medicines. Biologics can 

be →proteins (especially antibodies), 

→DNA or →RNA and are derived 

from living material using biotechnological 

processes. 

Biology. Science of the structure and 

function of living organisms. The main 

traditional subdisciplines are zoology, 

botany and anthropology. Today, interest 

centres on →molecular biology, 

with the allied fields of →genetic engineering 

and genomics, and on immunology, 

neurology (the study of the 

nervous system) and biochemistry. 

Biomarkers. Biomarkers are measurable 

biological indicators that can be 

used to evaluate normal biologic 

and/or disease processes or responses 

to a drug or treatment. This broad def- 

26 

inition includes all diagnostic →tests, 

imaging technologies and any other 

objective measure of a person’s health 

status. Thus, biomarkers are not new, 

but because we have a large number of 

new tools such as →proteomics and 

→genomics, we are discovering more 

novel markers that may have greater 

applicability to improving drug development 

and healthcare. The goals of 

biomarker researchers are many, including 

identifying biomarkers that 

can provide a more precise definition 

of disease, risk and clearer prognoses, 

and also serve as useful indicators of 

a drug’s activity, efficacy, and safety. 

Efforts are also underway to find 

markers that can aid drug development. 

Playing a key role in many areas 

of human healthcare, biomarkers have 

been around since scientists began to 

evolve an understanding of human 

biology, diseases and therapeutic interventions. 

BioS. Biotech services facility at Roche 

Basel. In this fermentation plant, proteins 

for preclinical research and development 

are manufactured using 

genetically modified microorganisms 

and animal and human cell cultures. 

The BioS is also used to develop and 

optimise fermentation processes for 

the manufacture of therapeutic proteins 

(e. g. antibodies). The scientists 

at the BioS work closely with their 

colleagues from other Roche departments 

(particularly in →Penzberg) and 

maintain contacts with universities 

and industrial partners worldwide.

The BioS is equipped with a total of 

27 fermenters, with capacities ranging 

from 2 to 1,400 litres. These fermenters 

contain microorganisms or 

cell cultures that produce the proteins 

in either the cells or culture medium. 

The proteins are then purified in biochemical 

laboratories and used in the 

search for new drugs or even as potential 

new drugs themselves. 

Biosafety. Term used to refer to the 

safe handling of biological agents such 

as microorganisms (particularly genetically 

modified microorganisms) 

and of animals, blood, blood components 

and other human and animal 

body fluids. The goals of biosafety are 

to ensure occupational safety by protecting 

staff from accidents and disease, 

and environmental safety, by 

preventing the release of potentially 

hazardous biological materials into 

the environment. These goals are 

achieved through a combination of 

physical and biological containment 

measures and protective measures for 

staff. Biological containment measures 

include the use of non-pathogenic microorganisms 

or those with the lowest 

risk potential and the culturing of 

microorganisms with hazard-reducing 

properties such as a dependency on 

certain culture media or specific conditions 

of temperature and humidity. 

Molecular biological safety measures 

include the deliberate restriction of 

undesirable gene transfers and the 

avoidance of superfluous genetic information 

that is not required for a 


Biosafety 

particular purpose. In many cases, 

staff health can also be improved by 

protective vaccinations. Apart from 

the customised design and construction 

of buildings, laboratories or production 

areas, technical measures include 

the use of laboratory facilities, 

equipment and resources designed to 

prevent the contamination of humans 

with leaked biological material. Microbiological 

safety cabinets and sterilising 

autoclaves are particularly important 

in this respect. Good personal 

hygiene, correct working practices and 

a meticulously observed disinfection 

programme also contribute to employee 

safety. 

Biosafety is governed by a number 

of regulations and standards, including 

national legislation and international 

guidelines and internal Roche 

directives and operating procedures. 

A biological safety officer at each site 

coordinates and monitors compliance 

with all relevant regulations and 

guidelines and represents Roche in its 

dealings with advisory committees 

and regulatory authorities. 

On the basis of guidelines issued by 

the US National Institutes of Health 

and the recommendations promulgated 

by the Organization for Economic 

Cooperation and Development, 

a biosafety system with four 

safety levels has been established 

worldwide. In order to take appropriate 

account of the biological risks, four 

biosafety levels have been assigned to 

the four risk groups (Biosafety Level 

BL 1 “no risk” to BL4 “high risk”). 

27

Biosimilars or follow-on biologics (FOBs) 

Each consists of a set of technical, 

organisational, staff-related, medical 

and biotechnological safety measures. 

Thus, the laboratory and production 

strains of →Escherichia coli, Bacillus 

subtilis and Saccharomyces cerevisiae 

(bakers’ yeast) can be classified as 

“risk-free” under all known criteria, 

provided they are processed in appropriate 

areas (BL1) and in accordance 

with the rules of good microbiological 

practice. The same applies to hamster 

cells, which play a key role in the production 

of monoclonal →antibodies. 

Such cells do not pose any health risk 

to staff member or the environment. 

The regulations for working at biosafety 

level BL2 are more comprehensive, 

requiring the use of safety cabinets 

on the technical side and the 

systematic inactivation of liquid and 

solid waste products. At the staffing 

and organisational level, BL2 requires 

safety training courses, access restrictions 

and certain safe working procedures. 

These measures substantially 

reduce the release of microorganisms 

and enable laboratory staff to work 

safely even with pathogens that can 

trigger treatable human diseases, e.g. 

salmonella infections. The very strict 

BL3 and BL4 safety levels require complex 

technical facilities. Air filters, 

air-locks, and negative-pressure work 

areas used in combination with regulated 

working procedures, ensure that 

dangerous materials are hermetically 

sealed off from the outside world. All 

pathogenic or otherwise dangerous 

organisms (→viruses, →bacteria, fungi, 

28 

etc.), can be handled at this biosafety 

level without jeopardising the public 

or the environment. Such operations 

are required only when serious diseases 

such as AIDS, caused by the 

HI virus (risk group 3), need to be 

researched. 

Biosimilars or follow-on biologics 

(FOBs). A biosimilar is a new biological 

medicinal product claimed to be 

“similar” to a reference medicinal 

product which is submitted for marketing 

approval by an independent 

applicant after the patent for the originator 

product has expired. 

While it is relatively easy to copy 

small chemical molecules, it is more of 

a challenge to copy biological products 

because the manufacturing processes, 

which involve living cells, are extremely 

complex and difficult to 

reproduce. For this reason these second-wave 

products or “second-entry 

biologics” cannot be classified as 

generics, and the term “biogeneric” is 

inappropriate because the testing 

required to develop these products is 

more demanding than that for a traditional 

generic for which the regulatory 

authorities in Europe and the United 

States will accept a limited set of 

data. For this reason, these authorities 

are naming them “similar biological 

medicinal products” or “biosimilars” 

(Europe), and “follow-on biologics/ 

proteins” (USA). Roche’s position is 

that second-entry biologics should 

adhere to and meet the same rigorous 

preclinical, clinical, and quality stan-

dards as innovative originator products, 

and be submitted to the same 

strict post-marketing surveillance 

(pharmacovigilance). In addition, 

biosimilars/FOBs should not be interchangeable 

with originator products 

and should have distinct naming and 

labelling requirements (INN) to make 

them individually identifiable. 

Since the first innovative biological 

products (e.g. proteins, antibodies) are 

already going off patent, a second wave 

of products claimed by the manufacturers 

to be similar to an innovative 

product could appear on the market in 

the near future. 

Biotechnology. The use of microorganisms, 

cell cultures, tissue cultures 

or parts thereof for manufacturing 

purposes. In its most common form 

it involves using the metabolism of 

microorganisms to obtain products 

that it would be extremely difficult 

or impossible to synthesise chemically. 

Biotechnological processes (or bioprocesses) 

were used long before anyone 

was aware that microorganisms 

existed. Beer, cheese and yoghurt, 

for example, are just as much biotechnology 

products as a genetically engineered 

→interferon. Biological wastewater 

treatment is another example of 

a large-scale bioprocess. 

Traditional biotechnology is based 

on the use of common non-pathogenic 

microorganisms, primarily to promote 

fermentation (e.g. the conversion of 

sugar to alcohol). The range of potential 

applications was expanded dra- 


Blood cells 

matically by →genetic engineering. 

Genetic engineering is a branch of 

modern biotechnology which makes it 

possible to “programme” microorganisms 

to perform specific tasks by 

inserting the appropriate genetic information 

into their →DNA. Thus virtually 

any →protein, regardless of its 

origin, can be produced by microorganisms 

or cell cultures, provided 

its genetic blueprint (the gene coding 

for the protein) is known. 

Roche uses genetically modified microorganisms 

or cell cultures to produce 

various proteins for research purposes, 

for diagnostic tools (antibodies) 

and to manufacture drugs including 

Pegasys, Herceptin, MabThera/Rituxan 

and →NeoRecormon (→production, 

biotechnological). Furthermore, Roche 

sources biotechnologically manufactured 

intermediates for the antibiotic 

→Rocephin and the immunosuppressant 

→CellCept from toll manufacturers. 

Biotransformation. Chemical conversion 

of a substance by microorganisms 

or →enzymes. 

Blood cells. Collective term for the 

cells circulating in the blood: leukocytes, 

erythrocytes and platelets. The 

erythrocytes, or red blood cells, are 

responsible for oxygen transport, the 

platelets for blood clotting. Blood 

clotting disorders may take the form of 

persistent bleeding in newborn infants 

or following surgery or difficult births 

when certain coagulation factors are 

29

Blood-screening 

temporarily inactive or are produced 

in inadequate amounts (e.g. in the 

inherited disease hemophilia). A different 

type of clotting disorder occurs 

when platelets form an obstruction in 

the arteries (a thrombus), causing 

thrombosis, embolism or heart attack. 

The leukocytes, or white blood cells, 

are subdivided into →granulocytes, 

→B and →T lymphocytes, macrophages, 

monocytes, natural killer cells 

and dendritic →cells. These are all 

important constituents of the body’s 

→immune system. B lymphocytes produce 

the host of →antibodies present 

in the body, though not without vital 

support from a group of T lymphocytes 

known as helper T cells (→AIDS). 

Abnormalities in the development of 

mature white blood cells cause the various 

forms of leukemia, some of which 

can be treated with →Roferon-A. 

Blood-screening. In blood banks, 

screening for infectious disease agents 

is a vital measure for ensuring blood 

and plasma safety. This type of screening 

focuses on the detection of infectious 

agents that may have eluded 

detection through routine donor 

screening processes. The goal is to keep 

infected units of blood out of the 

supply, and therefore prevent the accidental 

introduction of chronic or 

potentially life-threatening diseases 

such as HIV, hepatitis, or West Nile 

Virus to someone who is already being 

treated for a serious medical condition. 

Because patients receiving transfusions 

are often already very sick, 

30 

their →immune systems are generally 

weaker and more susceptible to new 

infections. 

Published articles in the scientific 

literature suggest that →PCR-based 

NAT (nucleic acid amplification testing) 

can reduce the current window 

for any possible transmission of hepatitis 

C down to 11 days from the current 

70 days for antibody screening. 

Board of Directors. Unlike the boards 

of other major companies, the Roche 

Board of Directors (originally the 

Board of the operating →parent company, 

and since 1989 the Board of 

Roche Holding Ltd [→holding company]) 

has always had relatively few 

members. It has always included members 

of the founding family and 

prominent scientists from the biomedical 

fields, and thus has been characterised 

by a high degree of continuity. 

When Roche was incorporated as a 

limited company in 1919, the then 

president of the Basler Handelsbank, 

Albert Koechlin-Hoffmann (a brotherin-law 

of the founder), was appointed 

chairman of the Board, retaining this 

position until his death in 1927. 

He was succeeded by the lawyer Dr 

A. Wieland-Zahn, followed, in 1940, 

by the then managing director, Dr 

Emil Christoph →Barell. Barell was 

named honorary chairman in 1952. 

Following Barell’s death in 1953, Dr 

Albert Caflisch became chairman, a 

post he held until his untimely death 

in 1965. The chairmanship passed to 

Dr Adolf Walter Jann, who was suc-

ceeded by Fritz Gerber in 1978 as 

Chairman and Chief Executive Officer. 

Gerber stepped down as CEO in 

December 1997, and in April 2001 

resigned as Chairman of the Board. He 

was appointed Honorary Chairman 

and remained a member of the Board 

until 2004. CEO Dr Franz B. Humer 

succeeded Gerber as Chairman of the 

Board. 

Breast cancer. As many as eight to 

nine percent of women will develop 

breast cancer during their lifetime, 

making it the second most common 

cancer in the world. The exact causes 

of breast cancer are not known, but age 

and a family history of breast cancer 

are probably the most important risk 

factors. Breast cancer is not just one 

single disease, so if it is diagnosed, a 

number of tests are performed to determine 

the stage and type of disease. 

Breast cancer is generally classified 

as “early” or “advanced” (metastatic), 

in four stages, depending on tumour 

size and whether the cancer has spread 

beyond the initial site in the breast to 

other parts of the body. Most women 

with breast cancer are diagnosed at an 

early stage, and more than 80 percent 

survive more than five years after diagnosis. 

Advanced (metastatic) breast 

cancer develops when cancer cells 

break away from the breast and settle in 

other parts of the body. Approximately 

50 percent of patients will develop advanced 

(metastatic) breast cancer after 

they have received primary treatment 

for early-stage breast cancer. 


Breast cancer 

There are also several types of breast 

cancer that grow at different rates and 

respond in very different ways to treatment. 

For this reason, malignant tissue 

should always undergo a number of 

tests to determine the type of tumour 

e.g. its estrogen-receptor (ER), or HER2 

(Human Epidermal growth factor 

Receptor 2) status. 

Depending on the type, spread and 

size of the tumour at the time of initial 

diagnosis, it may be appropriate to 

choose a primary systemic therapy 

(neoadjuvant therapy) to reduce the 

size of the tumour before it is surgically 

removed. This approach improves 

the chances of breast-conserving 

surgical treatment and also 

provides valuable information regarding 

the tumour’s sensitivity to the 

medication used, which can guide further 

treatment after surgery. 

Approximately two-thirds of breast 

tumours overexpress a high number 

of estrogen receptors (ER) on the cell 

surface. In these tumours, the female 

hormone estrogen regulates cell 

growth. Breast cancers that are dependent 

on estrogen are called ERpositive. 

Hormonal therapies such as 

tamoxifen or aromatase inhibitors 

block the growth-promoting effects of 

estrogen and can be used as both an 

adjuvant therapy after primary surgery 

or during the advanced (metastatic) 

stages of the disease. 

The human epidermal growth factor 

receptor 2 (HER2) is a protein 

produced by a specific gene with cancer-causing 

potential. HER2 acts as a 

31

Burgdorf 

receptor for growth factors circulating 

in the blood and influences the rate of 

cell growth and differentiation. When 

the gene that provides the code for the 

HER2 protein is amplified, it triggers 

an overproduction, or “overexpression”, 

of HER2. Excess amounts of 

HER2 lead to uncontrolled or malignant 

cell growth, i.e. to the development 

of cancer. In HER2-positive 

breast cancer, increased quantities of 

the HER2 protein are present on the 

surface of the tumour cells. This is 

known as “HER2-positivity”. HER2positive 

breast cancer affects 20 to 30 

percent of women with breast cancer, 

and is a particularly aggressive form of 

the disease that requires special and 

immediate attention because the tumour 

is fast-growing, responds poorly 

to chemotherapy and there is a higher 

likelihood of relapse. 

Biologically engineered →monoclonal 

antibodies offer specific treatment 

options for some breast cancers. 

For the 20 to 30 percent of breast 

tumours that are HER2-positive, for 

example, →Herceptin (trastuzumab), 

is the only approved monoclonal antibody 

therapy that specifically targets 

HER2, inhibiting tumour growth and 

leading to tumour cell death. Every 

woman with breast cancer should be 

tested for HER2 status to determine 

whether she might benefit from Herceptin 

therapy. 

Burgdorf. Location of a Swiss medical 

device supplier that has been a global 

leader in the research and develop- 

32 

ment of insulin pumps for the treatment 

of →diabetes since 1984. Roche 

acquired the Insulin Pumps division of 

Disetronic in 2003 (→insulin pump 

therapy). 

Disetronic’s amalgamation with 

Roche has facilitated a more integrated 

approach to diagnosing, treating and 

monitoring diabetes. For Roche, the 

acquisition of Disetronic has further 

strengthened its position in diabetes 

management (→Diabetes Care). 

B lymphocytes. White blood cells that 

carry membrane-bound →antibody 

molecules on the cell surface. The 

specificity of the membrane-bound 

antibody enables the →immune system 

to recognise defined →antigens. 

Depletion of B lymphocytes has 

proved to be a successful treatment 

strategy for non-Hodgkin’s lymphoma 

and autoimmune rheumatoid arthritis, 

as →Genentech’s biotherapeutic 

Rituxan (MabThera) has shown.


C 

Cardiology. Study of the heart and 

heart disease, including the diagnosis 

and treatment of cardiovascular disease. 

Cardiology is one of the key 

research areas in modern medicine 

(→cardiovascular). 

Cardiovascular. Pertaining to the 

heart and blood vessels (cardiovascular 

system). Since over 40 percent of 

the population in the industrialised 

world die of cardiovascular disease, 

usually as a consequence of high blood 

pressure (hypertension), it constitutes 

one of the key areas of pharmaceutical 

research. The →ACE inhibitor Inhibace, 

the beta-blocker Dilatrend and 

the diuretic Torem are important 

contributions by Roche to the medical 

treatment of hypertension. Activase, 

the first genetically engineered 

(→biotechnology, →production, biotechnological) 

tissue plasminogen 

activator – a drug that dissolves blood 

clots after a heart attack – was launched 

in the United States by →Genentech. 

→Chugai markets the antianginal 

agent Sigmart. In diagnostics, Roche is 

pushing ahead with projects linking 

treatment and diagnosis for the ultimate 

benefit of patients. Thus, for 

example, the innovative heart test 

Elecsys proBNP is used in the diagnosis 

of early forms of heart failure by 

measuring the concentration of the 

protein NT-proBNP in the blood. 

Since the NT-proBNP level rises in line 

with the severity of the condition, the 

CellCept 

test helps doctors decide on the treatment 

and evaluate the prognosis of 

heart failure patients. 

Therapeutic monitoring with Elecsys 

proBNP can help reduce the number 

of hospital referrals and fatalities 

of cardiac origin. 

CellCept (mycophenolate mofetil, 

MMF, →biotechnology). Immunosuppressant 

acquired by Roche in the 

Syntex acquisition of 1994. It was 

developed in Palo Alto and was being 

reviewed by the health authorities (to 

decide whether to grant a marketing 

licence) at the time of the takeover. 

Global approval of the product from 

1995 on marked Roche’s entry into 

the field of →organ transplantation, a 

new segment for the company. Cell- 

Cept is used to prevent acute kidney 

transplant rejection. In the United 

States and Europe it is also approved 

for use after heart and liver transplantation. 

CellCept possesses a novel mechanism 

of action. The results of largescale 

international clinical →trials had 

previously shown that, compared with 

placebo or azathioprine, a drug frequently 

used in transplant patients, 

MMF reduces the incidence of kidney 

rejection by around 50 percent. Cell- 

Cept has the additional advantage of 

low chronic toxicity. Furthermore, 

when CellCept is used, dosages of 

other immunosuppressants, whose 

side effects include kidney damage, 

hypertension and hepato- and neurotoxicity, 

can be reduced. 

33

Cell, human 

In October 2003 Aspreva Pharmaceuticals 

and Roche announced a 

unique collaboration that represents a 

new partnership model for the pharmaceutical 

industry. Under the terms 

of the deal Aspreva Pharmaceuticals 

acquired exclusive worldwide rights 

to develop and market CellCept in 

all autoimmune disease applications, 

such as psoriasis and lupus nephritis. 

Cell, human. Every individual is made 

up of the almost inconceivable number 

of 100 trillion cells. Excluding the 

red →blood cells, the →cell nucleus of 

each of these cells contains a complete 

human →genome (a person’s genetic 

blueprint). This information is encoded 

in some 3 billion nucleobases, 

the building blocks of the genetic 

material →DNA. 

Cell nucleus. A person’s genetic material, 

or →DNA, is packed into 23 pairs 

of →chromosomes contained in the 

nucleus of each cell. One chromosome 

in each pair is derived from the person’s 

mother, the other from the father. 

Cells, dendritic. White blood cells 

that play a key sentinel role in the 

→immune system: dendritic cells 

migrate to all mucosal tissues and the 

skin in order to recognise and take up 

→antigens of foreign invaders through 

macro-pinocytosis and phagocytosis 

for presentation as antigenic peptide 

fragments on the cell surface. In contrast 

to →macrophages, dendritic cells 

function as antigen-presenting cells that 

34 

initiate cellular immune responses by 

triggering activation of →T lymphocytes. 

Cephalosporins. A group of antibiotics 

that are chemically related 

to the penicillins. One example is 

→Rocephin. 

C.E.R.A. Stands for Continuous 

Erythropoietin Receptor Activator. 

C.E.R.A. is the first of a new class of 

agents that could represent significant 

progress in →anemia management. 

The preparation has a unique mode of 

action. Traditional short-acting erythropoietin-stimulating 

agents (ESAs) 

are quickly internalised and degraded 

after binding to the receptors involved 

in stimulating red blood cell production. 

Unlike traditional ESAs, C.E.R.A. 

has a greatly reduced affinity for the 

receptors, allowing it to stimulate red 

cell production without immediate 

internalisation and degradation. This 

distinct molecular interaction is believed 

to play a role in providing targeted, 

stable and sustained control of 

anemia. 

Its brand name Mircera has been 

approved by European health authorities 

(→EMEA). In April 2006, on the 

basis of this approval and additional 

data, Roche submitted licensing applications 

to the regulatory authorities in 

the United States and the European 

Union for the treatment of anemia in 

chronic →kidney disease, including 

dialysis patients.

Chemotherapeutic agents. Active 

pharmaceutical ingredients produced 

by chemical synthesis for the treatment 

of disease, as opposed to active ingredients 

of natural origin obtained entirely 

by physical methods (extraction) 

or by fermentation or using biotechnology 

or recombinant DNA techniques. 

Child-proof drug containers. Medicines 

should always be kept out of 

reach of children. However, despite 

printed warnings and educational 

campaigns this rule is often ignored. 

Because of this, the packaging of medicines, 

particularly of those that pose 

special risks, is designed to be childproof, 

as far as possible. Blister packs 

have proved effective for tablets of various 

types and give quite good protection 

for babies and toddlers. Special 

safety caps that can be opened only by 

a combination of movements (simultaneous 

pushing and twisting, for example) 

are used on plastic bottles. 

However, this is just the sort of thing 

that playful, inquisitive children can 

find particularly attractive. Packaging 

technology is constantly faced with 

two conflicting requirements: →medicines 

should be inaccessible to children 

but easily accessible to disabled 

or elderly patients. This means that 

compromises are inevitable. Keeping 

medicines out of children’s reach is 

still the best solution. 

CHMP. Abbreviation for the (European) 

Committee for Human Medicinal 

Products in London, which in- 


Chromosomes 

creasingly plays a leading role in the 

approval (→registration) of new drugs 

and drug monitoring in the EU countries 

(→EMEA). 

Cholesterol. A natural steroid belonging 

to the group of sterins (sterols) 

classed as lipids (“fats”). Mention the 

word “cholesterol” and most people 

immediately think of something harmful 

– something that is bad for the 

heart and circulation. Less well known 

is the fact that cholesterol is a very 

important and essential component of 

our diet, a vital constituent of all animal 

cell membranes, and that without 

cholesterol the body would not be able 

to produce any bile acid or vitamin D, 

for example. Nevertheless, an elevated 

cholesterol level is certainly harmful, 

representing one of the principal risk 

factors for atherosclerosis (a disease 

affecting large and medium-sized 

arteries) and coronary heart disease. 

These conditions occur when excess 

cholesterol is deposited and calcifies 

in the vessel walls. For this reason, an 

accurate measurement of cholesterol 

levels is an essential part of a patient’s 

risk assessment. 

Chromosomes. Rod- or hook-shaped 

structures comprised of →proteins 

and →DNA that carry a cell’s genetic 

information (→cell, human). In the 

cells of higher plants and animals and 

in man, chromosomes are always 

arranged in pairs. Humans have 23 

chromosome pairs. The genetic information 

is determined by the arrange- 

35

36 

Chromosomes 

Chromosome 01 

Prostate cancer 

Alzheimer’s 

Chromosome 04 

Huntington’s 

chorea 

Chromosome 07 

Obesity 

Cystic fibrosis 

Juvenile 

diabetes 

Chromosome 10 

Refsum disease 

Gyrate atrophy 

Chromosome 02 

Bowel cancer 

Essential 

tremor 

Chromosome 05 

Asthma 

Cockayne 

syndrome 

Hair loss 

Chromosome 08 

Werner’s 

syndrome 

Burkitt’s 

lymphoma 

Chromosome 11 

Juvenile 

diabetes 

Various types 

of cancer 

Long qt 

syndrome 

Chromosome 03 

Lung cancer 

Bowel cancer 

Essential 

tremor 

Chromosome 06 

Juvenile 

diabetes 

Epilepsy 

Chromosome 09 

Chronic 

myeloid 

leukemia 

Malignant 

melanoma 

Chromosome 12 

Phenylketonuria


Chromosome 13 

Breast cancer 

Retinoblastoma 

Chromosome 16 

Crohn’s disease 

Chromosome 19 

Arteriosclerosis 

Myotonic 

dystrophy 

Chromosome 22 

Di-George- 

Syndrome 

Chronic myeloid 

leukemia 

Neurofibromatosis 

type 2 

Chromosome 14 

Alzheimer’s 

Chromosome 17 

Breast cancer 

Various types 

of cancer 

Chromosome 20 

Severe 

combined 

immunodeficiency 

Chromosome XY 

Duchenne 

muscular 

dystrophy 

Fragile x 

syndrome 

Severe 

immunodeficiency 

Testis 

determining 

factor 

Chromosomes 

Chromosome 15 

Marfan 

syndrome 

Prader-Willi 

syndrome 

Chromosome 18 

Pancreatic 

cancer 

Bowel cancer 

Chromosome 21 

Trisomy 21 

Amyotrophic 

lateral 

sclerosis 

Alzheimer’s 

The diagramme shows a 

small selection of hereditary 

disorders which 

have been linked to specific 

chromosomes. 

37

Chugai 

ment of the base pairs (→gene “building 

blocks”) on the DNA double helix. 

In humans the full chromosome set is 

made up of roughly 6 billion base 

pairs. (See diagramme on pages 36 and 

37.) 

Chugai. Leading research-based 

pharmaceutical firm in which Roche 

acquired a majority stake at the end 

of 2002, creating the fourth-largest 

pharmaceutical company in Japan. 

Chugai focuses its activities primarily 

on bioengineered products and the 

therapeutic areas of oncology, renal 

disorders, bone and joint disorders, 

cardiovascular disease, transplantation, 

infectious diseases and immune 

disorders. The company has development 

sites in the United States and 

Europe and sales and marketing organisations 

in France, Germany and 

Great Britain. Worldwide, Chugai 

employed approximately 5500 people 

at the end of 2005. Its key products 

include Epogin (drug for treating 

anemia in chronic renal insufficiency), 

Alfarol (for osteoporosis), Neutrogin 

(for the treatment of chemotherapyinduced 

neutropenia) and Sigmart 

(antianginal agent). 

At the start of 2003 Roche and 

Chugai announced their intention to 

jointly develop and market MRA, 

Chugai’s innovative biopharmaceutical 

drug for the treatment of rheumatoid 

→arthritis. 

Clinical chemistry. In diagnostics, 

the application of qualitative and/or 

38 

quantitative analytical methods to 

determine the constituents of body 

fluids. Among other things, this includes 

tests for →enzymes, substrates, 

electrolytes or specific →proteins, 

which may be performed before treatment 

is started or to monitor its 

effects. The techniques used include 

enzymatic assays, measurements with 

ion-selective electrodes, photometric, 

turbidimetric or potentiometric techniques. 

The →Diagnostics Division offers 

a comprehensive range of clinical 

chemistry reagents and →analytical 

systems that enable automated sample 

processing in the clinical laboratory. 

Clinical Research Ethics Advisory 

Group (CREAG). As well as providing 

input in specific instances, the CREAG 

keeps Roche updated on ethical issues 

from the wider health arena and acts 

as a sounding board by regularly participating 

in periodic ethics discussions 

with Roche. In addition, the CREAG 

will also monitor Roche’s posting of 

trials on www.Roche-Trials.com to 

ensure that information on the website 

always accurately reflects the Roche 

Policy on Transparency in Clinical 

Trials. 

Clone. A group of genetically identical 

cells derived by repeated division from 

a single parent. Cells are called polyclonal 

if they are derived from more 

than one clone and are therefore genetically 

different. Monoclonal cells or 

microorganisms are identical copies of 

a single parent cell or organism.

Coagulation self-monitoring. Longterm 

anticoagulant treatment is a 

strain for many patients, and the frequent 

venepunctures needed to monitor 

variations in clotting time add to 

this burden. Since 1993 there has been 

CoaguChek S – a simple, convenient 

and reliable system for coagulation 

self-monitoring. 

an easier way for patients to check 

their clotting time – CoaguChek, 

which was replaced by the CoaguChek 

XS system in 2005. Based on a dry 

chemical method with only a few 

steps, this system enabled patients to 

check their prothrombin time (clotting 

time) in an even simpler, safer and 

more precise procedure taking just one 

minute. The CoaguChek systems are 

the most frequently used patient selfmonitoring 

systems, offering rapid, 

accurate and almost painless, minimally 

invasive measurement of prothrombin 

time. 

Cobas. All the products and services 

of the →Diagnostics Division’s →Professional 

Diagnostics business area 


Cobas 

destined for the professional diagnostics 

user. The cobas brand embodies 

outstanding product quality and reliability. 

The division has accumulated several 

years’ experience with modular 

systems. In 2002 the division introduced 

the first integrated modular laboratory 

system for →clinical chemistry 

and immunochemistry, the Modular 

Analytics SWA (serum work area) for 

laboratories with a high workload. 

The cobas 6000 product range introduced 

in June 2006 represented the 

first in a new generation of systems 

(cobas modular platform) for laboratories 

with a medium-sized workload. 

Additional systems for laboratories 

with low and high workloads are to 

follow. 

With five modules that can be combined 

to create customised solutions, 

two reagent carriers and appropriate 

software, the cobas modular platform 

can handle over 150 analytes. These include 

more than 90 assays for clinical 

chemistry, for example electrolytes or 

serum proteins, homogeneous →immunoassays 

for drug doping tests and 

therapeutic monitoring, and over 40 

heterogeneous immunoassays for thyroid, 

hormone, tumour and cardiac 

diagnostics and other applications. 

The cobas e pack and cobas c pack 

reagent carriers are used for these 

assays. Users of Cobas Integra will 

be familiar with these easy-to-handle 

packs, which require no reagent preparation 

and remain stable for a long 

time once on board the system. 

39

Communication, employee 

The concept inherent in the cobas 

modular platform ensures flexibility, 

speed and cost-effective working. 

Additional components such as preanalysis 

systems, IT tools and innovative 

new markers can also be used 

to assemble a complete laboratory 

solution. 

The cobas 6000 product range is a 

compact, efficient →analytical system 

that has been optimised specifically for 

medium-sized laboratories and their 

need to cover a wide variety of parameters. 

This new equipment generation 

builds on the strengths of the existing 

serum work area concepts and gives 

Roche customers versatility in meeting 

the growing needs of the laboratory. 

From a single analytical module to a 

complete unit for clinical chemistry 

and immunology, the cobas 6000 

product range covers over 95% of the 

daily routine, producing significant 

gains in laboratory diagnosis – increased 

flexibility, increased safety, 

increased efficiency and increased 

convenience. The proven modular 

equipment concept offers an exceptionally 

broad diagnostic spectrum 

with the maximum of consolidation. 

Communication, employee. Of those 

groups interested in information from 

the company, the employees occupy 

a special position. They must be informed 

at first hand about important 

developments in their work environment. 

Only well informed employees 

can identify fully with their company. 

Moreover, each employee also dissem- 

40 

inates information about the company 

in his or her family and social circles 

and in that way influences the company’s 

standing. 

Basic responsibility for providing 

information to employees rests with 

the managements of the individual 

→divisions and affiliates. They obtain 

the relevant details directly from the 

divisions and functional units concerned. 

Vehicles for information include 

briefing sessions, seminars, newsletters, 

notices, circulars and the company 

intranet. In addition, most affiliates 

also publish in-house periodicals 

for their employees. At Group level the 

most important activities going on 

around the Roche world are reported 

in Hexagon, a newspaper that is published 

quarterly and distributed to all 

employees. 

Communication, financial. A company 

like Roche, whose shares are 

quoted on the stock exchange, has to 

keep the financial world regularly 

informed of its general business situation. 

The main vehicle for financial 

information is the company’s annual 

report, which is supplemented by halfyearly 

and quarterly sales reports distributed 

via internal channels and to 

the public media. In addition, representatives 

of the shareholders or of 

groups interested in acquiring shares 

(financial analysts, representatives of 

banks and institutional investors such 

as pension funds and trusts) are invited 

to regular briefings.

Communication, general. Communication, 

particularly of data, facts and 

intentions. The Group’s information 

policy is defined in the Roche →Corporate 

Principles. Apart from the company’s 

own employees and the general 

public, information is also disseminated 

to specific groups, such as the 

media, government authorities, shareholders, 

financial analysts, political 

groups and local residents living near 

company facilities, along with consumer 

organisations, schools, trade 

unions and churches. 

At Roche headquarters the “raw 

information” is collected by contact 

persons in the individual →divisions 

and operational units, prepared by the 

Corporate Communications department 

in line with the needs of the 

various recipients and then released. 

Group companies have their own 

information departments that are 

adapted to their own particular needs. 

All available information channels are 

employed: media releases, audiovisual 

materials, Internet, Intranet, books 

(Editiones Roche) and other publications, 

personal contacts, media conferences 

and seminars. This reference 

guide is also intended as a source of 

general information. 

Communication, product-related. A 

sophisticated industrial product and 

the information that goes with it form 

an indivisible whole. The product 

cannot be used properly without the 

corresponding information. Productrelated 

information accounts for a sig- 


Competition 

nificant proportion of a company’s 

overall costs, but it is an essential service, 

particularly in the launch phase of 

innovative products. 

In the case of drugs this means the 

pack and the package insert on the one 

hand and the information and promotional 

activities directed at customers 

on the other. For decades the healthcare 

professions held the view that 

product information should be aimed 

exclusively at doctors and pharmacists, 

not at patients. However, it is 

now generally recognised that consumers 

– in other words, patients – 

must be given information that will 

allow them to use a medicine correctly. 

The information and promotional 

material sent to doctors and other 

healthcare professionals independently 

of the product are, of course, of 

a scientific nature. In many countries, 

including Switzerland, pharmaceutical 

manufacturers adhere to self-imposed 

rules concerning the provision of such 

information. The information must be 

accurate, objective, scientifically sound 

and supported by scientific publications. 

Competition. Efficient mechanism for 

coordinating economic activity. Competition 

results in a complex process of 

learning, exploration and discovery; it 

presupposes a large number of competitors 

vying for customers’ business. 

Experience teaches that countries 

with competitive market economies 

are better able to attain standard-ofliving 

targets than economies in which 

41

Copyright 

central planning or regulation predominates. 

Roche is therefore a firm 

believer in competitive markets and 

regards them as essential for the technological 

advances needed to drive 

long-term prosperity. 

Competition is the rule in all 

Roche’s businesses. Whether this is 

really the case in the pharmaceuticals 

sector is often (and unjustly) questioned 

because drug prices are subject 

to official controls in most countries. 

Nevertheless, competition does predominate, 

manifesting itself in three 

distinct forms. In straightforward 

commodity competition (often the 

only type considered), price is the sole 

deciding factor involved in a purchase. 

In imitative competition, buyers and 

sellers also operate with established 

methods and products, but in this 

case the usefulness and quality of the 

products and the standard of service 

– not only the price – play a part in 

decisions to buy. These two forms 

of competition predominate in the 

market for non-patented medications 

and →generics. Finally, innovative 

competition operates through the 

development of new products and by 

solving hitherto unresolved problems, 

thus displacing older products from 

the market. In the research-based 

pharmaceutical industry, this third 

form of competition is extremely intensive. 

The market basically accepts all 

three forms of competition. Government 

authorities, however, tend to 

consider only competition on price, 

42 

thereby impeding the innovative competition 

which is vital to medical 

progress. 

Copyright. There are two basic ideas 

behind copyright laws. First, because 

an author’s work is an expression of 

his personality, he should have a right 

to determine the forms in which it is 

made available to the public and 

whether it must appear with his 

name. And secondly, an author should 

be remunerated for his creative work. 

Only the specific expression of an idea 

is copyrightable, and only a tangible 

embodiment constitutes the work. 

Copyrights need not be registered and 

are usually valid for up to 70 years after 

the author’s death (50 years in the case 

of computer programmes). The degree 

of protection varies from one country 

to another, and cross-border protection 

is governed by international 

agreements. 

Technological advances have opened 

up new ways of utilising copyright 

materials (particularly in films, radio 

and television), as well as previously 

undreamed-of means of reproducing 

and distributing them (radio and television 

broadcasts via satellite, publication 

on the Internet). As a result, copyrights 

are widely and routinely abused, 

sometimes consciously but more often 

not. 

Industry has a powerful interest in 

seeing copyright laws enforced, since 

the works covered include scientific 

publications, computer programmes, 

audio-visual productions and teaching

and learning systems. Owing to the 

uninhibited use of modern techniques 

of recording and reproduction, this 

whole field is now in a state of flux. 

A copyrighted work from 2006, for 

example, should be declared as follows: 

©2006 F. Hoffmann-La Roche Ltd. 

Corporate functions. Name given to 

units based at Group headquarters, 

whose duties are not connected directly 

with Roche products, but involve the 

provision of services for the entire 

Group. Such functions include legal 

affairs, finance and accounting, human 

resources, communications and 

safety, health and environmental protection. 

Roche’s corporate functions 

are analogous to a →division. 

Corporate Governance. A system for 

ensuring open, transparent and responsible 

management and control of a 

company. The Roche Group meets all of 

the requirements with respect to Corporate 

Governance, complying with the 

existing legal regulations, the SWX 

(Swiss stock exchange) directives (including 

their Commentaries) and the 

Swiss Code of Best Practice for Corporate 

Governance as promulgated by the 

Swiss business federation “economiesuisse”. 

The existing internal company 

regulations, in particular the company’s 

Articles of Incorporation and Bylaws, 

consider all the principles that govern 

the management and supervision of 

our company including the necessary 

checks and balances in order to ensure 

good corporate governance. 


Corporate Principles 

Roche is committed to all its stakeholders 

and strives to serve the diverse 

interests of customers, employees, 

shareholders and holders of Roche 

non-voting equity securities in a balanced 

fashion. This commitment is 

reflected in our operating businesses’ 

focus on value creation, in a management 

culture that conforms to modern 

standards of corporate governance 

and in our Group’s policy of communicating 

transparently. 

Detailed information is accessible 

to all stakeholders – shareholders, 

employees, customers, suppliers and 

the general public – on the Internet 

(www.roche.com). 

Corporate Principles. A compilation 

of guidelines, objectives and principles 

defining the way in which the Group 

conducts its business. In a very broad 

sense, these principles can be compared 

to the constitution of a country 

or state, though they are not meant 

to be interpreted (and it would be 

impracticable to interpret them) as 

having legal force. They enable the 

Group’s employees to situate their own 

activities within a broader context. 

Published in eight languages, the 

Roche Corporate Principles, which were 

slightly revised in 2003, set out guidelines 

on the key issues of service to 

patients and customers, respect for the 

individual, commitment to responsibility, 

commitment to performance, 

commitment to society, commitment 

to the environment, commitment to 

innovation and continuous impro- 

43

44 

Counterfeit drugs 

vement. Training courses are held to 

instruct the Group’s employees 

around the world on what the principles 

mean and how to apply them 

in their daily work. 

Counterfeit drugs. Drug products in 

which the active ingredient has been replaced 

by an agent with similar actions. 

The use of such products to treat severe 

illnesses can thus have life-threatening 

consequences. Counterfeit drugs also 

damage people’s trust in the healthcare 

systems. Fraudulent drugs crop up regularly 

in a good many countries, and 

there have even been instances of counterfeit 

Roche products being sold. 

The magnitude of the drug counterfeiting 

problem is difficult to gauge, 

since fraudulent drug products are often 

sold on the black market; in some 

countries they are commonplace. The 

contributing factors are diverse and 

are often related to a country’s economic, 

legislative and political situation. 

Foreign exchange shortages, 

inadequate →patent and →trademark 

protection, lax import controls, haphazard 

distribution networks and, 

not least, corruption all facilitate the 

traffic in counterfeit drugs. 

These illegal activities can only be 

combated in cooperation with the authorities. 

As the health policy aspects 

of the problem generally transcend 

national boundaries, observed cases 

of drug counterfeiting are reported 

to the appropriate departments of the 

→WHO, as well as to the national 

authorities. 

Cultural sponsoring (cultural commitment). 

Roche has been an active 

patron of contemporary art and cultural 

projects since it was founded in 

1896 – a heritage reflecting the influence 

of the founder’s family. This side 

of corporate giving has tended to focus 

most strongly on music, but also includes 

support for the visual arts and 

architecture. Roche sees close affinities 

between innovation in the arts and 

in a research-based company. Roche 

is convinced that the intellectual 

stimulation of contemporary culture 

enriches employees’ daily lives and 

contributes to making Roche an innovative 

company. 

Most Roche employees work in an 

environment where original works of 

contemporary →art are “part of the 

atmosphere”. Distinctive modern 

→architecture in the Bauhaus tradition 

has been one of the hallmarks of 

Roche sites since Otto Salvisberg created 

the first masterplan for Roche 

Basel and defined the architectural 

idiom that still shapes the way Roche 

builds today. The Roche buildings are 

also designed for transparency and 

flexibility, so that they can be adapted 

to changing circumstances without 

compromising their architectural integrity. 

Roche Basel’s new research and 

biotech production buildings, both 

designed by Herzog & de Meuron, 

are recent examples of a responsible 

approach to site development. 

Launched in 2003, Roche Commissions 

regularly awards commissions 

for new musical works by outstanding

contemporary composers. Roche selects 

the composer on the basis of 

recommendations made by the artistic 

directors of the Lucerne Festival, 

Carnegie Hall and the Cleveland 

Orchestra. The commissioned work is 

premiered by the Cleveland Orchestra 

at the Lucerne Festival SOMMER. The 

following season, the same orchestra 

performs it for the first time in the 

United States at Carnegie Hall. Informal 

contacts and discussions between 

the composers and Roche scientists 

form an essential part of the project, 

highlighting the parallels between innovation 

in art and in science and the 

challenge of doing creative work in any 

area. Roche Commissions continues a 

tradition shaped largely by the influence 

of the conductor and arts patron 


Cultural sponsoring (cultural commitment) 

Premiere of the Roche Commissions work by Hanspeter Kyburz. 

Paul Sacher, who represented Roche’s 

founding family on the Roche Board 

for many years. It sums up the essence 

of the Roche innovation model: the 

pursuit of excellence, a willingness to 

engage with the new and the courage 

to take risks. 

These fundamental values are now 

being opened up to more and more 

Roche employees through projects 

such as Roche ’n’ Jazz – a series of 

concerts run in partnership with local 

jazz clubs. In Basel Roche ’n’ Jazz was 

launched in partnership with the 

Basel-based bird’s eye jazz club and 

the Museum Tinguely, each of which is 

an equal stakeholder. As part of this 

project the Museum Tinguely will be 

hosting laid-back, but musically highclass, 

jazz concerts featuring first-rate 

45

Cystic fibrosis (CF) 

performers from Switzerland and 

abroad. 

To mark its centenary in 1996, 

Roche donated to its home city of 

Basel the Museum Tinguely, a museum 

featuring the work of the Swiss sculptor 

Jean →Tinguely (1925–1991). The 

museum, designed by the famous 

Swiss architect Mario Botta, is located 

close to Roche headquarters in Basel’s 

historic Solitude Park, overlooking the 

Rhine river. The museum’s permanent 

collection includes mechanical sculptures, 

reliefs and drawings from all 

periods of Tinguely’s career. The museum 

also offers a varied and lively 

programme of special exhibitions exploring 

Tinguely’s relationship with 

artists of his own and earlier generations 

(from Marcel Duchamp and Kurt 

Schwitters to Niki de Saint Phalle and 

Yves Klein) and themes of particular 

relevance to Tinguely’s work (e.g. contemporary 

kinetic art). 

Cystic fibrosis (CF). The commonest 

inherited disease in many European 

countries and the United States, 

caused by a mutated gene on →chromosome 

7. This gene often displays 

several →mutations. The result is an 

abnormal →protein in the pancreas, 

the glands lining the airways and lungs 

and in the sweat glands, causing thickening 

of pancreatic secretions and the 

mucus secreted in the lungs because of 

lack of fluid. CF patients suffer from 

respiratory tract infections because 

the sticky mucus which they are unable 

to clear from their airways is a 

46 

good breeding ground for bacteria. 

This leads to the destruction of tissue 

and progressive impairment of respiratory 

functions. Consequently, most 

CF sufferers have a life expectancy of 

no more than 30–40 years. 

The →DNA of dead bacteria and 

phagocytes makes the mucus in the 

lungs viscous. The genetically engineered 

drug Pulmozyme, which contains 

the enzyme DNase as its active 

ingredient, reduces mucus viscosity 

and improves airway clearance. Inhaled 

as an aerosol spray, Pulmozyme 

was discovered by →Genentech and 

codeveloped in Europe by Roche. 

Roche also markets the product in 

Europe. 

Cytokines. Hormone-like →proteins 

which, even in minute concentrations, 

mediate and regulate interactions between 

different cells, creating an intercellular 

communications network. As 

a rule, cytokines are synthesised only 

in activated cells as a reaction to an external 

signal (often another cytokine) 

and are released into the extracellular 

environment. They then bind to cytokine-specific 

receptors on the surface 

of target cells, where they trigger 

biochemical signals. Many cytokines, 

such as →interferons, interleukins and 

colony-stimulating factors, influence 

the cells of the hematopoietic and 

→immune systems. Four cytokine 

families exist: hematopoietins, →interferons, 

chemokines, and tumour 

necrosis factors.

Cytostatic agent. Natural or synthetic 

substance that inhibits the 

growth of cells. Cytostatic agents are 

used mainly for cancer chemotherapy 

(→oncology). 


Cytostatic agent 

47

48 

Derivative 

D 

Derivative. A compound with modified 

properties derived from a basic 

chemical structure. 

Diabetes. Disease in which the body 

is unable to produce insulin or cannot 

properly utilise the insulin it produces. 

It is characterised by high blood glucose 

levels and affects approximately 

1–5 percent of the world population. 

Diabetes can be dangerous not only 

because of the short-term problems it 

causes, but also, and more particularly, 

because of the long-term damage that 

can occur in the course of the disease. 

Patients with this chronic, lifelong 

disease have above all to learn how best 

to live with it and how to prevent its 

Accu-Chek Compact Plus: Blood glucose 

measuring system with integrated 

lancing device and test strip drum. An 

ideal device for use away from home. 

late complications. →Glucose selfmonitoring 

is important here. The 

→Diagnostics Division’s →Diabetes 

Care business area supplies a wide 

range of products and services for 

treating and monitoring diabetes. 

Diabetes Care. Business area in the 

→Diagnostics Division. Its aims are 

not only to improve the quality of life 

of people with →diabetes by offering 

them innovative products (e.g. Accu- 

Chek Aviva and Compact Plus glucose 

meters, Accu-Chek Multiclix lancing 

device, Accu-Chek Pocket Compass 

and Accu-Chek SmartPix data management 

systems, Accu-Chek Spirit 

insulin pump and the Accu-Chek 

FlexLink infusion set), services and information, 

but also to make the disease 

manageable in the long term and 

thereby reduce the overall economic 

cost of →diabetes and its complications. 

In early 2003 Roche submitted a 

tender offer to Disetronic (→Burgdorf) 

for its Insulin Pumps division. 

Bringing these two businesses together 

will make Roche a pioneering leader 

in systems combining blood glucose 

monitoring and insulin delivery. This 

is the ideal way to link diagnosis and 

therapy for people with diabetes. 

Diagnostics Division. Global leader 

in the diagnostics market. Formed in 

1969, the division offers a unique 

range of innovative tests and services 

for researchers, doctors, patients, 

hospitals and laboratories worldwide.

The division now consists of the 

following business areas: →Applied 

Science, →Molecular Diagnostics, 

→Professional Diagnostics and →Diabetes 

Care. 

The Applied Science business area 

develops and markets components 

and reagents for life science research, 

focusing on genome research and 

proteomics, for the pharmaceutical 

and diagnostics industry and for food 

monitoring. Molecular Diagnostics has 

made the →polymerase chain reaction 

(PCR) into a world-leading technique 

for DNA tests. This business 

area specialises in the development 

and marketing of six unique PCR 

applications: women’s health, virology, 

blood banks, microbiology, oncology 

and genomics. Professional 

Diagnostics is a leading developer and 

supplier of new technologies and integrated 

solutions that help to maximise 

the efficiency and cost-effectiveness of 

clinical laboratories. The business area 

also supplies products and systems for 

near-patient diagnosis in hospitals and 

outpatient facilities. As a market leader 

in the field of diabetes management, 

Diabetes Care focuses on the development 

of novel technologies and services 

that make life easier for people 

with diabetes and which it markets 

under the Accu-Chek brand name. 

Efforts to develop innovative products 

are supported by research centres in 

Switzerland, Germany, Austria and the 

United States. The division responds 

directly to customer needs by providing 

special programmes. Many chronic 


Diagnostics research 

diseases can already now be treated 

more selectively through a targeted 

combination of diagnosis and treatment. 

Using the latest technologies 

(e.g. the →AmpliChip), Roche is developing 

innovative molecular diagnostic 

tests. This technological advance will 

also benefit patients, since accurate 

diagnosis is crucial to the successful 

outcome of treatment. 

Diagnostics research. Research field 

concerned with developing reagents, 

methods and analysers used to study 

the causes of disease, or which provide 

rapid, reliable information on the 

presence of a disease or its course so 

that appropriate treatment can be initiated 

as early as possible. Methods of 

monitoring treatment are also developed 

for the important job of checking 

how effective a given therapy is once it 

has been started. Regardless of which 

of these categories a project falls into, 

the aim is to help patients by improving 

the diagnosis and treatment of 

disease, while at the same time helping 

to reduce health care costs (→analytical 

systems). 

The Diagnostics Division invests 

substantial amounts in research and 

development, focusing on the areas 

of diabetes, immunodiagnostics and 

molecular diagnostics. Research and 

development activities associated with 

→diabetes are designed to make life 

easier and safer for people with diabetes, 

for example by means of integrated, 

even more user-friendly equipment 

components and insulin pumps 

49

Distribution centres 

and by providing blood glucose measurement 

methods that only require 

minimal amounts of blood or even no 

blood at all. Software programmes for 

those who need to perform several 

tests a day and therefore have to manage 

a large amount of data represent 

another key area. 

Researchers working in laboratory 

diagnostics are developing automated 

integrated solutions designed to increase 

productivity and reduce costs, 

and reliable diagnostic techniques that 

can help to maximise the efficacy of 

medical treatments. 

New, high-quality →biomarkers are 

being produced with the aim of obtaining 

information about the course 

of diseases or the efficacy of treatment. 

With the next generation of system 

platforms it should be possible to 

measure combinations of markers 

using protein chips. The corresponding 

IMPACT system is currently 

undergoing feasibility testing and 

should initially help to speed up clinical 

trials with new markers. 

Diagnostic tests and systems based 

on DNA chip and →PCR technologies 

represent another focus of intensive 

research activity. 

Roche is also working on the development 

of high-quality systems and 

reagents for life science research, 

specifically in the highly promising 

areas of →sequencing, →proteomics 

and gene analysis. 

Distribution centres. Centres which 

employ optimised logistics processes 

50 

and functions to bring the products 

distributed by the divisions to the customer 

with maximum efficiency. 

Top priority is given to compliance 

with product-specific requirements. 

Thus, for example, it must be possible 

to prove that refrigerated products 

remain within the stipulated temperature 

range during transport. 

As part of the Supply Chain Strategy 

for the →Diagnostics Division, two 

global distribution centres are responsible 

for distributing goods and products 

both to regional warehouses 

managed by the national companies 

and to end customers: The German 

site in Mannheim is responsible for 

supplying the EMEA regions (Europe, 

Middle East and Africa), Asia–Pacific, 

Iberia/Latin America and Japan, while 

Indianapolis supplies North America 

and many other countries with test 

strips manufactured in the United 

States. Wherever possible, the two 

global distribution centres supply 

end customers directly. Customers in 

Europe order products from their local 

distributor, which forwards their 

orders electronically to the centre in 

Mannheim within minutes. Mannheim 

delivers direct to customers in 

Germany, the Netherlands, Belgium, 

Austria, Italy, Switzerland, Scandinavia, 

Great Britain and other countries 

within 24 hours. Spare parts, 

which are dispatched to all European 

countries from the DCS (Distribution 

Centre Spareparts) in Mannheim, can 

even be delivered to any location in 

Europe within a few hours.

Where direct delivery is either not 

cost-effective or not possible or appropriate 

for service-related reasons, the 

national organisations restock their 

warehouses from the distribution centre 

so that they can supply customers 

in their country. Seventy percent of 

all diagnostic products supplied to 

subsidiaries and customers worldwide 

start their journey in Mannheim. Most 

distribution centres are operated by 

Roche Diagnostics itself, but physical 

distribution is outsourced to specialist 

service providers wherever economically 

advantageous. 

In contrast to the Diagnostics Division, 

the Pharmaceuticals Division has 

no global or regional distribution centres. 

Every Roche subsidiary has one 

or more national distribution centres, 

which deliver direct to customers. In 

countries with no Roche-owned subsidiary, 

products are supplied direct 

to one or more agents. These agents 

ensure that products are distributed 

to doctors, pharmacies and hospitals 

through a local distribution network. 

Divisions. Independent operating 

units covering all important activities 

from research and development, 

through production, to marketing and 

sales. Each division is responsible for 

the success of its business activities. 

Roche has a →Pharmaceuticals Division 

and a →Diagnostics Division. 

Originally Roche was strictly a 

pharmaceuticals company. Subsequent 

divisions started as offshoots of 

pharmaceutical operations and were 


Divisions 

greatly expanded from 1950 on. After 

1980 the Group started to reconcentrate 

its activities on its core areas of 

competence and divested its cosmetics, 

instrumentation and crop protection 

businesses. In mid-2000, the 

fragrances and flavours business 

(Givaudan) was spun off. In 2003 the 

Vitamins and Fine Chemicals Division 

was sold to the Dutch company DSM. 

Although the relative importance of 

each division to the Group’s overall 

business has varied considerably, the 

Pharmaceuticals Division still retains 

its pre-eminent position. 

Roche is pursuing a ground-breaking 

strategy designed to position the 

company as a clear global leader in 

the healthcare market. This strategy is 

systematically geared to medical innovation. 

We aim to develop customised 

solutions to medical problems for 

which no satisfactory option currently 

exists and thereby create added value 

for all relevant stakeholders – patients, 

doctors and healthcare systems as a 

whole. 

Roche is committed to giving doctors 

the tools they need for better diagnosis 

and more specific treatment by 

providing them with a clearer understanding 

of the molecular principles 

of disease. This is the only approach 

capable of achieving a consistent 

improvement in patients’ treatment 

options. With the aid of innovative 

diagnostic methods doctors are able to 

identify patient groups with comparable 

clinical conditions with increasing 

accuracy and offer these patients the 

51

52 

DNA 

benefits of specific therapeutic strategies. 

We concentrate our resources totally 

on two research-intensive business 

areas: pharmaceuticals and diagnostics. 

We focus particularly on those 

areas where needs are great and our 

expertise can be applied to beneficial 

effect: oncology, virology, diabetes, 

inflammatory disorders, the central 

nervous system and metabolic diseases. 

We strive to be a leader in these 

areas. Today Roche is the market 

leader in growth areas such as oncology, 

transplantation and hepatitis and 

a global leader in molecular diagnostics, 

clinical laboratories and diabetes 

monitoring. 

Research at the highest international 

level lies at the heart of our 

strategy. In creating innovative solutions, 

Roche can rely on its own 

state-of-the-art pharmaceutical and 

diagnostic research and on a globally 

cooperating research and development 

network. →Genentech in the 

USA and →Chugai in Japan – companies 

in which Roche has a majority 

shareholding – work largely autonomously 

because we believe that 

this significantly enhances diversity 

and thus the ultimate result. 

We expand our own research capacities 

through a series of scientific and 

commercial cooperative ventures with 

external biotech companies, universities 

and research institutions at home 

and abroad. 

DNA (Deoxyribonucleic acid). The 

double helix molecule containing the 

→genetic information of almost all 

living cells. DNA is able to replicate 

itself when cells divide. Its main building 

blocks, and the actual carriers of 

genetic information, are the bases adenine, 

guanine, cytosine and thymine, 

usually referred to by their initial 

letters. The sequence in which the A, 

G, C and T bases are arranged in genes 

forms the genetic code, the set of 

instructions that determines an individual’s 

hereditary makeup by directing 

the production of →proteins. In 

protein synthesis the instructions in a 

strand of DNA are first transcribed by 

special polymerase →enzymes into a 

mirror-image copy known as messenger 

ribonucleic acid (mRNA). This 

copy is then translated by ribosomes, 

the protein factories in a cell. DNA is 

not restricted to human cells (→cell, 

human); it is found in viruses and bacteria 

as well as in the cells of all plants 

and animals. 

DNA chips. DNA microchips making 

it possible to perform genetic 

and functional analyses of complete 

→genomes or to carry out other 

complex gene-based inquiries. These 

minute chips contain arrays of up to 

hundreds of thousands of DNA probes 

(→genetic engineering techniques). 

At present DNA chip technology is 

primarily being used in biomedical 

research, for example in cancer research, 

and in identifying factors that 

cause certain patient groups to re-

Body 

spond to particular drugs. In 1995 

Roche became the first major pharmaceutical 

company to enter into a first 

collaborative venture with Affymetrix, 

one of the world’s largest DNA chip 

manufacturers, and thus was one of 

the pioneers in applying chip technology 

in therapeutics and diagnostics. In 

2003 Roche →Molecular Diagnostics, 

a business area of the →Diagnostics 

Division, became the first company to 

sign a landmark non-exclusive agreement 

to develop Affymetrix microarray 

technology for diagnostic use. 

In 2005 the company received FDA 

clearance for the →AmpliChip CYP450 

test, the first and only FDA-approved 


Drug Safety Monitoring 

Information storage in the DNA of genes 

Cell 

Nucleus 

Chromosome Nucleotides 

DNA 

Server PC Hard disk Programme Bits 

101101001 

The aim of human genome research is to decipher the information encoded in 

man’s genes (in the form of roughly three billion pairs of the nucleotide bases A, 

T, C and G) and establish how defects in the storage and processing of this information 

and changes in a cell’s genetic material (e.g. mutations) cause disease. 

test for analysis of inherited genetic 

variations that influence metabolism 

of many widely prescribed drugs. 

Roche continues to explore development 

of this technology for use in the 

differential diagnosis of cancers such 

as leukemia and lymphoma. 

Drug resistance. Ability of some microbial 

pathogens to withstand attack 

from specific →antimicrobials. 

Drug Safety Monitoring. Central unit 

at Roche which systematically collects 

all information on adverse drug reactions 

(also known as side effects), evaluates 

this information on the basis of 

53

Drug Safety Monitoring 

the available data or literature reports 

and submits the findings to regulatory 

authorities throughout the world. This 

unit provides management with information 

on which to base decisions on 

whether to include a particular warning 

in a product’s package insert or 

even completely withdraw the product 

from the market. 

It draws up proposals on the best 

ways of informing doctors, pharmacists 

and patients so as to avoid any 

possible harm. 

The tools used to monitor drug 

safety include voluntary spontaneous 

reporting systems (SRSs), literature 

reviews, intensive hospital monitoring 

and clinical →trials. Each has its 

advantages and disadvantages, and an 

accurate picture of potential and 

proven side effects can be obtained 

only by combining information from 

all of these sources. Information exchange 

with other companies and 

organisations which collect information 

on drug side effects is also important. 

54


E 

Early detection. Targeted medical investigation 

designed to detect diseases 

or developmental disorders as early as 

possible and thus prevent their occurrence. 

E-business (electronic business). 

Business activities carried out via the 

Internet. The term is another addition 

to the growing list of e-words, which 

includes “e-mail” and “e-commerce”. 

E-business is a product of the revolution 

which the Internet and associated 

technologies (in short, the “Web”) 

have brought about in key sectors of 

trade and commerce. By no means is it 

confined to buying and selling. Among 

other things, the Internet is also a 

channel for providing services to customers 

and for collaboration between 

businesses. Today major companies 

are increasingly taking advantage of 

the Internet – and the new culture and 

opportunities it has created – in their 

business operations. Because of its versatility, 

availability and global reach, 

companies are using the Web for purchasing, 

joint promotional campaigns 

and collaboration in research, to give 

just a few examples. 

The pharmaceutical industry is not 

allowed to sell medicines direct to consumers 

– not even over the Internet. 

Roche uses the World Wide Web for 

purchasing, sales and marketing activities 

and to support business-to-business 

cooperation in all areas. 

Ecology 

Ecology. First coined by Ernst Haeckel 

in 1866, the term “ecology” comes 

from the Greek and means the study of 

a system or organism in relation to its 

environment, with particular emphasis 

on the interdependence of all the 

forces and phenomena involved. In 

a more general sense, ecology is the 

study of the conservation of the lifesupporting 

elements in our environment, 

in particular the soil, water and 

air, and of plant and animal habitats. 

From this viewpoint, ecological 

knowledge and approaches are relatively 

new. 

The world we live in is a world of 

substances. The air we breathe, everything 

we touch, eat and drink consists 

of real, chemically definable substances. 

In addition, however, man 

has produced numerous substances 

which do not occur in nature – we have 

only to think of plastics, dyes, fibres, 

lubricating and cleaning materials 

and, of course, drugs. Synthetic starting 

materials are often required for the 

manufacture of these products. Without 

these synthetic substances today’s 

civilisation would be unthinkable. In 

this area, therefore, a return to nature 

has become an evolutionary impossibility. 

But we know that man-made 

substances can upset natural systems 

and it is the task of ecology to identify 

such sources of disruption and then 

either prevent, modify or, if necessary, 

eliminate them. 

In technical parlance this field is 

called ecotoxicology. There are two 

main aspects: →occupational hygiene, 

55

56 

Elecsys 

that is, the protection of the individual 

at his place of work, and →environmental 

protection, that is, protection 

of the air, water and soil. A third 

aspect, industrial safety, should also 

be mentioned in this context, since 

accidents and incidents can cause 

injury and harm the environment. 

Roche adopts an integrated approach, 

grouping →safety, health, environmental 

protection and occupational 

hygiene together as a single organisation. 

It is a basic tenet of company 

policy not to carry out any industrial 

activity which has been proved to be 

harmful (→sustainability). 

Elecsys. Tradename and family name 

given to →analytical systems supplied 

by the →Professional Diagnostics 

Modular for clinical and immunological 

tests. 

business area of the →Diagnostics 

Division. Elecsys 2010 and Modular 

Analytics E170 are modern, innovative 

laboratory →immunoassay analysers 

capable of testing for a wide range 

of parameters including thyroid and 

fertility hormones, →tumour and 

cardiac markers or markers of infectious 

diseases and →osteoporosis. The 

underlying technology is based on 

electrochemiluminescence (ECL), i.e. 

chemiluminescence initiated by an 

electrical voltage. 

EMEA (European Agency for the 

Evaluation of Medicinal Products). 

London-based European Union agency 

which works in cooperation with the 

regulatory authorities of each Member 

State in the EU-wide drugs →registration 

system established in 1995. The 

EMEA coordinates the scientific resources 

made available by national 

authorities. New drugs are registered 

either via a centralised procedure 

(biotech preparations, drugs for HIV, 

diabetes, cancer and neurodegenerative 

disease and optionally for other 

indications) that involves applying 

directly to the EMEA, or by a decentralised 

procedure in which an application 

is submitted in the Member 

States. If, in centralised procedures, 

the →CHMP delivers a positive opinion, 

the Commission will then issue a 

marketing authorisation that is valid 

in all member states. Once products 

have been authorised, the EMEA continues 

to supervise them by measures 

such as inspections of manufacturing

sites and monitoring of side effects. 

The EMEA also contributes to the development 

of European and international 

harmonisation, in particular 

within the framework of the EU- 

Japan-US tripartite International Conference 

on Harmonisation. 

Employee health service (also 

known as the medical service). 

Confidential contact point for all employees 

who have questions about 

health problems or about protecting 

themselves against health hazards in 

the workplace. Its services fall into 

four main categories: 

Occupational healthcare services 

include treatment for work-related illnesses, 

occupational injuries or exposures 

to noxious agents, and preplacement 

examinations to assess suitability 

for certain work assignments. If an 

employee is found to be unsuitable for 

a particular job, the options for rehabilitation, 

reintegration or retraining 

in a different job are investigated. 

Since the emphasis here is on preventing 

harm to employees’ health, workplaces 

undergo systematic risk analyses 

and structured health and safety 

plant inspections (audits). The aim of 

curative occupational medicine is to 

ensure the prompt specialist assessment 

and treatment of work-related 

injuries, health problems or injuries. 

The preventive services available in 

Basel, for example, include individual 

health assessments and counselling 

sessions (cardiovascular risk factors, 

nutrition, stress, substance abuse, etc.) 


Employee representation 

or group-specific counselling sessions 

(e.g. for night-shift workers), and 

campaigns or forums on healthrelated 

topics (e.g. vision in the workplace, 

travel-related health, melanoma 

and other cancer prevention campaigns). 

Input from experts in occupational 

health and ergonomics can 

make a valuable contribution to preventive 

health even at the planning 

phase of new construction or renovation 

projects. The company physiotherapist 

at Basel can improve the 

behaviour of employees by offering 

ergonomic training courses (behavioural 

prevention with training in 

screen ergonomics, lifting and carrying, 

back exercises, etc.). The goal here 

is not only to prevent damage to health 

but to help promote increased wellbeing 

at work. 

During the day employees have 

access to an on-site first-aid clinic. The 

emergency room is used for preliminary 

treatment and triage during medical 

emergencies and also for fine 

decontamination and treatment for 

the effects of noxious substances. The 

company has its own ambulance (with 

emergency doctor) and an on-call 

medical service to deal with incidents 

that have injured several people. The 

aim is to ensure that employees receive 

competent preclinical aid at the scene 

and to provide access to an expanded 

range of treatment facilities in the 

clinic. 

Employee representation. Employee 

representative bodies are provided for 

57

Energy supplies 

in the labour laws of a large number of 

countries. In addition to informing 

and consulting with local staff associations 

and works councils, Roche concluded 

a voluntary agreement in 1996 

to set up the Roche Europe Forum 

(REF), made up of representatives 

elected by employees at Roche companies 

in countries of the European 

Union and Switzerland. The REF 

includes representatives from Switzerland 

and Great Britain, even though 

these countries are not covered by the 

relevant European Union directive. 

Company representatives brief and 

consult the Roche Europe Forum on 

economic issues at annual meetings. 

Energy supplies. All Roche plants 

require large amounts of energy for 

production, heating, ventilation, air 

conditioning and transport. 

In 2005, the Roche Group met 

around 70% of its total primary energy 

requirement with fossil fuels and 

refuse, 28% with bought-in electricity 

and 2% with district steam. In the 

fossil fuels category, natural gas accounted 

for over 57% of fuel consumption. 

The remainder was covered 

by heating oil (41%) and refuse (2%). 

Electricity is needed not only for 

production processes, but also for air 

conditioning, ventilation and lighting 

and to power equipment and computers 

in laboratories and offices. For this 

reason an increasing number of sites 

are using cogeneration plants to generate 

steam for heating and low-cost 

electricity for their own needs. It is 

58 

thus possible to cut consumption of 

expensive electricity from external 

grids. 

Since energy is joining raw materials, 

labour and plant maintenance as an 

increasingly important production cost 

factor, energy conservation measures 

have been an important topic at Roche 

for several years. Correspondingly 

ambitious energy saving targets have 

been set. Efforts are being concentrated 

on improving utilisation of process 

heat, for example from waste streams 

such as condensate or cooling water. 

Secondary energy sources such as 

steam, boiler feed water for steam 

production, sanitary hot water, cooling 

water and brine for chemical 

processes and compressed air are 

mostly produced or reprocessed in 

company plants. 

Environmental protection. The prevention 

or reduction of environmentally 

harmful emissions and waste and 

the conservation of raw materials and 

energy (→energy supplies). This not 

only has ecological advantages but – by 

reducing manufacturing costs – yields 

economic benefits as well. At Roche 

the overriding importance of environmental 

protection is set down in the 

Group’s policy on safety, health and 

environmental protection and in corresponding 

directives. The considerable 

sums spent on environmental 

protection have come to be regarded 

as normal expenditures on a par with 

labour, raw materials and utility costs. 

Every new process and every new

production facility is now optimised 

at the development stage with regard 

to environmental protection. At Roche 

cost-conscious environmental protection 

is recognised as a success factor 

for the future. 

→Wastewater treatment is one of 

the oldest, and also one of the most 

important and costliest, of the forms 

of environmental protection undertaken 

by the chemical industry. By no 

means is it the only area where the 

industry takes its environmental 

stewardship seriously. 

Gaseous emissions from production 

facilities and boiler rooms at Roche 

sites are treated using advanced emission 

control technologies (→air pollution, 

control of). Noise emissions are 

monitored periodically around site 

perimeters and corrective action taken 

should noise levels ever become a nuisance 

to nearby residents. 

Every biotechnological, chemical or 

pharmaceutical production process 

generates unusable by-products, and 

at times they can pose special problems. 

Roche’s waste control policy is 

based on the following sequence of 

priorities: “avoidance – reduction – 

recycling – environmentally responsible 

disposal”. Waste is thus not a problem 

that gets set aside until production 

is done; on the contrary, processes are 

designed to keep waste arisings and 

hazardous by-products to a minimum. 

→Recycling, that is, the reprocessing 

and reuse of waste, and particularly of 

waste solvents, is of great importance. 

Moreover, Roche also makes an effort 


Environmental protection 

to valorise by-products – in other 

words, to process potential waste materials 

in such a way that they can be 

used by third parties as secondary raw 

materials. As it is impossible to produce 

anything without creating some 

waste, methods of disposal must be 

sought which do not jeopardise or unduly 

impact on the environment. 

Waste products are therefore analysed, 

categorised by chemical composition 

and then treated and disposed of 

accordingly. 

In terms of volume, the biggest 

problem is posed by contaminated 

organic solvents originating for the 

most part from the manufacture of 

active pharmaceutical ingredients. 

Owing to high quality requirements 

for these end-products, it is often impossible 

to reprocess solvents, which 

then have to be incinerated in an environmentally 

compatible way in Groupowned 

or external facilities. In disposing 

of waste, Roche opts wherever 

possible for thermal destruction 

rather than dumping in landfill sites. 

Thermal destruction not only makes it 

possible to utilise the calorific value of 

wastes for generating energy but 

produces mineral residues with no 

adverse environmental impact. 

Until a few years ago environmental 

protection was still a secondary activity 

of a few individuals. Today, by 

contrast, production facilities can call 

upon the services of on-site specialist 

departments to cope with the vast 

number of tasks and problems in this 

area. Nevertheless, it is important to 

59

60 

Environmental risk assessment 

bear in mind that environmental protection 

begins at the individual workplace: 

everyone can, and must, help. 

Precautionary environmental protection 

is also promoted by the collection 

of experimental data on the fate 

and effects of substances in the environment. 

The results are made available 

to the users of intermediates and 

end products in the form of →safety 

data sheets or incorporated in →environmental 

risk assessments. These 

information tools form the basis for a 

targeted approach based specifically 

on appropriate safety measures 

(→ecology, →safety). 

Environmental risk assessment. 

Since the possible environmental risks 

associated with drugs have to be 

assessed during the →registration procedure, 

both the EU and the USA have 

introduced appropriate regulations. 

Accordingly the degradability and environmental 

fate of new products are 

estimated and the results compared 

with any toxic effects on organisms 

in the environment (primarily algae, 

water fleas and fish). Roche has been 

producing environmental risk assessments 

for over 10 years, not only for 

drugs but also for its production operations 

and intermediates. 

Enzymes. Proteins which act as biocatalysts 

in living →cells, initiating and 

accelerating a wide variety of reactions, 

including metabolic processes. 

Enzymes, often bound to solid carrier 

materials, are used in numerous 

biotechnological applications. One 

very important example is the heatstable 

Taq polymerase enzyme from 

Thermus aquaticus, a bacterium found 

in hot springs in the Yellowstone 

National Park. Thanks to its special 

properties, this enzyme has played a 

pivotal role in automating the →PCR 

method. 

Enzymes are also implicated in disease. 

Many pathogenic situations are 

at least partly due to defects in the regulation 

of enzyme activity. In such 

cases excess enzyme activity can be 

inhibited by drug treatment. Some 

bacterial enzymes are the sites of 

action of antibiotics, and most antiviral 

agents act on virus-specific enzymes, 

for example reverse transcriptase 

and a special protease in the case 

of the →AIDS virus HIV. The influenza 

medicine →Tamiflu inhibits 

the viral enzyme neuraminidase. 

Epidemiology. The study of the distribution 

and determinants of disease 

frequency in human populations (in 

specific geographical areas, population 

groups or periods). 

Erythropoietin. Hormone secreted by 

the kidney which controls the production 

of red →blood cells (erythrocytes). 

Abbreviated to EPO or ESA 

(erythropoietin-stimulating agent). If 

too little erythropoietin is produced, 

severe →anemia results. The successful 

deciphering of EPO’s genetic code 

opened the way for biotechnological 

production. Recombinant EPO, or

epoetin beta (tradename →NeoRecormon, 

Epogin), has been used since the 

early 1990s to successfully treat anemia 

in patients with chronic →kidney 

disease, premature infants and patients 

with certain types of cancer. New 

erythropoietin-stimulating agents are 

in development for treating renal 

and cancer-related anemia, including 

Mircera, the first continuous erythropoietin 

receptor activator (→C.E.R.A.). 

Escherichia coli. Abbreviation: E. 

coli. Non-pathogenic intestinal bacteria 

in humans. Laboratory strains of 

these bacteria are used to produce recombinant 

→proteins. The most commonly 

used strain is K12, which is 

unable to survive in the human gut as 

a result of various defects, and can 

only grow under controlled laboratory 

and production conditions. 


Escherichia coli 

61

FDA. Abbreviated name of the Food 

and Drug Administration, the US drug 

regulatory authority responsible for 

promoting and protecting public 

health by helping safe and effective 

products reach the market in a timely 

way, monitoring products for continued 

safety after they are in use, and 

helping the public obtain the accurate, 

science-based information needed to 

improve health. 

Fluoro-uracil Roche. A pioneering 

treatment for cancer launched by 

Roche in 1962 which has become a 

standard treatment in breast, bowel, 

pancreatic and several other kinds of 

cancer. The active ingredient, 5-fluorouracil, 

works by mimicking one of 

the building blocks of →DNA and 

thereby disrupting DNA duplication, 

preventing cells from dividing. It can 

therefore stop the growth of rapidly 

dividing cancers, though it also leads 

to the death of normal cells that are 

actively dividing, including cells of the 

gastrointestinal tract, hair follicles, 

mucous membranes and others. This 

can lead to unpleasant side effects. A 

major advance came thirty years after 

the drug was launched with Roche’s 

development of →Xeloda, which is not 

converted to 5-fluorouracil until it is 

inside tumours. This greatly reduces 

side effects elsewhere in the body 

(→oncology). 

62 

FDA 

F 

Inside look at the coating process: 

an ultrathin coating is sprayed onto 

tablets as they are kept continually 

in motion in a coating pan. 

Formulation. Science of preparing 

drugs in appropriate dosage forms. 

Correct formulation is essential for 

efficacy and the prevention of adverse 

reactions. It also affects the shelf-life 

of drugs. The term “bioavailability” is 

used to designate the total effect of 

dosage form, active ingredient and 

excipients on the absorption and fate 

of the drug in the body (→generics, 

→counterfeit drugs). 

Foundations, scientific. As a researchbased 

company, Roche has always 

fostered close links with universities 

and institutes that conduct →basic 

research. The Roche Study Foundation 

was established in 1924 to enable 

young scientists to participate in 

scientific research projects. On the 

company’s 40th anniversary (1936) 

the Emil Barell Foundation (→Barell) 

was set up to provide start-up support 

and interim funding for biomedical 

research. In 1947, following the company’s 

golden jubilee, the Fritz Hoff-

mann-La Roche Foundation was inaugurated 

to promote an interdisciplinary 

approach to scientific and medical 

problems (→Hoffmann-La Roche, 

Fritz). The 75th anniversary (1971) 

saw the establishment of the Roche 

Foundation for Scientific Exchange 

and Biomedical Collaboration with 

Switzerland. This organisation provides 

support for Swiss universities by 

encouraging exchange of experience 

with outstanding foreign scientists. 

In 1983 the four foundations were 

merged, while retaining their original 

aims, to form the Roche Research 

Foundation. In 1999 the Roche 

Research Foundation extended its 

support to the research in biology, 

chemistry and medicine. The primary 

area of chemistry had hitherto formed 

part of the “Stipendienfonds der Basler 

Chemischen Industrie”. 

The Roche Organ Transplantation 

Research Foundation (ROTRF) was set 

up in 1998 as a legally independent, 

non-profit organisation. Its aim is to 

promote research in →organ transplantation 

and thereby further improve 

treatment outcomes for people 

receiving organ transplants. The foundation 

particularly supports the advancement 

of research in those areas 

of transplant medicine where there are 

still unmet medical needs. The Roche 

Foundation for Anemia Research 

(ROFAR), a new type of research foundation 

with an international scope and 

a specific therapeutic focus, was set up 

in 2004 to stimulate innovative research 

that will open up new avenues 


Fuzeon 

of exploration in the area of anemia. 

It is legally independent of Roche and 

managed by an international Board of 

Trustees. 

Fuzeon. Product which was developed 

in collaboration with Trimeris Inc., is 

the first of a new class of highly innovative 

anti-HIV drugs known as ‘‘fusion 

inhibitors’’. It is unique because it 

is the only anti-HIV drug that actually 

works outside the cell, protecting it 

from being infected, whereas all other 

anti-HIV drugs work only after the 

cells have been infected. Fuzeon is administered 

by subcutaneous injection 

twice daily, and is indicated for use 

in patients who have already received 

other anti-HIV therapy. Fuzeon brings 

new hope to patients with resistant 

HIV strains by increasing their 

chances of achieving undetectable viral 

load – the optimal treatment goal for 

all people living with HIV (→AIDS, 

→antimicrobials, →Prix Galien). 

63

64 

Gene 

G 

Gene. Unit of →genetic information. 

A gene is a segment of →DNA that 

carries instructions for making a 

strand of messenger ribonucleic acid, 

and hence is the blueprint for a specific 

→protein. An organism’s complete 

gene complement, which contains all 

its genetic information, is called the 

→genome. 

Gene chip. Gene chips are fingernailsized 

slices of glass arrayed with up to 

a million →DNA sections. Gene chips 

are used to unambiguously verify the 

presence of specific →genes within a 

cell sample. They act like “screening 

antennae”, each of which is designed to 

detect a highly specific gene. An unambiguous 

reaction occurs if one of the 

screened genes is present in the applied 

sample. Gene chips have become 

an indispensable tool for the detection 

of specific infections (→AmpliChip 

CYP450 test). 

Gene segment. Functional →DNA 

segment of a →gene. 

Genentech, Inc. Leading biotechnology 

company engaged in the discovery, 

Genes are blueprints for protein synthesis 

Cell nucleus 

Chromosomal 

DNA 

Messenger RNA is read by a ribosome 

Messenger RNA 

Working copy of a gene 

Enzyme 

RNA polymerase 

Amino acids 

(building blocks of proteins) 

Ribosome 

(protein factory) 

Amino acid chain 

Folded protein 

(active) 

An activated gene on a chromosome in the cell nucleus serves as a template for a 

strand of messenger RNA (mRNA). This “working copy” of the gene passes out of 

the nucleus to a ribosome, which uses the mRNA as a blueprint for synthesising 

the protein coded for by the gene. As the chain of amino acids grows, it folds into 

a characteristic shape to form a biologically active protein.

production and marketing of biotherapeutic 

products. Headquartered 

in South San Francisco, California 

(United States), Genentech employs 

around 10,000 people. In 1990 Roche 

acquired 60 percent of Genentech’s 

shares and the right to purchase the 

remaining shares at a later date. Roche 

exercised this option in 1999. After 

several subsequent public offerings of 

Genentech stock, Roche now holds 

roughly a 56 percent stake in the company. 

The company operates independently 

and is listed on the New 

York Stock Exchange under the ticker 

symbol DNA. The Roche Group is represented 

on the Genentech board by 

three directors. 

Genentech was a pioneer of modern 

→biotechnology. In 1977 the company 

synthesised the first recombinant 

human protein in a microorganism 

and played a key role in the production 

of recombinant human insulin, the 

world’s first genetically engineered 

drug, which was launched in 1982. 

Genentech’s most important products 

include the top-selling cancer drugs 

→Avastin, Rituxan and →Herceptin. 

Rituxan – for the treatment of non- 

Hodgkin’s lymphoma – was developed 

by Idec Pharmaceuticals, Genentech 

and Roche and launched in late 

1997. The product is marketed as 

→MabThera outside the United States 

and Japan. Herceptin, the first monoclonal 

→antibody for the treatment of 

metastatic breast cancer, was approved 

by the →FDA in 1998 and has since 

been launched by Roche in additional 


Generic names 

countries in Europe, the Far East and 

Latin America (→oncology). In the 

United States, Genentech markets 

seven other products for diseases such 

as →cystic fibrosis, growth hormone 

deficiency, myocardial infarction and 

stroke. 

Generic names. Designations assigned 

to chemical compounds. In 

science chemical compounds are represented 

schematically by their structural 

formulas and in writing by their 

full chemical names. Both types of 

description are unsuitable for daily 

use because of the need to draw the 

formulas and because the length and 

complexity of the chemical names 

make them unpronounceable and difficult 

to remember. For this reason 

shortened generic names have always 

been given to chemical compounds. 

With this practice a need to systematise 

these names and give them an 

official status emerged. Various countries 

have an official body which 

assigns and publishes generic names. 

These are then known as International 

Nonproprietary Names (INNs). The 

international use of generic names is 

governed by the World Health Organization 

(→WHO). The first step is to 

publish the proposed generic names. If 

no objection is received within four 

months, they are given the official status 

of recommended INNs. In Great 

Britain generic names of active pharmaceutical 

ingredients are termed 

British Approved Names (BANs), and 

in the United States US Adopted 

65

Generics 

Names (USANs). The distinction between 

generic name and trademark is 

an extremely important one. Generic 

names refer to the active ingredient 

of a branded pharmaceutical product 

only and not to the product itself. A 

branded pharmaceutical is a ready-touse, 

precisely measured and defined 

dosage form containing numerous 

other substances (such as carriers, stabilisers 

and coatings) in addition to 

the active ingredient. The product is 

identified by its trademark. Trademark 

and generic name must never be used 

synonymously. 

Generics. Term applied to “copies” of 

brandname →pharmaceuticals. After 

the →patent on a brandname drug has 

expired, other pharmaceutical companies 

can start to copy it using the 

extensive documentation filed with 

the authorities by the original discoverer 

and manufacturer. If the chemical 

and pharmaceutical quality of the 

generic is identical to that of the original 

product, the authorities will grant 

marketing authorisation without demanding 

clinical →trials to ascertain 

its side effects profile and efficacy. 

This means that generic manufacturers, 

which are mostly specialised 

companies geared to the needs of their 

domestic markets, have virtually no 

research and development costs and 

can sell their products at considerably 

lower prices than the original manufacturer. 

However, since a branded pharmaceutical 

is a balanced, thoroughly 

66 

tested formulation of active ingredient 

and excipients, there is no cast-iron 

guarantee that a generic copy will be 

equally effective, even though it contains 

the same dosage of the same 

active ingredient as the original. The 

generic is then said to have a different 

bioavailability (→analysis). 

It is therefore possible for original 

and generic to display differences in 

quality even though their chemical 

composition is identical. Such differences 

may be significant for the patient. 

Optimal crystal shape or size and 

fine details of product →formulation 

can give the original an earlier or more 

constant onset of action, better bioavailability 

or longer action. In addition, 

the manufacturer of the original 

product conducts international drug 

surveillance, often over a period of 

decades, for the purpose of documenting 

side effects and interactions with 

other drugs and providing warnings or 

information to doctors, if necessary in 

conjunction with the health authorities. 

In many countries the health authorities 

encourage generics for economic 

reasons because they provide 

short-term relief for healthcare budgets. 

Generics make no contribution 

to medical progress, however. 

Genetic engineering. A set of techniques 

for the isolation, characterisation, 

specific alteration and transfer 

of genetic material. Every living cell 

contains coded instructions for the 

synthesis of thousands of →proteins

that enable the cell, and the whole 

organism, to perform its biological 

functions. The chemical substance 

deoxyribonucleic acid (→DNA) is the 

carrier of these instructions, the genetic 

code. The →chromosomes are 

the biological structures that contain 

DNA. Each →gene, or unit of inheritance, 

corresponds to a section of DNA 

and contains the instructions for synthesising 

a particular protein. 

1973 is regarded as the year in which 

genetic engineering was born. It was 

then that two Americans, Herbert 

Boyer and Stanley Cohen, first succeeded 

in transferring functional genetic 

information for synthesis of a 

foreign protein to E. coli bacteria. 

Since then molecular biology techniques 

have been developed that allow 

the isolation, analysis or de novo synthesis 

of individual genes from a 

→virus or organism and their transfer 

to microorganisms such as →bacteria 

or mammalian cells (→genetic engineering 

techniques). The foreign gene, 

which contains the instructions for 

synthesising a particular protein, can 

be read and expressed (activated) in 

the host cell only if “control regions” 

guide the reading process in the host 

cell. Only if the foreign gene is stable 

and active can the “genetically engineered”, 

or recombinant, host cell be 

used. 

In this way biologically useful substances 

of human or animal origin can 

be produced in large quantities in 

biotechnological processes. This production 

technique is especially valu- 


Genetic engineering 

able when a substance is produced 

only in minute quantities in the original 

cell and can thus be obtained only 

by a complicated process, in insufficient 

amounts and in a highly impure 

form. Another important feature of 

this production method is safety. 

While protein concentrates isolated 

from human tissue can harbour pathogenic 

contaminants (e.g. HIV or 

hepatitis viruses), this is not the case 

with genetically engineered products. 

One example of a genetically engineered 

product from Roche is human 

→interferon alfa (→Roferon-A), a protein 

that inhibits the spread of viruses 

in the body as part of the natural 

immune response to viral infection. 

In 1980 recombinant techniques made 

it possible to produce large quantities 

of interferon in pure form. Before the 

advent of genetic engineering, years 

of work had failed to yield sufficient 

material even to completely clarify its 

chemical structure. 

Genetic engineering techniques 

are an important and integral part 

of Roche’s biomedical research as a 

whole, in which biochemical, chemical, 

physicochemical, cell-biological, 

immunological, microbiological and 

genetic engineering techniques all 

complement each other. 

Roche’s interest in genetic engineering 

is focused on the medical use of 

recombinant substances in diagnosis 

and treatment. 

The diverse portfolio of genetically 

engineered pharmaceutical and diagnostics 

products comprises more than 

67

Genetic engineering techniques 

10 recombinant biopharmaceuticals 

(MabThera/Rituxan, NeoRecormon, 

Herceptin, Pegasys, Avastin, Nutropin, 

Pulmozyme, Neutrogin, Activase, 

Xolair, Zenapax, Raptiva and Roferon-A) 

and numerous diagnostic tests 

incorporating genetically engineered 

substances or based on techniques 

such as →PCR or chip technology. 

Genetic engineering techniques. 

Genetic engineering currently employs 

the following techniques: 

– Transformation: incorporation of 

a natural →DNA molecule, or one 

produced →in vitro using recombinant 

methods, into a host cell so 

that the DNA molecule is passed on 

to the host’s offspring. The following 

cells and organisms can now 

be transformed: numerous species 

of bacteria, yeasts, cell cultures of 

plant, animal or human origin, fruit 

flies, mice and certain plant species. 

Higher animals and plants that 

have undergone transformation are 

said to be transgenic. The transformation 

of human embryos is illegal. 

– Expression: When a →gene is expressed, 

the →DNA is used as a 

template for the transcription of a 

complementary strand of →mRNA 

(messenger RNA) which is translated 

into a →protein. Control 

sequences direct the expression of 

genes at specific times and in specific 

cell types of our body or in a 

recombinant cell used for production 

of proteins. 

68 

– Site-directed mutagenesis: introduction 

of point mutations (alteration 

of individual nucleotide 

building-blocks) at a particular site 

in a DNA molecule that has undergone 

in vitro manipulation. 

– Gene disruption: targeted inactivation 

of a single →gene in a microorganism. 

– Sequencing: determination of the 

order in which the nucleotide bases 

are arranged in a DNA molecule 

and decoding of the genetic information 

contained therein (amino 

acid sequence of the corresponding 

proteins or structure of control 

regions). 

– PCR technique (→polymerase chain 

reaction): biochemical replication 

of any isolated DNA segment; an 

important technique in biomedical 

→basic research, pharmaceuticals 

research and →in vitro diagnosis. 

– DNA probe: a technique by which 

complementary DNA strands or 

→RNA molecules are “fished out” of 

a cell extract or made visible using 

short pieces of single-stranded 

DNA; also known as hybridisation. 

The extracorporeal fertilisation of 

human or animal ova (in vitro fertilisation), 

the transfer of embryos and 

the breeding of chimeras (crossing 

of different animal species) are not 

genetic engineering techniques, as 

they do not alter the DNA. 

Genetic information. Originally a 

vague term to explain the transmission 

of inherited traits. Today genetic infor-

mation is known to be stored in the 

→DNA in an individual’s chromosomes. 

The information stored directly 

in DNA specifies the structure 

of all the →proteins an individual 

produces along with instructions on 

where and when protein synthesis will 

take place. The interplay between this 

information and a person’s cellular 

machinery supplies a genetic programme 

controlling embryonal development, 

the processes of life and, 

possibly, death. 

Genetics. Study of the mechanisms 

of inheritance. Classical genetics investigates 

the laws governing the inheritance 

of traits over generations, particularly 

in higher organisms. The 

underlying mechanism is the inheritance 

of →genes from parent to offspring. 

Originally discovered by the 

monk Gregor Mendel in the 19th century, 

genes are now known to be →DNA 

molecules. Molecular genetics studies 

the basic laws of inheritance at the molecular 

level (→protein, →genome). 

Genome. The complete set of →genes 

of an organism, such as a →virus. 

The human genome is contained in 

23 pairs of →chromosomes (see diagramme 

on page 70). 

Genomics. Study of the structure and 

function of the →genome and all 

→genes. 

Glucose. A simple sugar that is the 

body’s main source of energy. Glucose 


GlycArt Biotechnology AG 

is formed from the breakdown of food 

in the digestive tract and transported 

to cells via the circulation. The concentration 

of glucose in the blood 

– the blood sugar level – can be measured 

with →test strips and blood 

glucose monitoring systems (→glucose 

self-monitoring). 

Glucose self-monitoring. Measurement 

of →glucose in the blood by diabetic 

patients, with the aim of achieving 

optimal control of blood glucose 

levels. The glucose level is usually 

measured with the aid of handy, unobtrusive 

blood glucose meters and 

corresponding →test strips. A tiny 

drop of blood, e.g. taken from the fingertip, 

is applied to a test strip, and the 

meter very soon displays the precise 

blood glucose level. In special training 

courses, and with the aid of helpful 

data management systems, patients 

learn how to draw the correct conclusions 

from the readings and thus 

achieve the best possible control of 

their blood glucose levels. Poor control 

can, in the long term, lead to serious 

health problems, e.g. blindness, kidney 

damage, vascular disorders and amputations. 

GlycArt Biotechnology AG. Biotechnology 

company engaged in the discovery 

of biotherapeutic products. 

Based in Schlieren (Zurich, Switzerland), 

GlycArt employs about 40 

people. The company was founded in 

2000 as a spin-off from the Swiss Federal 

Institute of Technology (ETH) in 

69

Zurich and raised about USD 16 million 

from an investment syndicate. 

GlycoMAb is the company’s proprietary 

technology for improving the 

specific biological activity of therapeutic 

monoclonal →antibodies for 

target cell ablation. GlycoMAb is based 

on an active modulation of antibody 

glycosylation during production, which 

results in antibody products with 

increased ADCC (antibody-dependent 

70 

GlycArt Biotechnology AG 

Virus 

Viral envelope 

Hereditary 

information 

The genome of 

a virus consists 

of approx. 

1,000 base pairs 

Equivalent to 

one page 

with 20 lines of text 

Comparison of viral, bacterial 

and human genomes 

Genome 

Bacterium 

Plasmid 

The genome of 

a bacterium 

consists of approx. 

1,000,000 base pairs 


one 1,000-page book 

All hereditary information 

(genome) stored on chromosomes 

in cell nucleus 

Human cell 

The genome of 

a human cell 

consists of approx. 

3,000,000,000 base pairs 


3,000 books 

of 1,000 pages each 

Viral, bacterial and human cells contain different amounts of genetic information, 

which is deciphered by genomic research. 

cellular cytotoxicity). In 2004 Roche 

and GlycArt entered into a license 

option agreement to develop nextgeneration 

antibodies for one of 

Roche’s product candidates. In July 

2005 Roche acquired 100% of the 

company. GlycArt remains an independent 

research site, but works 

closely with Roche’s Therapeutic 

Protein Initiative in →Penzberg 

(Germany), bringing its GlycoMAb

technology as well as its capabilities 

in antibody humanisation, expression 

and screening to the Roche Group. 

GlycArt’s most advanced products 

(called GA101 and GA201) are monoclonal 

antibodies with enhanced 

ADCC in preclinical development 

for cancer. The company has a number 

of other research programmes 

(→research; →Pharmaceuticals Division). 

Good clinical practice regulations 

(GCP). The standards that govern the 

planning, conduct and reporting of 

clinical →trials; designed to ensure 

that the rights (e.g. patient briefing, 

liability in the event of a claim, data 

protection) and safety of patients and 

volunteers (healthy, willing test subjects) 

are protected and reliable data 

are collected. 

GCP regulations set out the rights of 

volunteers and patients, the rights and 

duties of ethics committees and the 

duties of investigating physicians and 

of pharmaceutical companies sponsoring 

trials. In particular, they determine 

the information that must be 

contained in patient informed consent 

documentation and specify how investigating 

physicians must go about 

obtaining consent from patients or 

healthy volunteers who are to take part 

in a clinical trial. They also contain 

detailed provisions on the duties of 

investigators and sponsors concerning 

the formulation of trial protocols and 

compliance with the regulations that 

apply to clinical trials, the reporting of 


Good clinical practice regulations (GCP) 

adverse drug events, recording of data 

and archiving of documentation. The 

GCP regulations also define the quality 

standards the trial medication 

must meet and what →quality control 

(monitoring) and →quality assurance 

measures (audits and inspections) the 

sponsor must take in order to ensure 

that the trial data are accurate and that 

the investigating physicians and company 

employees observe all statutory 

and ethical requirements. 

The principles of GCP are based 

on the Nuremberg Code (which established 

strict ethical standards for 

research on human subjects and was 

drawn up following the Nuremberg 

war crimes tribunal) and its successor, 

the Declaration of Helsinki. The European 

Union’s GCP directive came into 

force in July 1991. The World Health 

Organization (→WHO) has published 

similar guidelines, and many countries, 

including Switzerland, have 

made GCP part of their national regulations 

on clinical →trials. The ICH- 

GCP guidelines, agreed in 1996 by the 

US, Japanese and EU health authorities, 

represent the culmination of efforts 

to harmonise differing national 

requirements (ICH stands for International 

Conference on Harmonisation 

of Technical Requirements for Registration 

of Pharmaceuticals for Human 

Use). Compliance with these guidelines 

in clinical research has since been 

declared mandatory by the health 

authorities in other countries, such as 

Australia and Canada. 

71

Good laboratory practice regulations (GLP) 

Good laboratory practice regulations 

(GLP). Internationally recognised 

guidelines for a quality assurance 

system concerned with the 

organisational process and general 

conditions governing the performance 

of certain experiments in the laboratory. 

The GLP guidelines rule on the 

planning, performance, monitoring, 

recording, archiving and reporting of 

these tests (→trial, experimental), so 

that such tests can be fully reproduced 

at any time. 

The GLP principles apply to the 

non-clinical safety testing of “test systems” 

(chemicals, biological products, 

e.g. proteins, living organisms) that 

are contained in drugs, pesticides and 

biocides, veterinary drugs, cosmetics, 

food additives and industrial chemicals. 

The purpose of these safety tests is 

to obtain data on the properties, toxicity 

(→toxicology) and safety of the test 

systems for human health and the environment. 

Thus, before a pharmaceutical 

preparation intended for use in 

humans or animals can enter clinical 

trials, it must undergo extensive testing 

in animal experiments (→in vivo 

tests) or the test-tube (→in vitro tests). 

The GLP guidelines lay down standards 

concerning the tasks and qualifications 

of all the personnel in an institute/laboratory, 

the quality assurance 

programme (→quality assurance), the 

premises, the equipment, materials 

and reagents used, the experimental 

animals, the handling, storage and 

characterisation of the test systems, 

the standard operating procedures 

72 

(SOPs), the experimental sequence of 

the test, the test report and the archiving 

and storage of all resulting data 

and materials. 

The GLP guidelines are legally binding 

in all countries of the European 

Union (since 1990), Switzerland (since 

1986), the United States (since 1979) 

and Japan (since 1982). In other 

words, the above-mentioned nonclinical 

safety tests must be performed 

in accordance with GLP, otherwise the 

tests are not recognised and therefore 

rejected in the corresponding licensing/ 

→registration procedures. 

The above-mentioned legislation 

also requires all institutes/laboratories 

performing GLP tests to undergo 

inspection at regular intervals (every 2 

years in Switzerland) by officials of the 

respective country in order to check 

compliance with the GLP guidelines. 

Such inspections may be completed 

within a day, or can last as long as three 

weeks. Bilateral international agreements 

regulate the mutual recognition 

of the GLP guidelines between individual 

countries. In practice this 

means, for instance, that GLP tests 

conducted in the GLP facility at Roche 

Basel are accepted in licensing procedures 

in the United States, Japan and 

the European Union, since the relevant 

Swiss authority, Swissmedic, has rated 

this facility as “fully complying with 

the GLP guidelines”. 

Good manufacturing practice regulations 

(GMP). Regulatory standards 

for pharmaceutical manufacturing.

Comprehensive monitoring of manufacturing 

processes is vital in the pharmaceutical 

industry in order to ensure 

that the consumer receives high-quality 

medicines. As a company is responsible 

for the products it manufactures, 

not a single step in the process can 

be left to chance. The guidelines issued 

by the World Health Organization 

(→WHO) concerning the manufacture 

and quality control of drugs are 

now recognised as the “state of the art” 

by over 40 countries. The European 

Commission began the phased introduction 

of GMP in 1989. Today it 

provides a binding directive that establishes 

a uniform standard in all 

member states. These regulations have 

also been fully incorporated in Swiss 

legislation since 2002. In addition to 

qualified personnel, suitable rooms 

and equipment, the GMP regulations 

specify a quality management system 

that covers everything from the inspection 

and storage of raw materials 

to the actual production process (pharmaceutical 

formulation and packaging), 

production hygiene, analysis and 

release, distribution records and complaints 

procedures. Similar guidelines 

exist for the manufacture of active 

pharmaceutical ingredients. 

Granulocytes. Cells of the innate, 

non-specific immune system. Like the 

→lymphocytes, they are a type of 

white →blood cell. By far the most important 

subgroup of granulocytes are 

the neutrophils, or neutrophilic leukocytes, 

which mainly destroy bacterial 


Graz 

pathogens. Basophils and eosinophils 

combat parasites but are also involved 

in allergic reactions and inflammation. 

A lack of neutrophils, as can 

occur after chemotherapy for cancer, 

can lead to life-threatening infection. 

Graz. The only development and production 

centre in the world for blood 

gas and electrolyte analytical systems 

distributed by the →Diagnostics Division. 

This Austrian location further 

enhances research, development and 

production capacity for near-patient 

diagnosis. These analytical systems are 

used for measuring vital parameters 

from whole blood, not in a central laboratory 

but rather in the immediate 

vicinity of the patient – for example in 

the operating theatre, emergency outpatient 

department, intensive care 

unit, or even at the site of an accident. 

The systems produced in Graz are distributed 

worldwide. By investing in 

this site, Roche has played a trailblazing 

role in establishing the healthcare 

cluster (Human.technology Styria 

GmbH) in the Graz region. The company 

works closely with the universities 

and hospitals in Graz. Around 

300 people work at the Graz site. 

The new building with its futuristic 

architecture was designed by the Grazbased 

architect Ernst Giselbrecht. 

With its V-shape, the building not only 

stands out for its design, it also makes 

the best use of the 20,000 square metre 

site. This building is also at the cutting-edge 

in terms of ecoefficiency 

with its innovative, environmentally 

73

Grenzach-Wyhlen 

compatible infrastructure – in contrast 

with traditional buildings, the 

concrete ceilings and walls, for example, 

are used to heat and cool the 

internal rooms – and the energy-saving 

sun protection system capable of 

generating a cushion of heat around 

the outer shell of the building. With its 

impressively clean lines, the company 

building sets design standards that 

will probably serve as a benchmark for 

the subsequent development of the 

Graz West Technology Park (→ecology, 

→architecture). 

Grenzach-Wyhlen. A municipality 

in the state of Baden-Württemberg 

(Germany). Situated on the →Rhine, 

it borders on Switzerland, immediately 

east of Basel. Fritz →Hoffmann-La 

Roche opened a production facility 

in Grenzach in 1897, not long after 

operations had commenced in Basel, 

because the German state granted only 

a limited period of patent protection 

for imported products. Since then the 

plants in Grenzach and Basel have 

developed in parallel, although production 

facilities in Basel have increasingly 

had to compete for space with 

research and administration. Today, 

from its headquarters in Grenzach- 

Wyhlen, Roche Deutschland Holding 

GmbH coordinates the operations of 

Roche in Germany. Employing over 

10,000 employees at its sites in 

Grenzach-Wyhlen, →Mannheim and 

→Penzberg, the company is one of 

Roche’s most important national 

organisations worldwide. 

74 

Roche Pharma AG employs around 

1,000 people in Grenzach-Wyhlen. 

They are responsible for the marketing 

and distribution of prescription medicines 

for the whole German market. 

Clinical →trials required for marketing 

authorisation are also coordinated 

from Grenzach. Depending on the indication, 

these trials are conducted in 

conjunction with renowned university 

hospitals and selected suitably qualified 

medical practices across Germany. 

In Europe, Roche Pharma AG is the 

Roche Group leader in terms of pharmaceutical 

sales. 

Group. A combination of companies 

that are legally independent but have a 

common commercial goal. The Roche 

Group incorporates all those companies 

that are wholly owned by Roche 

Holding Ltd, Basel, or in which it has a 

majority interest. Group management 

is based in Basel (→share capital). 

Guggenheim, Markus (1885–1970). 

Dr Markus Guggenheim joined Roche 

in 1910 but initially continued working 

in the laboratories of the Basel City 

Hospital, too. He was an outstanding 

representative of the then young science 

of biochemistry. His scientific 

work covered an exceptionally broad 

range and was still bearing fruit 

decades later. The substance levodopa 

(→antiparkinsonian agents), whose 

l-dopamine structure had been elucidated 

by Guggenheim before World 

War I, was first used to treat patients in 

the 1960s. His work also laid the foun-

dation for subsequent research into 

vitamins. In 1916 Guggenheim was 

blinded by an explosion in his laboratory 

in →Grenzach. In spite of this he 

remained head of research at Roche 

and in 1920 published a standard work 

on biogenic amines. He also created 

a classification system for scientific 

information that many years later was 

adopted almost unchanged for use 

with electronic data processing systems. 


Guggenheim, Markus 

75

Health. According to the World 

Health Organization (→WHO), the 

“state of complete physical, mental 

and social well-being”. So simply 

defining health in terms of the absence 

of illness and ailments is incomplete. 

The UN’s Universal Declaration of 

Human Rights states that health is a 

basic right. According to the WHO, 

health promotion refers to those 

measures designed to modify and promote 

individual behaviour and living 

conditions in a positive sense. Healthcare 

includes all those public and private 

institutions involved in preventive 

healthcare and disease management. 

The prevention, diagnosis and 

treatment of disease are closely interlinked, 

and the links will be made even 

closer through solutions that target the 

medical needs of individual patients. 

Roche creates innovative, individual 

solutions for hitherto unmet medical 

needs (→Divisions, →medicine, personalised). 

Intensive →research activities enable 

Roche to identify the causes of illness 

and establish individual →predispositions. 

Targeted →screening tests 

can then be used to discover in good 

time whether a particular predisposition 

might lead to an illness. This 

knowledge will then clear the way for 

preventive medical measures. 

If the illness has already manifested 

itself, however, quick and accurate 

diagnosis will provide the ideal basis 

for state-of-the-art medical treatment. 

76 

Health 

H 

Monitoring the course of the illness 

with diagnostic tests (→Diagnostics 

Division) will enable the treatment 

be tailored to the individual needs 

of the patient in order to ensure an 

improved quality of life (→Pharmaceuticals 

Division). 

Health protection. The totality of 

measures designed to prevent employees 

being harmed by chemical, physical, 

ergonomic, biological, psychological 

or other adverse influences at work. 

Together with →safety and →environmental 

protection, health protection 

is accorded equal priority with issues 

of quality, productivity and cost efficiency. 

New installations and workplaces 

are planned so as to satisfy all the 

requirements of modern health protection. 

In other words, employees are 

protected as much as possible from 

noise, pollutants, infectious pathogens, 

overexertion resulting from the lifting 

and carrying of loads, etc. through 

technical measures, for example enclosed 

and mechanised production 

systems. Existing workplaces are subjected 

to regular risk analyses. Any 

identified deficiencies are prioritised 

and rectified according to a clearly 

defined timetable. 

→Occupational hygiene and the 

medical service (occupational medicine, 

→employee health service) play 

an important role in health-related 

risk analyses in the workplace. Occupational 

toxicology assesses the hazards 

associated with chemicals in the

workplace. The results of these assessments 

form the basis for substance 

handling procedures. →Biosafety is 

concerned with questions of biological 

safety. 

Occupational medical examinations 

ensure that those with preexisting 

illnesses are appointed to jobs for 

which they are suitable as regards 

health. These examinations also serve 

to demonstrate that no work-related 

harm to health has occurred and that, 

should the worst happen, any corresponding 

damage is detected and 

treated in good time. 

Health protection in the broader 

sense also includes health promotion. 

It is in the interests of all employees, 

and also in the interests of Roche, that 

everyone remains fit and productive. 

A healthy diet, physical activity and 

an even balance between work and 

private life are important objectives of 

health promotion. The health service 

provides an ideal access point for 

personnel in this respect. 

Hepatitis, chronic. Inflammation of 

the liver. Chronic forms of viral hepatitis 

occur throughout the world. The 

main pathogens are hepatitis B and C 

viruses. The long term consequences 

of chronic hepatitis B or C can be 

extremely serious. They primarily include 

cirrhosis (build up of scar tissue 

in the liver), which can lead to liver 

damage and, ultimately, to a hepatocellular 

carcinoma (liver cancer). Both 

can prove fatal. As there is no vaccine 

against hepatitis C, it is very important 


Herceptin 

that drugs are available to treat the disease. 

The first →interferon, introduced 

by Roche in 1989, was →Roferon-A. 

The availability of Pegasys, used in 

combination with Copegus (ribavirin), 

has dramatically increased the number 

of patients achieving a sustained 

virological response (SVR rate) and 

who are thus effectively cured of hepatitis 

C. Nowadays, patients with certain 

genotypes (subtypes of the virus) 

have an over 90% chance of beating 

the disease and having undetectable 

levels of hepatitis C virus. Even patients 

with the more intractable types 

of disease can expect a greater than 

50% chance of responding to Pegasys 

plus Copegus. 

Following the introduction at the 

end of 2002 of new diagnostic tests for 

detecting and monitoring the disease, 

it is now possible to detect hepatitis C 

viruses with even greater speed and 

accuracy using →PCR and real-time 

PCR technologies. This will facilitate 

targeted drug treatment and optimal 

monitoring of the patient’s response to 

drug therapy. 

Herceptin. A humanised monoclonal 

→antibody (active ingredient trastuzumab) 

for the treatment of a particular 

kind of aggressive →breast cancer. 

Herceptin has been shown to be very 

effective in treating patients with 

breast cancer who express elevated 

levels of the protein HER2, to which 

it binds. Because normal cells do 

not over-express HER2, Herceptin is 

highly targeted towards cancer cells, 

77

causing very few of the kind of side 

effects normally associated with 

chemotherapy. Clinical →trials have 

shown Herceptin to improve survival 

by 25 percent in advanced breast cancer 

patients when given in combination 

with conventional chemotherapy, 

and to reduce the risk of relapse by 

50 percent in patients with early breast 

cancer when given with chemotherapy 

following surgery. First introduced in 

1998, Herceptin, marketed in the United 

States by →Genentech, has revolutionised 

the treatment of HER2-positive 

breast cancer. A joint global development 

programme is underway at 

Roche and Genentech to investigate the 

clinical efficacy and safety of Herceptin 

in other forms of cancer that exhibit 

overexpression of HER2 (→oncology). 

In 2000 Herceptin was approved 

in the European Union for advanced 

(metastatic) HER2-positive breast cancer. 

This was followed in 2006 by approval 

for early-stage HER2-positive 

breast cancer. Herceptin in combination 

with paclitaxel is now the firstline 

treatment for advanced breast 

cancer when anthracyclines are un- 

78 

Hexagon 

Refrigerated storage of Herceptin. 

suitable. It has also been approved as 

the first-line therapy in combination 

with docetaxel and as a tertiary treatment 

in monotherapy. The drug has 

also been approved for use after standard 

adjuvant chemotherapy for earlystage 

breast cancer. It is administered 

by intravenous infusion. 

The product is marketed by →Chugai 

in Japan. 

Hexagon. Six-sided polygon. A hexagon 

representing the benzene ring and 

containing the word Roche is the company 

logo (→trademarks, →basilisk), 

which appears on all products originating 

from factories bearing the name 

Roche. This includes the products of 

the traditional →Pharmaceuticals and 

→Diagnostics Divisions. The company 

logo was also the inspiration for the 

name of the worldwide employee newspaper, 

Hexagon, first published in 1998. 

Hitachi. Major industrial group with 

headquarters in Mito (Japan). For 

many years Hitachi and the →Diagnostics 

Division’s →Professional Diagnostics 

business area have cooperated 

in the field of clinical and immunochemical 

→analytical systems. Hitachi’s 

random-access systems, launched in 

the early 1980s, were a major technical 

breakthrough that substantially improved 

and simplified processing in

cobas 6000 (501/601) Analyzer – first 

fully-automated system for the analysis 

of clinical and immunochemical 

tests in an integrated platform for 

laboratories with a medium-sized 

workload (→cobas). 

clinical chemistry laboratories. With 

the introduction of the first integrated, 

automated Modular Analytics 

SWA platform for laboratories with a 

high sample throughput, the Roche/ 

Hitachi partnership became a pioneer 

in the merging of clinical chemistry 

and immunochemistry on a single 

platform. 

Hoffmann-La Roche, Fritz. Born in 

Basel, 24 October 1868, the third child 

of Friedrich Hoffmann and Anna 

Elisabeth Merian; died 18 April 1920. 


Hoffmann-La Roche, Fritz 

Founder of what is now the Roche 

Group. 

Fritz Hoffmann received his commercial 

training in companies trading 

in plant extracts and industrial chemicals. 

In 1893 he became a partner in 

the pharmacy Bohny, Hollinger & Cie. 

In 1895 he married Adèle La Roche. In 

1894, together with pharmacist Max 

Carl Traub, Hoffmann took over the 

Bohny, Hollinger & Cie. production 

facilities in Basel’s Grenzacherstrasse 

and in the same year founded the 

limited partnership Hoffmann, Traub 

& Co. This was renamed F. Hoffmann- 

La Roche & Co. on 1 October 1896 

after his partner’s withdrawal from the 

firm. In the same year Hoffmann hired 

Dr Emil Christoph →Barell as a 

chemist. As early as 1897 Hoffmann 

established a production facility in 

→Grenzach and then subsidiaries in 

Paris (1903), New York (1905), Vienna 

(1907), London (1908), St. Petersburg 

(1910) and Yokohama (1912). Thus, 

Roche’s international structure was 

shaped from its earliest years. 

With the outbreak of the Russian 

Revolution the entire Russian market, 

which at times had accounted for one 

fifth of sales, was lost at a single stroke. 

Coming on top of the difficulties experienced 

in Grenzach and the losses 

suffered in the countries involved in 

World War I, these events brought the 

company close to ruin. In April 1919 

the limited partnership was transformed 

into a limited company with 

a →share capital of CHF 4 million, and 

its finances were restructured. Hoff- 

79

mann’s health had suffered as a result 

of the severe strains caused by the war, 

and Barell took increasing responsibility 

for running the company. In the 

spring of 1919 Hoffmann fell ill with 

a severe kidney disease, to which he 

finally succumbed on 18 April 1920. 

He did not live to see his firm climb out 

of its deep trough. 

Hoffmann was one of the first to 

grasp the nature of the proprietary 

medicinal product: a ready-to-use 

formulation with a standardised composition 

and uniform potency, bearing 

a →trademark. He foresaw that the 

future belonged to such products and 

became one of the pioneers of marketing, 

using what were then completely 

new promotional techniques. He was 

80 

Holding company 

Fritz and Adèle Hoffmann-La Roche, photographed in 1896, the year Fritz Hoffmann 

founded his company. 

the architect of the great success of 

→Sirolin and the other branded products 

he put on the market. Promotional 

activities were aimed not only 

at consumers and pharmacists but, in 

the form of product-related →communications, 

particularly at doctors. 

Hoffmann placed great importance on 

having good articles by Roche scientists 

published in medical journals. 

And he introduced a genuine innovation 

in Europe at that time by publishing 

the company’s own scientific 

periodicals. 

Holding company. A limited company 

that owns a majority or all of the 

shares of several operating companies 

– the controlling company of a →group.

The controlling company of the Roche 

Group is Roche Holding Ltd, Basel 

(→share capital). 

Hormones. Potent, biologically active 

substances that are produced in the 

body by glands. Hormones reach their 

target organs via the circulation and 

regulate various bodily functions, such 

as growth, reproduction or metabolism. 

Insulin, for example, which is 

produced in the pancreas, regulates 

the glucose balance in the body, and 

the pituitary gland produces a range 

of hormones, including growth hormone. 

An extensive test menu of thyroid 

parameters, e.g. thyroid-stimulating 

hormone (TSH) plus T3, T4, FT3, FT4 

and T-uptake, and fertility hormones 

such as ACTH, testosterone, beta 

HCG, SHBG or estradiol is available 

on the immunochemical analysers offered 

by the →Professional Diagnostics 

business area of the →Diagnostics 

Division. 

Hybridomas. Hybrid cells used in the 

production of monoclonal →antibodies. 

Hypnotics. Drugs for the treatment of 

sleep disorders. The various types of 

sleep disorder include difficulty falling 

asleep (sleep onset disorder), inability 

to sleep through the night (broken 

sleep), premature awakening or combinations 

of these. Sleep disorders 

may be caused by illness but are more 

often due to external factors, aging 


Hypnotics 

or mental stress. Most sleep disorders 

are transient, disappearing once their 

causes have been eliminated. For this 

reason every effort should be made to 

identify any underlying factors. Treatment 

with a hypnotic can be a useful 

temporary supporting measure. 

Roche makes two hypnotics of the 

→benzodiazepine class: Rohypnol, for 

severe insomnia, and Dormicum/ 

Versed, an established treatment for 

sleep onset disorder. 

Dormicum (active ingredient midazolam) 

is the shortest-acting →benzodiazepine. 

Its chemical characteristics 

make it particularly suitable for intravenous 

and intramuscular administration, 

and it is therefore used widely in 

anesthesia and intensive care. 

81

Immune system. All the organs, cells, 

intercellular mediators, such as →cytokines 

and cell functions that together 

defend the body against attack by pathogens 

and other foreign substances. 

Immunoassay. Laboratory test based 

on the “antigen–antibody” reaction. 

The presence of specific →antigens 

and →antibodies in the body provides 

clear evidence of certain illnesses or 

functional disorders. The test provides 

specific information about the quality 

and quantity of these substances. 

Immunoglobulin (Ig). Term covering 

various classes of proteins that function 

as →antibodies: IgA protects the 

surfaces of mucous membranes against 

pathogens. IgD influences the way 

→lymphocytes function. IgE protects 

against intestinal parasites but also 

contributes to many allergy symptoms; 

→Genentech and partners have 

developed a humanised →antibody for 

neutralising IgE. IgG gives protection 

against microorganisms and their 

toxins. IgM is the first line of defence 

against microorganisms in the circulation. 

Susumu Tonegawa, working at 

the former Basel Institute for Immunology, 

elucidated the structure 

and interaction of the →gene segments 

responsible for the synthesis of the 

enormous variety of immunoglobulins 

(approximately 10 12 in number), 

an achievement for which he received 

the →Nobel Prize in 1987. 

82 

Immune system 

I 

Immunology. A subdiscipline of biology 

concerned with the study of the 

biochemical and biological principles 

of the body’s defence system against 

pathogens, e.g. →bacteria and →viruses 

and other foreign substances such as 

biological toxins and environmental 

poisons. The →immune system constitutes 

its subject of research. Since the 

immune system plays an important 

role in many illnesses, immunology is 

a key aspect of medicine in enhancing 

our understanding of →prevention, 

diagnosis and treatment. 

Indianapolis. North American headquarters 

of the →Diagnostics Division 

and responsible for all products 

launched, distributed and sold in the 

United States. The site is home to research 

and development, laboratories, 

manufacturing, distribution, information 

technology and corporate headquarters 

operations in support of the 

business areas →Diabetes Care, →Professional 

Diagnostics, →Molecular 

Diagnostics and →Applied Science. 

Research, development and production 

of →test strips for →glucose selfmonitoring 

and chemical reagents for 

diagnostic tests are likewise based in 

Indianapolis. 

The site currently employs around 

3,700 people, almost a third of whom 

are scattered across the United States 

working in field sales and customer 

service. 

The origins of the Indianapolis site 

date back to the year 1964, when the 

then BioDynamics was started and

soon constructed its office building on 

the current Roche plot (i.e. in the 

northeastern part of the city). The site 

has grown in size to 150 acres and includes 

18 buildings with a fully occupied 

floor area of 1.3 million square 

feet in both Marion and Hamilton 

counties. 

Indianapolis is also responsible for 

the production facility in Ponce, 

Puerto Rico. Following the takeover of 

Disetronic (→Burgdorf), the Diabetes 

Care business area in Indianapolis 

has assumed responsibility for Disetronic’s 

North American headquarters 

in Fishers, Indiana, and their field sales 

force. 

Indication. The reason or circumstances 

that justify a particular medical 

measure after an assessment of 

the relative risks and benefits. (A contraindication 

is the opposite, i.e. a 

reason or circumstance that rules out 

a particular measure.) In the case of 

→pharmaceuticals, an indication is a 

disease or condition for which a particular 

preparation is thought to be an 

appropriate treatment. 

Influenza (flu). Serious, acute illness 

caused by infection with an influenza 

virus. Typical symptoms include sudden 

fever, headache, joint and muscle 

aches, fatigue and cough. The acute 

phase lasts five to seven days. Common 

complications include bronchitis, 

pneumonia, middle-ear infections and 

sinusitis, and some patients develop 

myocarditis (inflammation of the 


Influenza (flu) 

heart muscle). Complications occur in 

15 percent of adults and even more 

frequently in children and in patients 

Structure of the influenza virus – 

hemagglutinin (green) and neuraminidase 

(blue) are located on the surface 

of the virus. The genetic material of the 

virus can be seen in the viral core. 

Schematic view of the head of a neuraminidase 

molecule – the active site 

of neuraminidase is virtually identical 

in all viruses. The neuraminidase inhibitor 

Tamiflu acts by binding tightly 

to this site. 

83

Insulin pump therapy 

with a chronic underlying disease. 

Influenza epidemics occur every year 

in winter. They tend to spread explosively 

but last only a few weeks. 

Influenza activity is continuously 

monitored by the health authorities. 

About 10 percent of the adult population 

and 30 percent of children catch 

influenza each year. Hundreds of 

thousands of flu sufferers develop 

complications requiring hospitalisation, 

and, according to the WHO, the 

annual death toll worldwide ranges 

from 250,000–500,000. Until the introduction 

of neuraminidase inhibitors 

(→Tamiflu), there were no such targeted 

and effective medicines against 

the viruses that cause flu. Analgesics 

and cough remedies were administered 

in the hope of relieving symptoms. 

Antibiotics were often prescribed, 

even though they have no 

antiviral effect. Influenza vaccination 

is recommended as a precaution in the 

elderly and in people with chronic 

underlying disease. 

Insulin pump therapy. Continuous 

replacement of the vital human hormone 

insulin by means of a portable 

pump for the treatment of insulindependent 

diabetes mellitus. Since insulin 

pump therapy is very similar to 

the release of insulin in non-diabetics 

it is the most physiological form of 

insulin treatment currently available. 

The insulin pump is worn on the 

body as a kind of electronic insulin 

reservoir. It is so small and light – 

weighing just 100 g – that it fits com- 

84 

fortably in a trouser pocket or pouch. 

The pump delivers the exact amount 

of insulin required to cover the body’s 

basic physiological needs 24 hours a 

day. The insulin pump is connected to 

the body at all times by an infusion set 

– a thin tube with a tiny needle at the 

end. Since the needle of the infusion 

set is usually inserted subcutaneously, 

i.e. just beneath the skin, this form 

of treatment is known as continuous 

subcutaneous insulin infusion. 

While the insulin pump is a highly 

practical solution, it cannot “think” for 

itself. It therefore has to be programmed 

and users have to measure 

their blood glucose level at regular 

intervals. At the press of a button it 

can deliver an extra portion of insulin 

(bolus) to cover the body’s increased 

requirement after food, just like a 

healthy pancreas. Since the insulin 

contained in the pump is a fast-acting 

form, the insulin dose can be reduced 

or increased in the short term, e.g. 

during sport or meals. 

Interferons. Members of the →cytokine 

protein family. It has been known 

for decades that humans and animals 

never suffer from two viral infections 

(→viruses) – chicken-pox and measles, 

for example – at the same time. This 

prompted the British virologist Alick 

Isaacs and his Swiss colleague Jean 

Lindenmann to conduct a momentous 

experiment at the National Institute 

for Medical Research in London in 

1957. They infected fertilised chicken 

eggs with a virus. The cells of these

eggs then apparently formed trace 

amounts of a previously unknown, 

transmissible →protein that protected 

the egg and chicken cells against other 

viral infections. Isaacs and Lindenmann 

called this substance interferon. 

In Tokyo two Japanese scientists, 

Yasuichi Nagano and Yasuhiko Kojima, 

arrived independently at similar results. 

Interferon from one animal species 

protects only cells of the same species 

against viral infections. The human 

→immune system produces three 

types of interferon: alfa, beta and 

gamma (but there are more than a 

dozen different, though structurally 

very similar, alfa interferons). All have 

antiviral and immunomodulatory 

properties. They can, for a certain 

time, make uninfected but susceptible 

cells resistant to a broad spectrum of 

viruses. Interferons also have antiproliferative 

properties (inhibition of cell 

multiplication and tissue growth) that 

are of particular interest in relation to 

cancer. Interferon inhibits the growth 

of both normal and malignant cells 

(→in vitro). Interferons are also part 

of a complex mechanism that regulates 

the activity and maturation of 

important cells of the body’s immune 

system. 

Thanks to recombinant DNA technology 

(→production, biotechnological; 

→genetic engineering), interferon 

alfa is now available for the treatment 

of serious diseases in the form 

of →Roferon-A. Roche was one of the 

pioneers in the field of interferons. 


Investment 

In 1969 Dr Sidney Pestka, working 

at the former →Roche Institute of 

Molecular Biology, began isolating 

human interferon alfa and purifying it 

to homogeneity. In 1980 researchers 

in →Nutley, in collaboration with the 

Californian company →Genentech, 

produced the first complete interferon 

alfa using recombinant techniques. In 

January, 1981 Roche in Nutley became 

the first company in the world to begin 

clinical →trials with recombinant interferon 

alfa. Roferon-A, the recombinant 

interferon alfa-2a product from 

Roche, was approved for the treatment 

of some cancers (hairy-cell leukemia) 

in the United States and Switzerland in 

June 1986, and subsequently in other 

countries. 

Investment. The use of funds to purchase 

land, buildings, plant, machinery 

and other equipment to create 

or maintain jobs – in other words, to 

enable industrial activity. In addition 

to these capital expenditures, it is also 

possible to invest in intellectual property 

(→trademarks, →patents). The 

acquisition of companies or parts of 

companies with the aim of expanding 

one’s own corporate activities can also 

be regarded as investment. 

The manufacture of pharmaceutical 

products is a capital-intensive business, 

requiring an unusually high level 

of investment. 

The investments a company makes 

over a certain period – a financial year, 

say – can serve a wide range of purposes, 

including the manufacture of 

85

new products, the expansion of existing 

production capacity, the improvement 

of existing processes, plant renewal, 

→research or →environmental 

protection. The various purposes are 

usually interconnected. The motives 

for making such investments are 

equally diverse. Apart from market 

growth, the reasons for investment 

(or its opposite, disinvestment) include 

technical advances, the need to 

safeguard a market position, government 

regulations (concerning environmental 

protection, for example) 

and political changes, such as the 

creation of supranational economic 

zones. Since investment usually leads 

to the creation of jobs, many countries 

encourage – or even try to compel – 

companies to invest. In many cases, 

therefore, instead of being the result 

of completely free business decisions, 

investment is a consequence of particular 

constraints (→production sites). 

Analysis of the profitability of 

planned investments has become a 

science in its own right and, of course, 

is also undertaken on a large scale at 

Roche. However, no matter how much 

systematic analysis has been carried 

out, at the moment an investment 

decision is taken no one can say with 

certainty if it will prove correct, since 

all the factors that have been considered 

may change over time. This 

accounts for a major part of entrepreneurial 

risk. 

Invirase. Drug that inhibits the enzyme 

HIV protease. The first step in 

86 

Invirase 

Computer-generated model of the 

active ingredient of Invirase. 

→virus replication is the production of 

over-long polyprotein chains. During 

the maturation process these chains 

are cut to the right length by HIV 

protease. If this process is blocked, 

maturation cannot continue, and a 

non-infective virus is formed. 

Large-scale trials of the drug, which 

was the first protease inhibitor developed 

for the fight against →AIDS, 

showed it to be very effects. First 

launched in 1995, Invirase has a highly 

specific action against HIV and does 

not interact with human enzymes, 

making it very well tolerated. This has 

been confirmed in numerous trials 

and during extensive clinical use. 

From the original idea through to the 

marketable product, Invirase was 

developed within the Roche Group as 

an international project, and it has 

been awarded a number of prizes for 

innovation (→Prix Galien).

In vitro. (Latin: “in glass”). Refers to 

an experiment conducted outside a 

living organism (→trial, experimental). 

In vitro diagnosis. Whereas the term 

diagnosis on its own refers to the 

disease screening process, the prefix 

“in vitro” indicates where this takes 

place, i.e. outside the body using body 

fluids and tissues. 

In vivo. Refers to an experiment on 

a living organism (→trial, clinical). 

In vivo diagnosis. This form of tracking 

down illnesses is also defined by 

the site at which it takes place. Thus, 

“in vivo” translates into English as “in 

life", i.e. directly in the body. Examples 

of in vivo diagnostic investigations 

include x-rays or ultrasound scans. 


In vivo diagnosis 

87

Kidney disease, chronic. Chronic 

kidney disease (CKD) exists when kidney 

function is reduced or there is evidence 

that the kidney has been damaged. 

In the most severe form of the 

disease, the kidneys are no longer able 

to remove fluid and waste products 

from the body and the patient needs 

dialysis or a kidney transplant. In earlier 

stages, patients may not be aware 

they have CKD, but are at risk of the 

condition progressing and of developing 

serious complications. There are 

many causes of CKD, the most common 

being diabetes and high blood 

pressure. The kidneys also produce 

a substance called →erythropoietin, 

which is needed for the continuous 

production of red →blood cells. Damaged 

kidneys fail to produce sufficient 

erythropoietin. 

88 

Kidney disease, chronic 

K


L 

Landfills. In the past, a lack of knowhow 

and the appropriate technical resources 

meant that landfill dumping 

was the disposal method of choice. 

This approach was governed by legislation, 

as a result of which various 

local authorities have made suitable 

plots of land available for a charge, 

often for joint use by a number of 

companies. Improved knowledge of 

geological characteristics and negative 

experience have lead to the discontinuation 

of landfills for the disposal of 

chemical waste. Contaminated sites 

are subject to increased monitoring 

and thorough examination in order to 

evaluate the associated risks and initiate 

the steps required for containment 

or remediation of the site in question. 

Since Roche has always been a pharmaceutical 

company with relatively 

low volumes of chemical production, 

our total quantities of chemical waste 

and share of deposits in common 

landfill sites are, as a rule, small. As 

soon as a contaminated site is brought 

to our attention, Roche authorises the 

studies required to evaluate the associated 

risks. Depending on the outcome, 

steps for containment or, if necessary, 

remediation of the site are subsequently 

taken. This process is conducted 

in close collaboration with the 

competent authorities and in compliance 

with current legislation. Roche 

accepts responsibility for all waste 

deposited by Roche at its sites or landfills, 

even if the method of disposal was 

Landscaping, ecological 

widespread at the time and based on 

the relevant legal requirements. 

Landscaping, ecological. At Roche 

ecological landscaping means 

– creating natural living spaces for 

people, animals and plants; 

– using mainly indigenous species of 

plants; 

– covering roofs with turf wherever 

possible and practicable; 

– allowing runoff from roofs to soak 

away; 

– and giving preference to paving 

stones, marl or gravel instead of 

asphalt. 

When planning new facilities, 

Roche pays particular attention to the 

choice of location and the siting of 

buildings. Landscaping work is incorporated 

into the planning process at 

an early stage so as to achieve unity 

in the finished design. Interdependent 

elements such as traffic flows, “green 

belts”, soakaway areas and turf roofs 

are planned in a coordinated fashion. 

Open spaces are laid out in such a way 

that they not only have amenity value 

for people but also offer a suitable 

habitat for animals and plants. Given 

proper maintenance, these areas come 

close to providing a natural environment. 

At the Kaiseraugst site, for example, 

habitats similar to those of the 

surrounding region have been created: 

low-nutrient meadows in which the 

wind-borne seeds of plants from neighbouring 

areas are able to take root; 

gravelly areas of fallow land where the 

natural vegetation is allowed to estab- 

89

Languages 

lish itself, thus offering a suitable habitat 

to numerous animal species; and 

hedges of indigenous shrubs and 

dwarf trees serving as a sanctuary 

for many small mammals, birds and 

insects. 

Languages. A group of companies 

that operates in roughly sixty countries 

must decide on a single language 

for its communications. Even at Group 

headquarters in Basel about fifty different 

nationalities are represented, 

though in constantly changing combinations. 

Since a common language is 

essential for mutual understanding, 

English has been chosen as the official 

language of the Roche Group. English 

has become the international working 

language in science and technology, as 

well as in the business world. In medicine 

Latin has long since been replaced 

by English. Important documents that 

are binding for the whole Group are 

thus always drawn up in English, and, 

since 1986, departments at Basel headquarters 

that serve the entire Group 

have had English designations (→corporate 

functions). 

Logistics. Also known as supply chain 

management or materials management, 

logistics is the management of 

the whole value-added chain from the 

raw materials to the finished product. 

It covers all areas concerned with planning, 

purchasing, storage, transport 

and distribution. 

Important tasks in logistics include 

supplier selection, the specification of 

90 

procurement methods and the preparation 

of ordering and delivery plans. 

In production, the prompt, efficient 

and reliable supply of the required raw 

materials, auxiliaries, intermediates, 

active ingredients and packaging materials 

to the factories is a complex task 

requiring intelligent, integrated planning. 

The scope of the task varies 

greatly according to the type of materials 

involved. Active pharmaceutical 

ingredients are supplied throughout 

the Roche Group on a worldwide 

basis, but other goods are procured 

locally, for example just for the factories 

in Basel and Kaiseraugst together. 

In the Diagnostics Division, the best 

and most important suppliers are 

identified at a global level, and the 

local sites then buy the goods from 

these suppliers. 

Another task of logistics in the 

Pharmaceuticals Division is to store 

the purchased and manufactured 

goods, and here the requirements vary 

widely, according to the type of goods 

involved. The warehouses for raw materials 

and auxiliaries and active ingredients 

are equipped for transferring or 

filling these goods into the containers 

specified in individual orders and for 

the necessary labelling and →packaging. 

The remit of logistics also includes 

processing goods as efficiently, rapidly 

and safely as possible, taking due 

account of their nature and the client’s 

wishes. Highly detailed specifications, 

for example regarding refrigerated 

storage, batch tracking or separate

atch storage, have to be complied 

with for many products. These and 

other storage requirements are monitored 

by Quality Management and external 

authorities, thereby ensuring 

that goods of the highest quality are 

delivered to the customer intact. For 

certain goods and destinations Roche 

uses the services of specialist companies 

to organise and carry out shipment. 

Finally, the logistics staff have the 

task of selecting suitable logistics systems 

and providing support for the 

users of these systems. Logistics specialists 

also advise Group companies 

on suitable supply chain systems, economical 

shipment methods, inventory 

requirements and appropriate storage 

facilities. 

All of these activities must be carried 

out in accordance with various 

standards and principles, including 

→good manufacturing practice, “first 

in, first out”, shelf life, safety regulations 

and legal requirements. 

Lymphocytes. White blood cells that 

mount a specific defence against invading 

pathogens; they are part of 

the body’s →immune system. They are 

generated from hematopoietic (bloodforming) 

stem cells in the bone marrow, 

differentiating into →B lymphocytes 

and →T lymphocytes. 

Lymphokines. Mediators of the immune 

response, such as interleukins 

and →interferons. 


Lymphokines 

91

MabThera. A bioengineered chimeric 

monoclonal →antibody (active ingredient 

rituximab) for the treatment of 

→non-Hodgkin’s lymphoma (NHL). 

MabThera binds to a particular protein 

– the CD20 antigen – found on the 

surface of normal and malignant B 

cells. It then recruits the body’s natural 

defences to attack and kill the marked 

B-cells. Stem cells (B-cell progenitors) 

in bone marrow lack the CD20 antigen, 

allowing healthy B cells to regenerate 

after treatment and return to 

normal levels within several months. 

First introduced in 1997, MabThera 

(marketed as Rituxan in the United 

States, Japan and Canada) is indicated 

for the treatment of indolent and aggressive 

NHL. Due to its exceptional 

efficacy, proven in multiple large clinical 

trials, MabThera has grown to 

become not just the largest brand in 

92 

MabThera 

M 

the Roche Group’s portfolio, but the 

world’s top-selling anticancer product. 

Almost a million patients have received 

MabThera treatment in its first 

ten years on the market. The product is 

comarketed in the United States by 

→Genentech and Biogen Idec and in 

Japan by →Chugai and Zenyaku Kogyo 

Co Ltd. (→oncology). 

Macrophages. Cells that form part of 

the →immune system. Macrophages 

engulf and digest bacteria and other 

foreign cells and help →lymphocytes 

in mounting specific reactions to 

→antigens by secreting various sets of 

→cytokines and other effector molecules. 

Mannheim. City of 320,000 inhabitants, 

situated at the confluence of the 

Neckar and →Rhine rivers, in the state 

of Baden-Württemberg (Germany). In 

1872 Christoph Boehringer relocated 

his part of the original family company 

to this industrial and transport centre, 

which later became the headquarters 

of the globally operating Boehringer 

Mannheim group. 

As a result of the integration of 

Boehringer Mannheim into the Roche 

Group (1998), Mannheim has become 

an important Roche site. 

Employing around 7,000 people, 

Mannheim is one of the largest and 

most multifaceted Roche sites in the 

world. It is the nerve centre of large 

parts of the diagnostics business and 

the production site for important 

pharmaceuticals. Substances produced

y →biotechnology techniques are becoming 

increasingly important. Since 

1998 the company has invested around 

EUR 1 billion in the Mannheim site, 

creating almost 800 new jobs in the 

process. 

Its favourable location in Europe 

and exceptional infrastructure make 

the city of Mannheim, with its grid 

layout, the ideal base for the international 

logistics centre for diagnostics 

(→logistics). Roche subsidiaries and 

customers in 170 countries are supplied 

directly from Mannheim. The 

diagnostics distribution centre for 

Germany is based in Mannheim, the 

EMEA sales region (Europe, Middle 

East, South Africa) is managed from 

there and all marketing strategies for 

Germany are planned there. The Roche 

site in Mannheim is also responsible 

for global research, development, production 

and strategic marketing of 

diagnostics for the →Diabetes Care 

business area. 

For over 40 years, tests and monitoring 

systems have been researched, 

developed and produced in Mannheim. 

Roche Diagnostics’ most successful 

brand is Accu-Chek. For over 30 years, 

Accu-Chek has been tasked with delivering 

innovative products and solutions 

that meet the needs of people 

with diabetes and their carers. 

Marketing. The complex process of 

getting a product from the producer to 

the consumer, beginning with the creation 

of a product to meet a demand 

(or a largely unmet medical need) and 


Measurement units, analytical 

ending with a buyer becoming convinced 

that the product is what he or 

she needs. With this objective in mind, 

Roche is confronted with all conceivable 

market challenges and consequently 

makes use of a comprehensive 

range of marketing techniques. This is 

due to the broad range of products 

involved, the diversity of the customer 

groups served and the strict regulatory 

environment under which the marketing 

of prescription medicines and 

diagnostics operates. Purchasers of 

diagnostic products include e.g. doctors, 

healthcare organisations and the 

technicians who actually carry out the 

tests in the clinical laboratory. 

Prescription drugs are a special 

case. The actual consumer – the patient 

– does not choose the product, 

nor does he usually pay for it; he just 

takes it. The doctor is not the consumer; 

he does not pay for the drug 

but merely chooses it. Health funds or 

insurers are not consumers, either; 

they make general choices by including, 

or refusing to include, products in 

their reimbursement lists, but they do 

not choose treatments in individual 

cases; however, they pay for the drug in 

most cases and are thus referred to, 

appropriately, as third-party payers in 

the healthcare system. This complex 

situation necessitates the use of a wide 

variety of marketing techniques. 

Measurement units, analytical. Measurement 

units used in chemical 

→analysis to investigate the composition, 

structure and quantity of sub- 

93

Medicine, personalised 

stances contained in compounds and 

mixtures. Nowadays, inconceivably 

minute amounts can be detected. The 

principal measurement units are ppm 

= parts per million, ppb = parts per 

billion and ppt = parts per trillion. 

Most people, however, find it difficult 

to appreciate the relationships involved. 

For example, while one ppm 

can be expressed as 31 seconds in a 

year, one ppb is equivalent to just 

3/100 of a second in a year and one ppt 

is equivalent to one second in 31,688 

years. Admittedly, the detection of a 

particular substance says nothing 

about its effects, whether harmful or 

beneficial, as these depend on the 

properties of a substance detected as 

well as its concentration. Thus, the 

significance of an analytical finding 

can only be assessed in relation to the 

natural or acceptable levels. In other 

words, a qualitative assessment is 

needed in addition to the quantitative 

analysis. 

Another important measurement 

unit in chemistry is the pH value, 

which provides information about the 

“strength” of an acid (pH

The cobas TaqMan is loaded with samples 

for an analytical run. 

biology. The product range includes 

AmpliChip, Cobas Amplicor, Cobas 

AmpliPrep, Cobas TaqMan and Cobas 

AmpliScreen. 

Molecular Diagnostics also offers a 

wide range of →enzymes for industry. 

With its unusually comprehensive 

portfolio in the field of nucleic acid 

technology (NAT), Molecular Diagnostics 

supplies a wide array of innovative 

test products and services to 

researchers, physicians, patients, hospitals 

and laboratories worldwide. 

Currently based in →Pleasanton, 

California (USA), Molecular Diagnostics 

was created as a new business area 

of Roche Diagnostics in December 

1991 with the acquisition of the revolutionary 

amplification process known 

as →polymerase chain reaction (PCR) 

from Cetus Corporation. PCR, a Nobel-prize-winning 

technology, allows 

scientists to copy specific →DNA or 

RNA segments billions of times and 

amplify the genetic material in even 

minute samples sufficiently to produce 

detectable quantities. 


Molecular medicine 

A key technology used in many 

areas of genome research, PCR has 

enabled a whole new generation of 

highly sensitive diagnostic tests to 

be developed that allow disease 

pathogens to be detected directly 

(in contrast to the detection of an 

immune response to the pathogen). 

PCR-based tests are frequently used 

to diagnose infections or monitor the 

progress of an illness or the therapeutic 

outcome. They can also be used to 

detect variations and mutations of 

→genes, including inherited variations 

in humans or variations arising in diseases 

such as cancer. These are used for 

differential diagnoses to better predict 

prognosis, treatment selection, and 

response to therapy. 

More than 500 laboratories and 

over 50 companies around the globe 

have acquired licences from Roche for 

the patented PCR technology and 

PCR-based products and services. As 

a result, PCR and real-time PCR 

have become routine components of 

diagnostic tools and established themselves 

as the world’s leading DNAprobe 

technology. 

Since it was formed, Molecular 

Diagnostics has produced a comprehensive 

range of PCR-based equipment 

systems and diagnostic tests that 

have set new standards in the treatment 

of infectious diseases and helped 

improve the safety of blood and blood 

products across the world. 

Molecular medicine. The elucidation, 

diagnosis and therapy of diseases 

95

Molecule 

at the molecular level, especially on the 

basis of genetic causes: the growing 

body of knowledge from the mapping 

of the human →genome is making it 

possible to explain the causes and 

mechanisms of a large number of diseases 

(with the exception of infections 

and other diseases due to external 

factors) in terms of genetic defects or 

disorders. Molecular diagnostics, in 

particular the →polymerase chain 

reaction (PCR), will in future enable 

physicians to identify these causes at 

an early stage. The treatment and correction 

of such disorders increasingly 

rely on recombinant proteins, highly 

specific chemical substances that target 

the causes of disease. 

Molecule. A structure consisting of 

two or more atoms held together in a 

neutral state by chemical bonding 

forces. Expressed in the simplest 

terms, a molecule is the smallest possible 

unit of a chemical compound. 

One example of a molecular structure 

is H 2O or water. A water molecule consists 

of two hydrogen atoms and one 

oxygen atom. 

Monitoring. On the one hand, monitoring 

involves the continuous electronic 

observation of specific processes 

in patients, particularly at-risk patients. 

Cardiac activity and respiration 

are the primary processes monitored, 

but other additional functions such 

as temperature regulation or cerebral 

pressure can be included depending 

on the clinical condition in each case. 

96 

Impulses can be transmitted from the 

patient to the measuring device by 

means of a sensor or electrodes, for 

example. These devices are usually 

equipped with a screen for immediate 

viewing of the functions being measured. 

The results can be stored and 

subsequently used for diagnostic 

assessments or for documentation 

purposes. 

Alternatively, the success of longterm 

treatments can be observed 

(monitored) with diagnostic tests in 

order to provide definite proof that a 

particular treatment is actually working. 

Modern drugs can help keep viral 

replication low in chronic infections 

(e.g. HIV infection), but the development 

of resistance may require a 

change in medication, 

Multinationality. Since it was founded, 

Roche has been a multinational 

company. In 1896, the very year it was 

founded, Fritz →Hoffmann transferred 

most of production across the 

border to →Grenzach in Germany, 

because at that time the German state 

granted imported products only very 

short patent protection. In order to 

establish Roche’s market presence, 

Fritz Hoffmann had a distinctly international 

approach in his dealings (the 

concept of “multinational” did not yet 

exist). 

The first foreign subsidiaries were 

established by Fritz Hoffmann, and 

more followed between the world 

wars. Companies were opened in 

Brussels, Bucharest, Warsaw, Prague,

Shanghai, Bombay, Madrid, Buenos 

Aires, Montreal and Stockholm. After 

World War II, Roche continued to set 

up subsidiaries, but also acquired 

companies such as Syntex, →Genentech, 

Boehringer Mannheim or 

→Chugai to expand its international 

reach. 

The reasons for Roche’s multinational 

involvement are manifold. On 

the one hand, they can be explained 

by company- and industry-specific 

factors and, on the other, by factors 

external to the company. For instance, 

government restrictions on the free 

movement of goods as well as other 

regulations can make it necessary to 

set up companies in other countries. 

The establishment of a local sales company 

is generally voluntary, since every 

business likes to be close to its markets 

and customers. Frequently, however, 

the importing countries demand that 

the products be manufactured in the 

country itself, though as a rule the import 

of active ingredients is initially 

permitted. The creation of large economic 

zones such as the EU’s single 

market of course adds a new dimension 

to the concept of multinationality. 

For Roche, the United States is the 

largest single market. Roche, however, 

is a Swiss company and the Swiss market 

is very small. This market falls 

short by a wide margin of generating 

the necessary revenues to offset the 

research and development costs for 

innovative products. The costs incurred 

in Switzerland, therefore, have 


Mutation 

to be covered by sales on international 

markets. 

Roche is also multinational in terms 

of its people: in Basel, for instance, 

more than 50 nationalities work together 

at all levels. However, the most 

important reason for Roche’s multinationality 

is ultimately that neither 

disease nor medical science knows any 

frontiers. 

Mutation. Changes in the genetic 

material of a →cell; they can occur 

spontaneously or be deliberately induced 

in the laboratory (point mutations). 

Mutations can occur during the 

process of replication of genetic information 

before cell division or as a 

result of damage to the →DNA. Such 

damage may be caused by chemicals, 

irradiation or by ageing of the genetic 

material. 

97

NeoRecormon. Genetically engineered 

recombinant human →erythropoietin 

that stimulates the formation 

of red →blood cells. It is used to 

treat serious forms of →anemia in 

patients with chronic →kidney disease, 

premature babies and patients 

with certain types of tumour. 

NeoRecormon is a leading product 

for the treatment of anemia in cancer 

patients and patients with renal disease. 

Marketed by →Chugai under the 

trade name Epogin, it is approved in 

Japan for the indications of renal disease 

and anemia in premature infants. 

An application for the authorisation 

of its use in cancer was submitted in 

2005. 

NeoRecormon is indicated for the 

treatment of symptomatic anemia in 

adult cancer patients who are receiving 

chemotherapy for solid tumours and 

for symptomatic anemia in adult 

patients undergoing antitumour 

therapy for hematological tumours 

(such as multiple myeloma, low-grade 

non-Hodgkin’s lymphoma or chronic 

lymphocytic leukemia). 

NeoRecormon significantly reduces 

the need for blood transfusions, sparing 

patients their potentially detrimental 

effects. Subcutaneous Neo- 

Recormon has demonstrated its cost 

effectiveness in renal disease, with 

dose reductions of up to 30% compared 

to intravenous dosing, and European 

Best Practice Guidelines rec- 

98 

NeoRecormon 

N 

ommend NeoRecormon for practical 

and economic reasons. 

Neurotransmitters. Relatively simple 

chemical messenger molecules released 

by nerve cells (neurons); they 

include epinephrine, dopamine and 

glutamate. Dopamine deficiency is 

the cause of Parkinson’s disease 

(→antiparkinsonian agents). 

Nobel Prize. An annual international 

prize awarded by the Nobel Foundation 

for outstanding scientific achievement. 

Several laureates of this coveted 

award have contributed to Roche’s scientific 

accomplishments. The synthesis 

of vitamin C (ascorbic acid) from 

glucose (corn starch) – one of Tadeusz 

Reichstein’s most important achievements 

in the field of biochemistry – 

was successfully carried out for the 

first time in an industrial process at 

Roche and is still used today for largescale 

production. Numerous Roche 

scientists worked closely with Nobel 

laureates during their university 

studies, among them the chemists 

Otto Isler, who developed the first 

industrial synthesis technique for 

vitamins A and E, and Leo →Sternbach, 

the discoverer of the →benzodiazepines. 

A very close connection between 

Roche and the Nobel Prize was established 

in 1984 when the Swedish selection 

committee awarded the prize for 

physiology and medicine to Professor 

Niels Kaj Jerne and Dr Georges Köhler 

of Basel and Professor César Milstein

In 1984 Niels Kaj Jerne (left) and 

Georges Köhler shared the Nobel Prize 

for medicine with César Milstein 

(Cambridge). 

Susumu Tonegawa received the Nobel 

Prize for medicine in 1987 for his work 

done at the then Basel Institute for 

Immunology. 

of Cambridge (Great Britain). The pioneering 

work of the three researchers 

in elucidating the structure and mechanisms 

of the body’s immune system 

thus received international recognition 

and acclaim. Jerne and Köhler 

both worked at the former Basel Insti- 


Nobel Prize 

tute for Immunology, founded and financed 

by Roche. 

Professor Niels Kaj Jerne (1911 to 

1994), a Dane, wrote his doctoral 

thesis on antibody–antigen reactions 

and it has remained a standard work 

on the subject to this day (→antibodies, 

→antigen). His later theories, 

based on →molecular biology and 

genetics, laid the foundations for the 

modern science of immunology. He 

also developed the Jerne plaque assay, 

an important method for the quantitative 

assessment of immune responses. 

In 1969, having worked at a number 

of scientific institutions in Europe and 

the United States and at the World 

Health Organization (→WHO), Professor 

Jerne accepted the challenging 

task of setting up the Roche-backed 

Basel Institute for Immunology, which 

he directed until his retirement in 

1980. 

One of the many young scientists 

inspired and mentored by Jerne was 

the Munich-born biologist Georges 

Köhler (1946–1995), who joined the 

institute in 1971, shortly after it 

opened, to conduct the experiments 

for his doctoral thesis. After obtaining 

his doctorate at the University of 

Freiburg (Germany) in 1974, Dr 

Köhler was granted a two-year postdoctoral 

fellowship, during which he 

worked with Professor César Milstein 

at the Medical Research Council 

Laboratory of Molecular Biology in 

Cambridge. Early in 1975 the two 

researchers succeeded in producing 

monoclonal antibodies by fusing two 

99

Non-Hodgkin’s lymphoma 

types of immune cell. In 1976, Dr 

Köhler returned to the Basel Institute, 

where he had further success with pioneering 

experiments on the cellular 

genetics of antibody formation. In the 

spring of 1985 he was appointed head 

of the Max Planck Institute for Immunology 

in Freiburg. 

In 1987 another former member 

of the erstwhile institute, Professor 

Susumu Tonegawa, was awarded the 

Nobel Prize, in recognition of the work 

he had done in Basel in 1975–1981. 

During this period, he had succeeded 

in elucidating the structure and rearrangement 

mechanism of antibody 

genes. In doing so, he demonstrated 

that just a few hundred genes in the 

immune system’s B cells are responsible 

for the astounding variety of 

antibodies, of which some billions of 

different types exist. Professor Tonegawa 

has taught at the Massachusetts 

Institute of Technology in Cambridge 

(United States) since 1981. 

In 1993 the discoverer of the →polymerase 

chain reaction (PCR) method, 

the American Kary B. Mullis, was 

awarded the Nobel Prize for chemistry. 

Non-Hodgkin’s lymphoma. A group 

of several closely related cancers that 

affect the lymphatic system. Symptoms 

include swollen lymph nodes (in 

the neck, armpits or groin), coughing, 

shortness of breath, unexplained weight 

loss, fever, profuse sweating (particularly 

at night), and/or severe itchiness. 

However, these symptoms may also be 

signs of non-cancerous problems, 

100 

such as infections. There are no tests 

for early detection of non-Hodgkin’s 

lymphoma (NHL), so a medical consultation 

is essential if the symptoms 

persist. The exact cause of NHL remains 

unknown. However, research 

has focused on certain factors that 

may contribute to the development 

of lymphoma including genetic factors, 

impaired immune system and 

viruses such as HIV. The Roche drug 

→MabThera/Rituxan has dramatically 

improved the treatment of NHL over 

the past decade (→oncology). 

Nutley. A town in New Jersey (United 

States), near New York City. Since 

1929, when Roche moved there from 

New York and began its own largescale 

manufacture of pharmaceutical 

products, Nutley has been the US 

headquarters of the Roche Group. 

Today Nutley is an important centre 

for the discovery, development and 

sale of pharmaceuticals. In the USA, 

active pharmaceutical ingredients are 

produced in Boulder (Colorado) and 

Florence (South Carolina).


O 

Obesity. Also called adiposity. Obesity 

is still frequently regarded as more 

of a cosmetic than a health problem. 

Numerous studies conducted over recent 

years in the United States, Europe 

and several developing countries show 

that the number of grossly overweight 

people has increased appreciably and 

is continuing to grow. These people are 

almost always at high risk of developing 

– or have already developed – complications 

such as high blood pressure, 

elevated blood lipids, non-insulindependent 

diabetes, biliary disease 

and certain types of cancer. In light of 

this, the World Health Organization 

(→WHO) has set up the International 

Obesity Task Force to raise public 

awareness of obesity as a serious health 

problem, encourage prevention and 

treatment and facilitate international 

collaboration between experts, patient 

groups and health policy makers. 

Body mass index (BMI) has established 

itself as the international 

measure of obesity. It is calculated by 

dividing body weight in kilograms by 

body height in metres squared. If BMI 

is 20 or over and less than 25, weight is 

normal. A BMI of between 25 and 30 

is a sign that the patient is overweight, 

while an index over 30 indicates obesity 

or (over 40) severe obesity. Over 

40 percent of the population of 

the United States, Great Britain and 

Germany already have a BMI over 25, 

and the upward trend continues. In 

Japan, by contrast, only 20 percent of 

Occupational hygiene 

the population fall into this category. 

Apart from eating habits and lifestyle, 

research conducted in recent years has 

shown that genetic factors play a major 

role in predisposing certain individuals 

to obesity. 

Nowadays health experts recommend 

drug treatment not only for 

obese patients, but also for overweight 

patients with risk factors such as 

elevated lipids or high blood pressure. 

To treat these patients Roche has 

developed Xenical (active ingredient 

orlistat), a drug which blocks the 

breakdown and absorption of dietary 

fat in the gastrointestinal tract. When 

it is used in conjunction with a moderately 

fat-reduced diet, a permanent 

reduction in body weight in the order 

of 10 percent can be achieved. 

Unlike appetite suppressants, which 

act on →neurotransmitters in the brain 

and thus produce a number of side effects, 

Xenical acts only in the digestive 

tract. It has the additional advantages 

that it does not enter the circulation 

and markedly lowers elevated blood 

lipid levels. The weight loss achieved 

with Xenical can also improve risk 

factors associated with obesity, such as 

type II diabetes, hyperlipidemia and 

high blood pressure. 

Occupational hygiene. Scientific discipline 

concerned with protecting employees 

from potentially detrimental 

environmental influences at the workplace 

by identifying, evaluating and 

controlling chemical, physical, biological 

and other physiological work- 

101

Oncogene 

related risks. Harmful influences can 

adversely affect health and may even 

result, in a worst-case scenario, in occupational 

disease. The task of occupational 

hygiene in a company is to 

ensure that health hazards associated 

with the workplace are identified 

and eliminated before they cause any 

harm. Among other things, this 

involves periodically monitoring employees 

and assessing the risks associated 

with their working environments. 

Risks at the workplace are identified, 

for example, by analysing air samples, 

which may possibly be backed up by 

wipe tests of work surfaces and biological 

measurements (biomonitoring). 

Workplace assessments are carried 

out by means of risk analyses. To take 

chemicals handling as an example, the 

health risk associated with a given 

chemical is made up of its toxicity (the 

injurious effects it can potentially 

have) and by the way it is handled (e.g. 

the degree and duration of exposure). 

Expressed mathematically, risk = 

hazard × exposure. Recommending any 

necessary remedial action is an integral 

part of the occupational hygiene assessment. 

The identification, evaluation 

and control of the risks are the task 

of occupational hygienists, who work 

closely with other analysts (→analysis), 

safety experts (→safety), occupational 

physicians (→employee health service) 

and toxicologists (→toxicology). 

Oncogene. A gene that can cause 

cancer. More than one oncogene is 

involved in most types of cancer. 

102 

Oncology. The study of the diagnosis 

and treatment of cancer. An important 

therapeutic area at Roche. Cancer 

is the second most frequent cause 

of death in industrialised countries. 

Strictly speaking, it is not a single 

disease but rather a group of highly 

diverse clinical entities, all of which, 

however, are the result of uncontrolled 

(malignant) proliferation of human 

cells. 

The increasing success of cancer 

therapy is the result of a multimodal 

treatment approach involving surgery, 

radiotherapy, chemotherapy and immunotherapy. 

Immunotherapy, which 

specifically activates the body’s own 

defence mechanisms, has gained in 

importance in recent years. 

Roche has been involved in cancer 

research for decades and today is the 

world’s leading supplier of cancer 

drugs. The first successful cancer treatments 

were agents that killed dividing 

cells. Roche was a pioneer in this field 

with the introduction of →Fluorouracil 

Roche (5-fluorouracil, or 5-FU 

for short) in 1962. →Cytostatic or cytotoxic 

agents like 5-FU preferentially 

kill cancer cells, because they generally 

divide more rapidly than normal cells. 

However, such drugs also act against 

rapidly dividing normal cells, such as 

those of the gastrointestinal tract, 

mucous membranes and bone marrow. 

Consequently, they have serious 

side effects that are acceptable only in 

the treatment of severe disease. Roche 

has now developed a very well tolerated 

cytostatic agent called →Xeloda,

which is a significant advance in such 

therapies, offering an effective and 

convenient oral treatment option in 

breast and bowel cancer. 

New technologies have now opened 

up highly promising perspectives for 

the diagnosis and treatment of cancer. 

Recombinant DNA (→biotechnology) 

and hybridoma techniques were prerequisites 

for the development of 

→Roferon-A, the first of a series of 

immunotherapeutic agents. And certain 

antioxidants, such as vitamins C 

and E, may have an important role in 

cancer prevention. 

Roche and the US company 

→Genentech have collaborated in developing 

innovative agents which are 

revolutionising the treatment of cancer. 

These include the monoclonal 

→antibodies →MabThera (also known 

as Rituxan), →Herceptin, →Avastin 

and Omnitarg; and the small molecule 

→tyrosine kinase inhibitor →Tarceva. 

More than two million patients worldwide 

have benefited from Roche’s anticancer 

drugs in the past ten years. 

In addition to these products, Roche 

has also developed several drugs that 

can help relieve the significant side 

effects cancer patients have to endure 

as a result of their treatment, including 

Bondronat, →NeoRecormon and Kytril. 

Bondronat is used to treat bone metastases, 

relieving pain and reducing 

the frequency of bone fractures. Neo- 

Recormon, for →anemia, is given to 

reduce the need for blood transfusions. 

Kytril, which is used in Europe 

and the United States as concomitant 


Organ transplantation 

treatment during surgery, chemotherapy 

or radiotherapy, protects patients 

from the frequent and unpleasant side 

effects of nausea and vomiting. Both 

these products make a significant 

contribution to improving cancer 

patients’ quality of life. 

In the diagnostic field, Roche is 

pushing ahead with projects linking 

treatment and diagnosis for the ultimate 

benefit of patients. The development 

of →tumour markers that enable 

tumours to be detected and classified 

at an early stage should, in future, 

facilitate the early, targeted selection 

of the right drug for the individual 

patient and accurate monitoring of 

the therapeutic outcome. 

Organ transplantation. Patients with 

organ failure find themselves in a desperate 

situation because of the shortage 

of available organs and the long 

waiting period for transplants. Although 

those with kidney failure can 

always be treated by dialysis, the best 

solution is for them to receive a “new” 

kidney. In the case of liver, heart 

and/or lung failure, transplantation is 

the only alternative and operations of 

this kind are performed in specialised 

clinics all over the world. Certain other 

organs, such as the pancreas or small 

intestine or sometimes several organs 

simultaneously, can now also be transplanted, 

but the necessary surgical 

techniques are still in the developmental 

stage. 

Rejection of a transplanted organ, 

whether natural or artificial, can occur 

103

Orphan drugs 

at an early stage (acute rejection) or 

after a long process which destroys the 

organ over a period of years (chronic 

rejection). Most patients who receive 

an organ transplant have to take medication 

for the rest of their lives to protect 

the organ from rejection by their 

own body. This is achieved by means 

of drugs, often very aggressive ones, 

which suppress the →immune system, 

making the patients more susceptible 

to other diseases and to a series of 

severe side effects. For patients unfortunate 

enough to lose a transplanted 

kidney, there is always the fallback of 

dialysis; but if the transplanted organ 

is a vital one such as the heart, lungs, 

liver or pancreas, the only resort is a 

second transplantation. Drugs which 

can protect such patients against transplant 

rejection are of incalculable value. 

Roche is working to develop drugs 

which can help save the lives of patients 

with transplanted organs and 

ensure their well-being and autonomy. 

CellCept (mycophenolate mofetil) is 

an immunosuppressant that reduces 

the incidence of acute rejection. It is a 

less aggressive form of treatment, with 

a very favourable tolerance profile. 

Roche has also developed Valcyte (valganciclovir), 

a tablet form of antiviral 

medicine for the prevention and treatment 

of cytomegalovirus infection – 

cytomegalovirus is responsible for 

the opportunistic infections most frequently 

observed in transplantation 

patients. Roche collaborated with 

Protein Design Laboratories, Inc., to 

develop the first humanised mono- 

104 

clonal →antibody for preventing rejection 

of transplanted kidneys. The 

highly specific result of this work, 

Zenapax (daclizumab), was launched 

worldwide by Roche in 1998. 

Roche and Isotechnika, a company 

based in Edmonton, Canada, have 

signed an agreement stating their intention 

to jointly develop Isotechnika’s 

innovative transplant drug ISA247 

worldwide. ISA247 is an immunosuppressive 

agent that can be used in 

organ transplantation and for the 

treatment of →autoimmune diseases. 

Preliminary studies indicate that 

ISA247 is much more effective and 

possesses a much better side effect 

profile than other immunosuppressants 

of this type. The impressive 

properties of ISA247 hold out the 

prospect of substantial therapeutic 

advantages for patients over traditional 

calcineurin inhibitors. 

In 2005 Roche and BioCryst Pharmaceuticals, 

Inc. announced an exclusive 

license to develop and market 

BioCryst’s phase 1 compound BCX- 

4208 which prevents transplant rejection 

by a unique action on the body’s 

own reaction to determine when to 

initiate immune responses and when 

to accept or reject newly transplanted 

organs. It is hoped that BCX-4208 may 

offer autoimmune and transplant 

patients a potentially more effective 

treatment option. 

Orphan drugs. An expression current 

in the United States for →pharmaceuticals 

used to treat rare but life-threat-

ening diseases. Such products can 

never recoup their research and development 

costs, not to mention the marketing 

expenditure involved, and are 

thus often consigned to an “orphanlike” 

existence. Roche has developed 

a number of such preparations as a 

result of its basic research activities 

and, in the United States, has received 

special awards for these on several 

occasions. In the United States, orphan 

drug status is defined by legislation 

which affords special protection from 

competition over a period of several 

years if the medicinal product involved 

benefits no more than 200,000 

patients. 

Osteoporosis. A condition that is 

characterised by depletion of bone 

mass, deterioration of bone structure 

and an increased risk of fractures. In 

most cases the diagnosis is only made 

after a fracture has occurred, most 

typically a fracture of the hip, spine 

or lower arm. Numerous factors contribute 

to the development of osteoporosis, 

but by far the most significant 

is accelerated loss of bone mass, which 

becomes a concern in women during 

the menopause and in elderly men. To 

guard against this condition, doctors 

recommend a balanced diet rich in 

calcium and vitamin D and physical 

exercise. 

Osteoporosis is generally diagnosed 

by measuring bone density with quantitative 

computed tomography (QCT) 

or quantitative ultrasound (QUS). Bone 

markers can make a valuable contri- 


Osteoporosis 

bution to monitoring the progress of 

osteoporosis treatment by giving some 

indication of its efficiency and also by 

providing a means of monitoring 

patient compliance. Bone markers also 

help to assess the fracture risk and 

potential bone mass loss. They provide 

information on whether a prescribed 

course of treatment is proving successful 

a lot earlier than bone density measurements. 

The →Diagnostics Division’s 


area offers the following immunological 

serum marker tests: Bone absorption 

markers for sensitive monitoring 

of the progress of antiabsorption 

treatment and predicting the risk of 

fractures; bone formation markers for 

sensitive monitoring of the progress 

of anabolic and antiabsorption treatment; 

bone markers for monitoring 

treatment progress and predicting the 

risk of fractures; and intact parathyroid 

hormones for the differential 

diagnosis of hypercalcemia and hypocalcemia. 

To avoid bone damage, early 

diagnosis and initiation of treatment 

are essential. 

There is also a number of Elecsys tests 

for the Elecsys 2010, the E170 module 

for the Modular Analytics SWA and 

the e 601 module for the cobas 6000 

family of analysers. 

In addition to calcium and vitamin 

D substitution, bisphosphonates, 

selective estrogen receptor modulators 

(SERMs) and calcitonin in particular 

are used to treat osteoporosis. Roche 

has developed the preparation Bonviva 

(Boniva in the USA), which slows 

105

Osteoporosis 

the accelerated breakdown of bone 

and increases bone mass, thereby significantly 

reducing the incidence of 

fractures, e.g. vertebral fractures. Bonviva/Boniva 

is the first oral bisphosphonate 

approved for the treatment 

of postmenopausal osteoporosis that 

only needs to be taken once a month. 

Roche and its marketing partner 

GlaxoSmithKline have introduced the 

preparation in the United States and 

Europe. Launched in January 2006, 

Boniva Injection is the first approved 

intravenous form for the treatment of 

postmenopausal osteoporosis. Boniva 

Injection only needs to be administered 

once every three months and is 

primarily intended for patients who 

are unable to tolerate oral bisphosphonate 

treatment. 

→Chugai distributes the drug Evista 

(SERM) in Japan. 

106


P 

Packaging. Packaging serves to protect 

goods which often have to travel a 

long way to the consumer and in some 

cases pass through different climate 

zones. It also conveys information and 

aids identification and distribution. 

Suitable packaging is often required 

simply to be able to transport and sell 

a product. 

Packaging for pharmaceuticals must 

satisfy a wide variety of requirements. 

Dosage forms – tablets, capsules, prefilled 

syringes, vials, etc. – are sensitive 

products in loose form and only become 

usable medicines in combination 

with a number of packaging elements 

(e.g. bottles, tubes or blister packs). 

Packaging consisting of several elements 

(typically a container, labelling, 

a leaflet and a carton) are the rule, with 

each element fulfilling specific functions. 

The choice of packaging material 

must be adapted to the contents. 

Plastic containers or foil must be 

tested for compatibility with the products 

they are to contain, and even glass 

must fulfil quite specific requirements 

regarding neutrality and compatibility. 

An expiry date for the preparation 

is printed clearly on the pack, and 

other symbols allow the contents to 

be identified by manufacturing batch. 

Packaging should be user-friendly, but 

must also guard against the risk of 

→counterfeit drugs. 

The different requirements that 

packaging has to meet can often conflict, 

particularly with regard to eco- 

Palo Alto 

logical aspects or safety (→child-proof 

drug containers). Roche relies primarily 

on environmentally-compatible 

materials for its packaging, e.g. cardboard. 

Palo Alto. Research centre and one of 

the →Pharmaceuticals Division’s global 

research sites. Situated on a park-like 

campus, the centre currently employs 

around 1,000 people. Work at Palo 

Alto (California) focuses on the discovery 

and early clinical development 

of innovative new medicines to treat 

serious diseases, including arthritis, 

asthma and other respiratory diseases; 

anxiety, depression, schizophrenia and 

other psychiatric diseases; genitourinary 

diseases, HIV infection/→AIDS 

and →hepatitis C. The research centre 

in Palo Alto makes a significant contribution 

to Roche’s portfolio of new 

drugs. 

Located on the Roche campus in 

Palo Alto on San Francisco Bay, the 

company is in the heart of Silicon 

Valley, close to a number of renowned 

academic institutions, including 

Stanford University, the University of 

California, San Francisco, and the 

University of California, Berkeley. 

The synergies between the university 

and the private sector have created an 

environment in which leading-edge 

research can be conducted in numerous 

disciplines. 

Research operations began in 1961, 

when Syntex set up its headquarters on 

the current Roche site in Palo Alto. 

From the time of its formation until it 

107

Parent company 

was taken over by Roche in 1994, 

Syntex was widely renowned for its 

innovative approach in the synthesis 

of steroidal and nonsteroidal drugs. 

Two medicines that were developed 

at the Palo Alto site and are now on the 

market are CellCept (→organ transplantation) 

and Valcyte (→AIDS, 

→antimicrobials). 

Parent company. The origins of the 

Roche Group go back to the firm of 

F. Hoffmann-La Roche & Co. Ltd in 

Basel. The company was registered as a 

limited partnership on the initiative of 

Fritz →Hoffmann-La Roche on 1 October 

1896 and became a public limited 

company in 1919. In terms of 

commercial law it was a combined 

production, trading and holding company. 

As part of a capital restructuring 

carried out in 1989, the parent company 

became Roche Holding Ltd. 

Since then the Swiss operating company, 

F. Hoffmann-La Roche Ltd, 

Basel, has assumed some key parent 

company functions on behalf of the 

→holding company (→Group). 

Today, the parent company is one 

of Roche’s largest centres of research, 

production and administration. Group 

management and →corporate functions 

are based in Basel, as are the 

headquarters of the →Pharmaceuticals 

and →Diagnostics Divisions. Basel is 

also home to the global pharmaceutical 

functions and certain worldwide 

pharmaceutical research and production 

operations. 

108 

Patents. Legal protection for inventions. 

→Research is about discovery, 

gaining new insights. In the interests 

of progress, this knowledge should be 

made available to the public. But this 

would mean revealing it also to competitors, 

who could use the fruits of 

someone else’s work to further their 

own commercial ends. By patenting 

their findings, inventors or their legal 

representatives are guaranteed a certain 

head start, which enables them to 

recoup the cost of the research involved 

and, possibly, earn additional 

funds to finance other research projects. 

The publication of patents promotes 

the exchange of scientific and 

technical information and lays the 

foundations for new developments 

and progress. By means of patents, a 

company can either prevent the use of 

its discoveries by third parties, or put 

them at their disposal under licence 

for an appropriate fee. 

However, inventions can only be 

patented if they are genuinely new and 

original and are suitable for commercial 

exploitation. The protection conferred 

by a patent is generally limited 

to one country and lasts for about 

twenty years from the filing date. 

Accordingly, patent applications have 

to be filed in each country in which 

protection is desired, although regional 

and international patent 

treaties have considerably simplified 

the application process. Due to the 

long development phase for pharmaceuticals, 

it can be years before a drug 

product is approved (→registration)

and launched. This means that the 

effective period of protection is often 

about ten years or less. However, in all 

important markets, including the 

United States, Europe and Japan, 

patents for →pharmaceuticals can be 

extended for up to five years. 

Roche holds or has licences for over 

25,000 patents and patent applications 

in around 60 countries. These patent 

rights are not always strictly observed 

by third parties, and must then be 

enforced by legal action. 

Patient self-monitoring kits. Diagnostic 

tests for patients to perform 

themselves as a check on treatment for 

a specific disease, for example →glucose 

self-monitoring kits and →coagulation 

self-monitoring systems. 

PCR. →Polymerase chain reaction. 

Pediatric pharmaceuticals. Until 

now drugs have been systematically 

tested in children only if the disease in 

question was common in children and 

there was felt to be a great need for 

treatment, e.g. medicines for viral 

and bacterial infections, epilepsy or 

asthma. Since most other medicines 

were not systematically tested for 

safety and efficacy in children, doctors 

had to prescribe them outside the 

approved indications (“off-label”). A 

discrepancy thus exists between the 

very advanced standards of drug treatment 

for adults and the “trial-anderror” 

approach for children. This 

discrepancy is most marked when it 


Pediatric pharmaceuticals 

comes to neonates and toddlers. Most 

countries issue pediatric dosage tables 

for guidance purposes, but these are 

not based on systematic clinical trials 

and therefore do not meet the standards 

that currently apply to dosefinding 

in adults. 

On the one hand, the rules of the 

market on their own do not create sufficient 

demand for pediatric clinical 

drug development. On the other, 

impressive therapeutic breakthroughs 

have been made over recent decades 

in the treatment of children that offer 

a glimpse of the growing possibilities 

of modern drug treatments. Forty 

years ago a diagnosis of acute lymphatic 

leukemia (ALL) amounted to 

a death sentence for the child concerned. 

Systematic studies conducted 

since then have increased the survival 

rate by 10 to 20% per decade, so that 

nowadays some 90% of children survive 

ALL. These and other factors have 

prompted social intervention. The 

first step was made in 1997 by the US 

government with the introduction of 

two complementary pieces of legislation: 

one offered pharmaceutical companies 

a patent extension for clinical 

pediatric studies; the other compelled 

companies to conduct pediatric studies 

if a relevant need in children 

existed or was expected. 

An equivalent discussion was initiated 

in the EU in 2000 and a draft 

regulation was passed by the EU parliament. 

The final regulation was subsequently 

published in the Official 

Journal of the European Union in 

109

Pediatric pharmaceuticals 

December 2006 and entered into force 

in all countries of the EU one month 

later. In a welcome development, Swissmedic 

was involved in the preparation 

of the regulation even though Switzerland 

is not a member of the EU. The 

regulation requires the submission of 

a clinical pediatric investigation plan 

to the European Medicines Evaluation 

Agency (EMEA) on completion of 

phase 1 studies in adults. In return for 

preparing this investigation plan, 

companies receive a 6-month patent 

extension. A pediatric investigation 

plan is also required for drugs that are 

already on the market and for which 

a new indication or pharmaceutical 

form is requested. For drugs that have 

already undergone pediatric studies in 

other countries (primarily at the request 

of the US authority FDA), the 

existing data must be submitted to the 

European licensing authority. Specific 

projects are envisaged for older drugs. 

The EU discussion has provided 

greater clarity concerning the point at 

which children should be included in 

the drug development process. A careful 

assessment of the situation is required, 

taking account of potential 

uses, other currently available medication 

and the risk of exposing children 

to a new substance, the safety of which 

is still uncertain. Key guidelines for 

such an assessment are provided in 

the ICH (International Conference on 

Harmonisation) Guidance E11 on the 

“Clinical Investigation of Medicinal 

Products in the Pediatric Population”, 

which specifies the need for early initi- 

110 

ation of pediatric studies in the case of 

life-threatening diseases, and studies 

at a later stage for all other diseases, 

when much more is known about the 

safety and efficacy of the drug in 

adults. Many development projects are 

terminated before approval is granted 

either because of safety issues or because 

the drug under investigation is 

less effective than anticipated. Routine 

testing of all early-stage projects in 

children or the routine preparation of 

subsequent pediatric studies would 

be extremely time-consuming. Such a 

process would not only be unethical, 

but would also massively increase 

overall development costs and, especially 

if a project were subsequently 

terminated, serve no purpose. Fasttracked 

clinical development of new 

drugs for children will probably remain 

the exception, only used when 

breakthroughs in the treatment of lifethreatening 

illnesses are achieved. Possible 

examples would be new drugs for 

the treatment of currently incurable 

pediatric cancers or neuromuscular 

diseases. 

Introducing a pediatric factor into 

the general drug development process 

represents a substantial investment for 

all pharmaceutical companies since 

they will have to accumulate knowledge 

about the epidemiology of the 

target illness in children, the age-related 

course of the disease, its natural 

course in children without therapeutic 

intervention, its mechanism in various 

age groups and many other aspects. In 

the USA, this already forms the basis

for negotiations with the FDA. Modern 

drug development is a complex 

process that involves much more than 

just clinical trials. Increased demands 

will be made on two areas in particular: 

the development of suitable pediatric 

formulations, usually in liquid 

form since small children are unable to 

swallow tablets, and the inclusion of 

young laboratory animals in preclinical 

safety studies designed to predict 

the effects and side effects on the still 

developing organ systems of children. 

Global companies with a significant 

presence in the United States are 

already having to comply with US 

pediatric legislation. Roche has already 

conducted systematic clinical 

studies of a series of drugs in children, 

including Tamiflu, Xenical and 

Fuzeon. Investigation plans for other 

drugs such as Xeloda and Bonviva are 

being discussed with the FDA. This 

aspect will become even more important 

with the introduction of European 

legislation, and corresponding 

pediatric investigation plans are 

already being drafted. Roche has set up 

a permanent interdisciplinary group 

involving all the important pharmaceutical 

functions to meet the challenges 

posed by the pediatric legislation 

in the USA and the EU. 

Penzberg. A town south of Munich, 

on the edge of the Bavarian Alps in 

Germany, where Boehringer Mannheim 

found a suitable location in 1972 

for its biotechnology activities. In 

1998, the company was integrated into 


Pharmaceuticals Division 

Roche Diagnostics GmbH. The Penzberg 

site has developed into one of 

Europe’s leading →genetic engineering 

and biotechnology research and production 

centres. With a payroll of over 

4,000, Penzberg is the only Roche site 

that combines research, development 

and production operations of the 

→Pharmaceuticals und →Diagnostics 

Divisions. The facility concentrates on 

system development for immunological, 

clinical chemistry and molecular 

diagnostic (→PCR technology) applications 

and on the research, development 

and manufacture of therapeutic 

→proteins and other active ingredients. 

Pharmaceuticals. Collective term for 

products intended to restore health 

or prevent disease. Originally made up 

by pharmacists, most pharmaceuticals 

are now manufactured industrially. 

One possible definition might be: 

“Products of chemical, biotechnological 

or biological origin which are 

intended or purported to have a 

medicinal effect in man or animals, 

and which are used especially for the 

detection, prevention or treatment of 

diseases, injuries or disabilities.” The 

manufacture and sale of pharmaceuticals 

are subject to strict statutory controls 

in virtually all countries (→registration). 

Pharmaceuticals Division. The Pharmaceuticals 

Division comprises a 

number of functions in Basel itself, 

together with the Roche companies 

111

Pharmacoeconomics 

abroad that are responsible for the 

pharmaceuticals business. Roche began 

as a purely pharmaceutical company 

(→Hoffmann-La Roche, Fritz) 

and the Pharmaceuticals →Division is 

still the most important in the Group. 

The division consists of →Rx (prescription 

drugs), →Genentech and 

→Chugai. 

The division is organised on the 

principle of full vertical integration, 

which means it encompasses all →research 

and development, production 

and →marketing activities – as well as 

the necessary support functions. 

Roche seeks to research, develop 

and market clinically differentiated 

drugs that produce significant benefits 

for patients, either by saving life 

or by substantially improving quality 

of life. 

Roche has made significant contributions 

to the prevention and control 

of widespread and often life-threatening 

diseases. Its most important prescription 

drugs are used in the following 

therapeutic areas: metabolic 

disease, virology, oncology, blood diseases, 

disorders of the central nervous 

system, cardiovascular disease, inflammatory 

disease and transplantation 

medicine. 

Research is focused on the areas of 

inflammatory disease/bone disease, 

disorders of the central nervous system, 

vascular disease, oncology, metabolic 

disease, genitourinary disease 

and virology. 

112 

Pharmacoeconomics. A science 

which helps determine what benefits 

a new drug offers to offset its costs. As 

a result of the growing cost pressure 

on healthcare providers, pharmacoeconomic 

research has steadily gained 

in significance. 

Pharmacoeconomic research identifies 

and quantifies all relevant costs 

and consequences of a course of treatment 

and compares these with the 

existing standard. By “consequences” 

we mean the effects of the treatment, 

wanted and unwanted, as well as the 

usage of resources it entails. This 

makes it possible, for example, to ascertain 

whether an ostensibly highcost 

medicine could save even greater 

costs in the long run, because it would 

reduce the length of hospital stays. 

In most countries, pharmacoeconomic 

data are not required to obtain 

approval for a drug. However, this 

information is valuable and in some 

cases a prerequisite for inclusion on 

the drug reimbursement lists maintained 

by health authorities, health 

insurers and managed-care organisations. 

Pharmacogenetics. Investigates and 

describes the variations in the genes of 

individuals and their effect on the efficacy 

and side effects of →pharmaceuticals. 

This information can be helpful 

in the research and development of 

drugs, but it can also be used in selecting 

the right dosage of the right medicine 

for particular patients.

Pharmacogenomics. Considers the 

interaction between active pharmaceutical 

ingredients and the totality 

of all genes, i.e. the →genome of an 

individual. 

Pharmacokinetics. The study of the 

dynamic behaviour of pharmaceutical 

substances in biological systems; in 

particular it is used to describe the absorption 

of a substance into the body, 

its distribution throughout the body 

and its tissues, and its elimination 

from the body through metabolic conversion 

to other substances (which 

may or may not be biologically active) 

or expulsion in excreta, i.e. urine and 

bile ( →pharmacology). 

Pharmacology. The branch of science 

that deals with the study of drugs (and 

poisons) and their actions on living 

systems. The study of the interactions 

between exogenous substances, drugs 

or poisons and biological systems, that 

is, living organisms. The study of the 

effects of foreign substances on the 

body is referred to as pharmacodynamics; 

the fate of a foreign substance 

in the body – how it is absorbed, 

distributed, altered and ultimately 

eliminated – is known as →pharmacokinetics. 

The special area of pharmacology 

concerned with the nature 

and effect of poisons and thus also 

with the toxic effects of drugs, is called 

→toxicology. The results of pharmacological 

investigations form the basis 

for the field of pharmaceutical →formulation, 

which is concerned with spe- 


Phelophepa 

cific dosage forms and modes of drug 

delivery. 

Whether or not the effects of a 

promising drug are discovered depends 

largely on the types of pharmacological 

tests available. Not all diseases 

have suitable pathological 

models, for example, rats with high 

blood pressure. 

The →immune system can be both 

the target of treatment and a means 

of fighting a disease. For many, the 

term immunopharmacology means 

the influencing of the immune system, 

through stimulation, suppression 

or modulation, by endogenous and 

exogenous substances; others regard it 

as the study of the effects on the body 

of substances which also occur in the 

immune system, for example →antibodies 

and →cytokines (→Roferon-A). 

Phelophepa. Made up of two words 

from different South African languages 

which, when translated literally, 

mean “good, clean health”, 

Phelophepa is the name of a mobile 

clinic on rails. Roche has been supporting 

the “Train of Hope”, as local 

people call it, since 1994 and is one of 

its leading sponsors. In May 2002 

Roche was honoured with an award 

113

Plasmid 

for this project (→social responsibility). 

The 16-coach train provides basic 

medical care in rural districts of South 

Africa and spends 36 weeks a year travelling 

around the country. A permanent 

staff of 14 work with about 

40 students preparing for careers in a 

variety of medical fields and who each 

spend 14-days on the train gaining 

valuable practical experience. Over 

40,000 people are treated on the train 

every year. To date the Health Train has 

reached over seven million people in 

remote parts of South Africa. In addition 

to the Health Clinic, which is 

wholly funded by Roche, the train can 

provide help in the areas of dental, 

ophthalmic and psychiatric care. Phelophepa 

even has its own pharmacy 

on board. The personnel of the Roche 

Health Clinic also travel to various 

schools in the area in order to examine 

and treat local children with specific 

problems, for example ear infections. 

At each of the 36 annual stops visited 

by the so-called Edu Clinic, 

around 20 members of the local community 

come aboard for a five-day 

course that provides basic information 

on subjects such as first aid, hygiene, 

infectious diseases, sound nutrition 

and family health. This method of 

helping people to help themselves has 

brought about a significant and lasting 

improvement in the health of people 

living in the regions visited by the 

train. 

In 2001 the coach housing the 

train’s health clinic was officially re- 

114 

named the “Roche Health Clinic” in 

recognition of Roche’s long-standing 

and continuing support. Roche has assumed 

full financial responsibility for 

this clinic and provides all funding for 

maintenance, salaries, medical equipment, 

consumables and training materials. 

Since 2002 Roche has also been 

contributing to initial and in-service 

training activities to help the clinic’s 

staff stay abreast of the latest advances 

in primary care and provide the best 

possible services. Since 2003 the train 

has been able to offer several new services 

(cancer screening tests and diabetes 

prevention) thanks to additional 

funding provided by Roche. 

At a ceremony in 2002, South 

Africa’s Ambassador to the USA, Sheila 

Sisulu, presented Roche with an award 

for its involvement in the project. 

Plasmid. A small piece of bacterial 

→DNA which is capable of independent 

replication within a host organism. 

Most genetic manipulations are performed 

on bacterial plasmids. 

Pleasanton. Following the acquisition 

of Boehringer Mannheim by Roche in 

1998, →Molecular Diagnostics, a business 

area of the →Diagnostics Division, 

established its global headquarters 

in Pleasanton, California, USA 

(east of San Francisco Bay and Silicon 

Valley). Today Pleasanton is one of 

Molecular Diagnostics’ 3 centres of excellence, 

home to one of two research 

and development centres for the company’s 

growing range of →PCR- and

eal-time PCR-based analytical systems 

and tools for →in vitro diagnosis. 

The other research and development 

centre of excellence for Molecular Diagnostics 

is in Rotkreuz, Switzerland, 

with the Molecular Diagnostics’ main 

manufacturing centre of excellence in 

Branchburg, New Jersey, US. These 

tools and automation platforms, including 

the first microarray-based 

diagnostic system, are used worldwide 

in the areas of donor →blood screening, 

→genomics, infectious diseases, 

microbiology and →oncology. Around 

400 of the 1,100 employees of Molecular 

Diagnostics work in Pleasanton, 

500 in New Jersey, and 200 in Switzerland. 

Point of Care Testing. General term 

for all tests carried out not just in 

laboratories but wherever patients are 

treated, for example in intensive care, 

emergency admissions, medical practices, 

outpatient services, at pharmacies 

or at home. In these user-friendly 

tests, the specimen – a drop of blood 

or urine sample – is applied to the reaction 

zone and the result is available 

within seconds or no more than a few 

minutes. Point of Care tests permit 

rapid and reliable diagnosis, so treatment 

can be started without delay. This 

results in improved quality of healthcare 

and lower overall costs (→test 

strips, →Professional Diagnostics). 

Polymerase chain reaction (PCR). 

A molecular biological technique for 

copying selected portions of genetic 


Polymerase chain reaction (PCR) 

material (→DNA) millions of times 

over, as an aid to subsequent analysis. 

PCR technology was developed during 

the period of 1985–1989 by scientists 

at the California biotechnology firm 

Cetus Corporation, under the direction 

of Kary B. Mullis (who was 

awarded the →Nobel Prize for chemistry 

in 1993). In 1989 Roche scientists, 

in collaboration with Cetus 

Corporation, began developing the 

first commercial applications for the 

diagnosis of infectious diseases. In 

1991 Roche reached an agreement with 

Cetus concerning the acquisition of the 

rights to all technology and processes, 

as well as the patent rights for existing 

and as yet unknown PCR applications. 

Other assets of Cetus Corporation, 

including HIV and hepatitis C patent 

rights, were acquired by Chiron Corporation 

(now Novartis). 

In basic biomedical research, PCR 

is one of the key molecular biological 

tools for detecting and deciphering the 

genetic material of living organisms 

and analysing its function. PCR technology 

can also be employed to identify 

the genetic causes of many illnesses. 

In pharmaceutical research this 

can be vital for the development of 

new types of drugs that target the actual 

causes of disease. The technology 

is also used in forensic analysis and 

medicine, for example to determine 

paternity or to establish the biological 

origin of traces of blood, hair or semen 

found at the scene of a crime. 

One of the main applications of 

PCR technology is in the early diagno- 

115


Using PCR technology, a single fragment of genetic material (DNA) can be copied 

millions of times in just hours, yielding enough material for the detection of 

hereditary diseases, cancer cells or viruses. 

sis of infections and genetic conditions, 

and potentially of cancer. This 

applies, for example, to infections 

caused by →AIDS or →hepatitis C 

viruses, Chlamydia or tuberculosis 

bacteria, or sepsis-causing bacteria 

and fungi. PCR methods can detect 

latent pathogens which other tests 

cannot identify, or which they can only 

identify with difficulty or after a 

lengthy period. PCR tests are the most 

efficient method currently available 

for direct, rapid detection of HIV and 

hepatitis infection. Quantitative PCR, 

moreover, is the method of choice for 

monitoring the treatment of patients 

with HIV or hepatitis infections. 

PCR tests can also be used to improve 

the safety of the donated blood 

116 

and blood products used in a variety of 

medical therapies by providing highly 

sensitive screening for possible infection. 

The comprehensive range of tests 

produced by the →Diagnostics Division’s 

→Molecular Diagnostics business 

area, which are based on highly 

sensitive PCR and real-time PCR technologies, 

has brought about a revolution 

in routine clinical diagnosis. The 

first tests in this series were introduced 

in 1992; today, there are test kits 

for hepatitis C virus (quantitative and 

qualitative assays), for HIV-1 (quantitative 

and qualitative assays), for 

Mycobacterium tuberculosis, M. avium, 

M. intracellulare, Chlamydia trachomatis/Neisseria 

gonorrhoeae, hepatitis B

Cobas Amplicor – an automated molecular 

diagnostic system that performs 

amplification and detection automatically. 

Amplicor HIV-1 Monitor – a quantitative 

molecular diagnostic test for 

measuring viral load in the blood of 

HIV-positive patients. 

virus (quantitatively), the cytomegalovirus 

(quantitatively), and other pathogens. 

The Amplicor HIV-1 Monitor test 

sets new standards: It is the first commercially 

available test for determining 

the viral load in the blood of HIV 

patients. This provides a very reliable 

method for tracking the course of the 

infection and helps doctors employ 

medications such as protease inhibitors 

more effectively. The test was 



approved by the US health authorities 

in mid-1996, a mere seven months 

after application for registration, and 

has had an extremely positive reception 

in the market. Amplicor HIV-1 

Monitor, which has been available on 

the European market since 1995, has 

become the most frequently used test 

of the PCR range. 

In 1995 →Cobas Amplicor, the first 

automated system, was launched. This 

instrument performs the amplification 

and detection steps automatically, 

giving clinical laboratories a simpler, 

more efficient method for molecular 

diagnosis. The automation process 

was continued and completed in 2001 

with the introduction of the Cobas 

AmpliPrep. This device automates 

sample work-up so that all three stages 

of a diagnostic PCR test, i.e. sample 

preparation, amplification and detection, 

can now be processed by the 

appropriate automated systems. 

The latest development in the field 

of diagnostic PCR at Roche are devices 

offering “real time” PCR based on 

Roche “TaqMan” technology. The first 

Cobas TaqMan was launched in 2003. 

The TaqMan technology accelerates 

and simplifies the process of diagnostic 

PCR. It is, in fact, a highly sensitive 

quantitative method with a very wide 

linear measuring range. “Real time” 

PCR, combined with automation of 

the Cobas AmpliPrep and Cobas 

TaqMan instrument platform, represents 

another quantum leap in the 

development of diagnostic PCR 

methods. 

117

Predisposition 

In June 2005 Roche opened the 

world’s largest PCR production facility 

in Branchburg, New Jersey, USA. The 

site will focus on the manufacture and 

delivery of sector-leading products 

based on this technology. Roche has 

invested over USD 150 million in the 

construction of this new plant and the 

renovation of the existing factory. The 

new centre has enabled Roche to concentrate 

all the production operations 

of factories scattered across New Jersey 

on a single site in Branchburg. Up to 

800 employees will work in the new 

complex, which has created around 

350 new jobs. 

Predisposition. A situation that 

favours the development of an illness 

on the basis of an existing susceptibility. 

Such a susceptibility is either inherited 

or the result of constitutional 

factors such as age, sex or any kind of 

previous illnesses. 

Prevention. Involves measures taken 

to prevent diseases, etc. Prevention can 

be subdivided into three categories: 

primary prevention, which eliminates 

harmful factors before they can take 

effect; secondary prevention, which 

identifies and treats diseases at the 

earliest possible stage; and, finally, tertiary 

prevention, which attempts to 

prevent any deterioration or complications 

once a disease has occurred. 

Prices. In virtually all countries with 

the exception of the United States, 

pharmaceutical prices are set and con- 

118 

trolled by national pricing authorities. 

In Europe in particular, there is a complex 

network of price controls for 

drugs. The main reasons given for state 

control of pharmaceutical prices are 

alleged lack of competition, payment 

for drugs by state health insurance 

schemes and a general drive to contain 

healthcare costs. Funding limitations 

have forced most healthcare systems to 

implement a wide range of cost-containment 

measures. These range from 

systems that control the prices of new 

products as they enter the market (e.g. 

Europe), to systems that support the 

fast entry of large numbers of cheap 

generic products at the end of the 

patent life of a product (e.g. United 

States). The mechanisms applied to 

control market prices also vary considerably, 

from price comparisons with 

other countries (seen within and 

across all geographic regions) to 

“fixed-price” systems within the same 

health care system, where similar 

products are referenced and eventually 

also clustered into one price category), 

to imposed periodic price cuts across 

all pharmaceutical products (e.g. 

Japan). In some countries market prices 

are indirectly controlled through imposed 

limits on the profitability of 

pharmaceutical companies. Some countries 

actually operate a mixed regime 

incorporating elements from various 

systems. In most cases, such interventions 

adversely affect research-based, 

innovative companies and tend to 

strengthen the position of imitators. 

Though possibly of (short-term) ben-

efit to the health budget, or at least to 

the health insurers, in the long term it 

is an obstacle to progress. Value-based 

pricing (based on clinical and pharmaco-economic 

evidence) and the exploration 

of a personalised medicine 

approach (which looks into optimal 

allocation of scarce healthcare resources 

through identification of specific 

target patient groups) are increasingly 

requested by local healthcare 

authorities before they accept the price 

of a new pharmaceutical product. 

Prix Galien (Prix Galien de la 

Recherche Pharmaceutique). Highest 

and most prestigious award for 

pharmaceutical research. The Prix 

Galien is named after the ancient 

Greek philosopher and physician, 

Claudius Galenus (AD 130–200), who 

is generally recognised as the “father 

of modern pharmacology”. The Prix 

Galien has been awarded annually in 

France since 1970 (and latterly in other 

countries and at an international level) 

to a product which represents a significant 

medical breakthrough and can be 

said to display special innovative therapeutic 

properties. Various drugs from 

Roche’s pharmaceutical research laboratories 

have received the Prix Galien. 

Roche first won the prize in 1974 

with the →antiparkinsonian agent 

Madopar (levodopa plus benserazide). 

The award was recognition of Roche’s 

concentrated efforts to eliminate the 

severe side effects associated with previous 

therapies based on levodopa 

alone. 


Prix Galien 

In 1984 the prize was awarded to 

Tigason, the first truly effective treatment 

for severe forms of psoriasis. 

The active ingredient of Tigason is a 

retinoid. Despite the considerable risk 

of side effects, the jury felt that the 

relief of the severe, unsightly symptoms 

of psoriasis was so significant an 

achievement as to merit the award. 

In 1988 the Prix Galien went to the 

benzodiazepine antagonist Anexate, 

which offers dose-controlled reversal 

of the effects of benzodiazepines and 

thus adds a new dimension to anesthesia 

(→antagonists, →benzodiazepines, 

→psychotropic drugs). 

Neupogen and →Invirase (1998 

International Prix Galien) have also 

won national Galen awards in various 

European countries. 

Herceptin was awarded the Prix 

Galien in 2002. Herceptin was the first 

drug specifically developed to inhibit 

the function of the protein HER2, 

which is present on the cell surface in 

increased quantities in some forms of 

breast cancer. For women with HER2positive 

breast cancer, including those 

in an advanced stage of the illness, 

Herceptin promises a significantly 

improved life expectancy. The preparation 

is not burdened with the side 

effects of traditional chemotherapy, 

thus giving back patients a better quality 

of life (→oncology). 

In 2004 the International Prix 

Galien was awarded to →Fuzeon, the 

first of a new class of highly innovative 

anti-HIV drugs known as “fusion inhibitors”. 

Unlike existing HIV drugs, 

119

Product distribution 

which attack the virus once it has already 

infected the human cell, Fuzeon 

prevents the virus from entering the 

cells in the first place. 

Product distribution. The distance a 

Roche product has to travel to get 

from factory to consumer is often 

long and, depending on the type of 

product, may include a number of 

stops en route. Generally speaking, 

Group companies are responsible for 

distribution within their domestic 

markets (→logistics). Many diagnostic 

products, e.g. laboratory equipment, 

are not sold through specialist dealers 

since they are usually supplied direct 

to customers such as teaching and 

non-teaching hospitals, institutes, 

laboratories or pharmacies. 

Roche products intended for sale to 

individual users are distributed through 

a chain of specialist wholesalers and 

outlets (pharmacies and health-aid 

outlets). This method of distribution 

is reliable and economical, given that 

the products eventually have to reach 

innumerable points of sale. Together 

with pharmaceutical manufacturers, 

specialists further down the supply 

chain, and particularly pharmacists, 

often play a crucial role in providing 

information about products and 

maintaining inventories of them. Ideally, 

a drug should be available everywhere 

and at all times. In view of the 

great variety of preparations and the 

considerable differences in the quantities 

consumed, this can prove difficult. 

Even drugs which are rarely needed 

120 

must be constantly available in perfect 

condition. Similarly, adequate supplies 

of commonly used preparations must 

be assured to cope with emergencies 

(such as epidemics). The various links 

in the distribution chain between the 

manufacturer and the consumer provide 

for blanket coverage and make 

distances shorter for the consumer. 

Even though an efficient and reliable 

system of distribution exists in industrial 

countries – including Switzerland 

– provision must be made for emergencies. 

For this reason a firm such as 

Roche must always have staff on call 

who can arrange for the supply of 

urgently needed products even at 

night and at weekends. 

Many diagnostic products – laboratory 

equipment, for example – are not 

distributed via specialist wholesalers 

but are generally supplied directly to 

customers, which in this case include 

hospitals, laboratories, pharmacies 

and other healthcare institutions. 

Product safety. The pharmaceutical 

industry has the responsibility of 

developing products – medicines – that 

are safe to use and of monitoring them 

for the duration of their market life. 

The term “safety” is used here in its 

widest sense and includes identifying 

and taking action to minimise potential 

risks, including possible effects on 

the environment, as well as guarding 

against incorrect use and regularly 

monitoring stability. 

Before a preparation is administered 

to human subjects as part of a

clinical →trial, it is tested in the laboratory 

and in animals in accordance 

with a precisely defined programme 

(→toxicology and animal pharmacology). 

In clinical testing, the drug’s efficacy 

and side effects profile are established. 

During this period, the unit 

responsible for pharmaceutical development 

works out the most suitable 

dosage form. In addition, drugs should 

not look like candies (above all to 

avoid children eating them by mistake) 

and should be difficult to get at (→formulation, 

→child-proof drug containers). 

Each batch passes through 

→quality control and is released by 

→quality assurance. All reports of side 

effects after market launch are dealt 

with by the →Drug Safety Monitoring 

unit. 

Many risks can already be recognised 

at the animal testing stage or 

during clinical trials on human subjects. 

But others, such as allergic reactions 

or addiction potential, come to 

light only through post-marketing 

surveillance. 

The safety of diagnostic products 

focuses on two aspects: the reliability 

of the diagnostic product (correctness 

of the test result) and the safety of 

the diagnostic test procedure. While 

diagnostic tests are often conducted 

by trained staff members in doctors’ 

offices and medical laboratories, some 

are also performed by laypeople (e.g. 

blood glucose measurement by people 

with diabetes). This aspect is taken 

into consideration during the development 

of diagnostic products. Roche 


Production, biotechnological 

Diagnostics markets diagnostic systems 

consisting of measuring instruments 

(including spare parts), software, 

reagents, control and calibration 

solutions and consumables (e.g. blood 

sample vessels). Differing product 

safety requirements need to be taken 

into account and satisfied for each of 

these product categories. This is ensured 

through comprehensive checks, 

controls and release procedures in the 

various phases of a product’s lifecycle, 

starting from the initial concept, 

through development and production, 

to the monitoring of product sales on 

the market. 

Production, biotechnological. Biotechnological 

production processes, 

especially alcoholic fermentation (beer 

brewing, winemaking, etc.), are thousands 

of years old and widely used. 

Roche has been using them since 

about 1980 for the production of 

complex molecules and is now one of 

the world’s leading biotech companies. 

Active therapeutic and diagnostic 

substances and their precursors are 

produced in the company’s biotechnological 

production facilities. 

Industrial-scale biomanufacturing 

processes generally employ bacteria, 

yeasts, moulds or cell cultures. The 

main products that can be obtained 

by biotechnological methods are antibiotics, 

therapeutic →proteins and 

other active pharmaceutical ingredients 

and foodstuffs. The processes take 

place in bioreactors (fermenters) offering 

organisms an ideal environment 

121

Production, chemical 

in which to multiply rapidly and perform 

exactly the biosyntheses that are 

wanted. This is followed by generally 

elaborate separation and purification 

steps. 

Roche makes use of conventional 

fermentation and isolation processes 

for products manufactured by the 

→Diagnostics and →Pharmaceuticals 

Divisions. The precursors of the active 

ingredients of →CellCept and →Rocephin, 

for example, are produced by 

biotechnological methods. 

Products manufactured at →Penzberg, 

one of Europe’s leading biotechnology 

facilities, include →erythropoietin 

( →NeoRecormon), trastuzumab 

(→Herceptin), →interferon and pegylated 

interferon (→Pegasys), a wide 

range of monoclonal →antibodies 

used in diagnostic products and more 

than 20 products for the →Applied 

Science business area. 

All Roche biotechnological production 

activities worldwide comply with 

the guidelines of the Organization for 

Economic Cooperation and Development 

and the US National Institutes 

of Health, supplemented by national 

regulations and internal processspecific 

operating procedures. The 

production processes carried out at 

Roche are all on the lowest risk level 

(→biosafety). 

Production, chemical. Manufacture 

of chemical products. At Roche, active 

ingredients for →pharmaceuticals are 

produced by chemical synthesis. The 

layperson tends to think of chemistry 

122 

as a laboratory activity, conjuring up 

images of brightly coloured liquids 

bubbling in test tubes or flasks. A 

visitor to one of Roche’s chemical production 

facilities, however, will be surprised 

by the spotless premises housing 

numerous cylindrical vessels with 

complex fittings or stirring devices. 

These reaction vessels are connected 

to each other by pipes and some are 

equipped with stirrers. Specialist devices 

such as filtering equipment, centrifuges, 

distillation columns, dryers 

or product filling lines are also used. 

Nowadays, most of the production 

processes are computer-controlled, 

and technicians can intervene in the 

process sequence from monitors. 

The provision of chemical products 

has to combine economic efficiency 

with consistently high quality. In particular, 

active pharmaceutical ingredient 

production has to satisfy extremely 

demanding product purity requirements 

(→good manufacturing practice 

regulations). 

Consequently, the manufacturing 

process is described in meticulous 

detail in master batch records, and 

compliance with the specifications is 

constantly verified and documented. 

In addition, all of the raw materials 

and intermediates used are analysed 

and released by →quality control. 

Just as important are the measures 

taken to prevent, minimise and dispose 

of waste products, and pollutants 

in waste air and effluent. The primary 

goal is to avoid waste and by-products 

insofar as possible (→environmental

protection). The chemical production 

of active pharmaceutical ingredients 

involves various intermediate stages 

(known as steps), which are often 

manufactured at different production 

sites. Each step consists of several unit 

operations, such as mixing starting 

materials, reaction and working up 

the reaction mixture, separating and 

purifying the products and processing 

and recycling by-products. The plants 

are usually designed as multipurpose 

units, that is, different products can 

be produced on the same apparatus. 

Product changeover takes place at the 

end of a “production campaign” and 

requires thorough cleaning of the 

apparatus. 

Production construction projects. 

As a dynamic company that is constantly 

launching new drugs and diagnostic 

products, Roche attaches great 

importance to the ongoing modernisation 

and, where appropriate, expansion 

of its production sites and buildings 

(→investments). Accordingly, the 

company implements construction 

projects of varying scale. The construction 

of production facilities in 

particular is a highly time-consuming 

process, involving not just detailed 

planning and construction, but also 

the installation of the machinery and 

equipment and the commissioning 

and testing of the whole plant. Roche 

collaborates with numerous external 

partners, including architects, engineers 

and construction companies, 

on such projects. The construction of 


Production, pharmaceutical 

a production facility can take from two 

to six years depending on its size and 

complexity. 

Production, pharmaceutical. To make 

sure patients take exactly the right dose 

of medication in a safe and simple 

manner, active drug ingredients are 

supplied in user-friendly dosage forms. 

Sterile solutions, for example, are injected 

from infusion bottles, while solid 

dosage forms such as tablets or capsules 

are swallowed (→formulation). 

The task of pharmaceutical production 

is to formulate pure active ingredients 

as one or more of the presentations 

just mentioned, and, at the end 

of the production process, to package 

them as finished medicines (→packaging). 

Production of these presentations 

is generally a complex procedure, involving 

numerous intermediate steps, 

starting with the painstakingly precise 

weighing of active ingredients and 

excipients and ending with the final 

packaged product. 

The golden rules of pharmaceutical 

production are to manufacture highquality, 

safe and effective products 

and protect members of staff against 

contamination. The priority given to 

quality-awareness is reflected in the 

elaborate production facilities, the 

sophisticated production monitoring 

methods and the meticulous training 

given to employees. 

The critical steps involved in the 

production of prefilled syringes, for 

example, take place under a stream of 

123

Production, pharmaceutical 

highly purified air flowing in strictly 

parallel layers and totally free of 

particulate contaminants and microorganisms. 

In tablet production, automatic 

weighing machines help to eliminate 

any significant deviation from 

the specified tablet weight. Although 

thanks to modern information technology 

many processes and control 

routines are now computer-controlled, 

human beings are still the most important 

element in the quality assurance 

process. 

124 

Excipients, 

e. g. starch 

and talc 

Tablet 

Active 

ingredient 

Wetting 

Wet 

mixture 

Granules 

Drying 

Tabletting 

press 

Tablet core 

Sugar 

coating 

Excipient Active 

ingredient 

Empty 

ampoules 

cleaned and 

sterilised 

Inspection 

Suspended 

matter 

Perfect 

seal 

Active ingredient 

content 

Water, 

active ingredient 

and 

excipient 

Filtration 

Purified, 

sterile 

solution 

Ampoule 

filling 

Ampoules 

sealed 

Sterilisation 

in autoclave 

(at 121°C) 

Sterility 

Greatly simplified diagrams showing how finished dosage forms are produced. 

Roche drugs must be of perfect 

quality and satisfy a wide variety of 

regulatory requirements (→generics, 

→counterfeit drugs). This applies not 

only to pharmaceutical production in 

Switzerland, but to every production 

plant throughout the world. Certain 

pharmaceutical →production sites 

specialise in certain pharmaceutical 

forms (centres of excellence) and 

possess the corresponding manufacturing 

technologies and comprehensive 

know-how (→technology transfer).

Following the introduction of the 

strict GMP (good manufacturing 

practice) guidelines, visitors no longer 

have direct access to the rooms where 

pharmaceutical production takes 

place, but several stages of production 

can be observed through glass partitions. 

Production sites. Roche has a small 

number of large chemical and biotechnological 

production sites, the most 

important of which are in Europe and 

North America. The active ingredients 

are delivered from the production centres 

to 16 or so Group companies. 

These centres mainly produce active 

ingredients for medicines. The active 

ingredients are delivered from these 

centres to pharmaceutical production 

facilities across the globe, where they 

are processed and packed to produce 

finished pharmaceuticals (syringes, 

tablets, etc.). 

Historically, trade restrictions led 

Roche to build pharmaceutical production 

facilities mainly for the manufacture 

of finished pharmaceuticals, 

in a large number of countries. Today 

the pharmaceutical production facilities 

are highly specialised and generally 

supply a whole region or deliver 

their products to distribution centres 

worldwide. 

Nowadays, with progressive market 

liberalisation, there is lively crossborder 

trade in medicinal products. 

The successive elimination of trade 

barriers is resulting in a shift away 

from the old local production and dis- 


Professional Diagnostics 

tribution structures towards a more 

regionalised supply chain. 

Professional Diagnostics. In 2006 

the new business area of Professional 

Diagnostics was formed in the →Diagnostics 

Division with the aim of optimising 

the management of the current 

product portfolio, which ranges from 

large central laboratories running 

several thousand diagnostic tests a day 

to the self-monitoring of coagulation 

therapy by individual patients. The 

objective of this new business area is 

to generate added medical value with 

innovative markers and diagnostic 

systems that improve patient care. 

Additionally, enhanced screening, 

diagnosis, patient stratification and 

treatment monitoring using clinically 

relevant parameters will support 

decision making on the patient’s 

further treatment. The incorporation 

of customer insights in its range of 

tailor-made workflow solutions and 

information management for both 

decentralised and centralised settings 

further reinforces the superiority of 

the business area’s diagnostics products 

and services. 

As healthcare provision changes 

rapidly, so the business environment 

in the laboratories is expected to 

develop rapidly as well. For example, 

as IT continues to grow in importance, 

IT and workflow solutions have 

become a crucial field of diagnostics. 

The ongoing trend towards further 

customer consolidation demands novel 

business approaches. By establishing 

125

Profit 

this new business area Roche has 

addressed these challenges effectively 

and successfully. The global headquarters 

of the Professional Diagnostics 

unit is in Rotkreuz, Switzerland, where 

most of the diagnostic systems are 

developed and integrated. 

Profit. The difference between income 

and expenses, as shown in a company’s 

statements of income. The statements 

of income show how successful, in 

terms of profit (or loss), a company is. 

In free market economies the profit 

motive is the driving force behind 

entrepreneurial activity. The future is 

always uncertain, however, and the 

opportunity for profit is counterbalanced 

by the risk of loss. A company 

will make a profit only if the production 

decisions it makes are correct and 

its products can be sold. 

The profit motive is one of the main 

factors behind efforts to improve 

production methods and create new 

products. By contrast, profits derived 

from monopolies inhibit innovation, 

as there is no incentive to constantly 

offer new goods and services in the 

marketplace. 

Only profitable companies can survive 

in the long term. Profits are used 

to finance →investment in such things 

as →research and development, maintenance 

and expansion of production 

facilities and environmental protection. 

A sizeable portion also goes into 

the public coffers in the form of the 

taxes that enable the state to carry out 

its functions. 

126 

In a good year the greater part of 

what is left over after taxes have been 

deducted is usually retained and transferred 

to statutory and voluntary reserves. 

Reserves allow a company to be 

prepared for all eventualities and to 

make provision for the facilities that 

will help improve productivity and job 

security. The smaller part is paid out as 

a shareholders’ dividend, a return on 

the capital they have placed at the 

company’s disposal. 

Protease. →Enzyme which cuts certain 

other →proteins into shorter pieces. 

Such “protein scissors” can either break 

down proteins (e.g. pepsin in the 

gastrointestinal tract), activate them 

(e.g. thrombin in blood clotting) or 

cleave large polypeptides into smaller 

peptides (e.g. HIV protease, →AIDS). 

Proteins. Naturally occurring molecules 

composed of 20 different 

→amino acids arranged in long chains 

of varying sequence and length. Proteins 

consisting of just a few amino 

acids are called peptides. As a result 

of weak side chain bonds, they have a 

folded, three-dimensional structure of 

considerable elasticity and flexibility. 

This complex, three-dimensional structure 

can be visualised by x-ray structural 

analysis or computer modelling. 

Proteins can act as hormones (such 

as insulin), as signalling substances 

(such as →interferons) or as →enzymes, 

→antibodies or →receptors. 

Proteins are found in all living 

organisms and viruses. Without them,

there would be no life. Even →DNA 

itself would be a biologically inactive 

molecule without proteins. The human 

body contains an estimated 

50,000–100,000 different proteins. 

Proteomics. Study of the →proteins 

resulting from the information contained 

in a set of →genes. Unlike the 

→genome, which is a finite, essentially 

static entity, proteomes are dynamic, 

responding to shifts in temperature 

and nutrient environment, for example, 

or to the effects of stress and medication. 

A proteome thus comprises 

the total complement of proteins expressed 

by the genes of a cell or organism 

during a particular growth phase 

Healthy cells 

Cancer cells 


Proteomics 

and under a particular set of environmental 

conditions. These proteins can 

be separated and then related to their 

corresponding genes by mass spectrometry. 

Roche scientists have already 

constructed a number of proteome 

maps, and to date, thousands of the 

proteins they contain have been 

matched to the genes coding for them. 

Such analyses could conceivably be 

used to investigate the effects of 

pharmaceuticals, toxins or biological 

agents on an organism or to observe 

how, or how effectively, a drug acts 

during a specific stage of a disease. 

Roche approaches this issue in a 

variety of ways by using proteomics to 

try to identify new drug targets and 

Proteomics: Promising new approach 

to drug discovery 

extract 

proteins 

analyse the 

cancer protein 

apply 2D-gel by 

electrophoresis 

and separate 

possible cause 

of cancer 

new strategy for cancer treatment? 

! 

127

Psychotropic drugs 

new diagnostic markers, for example 

for cancers or rheumatism. 

Psychotropic drugs. Pharmaceutical 

agents that act on mental functions by 

modulating nerve cell activity in the 

brain. They are used primarily in the 

treatment of psychiatric or psychosomatic 

disorders. Three main types of 

psychotropic drug are distinguished: 

Neuroleptics (also called antipsychotics 

or major tranquillisers), which 

have a strongly sedative effect, are used 

to treat psychotic and highly agitated 

patients. 

The first antidepressants appeared in 

1957. Their development at Roche 

began with the observation of a side 

effect of Rimifon, a drug for the treatment 

of tuberculosis, which was found 

to have a marked mood-elevating 

effect. Investigation of the mechanism 

of action revealed that Rimifon inhibited 

monoamine oxidase A and B, two 

→enzymes with a key role in the 

metabolism of neurotransmitters in the 

brain. This gave rise to a whole new 

group of drugs for the treatment of 

depression. In the 1980s Roche found a 

new compound, moclobemide, which 

specifically inhibits monoamine oxidase 

A. It is the active ingredient of 

Aurorix, a very well tolerated antidepressant 

that is used to treat all forms 

of depression and social phobias. 

Minor tranquillisers or anxiolytics 

are psychotropic drugs used primarily 

in the treatment of anxiety and tension. 

The majority of drugs in this 

group are →benzodiazepines. 

128


Q 

Quality assurance. Far-reaching concept 

defining the conditions required 

for quality-conscious working practices, 

nowadays often referred to as 

a quality management system. This 

quality management system embraces 

all measures designed to ensure that 

pharmaceutical and diagnostic products 

meet the standards of quality 

appropriate to their intended use. 

Quality assurance encompasses compliance 

with →good manufacturing 

practice, →good laboratory practice, 

→good clinical practice and other regulatory 

requirements. For a healthcare 

company the manufacture of highquality 

products constitutes both an 

ethical commitment and an economic 

necessity. To achieve this goal, it is not 

enough to subject products to a final 

inspection: all employees must make 

quality a fundamental part of their 

contribution to the development, 

manufacture, →quality control, storage 

and distribution of each product. 

Quality control. This concerns sampling, 

specification and testing procedures, 

as well as organisation, documentation 

and release of products. It 

is part of the →good manufacturing 

practice regulations. Proper testing 

ensures that the product always meets 

the specifications registered with the 

regulatory authorities. 

Quality control tests are carried out 

on raw materials, intermediates and 

end products in laboratories equipped 

Quality control 

with the latest instruments. Chemical, 

physical, biological and pharmacological 

assays are carried out. Quality 

control contributes a significant part 

of the analytical documentation needed 

for applications to the drug regulatory 

authorities for approval of new 

products. Marketed products are also 

subjected to stability testing. In addition 

to actual testing, quality control 

departments can also approve the 

release of products after review of 

all quality-relevant analytical and 

production data and monitor quality 

assurance activities related to purchasing, 

manufacture, packaging, storage 

and the transport of products. Some of 

these administrative tasks can also be 

carried out by →quality assurance 

departments. 

129

Rapid diagnostic tests 

Rapid diagnostic tests. Refers to tests 

capable of providing an on-the-spot 

result – e.g. in doctors’ offices or 

emergency departments – within a few 

seconds or minutes. Such tests allow 

doctors to decide immediately on the 

appropriate treatment. 

Offering a range of systems and 

rapid tests for immediate analysis of 

cardiac function markers, blood clotting, 

urine diagnostics, →clinical chemistry, 

blood gases and electrolytes, the 


area of the →Diagnostics Division 

responds to customers’ requirements 

with integrated solutions for use on 

the spot. 

The product range includes Coagu- 

Chek systems, the Cardiac Reader 

system, the Reflotron Plus and Sprint 

Analyzer, the Urisys 1100 urine 

analyzer, the Combur and Chemstrip 

urine test strips, the Accutrend GCT 

meter, the DataCare POC and cobas IT 

1000 data management solutions. 

To meet modern hospitals’ wide 

variety of test needs, Roche also offers 

a selection of extremely flexible and 

powerful software tools and IT interfaces 

for the management of data. 

Reagents, diagnostic. Products and 

ancillary supplies used in →in vitro 

diagnosis to detect – both qualitatively 

and quantitatively – the most minute 

pathological changes in the composition 

of body fluids, and occasionally 

stool and tissue specimens. The 

130 

R 

→Diagnostics Division develops and 

markets reagents for →clinical chemistry, 

→toxicology, immunochemistry, 

molecular diagnostics, microbiology 

and blood coagulation tests. 

Clinical chemistry accounts for 

most of the assays carried out in routine 

laboratory diagnostics. Examples 

are tests for →enzymes, substrates, 

electrolytes and specific →proteins. 

In the field of toxicology, tests are 

performed to monitor the effects of 

drug therapy and to detect drug abuse. 

Such tests can be carried out in the 

clinical laboratory or at the point 

of care (in the doctor’s office, for example). 

Immunochemical / immunological 

tests are based on the principle of the 

antigen–antibody reaction. Specific 

antibodies (in particular monoclonal 

→antibodies), are used for the qualitative 

and quantitative determination of 

→antigens. 

Techniques based on the →polymerase 

chain reaction are particularly 

important in molecular diagnostics. 

Qualitative tests based on this method 

are used for diagnosing infections, 

cancer and genetic disorders, as well 

as in transplantation medicine, while 

quantitative tests allow determination 

of viral load (during therapy for 

→AIDS, for example). 

Microbiological tests are used to 

isolate and identify pathogens that 

may be present in both the bloodstream 

and the urine in infectious 

disease. Testing the sensitivity to antibiotics 

of pathogens isolated from

ody fluids is an especially important 

part of this branch of diagnostics. This 

shows which drugs are most effective 

against the organisms involved. Serology 

is concerned with the quantitative 

and qualitative determination of antibodies 

produced by the human body. 

Coagulation tests (→blood cells) are 

used for such purposes as monitoring 

anticoagulant therapy, detecting liver 

damage and ascertaining the causes of 

hereditary or acquired blood clotting 

disorders such as hemophilia. Patients 

can check their own prothrombin 

time, and thus determine their clotting 

status, with →coagulation self-monitoring 

tests. 

Receptors. Protein molecules, usually 

found on the surface or nucleus of 

→cells, that respond specifically to 

natural endogenous messengers such 

as →hormones, →neurotransmitters 

and →cytokines, thus triggering other 

biological events in or on cells. Pharmaceutical 

research seeks to identify 

chemicals that bind to receptors with 

high specificity, thus activating or 

blocking them. These mechanisms are 

exploited for therapeutic purposes, an 

example being the →benzodiazepines 

and benzodiazepine →antagonist developed 

by Roche. Roche research is 

also seeking to identify and synthesise 

antagonists for specific receptors on 

cells of the →immune system. This 

approach assumes that developing a 

drug to treat the underlying cause of a 

disease requires a detailed knowledge 

of the receptor and receptor-binding 


Recycling 

protein that provoke a pathological 

change. 

Recombination (in vitro recombination). 

A →genetic engineering technique 

that involves uniting specific 

pieces of →DNA from different sources 

in a test tube and then reintroducing 

them into a biological system. 

Recycling. The recovery of reusable 

materials from by-products and waste 

to help conserve resources, reduce 

waste volumes and cut pollution. 

Before being recycled, the recovered 

materials generally need to be separated 

and cleaned, a requirement that 

places economic and ecological limits 

on recycling, since these very operations 

and the associated energy consumption 

may themselves add substantially 

to environmental pollution. 

Thus, the recycling options have to be 

examined in each individual case. In 

certain situations, incinerating waste 

to produce energy is the preferred 

solution. On the other hand, costly 

recycling methods may be justified 

in the case of materials that present 

serious environmental hazards. 

One of the most important forms of 

recycling at Roche involves the recovery, 

by distillation, of waste solvents 

from production processes; they are 

then reused, usually in the same 

processes. Other substances, including 

heavy metals, are collected and sent to 

specialist companies for reprocessing. 

In general, the following materials are 

recycled: scrap metal, glass, paper and 

131

Regio 

cardboard, chemical catalysts and 

plastics. 

Regio. The name given to the region 

in the Upper Rhine valley where 

France, Germany and Switzerland 

meet. It is one of Europe’s best-integrated 

border areas in terms of population, 

trade, and tourism. The 

→Rhine forms the boundary first between 

Switzerland and Germany, then 

between Germany and France. The 

region shares a common Alemannic- 

Burgundian cultural heritage that 

finds expression, for instance, in architectural 

styles, eating habits and the 

closely related dialects. Large numbers 

of commuters cross the frontiers here 

every day to go to work: mainly from 

France into Switzerland and Germany 

and from Germany into Switzerland. 

The towns of St. Louis, Mulhouse, Lörrach 

and Müllheim and the Wiesental, 

Leimental, Birstal and Fricktal valleys 

are all usually considered to be part of 

the region. 

The “Regio” offers a number of 

advantages as a location for a chemical 

and pharmaceutical firm with worldwide 

operations. The university of 

Basel, together with its counterparts in 

nearby Freiburg (Germany) and Strasbourg 

(France), fosters a favourable 

climate for scientific work. In terms of 

transportation, the Basel region offers 

considerable benefits: it is an intermediate 

point on the main north-south 

rail and road routes, and the Rhine is 

Europe’s most important waterway. A 

highly educated workforce in all three 

132 

countries supports the economic development 

of the region. All the large 

Basel-based chemical and pharmaceutical 

firms have taken advantage of this 

location and set up factories and 

companies in the “Regio”. Thus, both 

Roche’s headquarters in Basel and 

Roche Deutschland Holding GmbH, 

in →Grenzach-Wyhlen (headquarters 

of the German affiliate) are based in 

the area. 

Registration. Before a drug that has 

completed development and clinical 

testing can be put on the market, it 

must first be evaluated by the authorities 

of the country concerned and then 

be officially licensed for sale through 

the issue of an official approval. The 

EU also has a centralised registration 

process that is intended, and in certain 

cases is mandatory, for innovative 

products. The thalidomide tragedy in 

Europe led to the realisation that safety 

needed to be greatly improved. As a 

result, in the late 1960s drug approval 

requirements were tightened, and the 

rigorous assessment of drug efficacy, 

safety and quality made mandatory. 

This in turn meant substantially 

lengthier approval procedures. 

The complete documentation required 

for registering a new drug 

(known in the United States as an 

NDA, or new drug application) generally 

extends to over 100 bulky files. It 

contains a detailed account of all findings 

and results that have been obtained 

with the drug in laboratory 

tests, →animal experiments and clini-

cal →trials. Additional, comprehensive 

data on the manufacturing and quality 

control of the product includes: a 

summary, data on the manufacturing 

process, the analytical and other quality 

control methods used and the 

chemical and physical properties of 

the active substance, as well as details 

on the finished product. The part dealing 

with pharmacology and toxicology 

contains findings from animal trials. A 

clinical part consolidates the experience 

gained with the drug during trials 

in healthy subjects and, especially, in 

patients with respect to efficacy, the 

incidence and nature of side effects 

and the drug’s metabolic fate in the 

body. An evaluation of the possible 

risks to the environment arising from 

the use of the drug is also a compulsory 

part of the registration process. 

The growing complexity of the regulations 

that must be observed when 

registration data are being prepared 

and compiled has led to a huge increase 

in the amount of time and 

money needed and in the number of 

investigations required. The task of 

assembling registration documentation 

for worldwide use is further complicated 

by the fact that government 

requirements can differ widely from 

country to country regarding both the 

content and format of the application 

dossier. There are also differences in 

official procedures and the criteria 

applied. In most countries drug registration 

applications are assessed solely 

on objective, scientific criteria. It can 

take anywhere from just a few months 


Research 

(in exceptional cases) to several years 

for a drug to complete the registration 

process. Efforts are being made to harmonise 

approval procedures generally 

(ICH = International Conference on 

Harmonisation) or at least in certain 

groups of countries, such as the EU 

(→CHMP, →EMEA). 

Research. The Roche Group’s productive 

and commercial performance 

depends to a great extent on the discovery 

and development of new products 

and systems. Furthermore, there 

are compelling legal and moral reasons 

why products related in any way to 

→health must be supported by solid 

scientific evidence. Research is therefore 

of fundamental importance to 

Roche (→research expenditure). Roche 

research is interdisciplinary and international. 

Although each →division possesses 

its own research organisation, both 

divisions work together on an interdisciplinary 

basis, for example in the field 

of oncology, since diagnosis and treatment 

will become much more closely 

intertwined in the future than in the 

past. Pharmaceutical research focuses 

on inflammatory diseases, bone diseases, 

disorders of the central nervous 

system, cancer, metabolic and viral 

illnesses. The →Pharmaceuticals Division’s 

main research centres are located 

in Basel (→parent company), →Nutley, 

→Palo Alto and →Penzberg. 

→Chugai has three additional research 

centres in Japan. In 2004, the Roche 

R&D Center China was established in 

133

Research expenditure 

→Shanghai. →Genentech, Inc. has its 

own research organisation in San 

Francisco. →GlycArt Biotechnology 

AG in Switzerland is also incorporated 

in the research network. 

The →Diagnostics Division has research 

centres in Switzerland, Germany, 

Austria and the United States 

(→Diagnostics research). 

Given the many diseases for which 

there is still no cure, the need for new 

and better treatments remains enormous. 

Research and development are 

therefore the engine that drives the 

company. Roche is pursuing an innovation 

strategy in which size alone is 

not what counts. It believes that 

having too large an organisation can 

actually slow innovation and reduce 

productivity in healthcare research. So 

Roche has taken a different approach, 

one that relies on a network of highly 

motivated centres of excellence that 

collaborate closely on research, exchanging 

information and technologies 

across geographic and organisational 

boundaries, while maintaining 

a large measure of scientific and operational 

independence. 

Roche’s own pharmaceutical and 

diagnostics research units occupy centre 

stage in this innovation strategy, 

with Genentech and Chugai, the two 

most important strategic allies, also 

playing a leading role. Complementing 

and strengthening the Group’s dynamic 

R&D capabilities are over 

50 scientific and commercial collaborations 

with biotech companies and 

universities. The Group’s innovation 

134 

model also includes Roche spin-offs 

like BioXell, set up in 2002, and the 

biotech company Basilea Pharmaceutica 

as potential drug development 

partners. Licensing agreements that 

give Roche access to new drug candidates 

and technologies are another important 

part of its strategy. Alliances 

and licensing are also a key component 

of innovation management in the 

Diagnostics Division, which in 2002, 

for example, acquired a broad portfolio 

of human papillomavirus (HPV) 

patents from Institut Pasteur. Roche is 

considered a partner of choice in the 

healthcare industry. 

Research expenditure. Global spending 

by the Roche Group on research 

and development (R&D) for new 

products and manufacturing processes 

amounts to some CHF 5.7 billion annually. 

Around CHF 5 billion are spent 

every year on pharmaceutical R&D 

alone (including →Genentech and 

→Chugai). Approximately two thirds 

of R&D costs are staffing costs, chiefly 

wages and salaries. The remaining 

third is needed for materials and studies. 

A growing proportion of research 

expenditure is spent on acquiring the 

licences for new substances in clinical 

and preclinical development. 

Research funds are channelled not 

only into innovative →research, but 

also into the development of →quality 

control processes or ensuring the 

safety of an established product. 

The greatest challenges in pharmaceutical 

R&D are posed by the rela-

tively low success rate – few candidate 

drugs selected for clinical testing actually 

make it onto the market – and also 

by the long development times. The 

total time from the discovery of a new 

active substance to its launch as a marketable 

drug is usually around eight 

years. However, since →patents must, 

wherever possible, be submitted at the 

beginning of development, over half a 

product’s patent life may have expired 

by the time it reaches the market. In 

the time that remains until patent expiry 

and the appearance on the market 

of →generics, the R&D costs of approximately 

USD 2 billion per product, 

plus the compound interest for the 

development phase, have to be recouped 

through sales. For this reason, 

and also for the benefit of potential 

patients, Roche is making considerable 

efforts to shorten development times 

and increase the R&D success rate. 

Restriction enzymes. →Enzymes obtained 

from →bacteria that cleave 

→DNA molecules at specific sites. 

They are important tools in →molecular 

biology, particularly →genetic engineering. 

Retention tanks. Watertight concrete 

tanks (usually underground) or open 

basins, each with a capacity of several 

thousand cubic metres. Accidents and 

fires can result in large quantities of 

contaminated water, which could 

cause significant damage if allowed to 

enter natural watercourses untreated. 

Roche has therefore constructed reten- 


Rheumatism 

tion tanks at all of its chemical production 

facilities to hold runoff from 

firefighting operations and spillage 

until it can be analysed and treated. 

Rheumatism. Umbrella term for various 

painful diseases of the musculoskeletal 

system that are now known 

to be different entities. These diseases 

include rheumatoid →arthritis, ankylosing 

spondylitis, osteoarthritis, and 

soft-tissue rheumatism. Osteoarthritis 

is a degenerative disease, most often 

seen in the elderly, that affects the joint 

cartilage of the hips, knees, fingers and 

toes or the intervertebral discs of the 

spine. Rheumatoid arthritis (RA) is 

a progressive, systemic autoimmune 

disease characterised by inflammation 

of the membrane lining in joints. This 

inflammation causes a loss of joint 

structure and function, resulting in 

pain, stiffness and swelling, and ultimately 

leading to irreversible joint 

destruction and disability. Characteristic 

symptoms of RA include swelling, 

pain, and movement limitation around 

joints of the hands, feet, elbows, knees 

and neck. In more severe cases of RA, 

the eyes, lungs or blood vessels may be 

affected. There can also be systemic 

symptoms such as osteoporosis, anemia, 

or generalised weakness. RA is 

thought to be caused by an abnormal 

immune reaction that results in the 

destruction of body tissue (→autoimmune 

diseases, →immune system). 

There is no cure for most forms of 

rheumatism, and patients are treated 

by physiotherapy, exercise, and with 

135

Rhine 

pain-relieving drugs. However, patients 

are now undergoing courses of 

treatment that are increasingly successful 

in inhibiting inflammation. 

The more modern forms of these 

therapies can even stop the process of 

joint destruction. The very first antiinflammatory 

drug, acetylsalicylic 

acid, was discovered about one hundred 

years ago and is still in use today. 

It has been joined by numerous other 

types of drug. Roche has contributed 

several non-steroidal anti-inflammatory 

drugs, such as Tilcotil. Roche 

Group research centres in →Palo Alto 

and at →Genentech are currently 

investigating specific aspects of the 

inflammatory process and studying 

various compounds which it is hoped 

will have a more selective effect on autoimmune 

reactions and the resulting 

tissue destruction. 

Rhine. A river that rises in the Swiss 

canton of Grisons and flows through 

Basel. The Roche headquarters are 

situated directly on the banks of the 

Rhine, as are the Roche facilities at 

→Grenzach-Wyhlen and →Mannheim. 

Its water is an essential resource used 

for cooling purposes at all of the production 

sites in the region. 

Ribosome. Molecular complex consisting 

of →RNA molecules and several 

dozen different →proteins. Ribosomes 

are cells’ “protein factories”. 

They synthesise proteins from amino 

acid building blocks by reading the 

genetic information carried by mes- 

136 

senger RNA molecules (the “working 

copies” of genes). 

Risk management. A structured 

approach to managing risks and 

opportunities. Risks (opportunities) 

are events that can negatively (or 

positively) affect the achievement 

of our objectives. The approach can 

be applied to a variety disciplines and 

consists in assessing risks and opportunities, 

deciding risk attitude and response, 

assigning and then monitoring 

the implementation of adopted actions 

and the residual risk itself. Roche 

has established an in-house function 

that provides assistance in adopting 

this methodology. This function also 

coordinates the Group risk assessment 

process, which involves compiling 

the various risks into a Group Risk 

Inventory. The approach is designed 

to improve proactive, factual and 

consequential decision making and 

accountability throughout the Group. 

One specific application of the risk 

management methodology is known 

as “business continuity planning”. 

This involves the systematic assessment 

of the organisation’s exposure to 

disruptive events and the preparatory 

implementation of appropriate measures 

(controls, inventory, crisis organisation 

or redundancy) to ensure a 

satisfactory level of resilience. Often 

applied to physical hazards like fire or 

IT/communications failures. 

Risk management planning. Important 

factor in assuring →safety, health

and →environmental protection. Risk 

management planning is required for 

those cases in which the preventive 

measures prove ineffective. 

Prevention includes all technical, 

organisational and personnel controls 

which can be sensibly adopted to 

reduce or eliminate potential risks. 

If, despite all preventive measures, an 

accident or incident does occur, the 

company must have invested reasonable 

resources in implementing comprehensive 

precautions to minimise 

the impact on human life and the environment. 

Part of risk management planning 

involves documenting the potential 

hazards that exist in all Roche subsidiaries 

with their own production 

facilities, mixing plants or warehouses, 

and defining and implementing the 

procedures needed to manage an incident 

or event. 

All active response units are 

grouped together in the emergency 

response team, which is comprehensively 

equipped to deal with any incidents. 

The fire brigade is the primary 

unit and can be supplemented by a crisis 

management team if circumstances 

require. The main tasks of the emergency 

response team include: 

– fire fighting, rescue services and 

dealing with spills and building 

evacuation; 

– making staffing, equipment and administrative 

arrangements to ensure 

optimum response efficacy; 

– maintaining and inspecting company-owned 

equipment; 


Risk management planning 

– fire safety inspections; 

– compiling special emergency response 

documents such as hazard 

and building registers; 

– undertaking precautionary planning 

and studies to create an optimum 

framework for all response 

units; 

– conducting exercises and training 

sessions. 

The size and composition of the 

team vary from one production or 

warehouse site to another and are 

geared to the hazards or potential risks 

at each. Fire service, local emergency 

response team and Group emergency 

response team are deployed on the 

principle of subsidiarity. The unit 

leader assesses the situation and enlists 

the help of the next highest unit as 

appropriate. 

Where the potential risk is great, 

physical asset values high and the public 

fire service unable to respond 

quickly enough or with adequate resources, 

a site fire service is operated. 

Where the local fire service is responsible 

for fire fighting, regular site visits 

ensure that fire fighters are familiar 

with both the site and its hazards. 

When incidents and accidents occur, 

it is the responsibility of the first 

aid and rescue service or the company 

medical service to offer first aid and 

tend to the injured. 

The emergency response team is 

also responsible for alarm procedures. 

The emergency response team and 

medical service can be alerted round 

the clock. 

137

RNA 

A further aspect of risk management 

planning is training staff in 

the correct way to behave if an event 

occurs. Building evacuation drills are 

conducted regularly in all Roche 

companies. At sites where chemical 

production takes place, emergency 

response facilities include equipment 

for measuring pollutant levels on site 

and in the surrounding area. 

RNA (ribonucleic acid). Biological 

molecules that perform various tasks: 

messenger RNA provides “working 

copies” of genes, ribosomal RNA and 

transfer RNA serve as tools in protein 

synthesis, and various RNA compounds 

have enzymatic functions. 

RNA is made up of nucleotides formed 

with the bases adenine, guanine, 

cytosine and uracil; it forms singlestranded, 

chainlike molecules. Chemically, 

RNA is very closely related to 

→DNA, the principal carrier of genetic 

information. 

Rocephin (antibiotics). First cephalosporin 

antibiotic in the Roche product 

range. Thanks to its outstanding 

therapeutic benefits and cost advantages, 

Rocephin was for many years 

the →Pharmaceuticals Division’s topselling 

drug. Rocephin is effective in 

a wide range of severe infectious 

diseases, including meningitis, and in 

patients with weakened immune 

defences (as seen in patients being 

treated for cancer). Rocephin is used 

to guard against infection in patients 

undergoing major surgery. Cost-bene- 

138 

fit analyses have shown that Rocephin’s 

once-daily dosing regimen 

reduces overall costs – fewer infusion 

sets are needed, hospital waste is 

reduced, patients spend less time in 

hospital and the workload for nursing 

staff is reduced. Once-daily administration 

also has significant advantages 

in outpatient treatment. 

Roche. Shortened form of the maiden 

name of the wife of Fritz →Hoffmann, 

Adèle La Roche. It was only by chance 

that this name came to be used as a 

designation for the Group as a whole. 

Around 1900, the firm’s general 

agent in France expressed his opposi- 

Early advertisement for Sirolin (Paris, 

turn of the 20th century).

tion to the brand name →Sirolin, 

which had been proposed by Roche 

Basel, and used the name “Sirop 

Roche” for the product in France. This 

was awkward for Fritz Hoffmann- 

La Roche, since it complicated worldwide 

promotion of Sirolin. As a way 

out of the problem, he added the 

words “La Roche” to the Sirolin trademark 

in all countries; this was later 

shortened to “Roche”. In this form, the 

word refers to the Roche Group as a 

whole and is also the brand name used 

by the →Pharmaceuticals and →Diagnostics 

Divisions (→trademarks). 

Roche Biomarker Programme, RBP. 

Led by an interdisciplinary matrix of 

experts in our →Pharmaceuticals and 

→Diagnostics Divisions, the Roche 

Biomarker Programme (RBP) supports 

and promotes the incorporation of 

→biomarker concepts such as →proteomics, 

→genomics and imaging 

techniques in the discovery, development 

and marketing of healthcare 

products. Identification of diseaserelated 

biomarkers in key therapeutic 

areas can potentially lead to improved 

diagnostic →tests, more efficacious 

treatments and enhanced disease 

monitoring and thus improve the 

medical outcome. 

Roche Charter on Genetics. The set 

of principles according to which 

Roche conducts its genetic research. 

Roche recognises that, based on the 

importance of genetic predisposition 

for complex disorders, the necessity 


Roche Charter on Genetics 

and promise of using genetic information 

for the discovery and delivery of 

new and improved diagnostics and 

therapeutics, and the legitimate interest 

of society in applying the aggregate 

results of genetic studies to the improvement 

of the human condition, 

genetic research is an essential and 

indispensable element in our quest to 

provide better healthcare. 

To achieve this goal, genetic research 

must be implemented in accordance 

with a number of scientific, 

ethical, societal and legal principles: 

– the commitment to the pursuit of 

research according to the highest 

standards of scientific rigour and 

excellence; 

– the right of every individual to selfdetermination, 

privacy and confidentiality 

regarding the procurement 

and use of genetic information 

with regard to both research and 

personal healthcare; 

– the obligation to abide by national 

and international research standards 

and applicable laws, and the 

need to respect specific social, 

moral, ethical, religious and other 

values affecting the procurement 

and use of genetic information; 

– the responsibility to prevent the 

misuse of genetic information obtained 

in the course of its research 

activities towards discrimination or 

exploitation of individuals and 

groups, as well as to oppose any 

such misuse as a matter of policy; 

– the mandate to not pursue the deliberate 

creation of genetically iden- 

139

Roche Connect 

tical human beings (often termed 

“human cloning”); 

– the communication of research results 

to the scientific community in 

a timely fashion and the support of 

general educational activities in the 

area of genetics; 

– the concept of providing appropriately 

considered benefits to 

communities contributing genetic 

material for research purposes; 

– the duty to integrate the principles 

enumerated above into a programme 

of scientifically and socially 

responsible, accountable and 

transparent use of genetic information 

for the development of 

new diagnostics and therapeutics, 

and 

– the value and importance of guidance 

and counsel from an independent 

scientific and ethics advisory 

group (SEAG) of acknowledged, 

outside experts representing the 

fields of biology, ethics, sociology, 

law as well as the community. 

Roche Connect. Staff profit-sharing 

scheme introduced worldwide in 2002. 

Roche allows all its employees to share 

in the success of the company on the 

stock market on preferential terms and 

to receive company dividend payments. 

Staff can invest a certain proportion 

of their salary in Roche nonvoting 

equity securities at a 20 percent 

discount. In the USA, where Roche 

Connect cannot be offered for legal 

reasons, employees have the option 

of participating in a local plan for 

140 

the procurement of ADRs (American 

Depositary Receipts). One ADR is 

equivalent to one Roche non-voting 

equity security. 

Roche Forum Buonas. The company’s 

own training and conference 

centre. Roche Forum Buonas was 

opened in January 2002 and comprises 

the Fritz Gerber Center – with conference 

and seminar facilities, a hotel 

wing and restaurant – and historic 

Buonas Castle, The Club and an impressive 

park. In addition to the 300- 

seat auditorium, the centre offers 10 

seminar rooms and 50 hotel rooms. 

With its clear and simple lines, the 

building, designed by Lucerne architects 

Scheitlin & Syfrig, has been carefully 

integrated into the unspoiled 

landscape of the Buonas peninsula, in 

the municipality of Risch on Lake Zug 

(Switzerland). Roche Forum Buonas 

provides a central venue where people 

from Roche Group companies around 

the world can meet (→training and 

development).

Roche Institute of Molecular Biology. 

An institute for basic research in 

Nutley, New Jersey (United States), 

founded in May 1967 by Hoffmann-La 

Roche Inc. This institute was the first 

centre for basic molecular biological 

research to be founded and financed 

by the pharmaceutical industry on 

a non-product-oriented basis. It attracted 

more than a hundred highly 

qualified scientists to Nutley. The research 

work undertaken by the Institute 

focused on unravelling basic biochemical 

mechanisms such as protein 

synthesis in the cell, research into gene 

expression and genetic recombination 

and the characterisation of various 

→receptors and biologically active 

→proteins in the →immune system 

and central nervous system. 

Despite its strong basic research orientation, 

some of the work done at the 

institute paved the way for major 

achievements in product-related research 

at Roche Nutley. For example, 

work by Dr Sidney Pestka on the isolation 

of →interferons began in 1969, 

and by the end of the 1970s the essential 

groundwork had been completed 

for genetically engineering a pure alfa 

interferon (→Roferon-A). In 1995 the 

institute in Nutley was closed down 

after a Roche subsidiary was founded 

in →Palo Alto. 

Roche Sample Repository, RSR. A 

collection of blood and →DNA samples 

from patients being treated in 

phase II or phase III clinical →trials 

with new medicines developed by 


Roferon-A 

Roche. The RSR will help researchers 

to identify possible links between 

genetic variations and differences in 

treatment response and the occurrence 

of drug side effects. 

Roferon-A. Genetically engineered 

interferon alfa-2a (→interferons, →cytokines) 

from Roche; first approved 

in June 1986 by the US Food and 

Drug Administration (→FDA) and in 

Switzerland for the treatment of hairy 

cell leukemia. This is a rare but hitherto 

invariably fatal form of blood cell 

cancer that, in about 90 percent of 

Roferon-A (interferon alfa-2a) 

Amino acid sequence 

Phenylalanine 

Threonine 

Tryptophan 

Histidine 

Aspartic acid 

Tyrosine 

Methionine 

Proline 

Glutamine 

Lysine 

Isoleucine 

Arginine 

Glycine 

Alanine 

Valine 

Leucine 

Serine 

Cysteine 

Sequence of the 165 amino acids in 

interferon alfa-2a. Also shown, the 

disulfide bridges joining two pairs of 

cysteine units; these links cause the protein 

to fold into a characteristic shape. 

This structure determines the biological 

properties and actions of interferon 

alfa-2a. 

141

Rotkreuz 

cases, responds to treatment with 

Roferon-A. Most of these patients can 

resume a normal life and even return 

to work. 

Roche began testing the effectiveness 

of Roferon-A in →AIDS patients 

as early as 1984. People with HIV infection 

suffer progressive deterioration 

of their immune system. About 

one quarter of patients with AIDS 

develop a potentially fatal form of 

metastatic cancer known as AIDSrelated 

Kaposi’s sarcoma. Roferon-A 

brings about marked improvement in 

about 25–40 percent of AIDS patients 

with Kaposi’s sarcoma; the disease 

regresses or even disappears. These 

patients are also less often subject to 

life-threatening infections. 

Roferon-A was approved in Switzerland 

in this indication in 1986 and 

subsequently in all other countries 

where AIDS occurs. Over the last ten 

years various improvements have been 

made to the manufacturing methods 

and product quality of Roferon-A. The 

drug’s clinical applications have been 

widened through the addition of various 

important indications: chronic 

myelogenous leukemia, cutaneous Tcell 

lymphoma and non-Hodgkin’s 

lymphoma, renal cell carcinoma and 

malignant melanoma (skin cancer). It 

has also been used in combination 

therapy for some solid tumours and 

has been employed extremely successfully 

in hemangiomas (benign tumours 

consisting of blood vessels) in newborn 

infants and young children. 

Pegasys is designed to stay in the body 

142 

longer than Roferon-A and can continue 

fighting the virus for longer. 

Patients are given Pegasys as an injection 

just once a week. In combination 

with Copegus (ribavirin), Pegasys 

achieves much higher response rates 

than Roferon-A. Pegasys is approved 

for a broad range of patients with 

hepatitis C, including those patients 

who have cirrhosis, are coinfected with 

HIV or who have “normal” ALT levels. 

In addition, Pegasys is the only pegylated 

interferon that is approved for 

the treatment of patients with chronic 

hepatitis B. 

Rotkreuz. Located in the Canton of 

Zug (Switzerland), Rotkreuz is home 

to the Diagnostics Division’s instrument 

centre, Roche Diagnostics AG, 

the Roche Diagnostics Ltd. (Switzerland) 

sales company, the head office of 

the →Professional Diagnostics business 

area and the Roche Microtechnology 

Centre, a centre of excellence for 

applied microtechnology. 

Roche Diagnostics AG currently 

employs over 700 people from around 

30 different countries. It is one of the 

world’s leading design, development, 

production and service centres for 

→analytical systems for →Molecular 

Diagnostics, →Professional Diagnostics 

and →Applied Science. The highly 

sophisticated →Cobas analytical systems 

that have revolutionised diagnostic 

technology on more than one occasion, 

include the Amplicor, TaqMan 

and AmpliPrep instruments (molecular 

diagnostics), the Cobas Integra

product line for →clinical chemistry, 

the LightCycler instruments for life 

science and the Cobas software range 

for hospitals. All the systems manufactured 

in Rotkreuz (consisting of hardware, 

software, disposable articles, 

service IT solutions) comply with the 

relevant international quality specifications 

(e.g. FDA, ISO standards) and 

regulatory requirements (→in vitro 

diagnosis or research). 

Roche Diagnostics Ltd. (Switzerland), 

which employs over 150 people, 

is responsible for selling and servicing 

the whole Roche Diagnostics product 

range – instruments, software, 

→reagents, tests and →test strips – to 

patients, laboratories, hospitals, medical 

practices and research institutes 

throughout Switzerland. 

Rx. Common abbreviation for prescription 

medicines. In the United 

States the symbol Rx, with the x 

formed by a line across the extended 

down-stroke of the R, is equivalent 

to the Rp (from Latin recipe: take) 

commonly used in prescriptions in 

Europe. 


Rx 

143

Safety 

Safety. The concept of industrial 

safety encompasses a wide spectrum 

of issues that have to be given top 

priority in the chemical industry. 

At Roche, safety questions are accorded 

the same degree of care as 

chemical operations and the manufacture 

of new products; in fact, they are 

an integral part of each project. The 

beginnings of an active safety policy 

can be traced back to the 1930s. In line 

with the technology used at that time, 

the initial emphasis was on accident 

prevention. Since then the enormous 

progress made in the fields of science 

and technology has opened up a wide 

range of possibilities, but it has also 

created new dangers and given rise to 

the need for additional safety regulations 

(→biosafety). The first (initially 

part-time) safety engineer was appointed 

in 1954. At the same time a 

safety committee was formed, with the 

initial task of examining the problems 

involved in technical safety in production 

and accident prevention. This task 

is now carried out by the Corporate 

Safety, Health and Environmental 

Protection department (CSE) and by 

similar units at Group companies. 

CSE issues regulations and directives 

as circumstances require and 

assesses procedures and processes with 

regard to occupational safety and environmental 

compatibility. By means of 

periodic audits it monitors the status 

of safety, health and environmental 

protection in the various production 

144 

S 

facilities. To cope with these tasks, it 

can call on the services of experienced 

chemists, biologists and engineers, as 

well as specialists in →occupational 

hygiene, accident prevention and environmental 

protection. In addition, 

the department plays a part in the 

advanced training of production and 

research personnel in the fields of 

safety, health and environmental protection, 

as well as sharing know-how 

with the authorities and other companies. 

Safety data sheet. Internationally 

harmonised system for providing information 

on chemical substances or 

mixtures to professional users. Safety 

data sheets primarily include information 

on identifying a particular 

substance or mixture and its physical, 

chemical, toxicological and environmentally 

relevant properties. They 

also list characteristics and provide 

safety advice in the form of hazardous 

substance and international dangerous 

goods transport classifications. 

Instructions on handling, storage and 

disposal in everyday and emergency 

situations are also provided. Roche’s 

safety data sheets are prepared by the 

Corporate Safety, Health and Environmental 

Protection department. 

Sapac Corporation, Ltd. Sister company 

of Roche from 1926 to 1989, 

with headquarters in New Brunswick 

(Canada). During that time, the Roche 

Group had a twin structure: each 

Roche shareholder was automatically a

Sapac shareholder as well. All Roche 

companies located in continental 

Europe and the Mediterranean region 

were members of the Roche Group. 

Sapac comprised all the Roche companies 

situated in North and South 

America, Asia, Oceania, the central 

and southern parts of Africa, Australia 

and Great Britain. 

This complex corporate structure 

was a product of international tensions 

between the two world wars. As 

far as possible, the company’s material 

and intellectual capital was to be kept 

from falling into the hands of an 

aggressor. Against this background, 

management decided to expand Roche’s 

American operations into an independent 

unit. It also examined ways of 

conferring a legally independent status 

on those members of the Group that 

were located in countries not directly 

exposed to the risk of war, so they 

could continue to be run as autonomous 

units should Switzerland become 

involved in hostilities. Following 

the annexation of Austria by the 

German Reich in 1938, the companies 

located outside continental Europe 

were consolidated into the existing 

(but hitherto “dormant”) Sapac holding 

company within a few days, and 

Panama City was designated its headquarters. 

After the war Sapac moved 

its legal domicile to Canada. In 1989 

Roche underwent a corporate restructuring. 

As Sapac had largely ceased 

to serve its original purpose, it was 

transformed into a pure →holding 

company (→share capital). 


Sequencing 

Screening. A selection or test procedure 

based on clearly defined criteria 

for recording data within a particular 

group. In medicine, screening is a diagnostic 

measure for the early detection 

of specific illnesses within a risk 

group for the purpose of identifying 

pathogens and initiating effective 

treatment as soon as possible. 

Sepsis test. Sepsis is one of the oldest 

known clinical conditions, and, despite 

huge advances in many other areas of 

medicine, still a major challenge to 

every doctor. Because of the lack of 

detailed information about the actual 

pathogen involved, the standard treatment 

in the first 72 hours of sepsis has 

to rely on broad-spectrum antibiotics. 

As a result, the fight against “blood 

poisoning” is increasingly being lost in 

this era of growing antibiotic resistance. 

A new PCR-based (→polymerase 

chain reaction) test developed by the 

→Diagnostics Division and known as 

the LightCycler SeptiFast test is set 

to remedy this situation. Within six 

hours the test can reliably detect the 

pathogen or pathogens that are causing 

sepsis with much greater accuracy 

and sensitivity than current techniques. 

Sequencing. Determination of the 

→DNA or →RNA sequence, i.e. the 

order in which the individual building 

blocks (nucleotides) are arranged in a 

DNA or RNA molecule. DNA sequencing 

has revolutionised the biological 

sciences and ushered in the era of 

145

Seveso 

Genome Sequencer 20 (GS20): Automated 

ultra-fast system for sequence 

analysis (determination of the sequence 

of bases in nucleic acids) based on an 

innovative microtechnology. 

genome research (→genomics). Of 

the various sequencing techniques 

currently available, the most popular 

technology is the Sanger method, 

which is based on electrophoresis. This 

formed the cornerstone of the human 

genome project. 

Scientists are increasingly relying 

on Roche’s GS 20 and FLX genome 

sequencers for their work on medical, 

biological or evolutionary research 

issues. The range of applications for 

these devices is growing all the time. 

Whereas they were initially used to 

decode the genes of simple fungi or 

bacteria, they are now being used to 

analyse human →genomes. Doctors 

hope to obtain new findings about the 

genetic causes of complex illnesses 

such as cancer, about virus identification 

and about the sites of action of 

new drugs. 

A large number of research institutions 

and companies are now working 

on technologies designed to lower the 

146 

costs of sequencing and increase 

throughput. The US company 454 Life 

Sciences was the first in the world to 

bring one of these techniques to market. 

The latest representative of this 

technique, the Genome Sequencer 20 

system, is distributed by →Applied 

Science and is being further developed 

jointly by Roche and 454 Life Sciences. 

Applied Science’s Genome Sequencer 

20 instrument sequences over 

20 million bases in a four-and-a-halfhour 

run – sixty times the number 

possible with Sanger technology, 

currently the most popular method. 

The nanotechnology-based special 

technology developed by 454 Life 

Sciences incorporates the 454 picoliter 

technology with its patented lightemitting 

sequencing chemistry and 

state-of-the-art informatics. The resulting 

system is ultra-fast and costeffective 

and suitable both for the 

sequencing of whole →genomes (= all 

of the genes in a cell) and individual 

→genes. The high speed is achieved 

partly through the parallel analysis of 

thousands of DNA or RNA molecules. 

The system can be used both to decode 

unknown nucleic acid sequences and 

to identify known existing sequences. 

Seveso. An industrial community in 

Lombardy about 30 km (19 miles) 

north of Milan. The name Seveso has 

become a symbol for a number of reasons. 

First of all, Seveso stands for the 

four adjoining communities (Seveso, 

Cesano Maderno, Desio and Meda) 

affected by a chemical accident that

occurred on 10 July 1976 at the works 

of Icmesa S.p.A. (part of the Givaudan 

group) in Meda. Givaudan, the former 

Roche subholding comprising the 

Fragrances and Flavours Division, was 

spun off as a separate company in May 

2000. Now a publicly traded company, 

Givaudan is headquartered in Vernier, 

near Geneva (Switzerland). 

Following an abnormal reaction, a 

mixture of chemicals escaped, affecting 

large areas of the surrounding four 

communities. As a result of this accident, 

Seveso came to symbolise the 

environmental hazards inherent in the 

chemical industry, and it revolutionised 

the safety philosophy of the 

whole Roche Group. 

Today, we can thankfully say that 

the damage caused was far less severe 

than initially feared. There were no fatalities. 

One hundred and ninety-three 

cases of chloracne – the characteristic 

skin disorder caused by exposure to 

dioxin – were confirmed by the international 

committee investigating the 

accident, but all those affected have 

since recovered and bear practically 

no trace of these lesions. Two children 

sustained minor visible scarring as a 

result of caustic soda burns. Neither 

the feared fetal malformations nor an 

increase in the number of miscarriages 

actually materialised. It is now thought 

that the quantities of dioxin released 

during the accident were less toxic for 

human beings than was at first supposed. 

Decontamination of the affected 

areas posed complex problems. The 


Shanghai 

chemicals were spread over a relatively 

wide area. In the end, the safest and 

most expedient method proved to be 

that of clearing away the layers of earth 

that had been permeated by the chemicals. 

The contaminated soil and 

rubble from the demolished buildings 

were landfilled near the factory site 

using an impermeable containment 

system. Problems were also encountered 

during disposal of the residues 

from the reaction vessel. Disposal was 

to have been carried out by a specialist 

company in an environmentally responsible 

manner and in accordance 

with legal requirements. But this plan 

failed, and the residues embarked on a 

bizarre journey lasting several months, 

before ending up in Basel for temporary 

storage. Ciba-Geigy Ltd (now part 

of the Novartis group) then offered the 

use of its high-temperature incinerator. 

The residues were incinerated under 

the supervision of the authorities, 

without any technical or environmental 

problems, in June 1985. 

Shanghai. Both Shanghai Roche 

Pharmaceuticals Ltd. and Shanghai 

Roche R&D Center (China) Ltd. are 

based in the Zhangjiang Hi-Tech Park 

in Shanghai. Shanghai Roche Pharmaceuticals 

Ltd. was founded in 1994. 

Roche’s first joint venture in China, 

Shanghai Pharmaceuticals Ltd. is dedicated 

to improving human health and 

quality of life by providing a wide variety 

of prescription drugs covering key 

therapeutic areas such as oncology, 

virology and transplantation. It brings 

147

Shanghai 

to China not only state-of-the-art 

technology and innovative products, 

but also a superior management system. 

With an investment of USD 3.7 

million, Shanghai Roche Pharmaceuticals 

Ltd. initiated a CRM (Customer 

Relationship Management) system in 

China, raising the bar to the highest 

level of practice internationally. This 

system earned the “Innovation Prize” 

at the “First Asian One-on-One Innovator 

Awards”. It was also named one 

of China’s top-ten CRM Systems in 

2002 and given an award for being the 

best implementation of CRM in China 

in 2003. 

A pioneer in the Chinese healthcare 

industry, Shanghai Roche has achieved 

tremendous accomplishments since its 

founding. It has enjoyed successive 

double-digit sales growth over the past 

ten years and has occupied a leading 

position in the IMS ranking for 

domestic prescription drug sales to 

hospitals for many years. The Shanghai 

Roche High-Potent Production 

Plant held its inauguration ceremony 

in October 2005. The plant, in 

which a total of CHF 21 million was 

invested, manufactures →Xeloda and 

→CellCept, two of Roche’s high-quality 

innovative products. 

In addition to developing its own 

business, Shanghai Roche plays an 

active role in supporting the development 

of the Chinese healthcare industry. 

Roche has invested more than 

RMB 10 million to sponsor local hospitals’ 

participation in international 

multicentre clinical trials for treat- 

148 

ments in the fields of oncology, hepatitis 

and transplantation. In 2002 Roche 

invested nearly RMB 100 million so 

that eight Chinese hospitals could participate 

in the HERA project, a global 

clinical trial of Herceptin breast cancer 

treatment. In the transplantation field, 

Shanghai Roche initiated a transplantation 

follow-up care management 

system and simultaneously founded 

a transplantation follow-up care coordination 

committee. These moves 

aim to promote clinical research at the 

domestic transplantation centre, to 

strengthen the long-term follow-up 

care of kidney transplant patients and 

to provide a foundation for the sharing 

of transplantation resources in days to 

come. 

Roche always maintains high moral 

standards and strives to be a good corporate 

citizen in all its business activities. 

Shanghai Roche has so far organised 

donations of cash and medicine 

with a total value of over RMB 22 million. 

Contributions have been made in 

response to earthquakes and floods 

and in response to need for other charity 

programmes in China. 

The Roche R&D Center (China) 

Ltd. (RRDCC) opened in October 

2004. It is one of Roche’s global pharmaceutical 

R&D facilities and its first 

wholly-owned R&D centre in Asia. Its 

activities focus on lead generation and 

optimisation for medicinal chemistry 

research. Collaborating with other 

R&D facilities, the RRDCC will contribute 

to the development of novel, 

high-quality clinical candidates. The

centre has cooperated with top Chinese 

research institutes on genetics 

research projects. Its establishment 

represents a key strategic decision that 

will allow Roche to continue to enhance 

its capabilities in medicinal 

chemistry at a global level. In addition 

to its role as part of Roche’s global 

R&D operations, the centre also provides 

key support to Roche’s business 

development strategy in China. 

Share capital. Incorporated as a limited 

company in 1919, F. Hoffmann-La 

Roche & Co. Ltd, Basel, originally had 

a capital stock of CHF 4 million, 

divided into 4000 shares with a nominal 

value of CHF 1,000. In 1920 the 

company’s capital stock was doubled 

to CHF 8 million. 

In 1927 various parts of the company 

were combined to form a separate 

corporation, →Sapac Corporation, 

Ltd. The Sapac shares, which had 

a nominal value of CHF 50, were 

paired with shares in F. Hoffmann-La 

Roche & Co. Ltd. As twin companies, 

Sapac and Roche underwent all the 

same changes in capital structure until 

1989. 

Non-voting equity securities of F. Hoffmann-La 

Roche Ltd. 


Share capital 

From 1928 to 1931 Roche’s share 

capital was reduced from 8 million to 

CHF 16,000 in a series of repayments 

to shareholders. During the same period 

a stock split doubled the number 

of bearer shares to 16,000, and a total 

of 48,000 non-voting equity securities 

in bearer form were issued. In 1943 the 

last franc outstanding on each share 

was also repaid to the shareholders. 

Capital stock was raised to the statutory 

minimum of CHF 50,000 solely 

by drawing on net reserves, resulting 

in a nominal value on paper of CHF 

3 1 / 8 per share. In 1971, to mark the 

75th anniversary of Roche’s founding, 

and again in 1984, one new non-voting 

equity security was issued for every 

10 shares or non-voting equity securities, 

bringing the total of outstanding 

non-voting equity securities to 61,440. 

In 1989 the Board of Directors approved 

a far-reaching capital restructuring. 

All outstanding shares in the 

sister company, Sapac, were redeemed, 

and it and F. Hoffmann La-Roche & 

Co. Ltd, which until this time had been 

the operating parent, were transformed 

into a pure holding company 

under the name Roche Holding Ltd. 

The former parent’s operating businesses 

and related assets and liabilities 

were transferred to a newly established 

Swiss operating subsidiary, F. Hoffmann-La 

Roche Ltd, Basel. The previous 

twin corporate structure was thus 

terminated, and Sapac became a 

Group subsidiary. 

On completion of the various transactions, 

Roche Holding Ltd had a 

149

Sirolin 

share capital of CHF 80 million, 

divided into 800,000 bearer shares 

with a nominal value of CHF 100. 

In addition, there were 3,330,134 nonvoting 

equity securities with no nominal 

value, but conferring the same 

rights as shares to participate in net 

profits and any liquidation proceeds. 

In November 1991 the capital stock 

of Roche Holding Ltd was doubled to 

1,600,000 bearer shares with a nominal 

value of CHF 100. The number of 

issued and outstanding non-voting 

equity securities was raised to 

7,025,627. 

Following the revision of the Swiss 

Code of Obligations in 2001, Roche 

Holding Ltd took the opportunity to 

lower the nominal value of its shares. 

The shares and non-voting equity 

securities were split one hundred-forone 

in May 2001. The existing share 

capital of CHF 160 million was restructured 

into 160 million shares 

with a nominal value of CHF 1. The 

company now has 702,562,700 nonvoting 

equity securities. 

Sirolin. Launched by Roche in 1898, 

this was the company’s first big-selling 

product. Earnings from this product 

formed the basis for the development 

of the firm up to World War I. It is a 

syrup based on guaiacol, which was 

thought to have antibacterial properties. 

SNPs. Single nucleotide polymorphisms 

(SNPs) are individual variations 

in →DNA building blocks (nu- 

150 

cleotides) distributed randomly across 

the →genome. SNPs can be located 

at any position inside or outside the 

→genes and thus produce widely 

differing effects. Since they can play a 

role in the differing degrees of efficacy 

and tolerability of drugs (→pharmacogenetics, 

→pharmacogenomics) SNPs 

are the subject of intensive research 

efforts. 

Social benefits. Benefits, primarily of 

a financial nature, but also those 

promoting the social wellbeing of 

employees, that are provided by a 

company in addition to contractually 

agreed wages and salaries. Such social 

benefits may originate as voluntary 

initiatives on the part of the company, 

or they may be in response to gradual 

changes in public opinion and the 

needs of society as a whole. The extent 

of social services depends, of course, 

on the commercial success of the company. 

Internationally operating com-

panies offer different social benefits 

from country to country in accordance 

with local value systems, government 

regulations or priorities resulting from 

employer–employee agreements. 

Social responsibility. Responsible 

safeguarding of the interests of society 

in connection with the company’s 

operations. Over and above its primary 

role as an innovative healthcare 

business, Roche also has a long heritage 

of wider community involvement 

– in humanitarian and social 

projects centred mainly in least 

developed countries, and through its 

support for scientific research, development 

opportunities for young 

scientists and contemporary music 

and arts. All these activities are an expression 

of an autonomous, innovation 

driven corporate culture that has 

developed over a period of more than 

a century. Roche seeks to fulfil its 

social obligations in all countries in 

which it operates. Wherever the operations 

of the company affect the environment 

or local, national or international 

communities, Roche aims to 

meet the highest standards of responsible 

business practice. Its contributions 

to society range from humanitarian 

aid, via educational and 

information campaigns and various 

aspects of →health (→Phelophepa) to 

→environmental protection and the 

promotion of →art. As a healthcare 

company, Roche can make a special 

contribution at the interface between 

health and illness (→AIDS Walk). 


Sternbach, Leo Henryk 

Stem cells. Precursor cells that are 

constantly being formed in the bone 

marrow. They give rise to differentiated 

daughter cells, which in turn undergo 

further differentiation to form 

blood cells and cells of the body’s 

→immune system. 

Sternbach, Leo Henryk (1908– 

2005). Father of the →psychotropic 

drugs Librium and Valium Roche. Leo 

Sternbach was born in the then Austrian 

town of Abbazia and studied 

pharmacy and chemistry at Jagiellonian 

University in Cracow, where he 

obtained his doctorate. He worked 

under Professor Karol Dziewonski as 

a postdoctoral researcher until 1937, 

and spent the next four years working 

with Professor Leopold Ruzicka of the 

Federal Institute of Technology in 

Zurich in the field of chemical synthesis. 

Sternbach then joined Roche Basel 

151

Studies, clinical 

as a research chemist. In 1941, he was 

posted to the American subsidiary in 

→Nutley where, in 1956/57, he discovered 

the →benzodiazepines, which 

soon became hugely important as 

medicines for the treatment of mental 

disorders and various physical illnesses. 

The best-known of these is 

Valium Roche, but they also include 

an extensive range of anxiolytic, antiepileptic 

and sleep-promoting compounds. 

Sternbach’s scientific findings 

are presented in over 120 publications 

and resulted in 240 patents. In 2005 

Sternbach was inducted into the US 

National Investors Hall of Fame for his 

contributions to medicine. 

Studies, clinical. →Trial, clinical. 

Sustainability. Sustainable development 

is development that meets the 

needs of the present without compromising 

the ability of future generations 

to meet their needs. Sustainability 

is an ongoing process that aims 

to achieve responsible innovation and 

progress. The principle of ecoefficiency 

is particularly important if 

progress is to be made in sustainable 

development. At Roche we are committed 

to sustainability and thus running 

our business in a way that is ethical, 

responsible and creates long-term 

value. Roche strives to create sustainable 

value for all major stakeholders 

and has been included in various ratings, 

investment funds and indexes 

(e.g. Dow Jones Sustainability Index) 

that have defined sustainability as one 

152 

of their key evaluation criteria. Therefore, 

sustainability reporting is integral 

to our annual report (→ecology, 

→environmental protection, →social 

responsibility, →Corporate Governance). 

Synthesis. The amalgamation of various 

individual parts to form a whole. 

Within medicine, a distinction is made 

between two different types of synthesis 

– artificial synthesis, which 

normally involves the production of 

chemical compounds →in vitro (“in 

glass”), and biochemical synthesis in 

biological tissues. Biosynthesis can 

involve either the formation or conversion 

of endogenous substances 

such as carbohydrates, fats or proteins 

in the living organism or the technical 

manufacture or complete synthesis of 

drugs in the laboratory. 

Systems biology. A new discipline 

that addresses the analysis of entire 

biological systems in dynamic interaction 

with their environment. Rather 

than analysing individual components 

of a cell, systems biology focuses on all 

components and their interacting networks 

at the level of genes, proteins, 

biochemical reactions and physiological 

processes. It is based on the growing 

understanding of how biological 

systems interact dynamically to give 

rise to physiological functions. Understanding 

complex biological and physiological 

interactions can help scientists 

find new ways to detect, prevent 

and treat multifactorial and polygenic

diseases such as cancer or type 2 diabetes. 

Individually tailored health care 

solutions can then be offered to very 

specific patient groups. SystemsX, the 

Swiss initiative in systems biology was 

created to enhance and extend transdisciplinary 

research and education at 

the highest level in the field of systems 

biology. Scientists from Roche and 

SystemsX’s Competence Center for 

Systems Physiology and Metabolic 

Diseases are collaborating in a joint research 

project entitled “Systems biology 

of the beta-cell-application to type 

2 diabetes progression”. The project 

aims to identify novel pathways for 

drug development in diabetes as well 

as new biomarkers of beta cell failure 

for diagnostics. Beta cells are located 

in the islets of Langerhans in the pancreas 

and produce and release the hormone 

insulin, controlling the level of 

glucose (sugar) in the blood. If the 

project identifies suitable biomarkers, 

the chances of finding a genuine cure 

and not merely a symptomatic treatment 

for diabetes will increase. 


Systems biology 

153

Tamiflu 

Tamiflu. The first orally administered 

neuraminidase inhibitor; a novel 

medicine launched in 1999 to treat 

infections caused by influenza viruses 

(→influenza). The enzyme neuraminidase 

in these viruses plays a crucial 

role in viral replication. Acting like a 

pair of “molecular scissors” it cuts 

newly formed virus particles free, enabling 

them to spread and infect new 

host cells. In the 1980s scientists found 

that a tiny piece of the neuraminidase 

protein was virtually identical in all 

influenza viruses. This major discovery 

paved the way for the development 

of the neuraminidase inhibitors, a 

class of compounds effective against 

Tamiflu packaging line. 

154 

T 

all clinically relevant strains of influenza 

virus. By blocking neuraminidase, 

these compounds prevent the 

→virus from spreading and thus stop 

the infection. For maximum effect 

Tamiflu needs to be taken within 

48 hours of the onset of symptoms. 

Tamiflu was developed as an oral medicine 

to offer patients the advantages 

of simple, reliable dosing. Another 

benefit of oral use is that the drug 

reaches the virus in every part of the 

body where it can do harm. Tamiflu 

has been tested in clinical →trials involving 

over 7,000 patients, and over 

40 million people have already been 

treated with the drug. In clinical trials 

in influenza patients, Tamiflu reduced 

the severity and duration of illness, 

with patients who received the drug 

recovering faster than those who did 

not. Tamiflu also helped reduce complications 

of the disease. Tamiflu is administered 

to adults and children one 

year and older for the treatment of 

influenza and also for prevention following 

contact with a patient suffering 

from influenza. Tamiflu can also be 

employed as a preventive measure during 

a general flu epidemic. The preparation 

is available in capsule form or as 

a powder for the preparation of an oral 

suspension. Tamiflu supplements, but 

does not replace, flu vaccination. 

Taq (Thermus aquaticus) polymerase. 

This →enzyme is a key factor 

in PCR and thus responsible for the 

→synthesis of genetic material in the 

form of →DNA or →RNA. The isola-

tion of this enzyme from the bacterium 

Thermus aquaticus helped 

make the →polymerase chain reaction 

process more robust and more suitable 

for daily use. 

Tarceva. Tarceva is a type of drug called 

a →tyrosine kinase inhibitor (TKI) that 

is designed to block tumour cell growth 

by targeting HER1/EGFR, an important 

protein for cell growth. Tarceva was first 

introduced in 2004 for the second-line 

treatment of patients with advanced 

non-small cell lung cancer and is 

comarketed in the United States by 

Genentech and OSI Pharmaceuticals. In 

2005 it was also approved by the FDA 

for the treatment of advanced pancreatic 

cancer in combination with gemcitabine 

and a variation application is 

currently being reviewed by EMEA. 

Tarceva is the only tyrosine kinase inhibitor 

that has demonstrated an overall 

survival benefit in non-small cell lung 

cancer, improving overall survival by 

42% and increasing one year survival by 

45%. Significantly, because of Tarceva’s 

unique mode of action, these benefits, 

while equivalent to traditional chemotherapy, 

were achieved without the debilitating 

side effects often caused by 

→cytostatic agents. Tarceva is available 

as a tablet, freeing patients from the 

need for complicated intravenous regimens. 

Roche and Genentech are continuing 

to explore the use of Tarceva in 

earlier lines of therapy as well as in numerous 

other tumour types, including 

ovarian, renal and many other kinds of 

cancer (→oncology). 


Technology transfer 

Technology transfer. Apart from research 

results protected by →patents, 

the chemical and pharmaceutical 

industries are constantly developing 

technology and know-how that have 

their own value as intellectual property 

because they are essential to the 

development and maintenance of 

industrial production. Technology 

transfer means putting such knowledge 

at the disposal of partners in 

other countries. The transfer between 

industrial nations covers an extraordinary 

range of technologies. The developing 

countries – intent on building 

up industries of their own – have the 

greatest need for such transfers. 

Whenever Roche establishes a production 

centre in one of these countries 

or contracts out production to a local 

manufacturer, there is a corresponding 

transfer of technology. 

The technology required and developed 

by the pharmaceutical and 

chemical industry is extremely dependent 

on know-how, and if suitable 

personnel and technical facilities are 

not available in the recipient country, 

the transfer will not make economic 

sense. Thus, technology transfer always 

entails some degree of adaptation 

to the specific needs and circumstances 

of the recipient country. 

Technology transfer is not, as its 

name might suggest, restricted to technical 

aspects of production. In addition, 

the products manufactured must 

be used correctly, and this calls for adequate 

communication of knowledge 

and skills. In the pharmaceutical field 

155

Tender 

the recipients of this know-how must 

understand the indications, effects and 

side effects of drugs. Access to new 

technology almost always results in 

the creation of new jobs. This does 

not necessarily result in a loss for the 

country passing on the technology, 

however, since additional demand is 

created by the spread of this expertise. 

The aim of technology transfer must 

always be to create a mutually beneficial 

partnership between the originating 

and recipient countries. 

As part of its ongoing commitment 

to increase access to HIV drugs and 

address the growing need for secondline 

treatments in sub-Saharan Africa, 

in 2006 Roche launched its “AIDS 

Technology Transfer Initiative”. 

The aim of this initiative is to share 

the knowledge that Roche has acquired 

in the manufacture of secondline 

HIV treatments and provide 

hands-on guidance to local manufacturers 

in countries within sub-Saharan 

Africa or those defined by the United 

Nations as “least developed”. The initiative 

is currently being implemented 

in 63 countries and revolves around 

the production of saquinavir, Roche’s 

HIV protease inhibitor that is recommended 

by the World Health Organization 

(WHO) as a second-line treatment 

in resource-limited settings. 

Tender. An invitation, usually issued 

by an official body, for bids for the 

supply of bulk quantities of specific 

goods, sometimes including the services 

necessary for their distribution. In 

156 

the pharmaceutical industry calls for 

tender are often issued when a country 

– particularly one with a state-run 

national health service or one in the 

Third World – wishes to buy bulk 

quantities of a drug needed to fight 

a particular disease. Deals involving 

tenders are significant from the point 

of view of quantity, but prices usually 

have to be kept very low. 

Test strips. Preferred tool for carrying 

out rapid diagnostic tests. They consist 

of a narrow strip to which one or more 

reagent fields are fixed. In these 

reagent fields, all the substances – such 

as chemicals, →enzymes, →antigens, 

→antibodies and excipients – that are 

needed to detect a particular substance 

are impregnated on an absorbent carrier 

material or incorporated into a 

film. On urine test strips up to ten constituents 

can be detected in the urine 

at the same time. The test is carried out 

by dipping the strip in a urine sample 

and then performing quantitative or 

qualitative assessment, either automatically 

using →analytical systems or 

with the naked eye by means of colour 

comparison. In the case of test strips 

for blood analysis, the specimen is applied 

to the reaction field. Nowadays, 

the results are assessed almost exclusively 

by reflectance photometry and 

only very seldom by inspection. 

Tests, diagnostic. Analyses performed 

as part of laboratory diagnosis. 

An exactly defined procedure is 

followed for each particular diagnostic

Test strips and other diagnostic products 

offering quick results are among 

the mainstays of medical diagnostics 

today. Such products are available for 

a wide array of blood and urine parameters. 

test (→Diagnostics research), entailing 

the use of →analytical systems (→AmpliChip 

CYP450 test) and diagnostic 

→reagents. The screening of donated 

blood (→blood-screening) for infectious 

pathogens is important for ensuring 

the perfect quality of blood 

products. A modern diagnostic test for 

identifying the causative agents of 

blood poisoning (→sepsis test) has 

been available since 2006. 

Tinguely, Jean (1925–1991). Artist 

who became famous as the creator of 

machine sculptures. Jean Tinguely was 

one of the outstanding artists of his 

time. Born in Fribourg in 1925, he 

grew up in Basel and found his true 

vocation as an artist in Paris. Along 

with Alexander Calder, he introduced 

movement into art and created highly 

individual, motor-driven machine 

sculptures. His spectacular displays of 

self-destructing machines in the 1960s 


Tinguely, Jean 

West facade of the Museum Tinguely, 

as viewed from Solitude Park. In 

the foreground, Tinguely’s “Floating 

Water Sculpture”. 

brought him worldwide renown. From 

the 1970s on he worked increasingly 

in Switzerland and exhibited his work 

in major international shows. 

To mark its centenary year, F. Hoffmann-La 

Roche Ltd presented the city 

and region of Basel with the Museum 

Tinguely, which was designed by the 

Ticino architect Mario Botta and built 

in Solitude Park, on the right bank 

of the Rhine. The museum exhibits 

works by Jean Tinguely that reflect the 

development of art in the second half 

of the 20th century. 

In the 1950s Tinguely’s sculptures 

– many of them in black and white – 

were characterised by severity and 

great clarity. In 1959 he created the 

first of the drawing machines; these 

Méta-Matics were a significant innovation. 

In 1960 he enjoyed great international 

success with the self-destructing 

machine Homage to New York. How- 

157

Toxicology 

ever, Tinguely’s style changed rapidly. 

He began to work with scrap iron and 

arc welding, and his sculptures became 

more provocative. 

In the 1970s, among other works, 

he produced the Carnival Fountain, in 

Basel. 

The final phase of Jean Tinguely’s 

work, in the 1980s, was associated with 

a number of major projects, including 

large-scale altars such as the Lola 

retable. 

Toxicology. A subdivision of →pharmacology 

dealing with the effects 

of poisons on the body. In any drug 

treatment the desired action against 

the disease is likely to be accompanied 

by other effects. These may be 

merely inconvenient in some cases, 

but highly undesirable or absolutely 

unacceptable in others. Pharmacologists 

study the desired effect of 

a drug on a pathological condition, 

while toxicologists seek to establish 

whether the medication produces any 

undesirable side effects. The fate of 

a chemical compound depends on 

whether the risk of side effects is 

acceptable when measured against 

the expected benefits. 

This risk-benefit ratio must be determined 

before the drug can be given 

to humans, hence the importance of 

→animal experiments. In experimental 

toxicology a compound is administered 

to different kinds of laboratory 

animals in exactly the same way, but at 

higher doses and over a longer period 

than envisaged for human beings. The 

158 

trial may entail just a single dose or 

may continue throughout the animal’s 

life (about two years in the case of 

rats). During the trial the same blood 

chemistry analyses are carried out as in 

hospital laboratories. At the end of the 

trial about thirty of the dead animals’ 

organs are subjected to histological 

examination. This reveals the dosage 

level that would be tolerated without 

harmful effects by the species in question 

and indicates the organ systems 

that might be damaged at higher 

dosages. Even if the results obtained 

in the animal experiments indicate 

that the substance is suitable, or even 

highly suitable, for use in human beings, 

this does not mean that it can 

subsequently be given to humans 

without further investigation. 

Trademarks. A visible sign or device 

that indicates that a product or service 

originates from a particular enterprise. 

Trademarks are extremely important 

for companies, which use them 

to identify their products and distinguish 

them from those of their competitors. 

Registered trademarks are 

identified by the following symbol: ®. 

Since they reassure customers that a 

certain level of quality will be maintained, 

trademarks are an important 

factor in marketing. For this reason a 

trademark may be used only by the 

owner or a licensee authorised by the 

owner. Any vehicle manufacturer may 

call his product a car, but only the 

owner of the Cadillac trademark may 

call his car a Cadillac.

Similarly, a →pharmaceutical product’s 

trademark must be distinguished 

from the →generic name of its active 

ingredient. The trademark Pegasys 

denotes the Roche pharmaceutical 

containing the active ingredient pegylated 

interferon alfa-2a. Pegylated 

interferon is the generic name of the 

active ingredient. 

Trademarks must also be distinguished 

from →patents. While a patent 

guarantees the inventor of a new product 

or process exclusive rights for a 

specific period, with trademarks it is 

immaterial whether the product is new 

or not. A trademark is protected for an 

indeterminate period, since in principle 

it can be renewed as long it is still 

being used. 

Trademarks can take various forms. 

They may be words, symbols or combinations 

of words and symbols, for 

example. The Roche logo, which must 

appear in a precisely specified shade of 

blue, is an example of a combined 

word-symbol trademark. It is used on 

all packaging, stationery and business 

cards, as well as in the company’s 

advertising. In the case of pharmaceutical 

products it is used in conjunction 

with a second →hexagon, which contains 

no wording and is colour coded to 

indicate the product’s therapeutic area. 

This double hexagon is a key feature 

of the Roche family design, helping 

to clearly distinguish Roche products 

visually from those of the competition. 

Trademarks are a product of human 

imagination. They may be geographically 

descriptive or contain references 


Trademarks 

to the nature of the product or to the 

manufacturer, but they may also be 

purely fanciful. 

For pharmaceuticals fanciful, invented 

names with no relation to the 

product concerned and names that do 

indicate the type of product are both 

used. Where possible, Roche prefers 

invented names that can be used in the 

same form worldwide. Care is taken to 

ensure that the word is linguistically 

compatible and has no objectionable 

connotations in any language. 

Trademark rights are usually acquired 

through a process of registration 

at the trademark office in each 

country. Since Roche operates worldwide, 

this means that Roche trademarks 

often enjoy legal protection 

in over 150 countries. Roche owns 

over 35,000 trademarks (registered 

or pending), which represent a very 

substantial material investment, quite 

apart from their incalculable value as 

intellectual property. 

Roche wants to protect its trademarks. 

Accordingly, it monitors the 

trademark activities of other companies, 

objects to the registration or use 

of marks similar to its own, and takes 

legal action where necessary. It keeps 

a special eye out for misuse of its 

trademarks by others in order to prevent 

good, well-known brand names 

from suffering the same fate as Vaseline 

or Frigidaire. Both were once 

legally protected brand names but 

degenerated over the years into 

generic terms, thus losing their value 

as trademarks. 

159

Training and development 

Training and development. Activities 

designed to prepare staff for future 

assignments and problem- and taskbased 

learning programmes to help 

them acquire competencies in new 

technologies and methods in a rapidly 

changing business environment. Employees’ 

skills and work practices need 

to keep pace with continual changes in 

the workplace. At Roche employees are 

offered a range of training and development 

opportunities geared to their 

individual needs. Based on Group objectives, 

programmes are developed 

– and continually reviewed and updated 

– which specifically address the 

needs of particular national markets or 

divisions or span a range of corporate 

activities. Courses specially adapted 

to Roche’s needs are prepared by inhouse 

specialists working in conjunction 

with leading educational institutions 

in Europe and the United States 

(→Roche Forum Buonas). 

Transfer prices. The prices of goods 

and services transferred within a corporate 

group are called transfer prices 

or internal charges. There is a regular 

and fairly intensive exchange of goods 

and services between the companies 

that make up the Roche Group. These 

internal transactions are paid for like 

any other business transaction. A similar 

internal price system to that used 

at Roche is practised by all other 

pharmaceutical firms operating internationally. 

These internal charges are 

set against the costs arising from 

Group activities that are wholly or 

160 

partially centralised but that serve the 

interests of the local companies or are 

often performed especially for them. 

Thus, the prices of goods supplied to 

subsidiaries by the parent company 

must take account not only of the 

manufacturing costs but also of 

expenditures on additional services 

such as research and development, 

medical and scientific information, 

→quality assurance, general administrative 

work and, last but not least, 

financing. 

Trial, clinical. Studies using human 

subjects with the aim of determining 

the benefits and safety of a drug. Clinical 

trials or studies are planned and 

carried out to strict scientific and 

medical standards and must satisfy 

binding ethical and legal norms. 

By means of strict observance of the 

detailed experimental design (close 

medical supervision, in addition to 

detailed, mandatory test protocols) 

the safety of the test subjects and patients 

and the quality of the results are 

guaranteed. Prior to the start of any 

clinical study, moreover, approval 

must also be obtained from independent 

ethics committees and, in most 

countries, from the national health 

authorities as well. Observance of 

ethical and legal norms is monitored 

by the ethics committees and in many 

countries also by the authorities, by 

means of independent inspections. 

With the “Helsinki Declaration” of 

1964, the World Medical Association 

established for the first time the prin-

ciples according to which clinical trials 

are to be run. These have been clarified 

and expanded in the course of several 

revisions. Additionally, the responsibilities 

of investigating physicians and 

the pharmaceuticals industry have 

been precisely set out and codified in 

→good clinical practice (GCP) regulations. 

Every clinical trial is preceded by extensive 

chemical and drug formulation 

experiments, not least for the purpose 

of developing a preliminary dosage 

form for administering the test substance 

to humans and animals. Moreover, 

the drug is subjected to detailed 

animal or in vitro testing for toxicity 

and pharmacological effects, both desirable 

and undesirable (→pharmacology, 

→toxicology). In particular, the 

metabolites of the test substance produced 

in the body and their effects on 

important organ systems must be 

identified in animals before clinical 

trials in humans can begin. But many 

drugs behave differently in humans 

than in animals; certain effects and 

side effects occur only in humans and 

not in animals, or vice versa. Based on 

experience, however, hypothetical models 

of the behaviour of drugs within 

the human body can be obtained. 

These must be painstakingly reviewed 

(→pharmacokinetics). Another precondition 

for proceeding to clinical 

testing in humans is a well-founded 

expectation that the new substance 

will meet therapeutic requirements 

more effectively than those already in 

use. That is why no more than one in 


Trial, clinical 

ten substances tested in animal studies 

makes it to the clinical stage. 

All data from the various human 

and animal tests are presented to the 

health authorities for review and 

comment, and a summary, called the 

“Investigational Drug Brochure”, is 

sent to ethics committees and investigating 

physicians. 

Clinical testing proceeds in four 

phases. Except for Phase I (see below), 

clinical studies are usually performed 

outside the drug company in hospitals 

and, in some cases, in specialised medical 

practices. The investigating physician, 

who is also responsible for the 

test subjects and patients, is required 

to inform them in advance of the 

purpose and goals of the trial and of 

possible effects and risks. The main 

concern of the investigating physician 

in carrying out a clinical study must 

always be to protect the patients from 

physical injury (the medical principle 

of “first do no harm”) and respect their 

right of privacy (doctor–patient confidentiality). 

Participation in a study is 

voluntary and the consent of the test 

subjects or patients to participate must 

be documented by their personal signature 

on the informed consent form. 

Participants have the right to quit a 

clinical trial at any time. 

Phase I trials test for tolerance in 

healthy volunteers (test subjects) by the 

administration of gradually increasing 

doses until the proposed therapeutic 

level is attained (tolerance test). 

In the next step, Phase II, the therapeutic 

effect at various dosage levels is 

161

Trial, experimental 

determined in controlled, randomised 

tests in a small group of patients. This 

permits the appropriate dosage range 

to be established. If the results of this 

step are also positive, that is, if the 

drug is well tolerated by patients and 

leads to cure of the disease or at least 

to alleviation of symptoms, the drug 

enters Phase III for broader testing. 

In this phase, the drug – again under 

controlled conditions and depending 

on the type of illness – is administered 

to anywhere from several hundred to 

several thousand patients to test its 

effectiveness under different conditions, 

as well as its interactions with 

other medications. 

Long-term treatment is carried out 

exclusively in Phase III, after which an 

application for →registration is submitted 

to the health authorities. Phase 

IV can begin once approval has been 

obtained. The aim of continued testing 

of the medication is to discover any 

unusual side effects, which may not 

appear until a drug has been used in 

many more patients, and to explore 

possible additional uses. In any case, 

even after the conclusion of the clinical 

trials programme, the drug is subject 

to continuous monitoring, since side 

effects (but also positive developments 

such as effectiveness in treating other 

illnesses) are occasionally discovered 

only after prolonged clinical experience 

(→Drug Safety Monitoring). 

With the aim of increasing transparency, 

and in accordance with the 

guidelines on the disclosure of information 

issued by the European 

162 

Federation of Pharmaceutical Industries 

and Associations (EFPIA), Roche 

launched a website in 2005, www.rochetrials.com, 

which gives patients and 

healthcare professionals a publicly 

accessible register for clinical trial 

preparations and a database with 

study results. 

Trial, experimental. Systematic experimentation 

designed to examine 

the biological and pharmacological effects 

of a substance. In rare cases, the 

therapeutic effectiveness of a substance 

is first discovered in clinical 

practice; as a rule, however, it is the 

experimental trial that leads to the 

discovery of therapeutic effects. 

Such experiments are carried out in 

vitro – that is, in the test tube, in cell 

cultures and in isolated organs – then 

in animals. The type of screening usual 

in the past – that is, using animals to 

test substances about which only rudimentary 

knowledge was available – is 

now rarely practised. To identify pharmacological 

and chemotherapeutic 

effects that are worth pursuing, a substance 

will first be tested in therapeutic 

models (e.g. computer simulations). 

Most compounds fail to pass these 

initial trials. The few that remain are 

subjected to further testing to sort out 

the range of effects in detail. This also 

permits the identification of undesirable 

effects. Once all these details are 

known, animal experiments are indispensable 

for clarifying effects and side 

effects in the intact organism. Pharmacokinetic 

and metabolic tests examine

the distribution and chemical changes 

the substance undergoes in the body. 

Only after comprehensive experimental 

testing has demonstrated the safety, 

as well as the desired effectiveness, of a 

potential new medicine can it be tested 

in humans. 

The experimental testing conducted 

during the course of product development 

also includes tests to investigate 

behaviour, degradability and possible 

harmful effects on organisms in the 

environment. 

Tumour markers. Substances or cellular 

changes whose presence, or increased 

concentration, in sample materials 

– e.g. stools, blood or urine – is 

directly connected with the presence 

or progression of malignant tumours. 

They are produced either by the tumour 

cells themselves or by other 

→cells that are triggered to do so. 

However, their significance is limited 

since such tumour markers can also 

occur in association with inflammatory 

processes in the body and even in 

Immunoassay CA-15-3: identifies a 

specific protein – a tumour marker – 

in the body of breast cancer patients. 


T lymphocytes (T cells) 

a healthy body. Tumour markers are 

primarily used to monitor the progression 

of cancers (→oncology). 

Tyrosine kinase inhibitor. A type of 

chemical compound that blocks a protein 

critical for cell growth. Human 

cells contain more than 900 types of 

kinase and these can malfunction to 

drive uncontrolled cell division, leading 

to cancer. This has been seen in 

several kinds of cancer and inhibition 

of such faulty kinases can help bring 

the cancer under control. Roche’s drug 

→Tarceva is an example of a tyrosine 

kinase inhibitor that has been shown 

to be effective in lung and pancreatic 

cancer (→oncology). 

T lymphocytes (T cells). Class of 

white →blood cells that are part of 

the →immune system; they mature in 

the thymus (→autoimmune diseases). 

T cells have two main functions: con- 

163

T lymphocytes (T cells) 

trolling immune responses (helper 

T cells) and eliminating cells that are 

abnormal or have been invaded by 

viruses or parasites (cytotoxic T cells 

or killer T cells). 

164


U 

Ultra-High-Throughput Screening, 

UHTS. Automated, high-performance 

test systems which facilitate efficient 

drug discovery. In the quest for new 

drugs, drug targets (proteins that play 

a key role in disease) are systematically 

screened for interactions with potential 

active drug ingredients from 

Roche’s extensive compound libraries. 

The aim of screening large compound 

libraries is to find suitable drug candidates 

quickly and make them available 

for development as medicines. 

Roche and Carl Zeiss Jena have 

jointly developed a new UHTS system 

that sets new global standards for 

screening systems. The new system can 

test up to 200,000 samples a day, performing 

up to ten measurements per 

sample. The centrepiece of the new 

technology is a novel detection system 

(a multichannel reader), combined 

with newly developed equipment and 

control software for processing the 

microtitre plates in which the tests 

are performed. Miniaturisation of test 

volumes, using microtitre plates with 

384 or 1,536 wells, dramatically reduces 

the amounts of biochemical 

reagents and chemical samples required. 

The custom-designed 96channel 

reader permits high-precision 

analyses of 384 samples in four steps, 

or of 1,536 samples in 16 steps, within 

a matter of seconds. The Zeiss reader 

employs all the optical detection 

methods customarily used in biological 

screening to detect interactions 

Ultra-High-Throughput Screening 

Roche’s multichannel screening system 

speeds up the discovery of new active 

ingredients. 

between potential active drug ingredients 

and drug targets (fluorescence, 

luminescence, and absorption measurements). 

It thus meets today’s exacting 

requirements for high-throughput 

efficiency in drug discovery. 

→Applied Science, a business unit 

of Roche Diagnostics, develops and 

supplies generic assays and reagents 

for UHTS and offers tailor-made solutions 

for customers’ needs. 

165

Viruses 

Viruses. Minute, often highly contagious 

pathogens consisting of an inner 

core of genetic material, in the form of 

→DNA or →RNA, which is frequently 

surrounded by one or more protective 

shells (capsids). Retroviruses contain 

genetic information in the form of 

RNA, which can be transcribed into 

DNA by the viral →enzyme reverse 

transcriptase. HIV, the causative agent 

of →AIDS, is a retrovirus. Viruses can 

only replicate with the help of biochemical 

“tools” provided by the host 

cells they invade. 

Drug treatment of viral diseases 

has so far proved very difficult, as 

substances intended to block viral 

replication often also interfere with 

important physiological processes in 

human cells and thus provoke side 

effects. It is only recently, with the 

characterisation of entire →genomes 

of many viruses, that new specific target 

structures have been identified. 

This characterisation of viral genomes 

coupled with PCR technology 

has also allowed development of 

highly sensitive diagnostic tests that 

quantify the amount of virus in 

blood, enabling monitoring of 

patient response to therapy as well 

as detection of dangerous viruses in 

donated blood and organs before 

they are used in transfusions or 

transplantation. With the help of 

→genetic engineering and computer 

modelling of active ingredients, 

highly effective drugs have been 

166 

V 

developed, including the HIV protease 

inhibitors →Invirase and Viracept 

for AIDS viruses. 

Certain viruses do not cause serious 

disease in subjects whose →immune 

systems are functioning normally. 

These include the rhinoviruses (responsible 

for the common cold), 

cytomegalovirus (CMV) and various 

other herpes viruses. However, if the 

immune system is impaired (as is the 

case in AIDS patients or people who 

have undergone chemotherapy or 

are immunosuppressed following an 

organ transplant), even these viruses 

can pose a threat. CMV, for instance, 

will then damage vital organs and 

cause blindness. 

Many viruses are dangerous to 

everyone, either because they can seriously 

damage organs even in healthy 

subjects or, in some cases, because they 

can cause cancer to develop. Measles, 

mumps and polio viruses are dangerous 

mainly for infants and young 

children. Infection with the rubella 

(German measles) virus during pregnancy 

causes damage to the unborn 

child. A number of other viruses pose 

a threat to adults too: type A and B influenza 

viruses, meningitis viruses, the 

various hepatitis viruses (A, B, C, D), 

the AIDS viruses HIV-1 and HIV-2, 

and the Epstein-Barr and human 

papilloma viruses, which can cause 

cancer. The Ebola virus and a number 

of other viruses found in tropical 

countries can prove rapidly fatal. 

People can be protected against 

viral infections by being inoculated

with killed or greatly attenuated 

viruses or with virus capsid proteins 

produced by genetic engineering. 

Inoculation (also called vaccination) 

stimulates the immune system to form 

“memory” cells, which, in the event 

of infection with an active pathogen, 

trigger the production of specific 

→antibodies and T lymphocytes that 

recognise the invader. 

Roche produces the following antiviral 

drugs: Cymevene/Cytovene (ganciclovir) 

for CMV infections, the HIV 

protease inhibitors →Fuzeon, Invirase 

(saquinavir) and Viracept (nelfinavir) 

for the treatment of AIDS, →Roferon- 

A (interferon alfa-2a) and Pegasys 

(pegylated interferon alfa-2a [40KD]) 

for →hepatitis B and hepatitis C, 

Copegus (ribavirin) for hepatitis C 

and →Tamiflu for →influenza. 


Viruses 

167

Wastewater treatment 

Wastewater treatment. Since the 

early 1970s Roche has invested substantially 

in the construction of modern 

wastewater treatment facilities. 

Chemically polluted effluents are 

treated for the most part at companyowned 

facilities combining chemical 

and biological treatment processes. 

Up to roughly 90 percent of organic 

pollutants are biologically degraded by 

microorganisms. The resulting sludge 

is separated, dewatered and then disposed 

of by environmentally responsible 

incineration methods. Effective as 

modern biological treatment systems 

are, however, effluents generated by 

Roche and other companies still contain 

compounds, such as chlorinated 

and aromatic hydrocarbons, which are 

poorly biodegradable. 

Roche scientists are working to 

develop and evaluate state-of-the-art 

processes for pretreating poorly 

degradable process effluents. This inhouse 

pretreatment ensures that problem 

compounds can then be readily 

biodegraded by existing treatment 

processes. 

WHO (World Health Organization). 

Agency of the United Nations, 

founded in 1947 for the purpose of 

promoting →health. Its headquarters 

are in Geneva. 

168 

W


X 

Xeloda. A chemotherapy agent (active 

ingredient capecitabine) taken in tablet 

form as a treatment for breast and 

bowel cancer. Xeloda is converted into 

the active cytostatic agent 5-fluorouracil 

(itself a product originally developed 

by Roche as →Fluoro-uracil Roche 

four decades ago) inside tumours, so it 

has much less effect elsewhere in the 

body, resulting in far fewer side effects 

without sacrificing efficacy. Xeloda was 

launched in 1996 and recently celebrated 

the milestone of the millionth 

patient treated. In addition to its currently 

licensed indications, Xeloda has 

also shown benefit in cancers of the 

stomach and pancreas, where it is hoped 

its use will shortly be approved. Studies 

investigating Xeloda in other types of 

cancer are in progress (→oncology). 

Xeloda 

169

Index 

Page numbers in italics refer to entries on the subjects listed in the index. Page 

numbers in regular type refer to pages where indexed subjects are mentioned. 

A 

Accu-Chek, 48–49, 93 

Accutrend, 130 

ACE inhibitors, 4, 33 

Activase (TNKase), 33, 68 

Adenine, 52, 138 

Adjuvant therapy, 31, 78 

Agonist, 4, 12, 26 

AIDS, 4, 15, 30, 60, 63, 86, 107–108, 

116, 126, 130, 142, 151, 166 

AIDS Walk, 5, 151 

Air pollution, control of, 5, 59 

Airol, 6 

Alarm centre, 6 

Alternatives to animal testing, 6, 11 

Alzheimer’s disease, 7 

Amino acids, 7, 126 

AmpliCare programme, 8 

AmpliChip CYP450 Test, 8,49, 53, 64, 

157 

Amplicor, 95, 117, 142 

Analysis, 9, 66, 93, 102 

Analytical systems, 9, 38, 40, 49, 56, 

78, 142, 156–157 

Anemia, 10, 20, 34, 60, 98, 103 

Angiogenesis, 10, 22 

Angiotensin, 4 

Animal experiments, 11–12, 132, 158 

Antagonist, 4, 12, 26, 119, 131 

Antibodies, 5, 12–13, 21, 28, 30, 32, 

70, 81–82, 99, 103, 113, 122, 126, 

130, 156, 167 

Antibodies, humanised, 13, 21, 77, 82, 

104 

Antibodies, monoclonal, 13, 21–22, 

32, 65, 77, 92, 104 

Antibodies, polyclonal, 13 

170 

Antidepressants, 128 

Antigen, 12–13, 32, 34, 82, 92, 99, 130, 

156 

Antimicrobials, 5, 14, 23, 53, 63, 108 

Antiparkinsonian agents, 16, 74, 98, 

119 

Apothecary jars, historical, 16 

Applied Science, 16, 49, 82, 122, 142, 

146, 165 

Apprenticeships, 17 

Architecture, 18, 24, 44, 74 

Art, 19, 44, 151 

Arthritis, rheumatoid, 20, 22, 38, 135 

Autoimmune diseases, 14, 20–21, 104, 

135, 163 

Avastin, 11, 19, 22, 65, 103 

B 

Bacteria, 13–14, 23, 28, 67, 82, 135 

BAN, 65 

Barell, Emil Christoph, 18, 23–24, 30, 

62, 79 

Basel, 6–7, 16–20, 24, 25–26, 44–46, 

57, 72, 79, 81, 90, 97, 108, 111, 

133, 149, 151, 157–158 

Basic research, 22, 25, 62, 68 

Basilisk, 25, 78 

Benzodiazepines, 25, 81, 98, 119, 128, 

131, 152 

Bioavailability, 9, 62, 66 

Biologics, 26 

Biology, 26 

Biomarkers, 26, 50, 139 

BioS, 26 

Biosafety, 27, 77, 122, 144 

Biosimilars or follow-on biologics 

(FOBs), 28

Biotechnology 23, 29, 33, 65, 93–94, 

103 

Biotransformation, 29 

Blood cells, 4, 21, 29, 34, 60, 73, 88, 

98, 131, 163 

Blood-screening, 30, 115, 157 

Board of Directors, 18, 23, 30 

Bondronat, 103 

Bonviva/Boniva, 106 

Boyer, Herbert, 67 

Breast cancer, 22, 31, 77 

Burgdorf, 32, 48, 83 

B lymphocytes, 13, 30, 32, 91 

C 

Caflisch, Albert, 30 

Capsules, 107, 123 

Cardiac Reader, 130 

Cardiology, 33 

Cardiovascular, 4, 33 

CellCept 29, 33, 122, 148, 170 

Cell, human, 34–35, 52 

Cell nucleus, 34, 131 

Cells, 60, 97, 163 

Cells, dendritic, 30, 34 

Cephalosporins, 34 

C.E.R.A., 10, 34, 61 

Chemotherapeutic agents, 35 

Child-proof drug containers, 35, 107, 

121 

CHMP, 35, 56, 133 

Cholesterol, 35 

Chromosomes, 34–35, 46, 67, 69 

Chugai, 21, 33, 38, 52, 78, 92, 97–98, 

106, 112, 133–134 

Clinical chemistry, 10, 38–39, 130, 143 

Clinical Research Ethics Advisory 

Group (CREAG), 38 

Clone, 38 

CoaguChek, 39, 130 


Coagulation self-monitoring, 39, 109, 

131 

Cobas, 9, 39, 79, 117, 142 

Cohen, Stanley, 67 

Communication, employee, 40 

Communication, financial, 40 

Communication, general, 41 

Communication, product-related, 41 

Communications, 80 

Competition, 41 

Copegus, 15, 77, 142, 167 

Copyright, 42 

Corporate functions, 43, 90, 108 

Corporate Governance, 43, 152 

Corporate Principles, 41, 43 

Counterfeit drugs (cultural commitment), 

44, 62, 107, 124 

Cultural sponsoring, 44 

Cystic fibrosis (CF), 46, 65 

Cytokines, 10, 46, 82, 84, 92, 113, 131, 

141 

Cytosine, 52, 138 

Cytostatic agent, 47, 102, 155 

D 

Index 

Derivative, 48 

Diabetes, 10, 22, 32, 48–49, 82, 93 

Diabetes Care, 32, 48–49, 82, 93 

Diagnostics Division, 5, 9, 16, 38–39, 

48, 50–51, 53, 56, 73, 76, 78, 

81–82, 94, 105, 108, 111, 114, 116, 

122, 125, 130, 134, 139, 145 

Diagnostics research, 49, 134, 157 

Dilatrend, 33 

Distribution centres, 50 

Divisions, 40–41, 43, 51, 76, 112, 133 

DNA, 26, 29, 34–35, 46, 52, 62, 64, 

67–69, 94–95, 97, 114–115, 127, 

131, 135, 138, 141, 145, 150, 154, 

166 

171

Index 

DNA chips, 9, 52 

DNA probe, 52, 68 

Dormicum, 81 

Dosage forms, 62, 107, 113, 123–124 

Dow Jones Sustainability Index, 152 

Drug resistance, 53 

Drug Safety Monitoring, 53, 121, 162 

E 

Early detection, 55 

E-business (electronic business), 55 

Ecology, 55, 60, 74, 152 

Elecsys, 9, 56 

EMEA, 34–35, 56, 133 

Employee health service, 57, 76, 102 

Employee representation, 57 

Energy supplies, 58 

Environmental protection, 9, 56, 58, 

76, 86, 122, 137, 151–152 

Environmental risk assessment, 60 

Enzymes, 29, 38, 52, 60, 95, 126, 128, 

130, 135, 154, 156, 166 

Epidemiology, 60 

EPO, 10, 60 

Epogin, 38, 61, 98 

Erythrocytes, 10, 29, 60 

Erythropoietin, 10, 60, 88, 98, 122 

Escherichia coli, 28, 61 

Expression, 71, 104, 141 

F 

FDA, 5, 62, 65 

Fermentation, 35, 121–122 

Fire service, 137 

Fluoro-uracil Roche, 62, 169 

Formulation, 62, 66, 113, 121, 123 

Foundations, scientific, 62 

Fusion inhibitors, 5, 63, 119 

Fuzeon, 63, 119, 167 

172 

G 

Gene, 7, 9, 14, 38, 64, 67–69, 82, 95, 

127, 146, 150 

Gene chip, 9, 64 

Gene disruption, 68 

Gene segment, 66 

Genentech, Inc., 22, 32–33, 46, 52, 64, 

78, 82, 85, 92, 97, 103, 112, 134, 

136 

Generic names, 65, 159 

Generics, 42, 62, 66, 124, 135 

Genetic engineering, 23, 26, 29, 66, 

85, 111, 131, 135, 166 

Genetic engineering techniques, 52, 

67–68 

Genetic information, 52, 64, 68 

Genetics, 69 

Genome, 34, 52, 64, 69, 96, 113, 127, 

146, 150, 166 

Genome Sequencer GS20, 146 

Genomics, 17, 26, 69, 94, 115, 139, 

146 

Gerber, Fritz, 31 

Glucose, 48, 69, 82, 109 

Glucose self-monitoring, 48, 69, 82, 

109 

GlycArt Biotechnology AG, 69, 134 

Good Clinical Practice Regulations 

(GCP), 71, 129, 161 

Good Laboratory Practice Regulations 

(GLP), 72, 129 

Good Manufacturing Practice Regulations 

(GMP), 72, 91, 122, 129 

Granulocytes, 30, 73 

Graz, 73 

Grenzach-Wyhlen, 6, 74–75, 79, 96, 

132, 136 

Group, 74, 80, 108 

Guanine, 52, 138 

Guggenheim, Markus, 16, 74

H 

Health, 76, 133, 151, 168 

Health protection, 76 

Hepatitis, chronic, 15, 77, 107, 116, 167 

Herceptin, 32, 65, 77, 103, 122 

Hexagon, 78, 159 

Hitachi, 78 

HIV, 4–5, 8, 15, 30, 56, 60, 63, 67, 86, 

96, 100, 107, 115–117, 119, 126, 

142, 156, 166–167 

Hoffmann, Traub & Co., 6, 79 

Hoffmann-La Roche, Fritz, 6, 24, 

62–63, 74, 79–80, 96, 108, 112, 

138–139 

Holding company, 30, 80, 108, 145 

Hormones, 80, 131 

Human interferons, 85 

Humer, Franz B., 31 

Hybridomas, 81 

Hypnotics, 25, 81 

I 

Immune system, 4, 12–13, 21, 30, 32, 

34, 46, 82, 85, 91–92, 104, 113, 

131, 135, 141, 151, 163, 166 

Immunoassay, 39, 56, 82 

Immunoglobulin (Ig), 82 

Immunology, 82 

Indianapolis, 82 

Indication, 83 

Influenza (flu), 16, 83, 154, 167 

Informed consent, 71, 161 

INN, 29 

Insulin pump therapy, 32, 84 

Interferons, 29, 46, 67, 77, 84, 91, 122, 

126, 141 

Investment, 85, 123, 126 

Invirase, 15, 86, 119, 166 

In vitro, 6, 11, 68, 72, 85, 87, 115, 130, 

143, 152 


In vitro diagnosis, 68, 87, 115, 130 

In vivo, 72, 87 

In vivo diagnosis, 87 

J 

Jann, Adolf Walter, 30 

Jerne, Niels Kaj, 12–13, 98–99 

K 

Kidney disease, chronic, 34, 61, 88, 98, 

172 

Koechlin-Hoffmann, Albert, 30 

Köhler, Georges, 13, 98–100 

Kytril, 103 

L 

La Roche, Adèle, 79–80, 138 

Landfills, 89 

Landscaping, ecological, 89 

Languages, 90 

Leukocytes, 29–30, 73 

Lexotan, 25 

Librium, 25, 151 

LightCycler, 17, 143, 145 

Logistics, 90, 93, 120 

Lymphocytes, 73, 82, 91–92 

Lymphokines, 91 

M 

MabThera, 65, 92, 100, 103 

Macrophages, 34, 92 

Madopar, 16, 119 

MagNA Pure LC, 17 

Mannheim, 74, 92, 136 

Marketing, 93, 112 

Measurement units, analytical, 93 

Medicine, personalised, 76, 94 

Metabolism, 94 

Metabolites, 9, 161 

Milstein, Cesar, 13, 98–99 

Index 

173

Index 

Mircera, 34, 61 

Molecular biology, 26, 94, 99, 135 

Molecular Diagnostics, 49, 53, 82, 94, 

114, 116, 142 

Molecular medicine, 94–95 

Molecule, 26, 96 

Monitoring, 96 

mRNA, 68 

Mullis, Kary, 100, 115 

Multinationality, 96 

Museum Tinguely, 45–46, 157 

Mutagenesis, 68 

Mutation, 7, 13, 46, 97 

N 

Nanotechnology, 146 

NeoRecormon, 10, 29, 61, 98, 103, 

122 

Neurotransmitters, 16, 98, 101, 131 

New Drug Application (NDA), 132 

Nobel Prize, 12–13, 25, 82, 98, 115 

Non-Hodgkin’s lymphoma, 92, 100 

Non-voting equity security, 140, 149 

Nutley, 19, 24, 85, 100, 133, 152 

O 

Obesity, 94, 101 

Occupational hygiene, 9, 55, 76, 101, 

144 

Oncogene, 102 

Oncology, 13, 22, 47, 62, 65, 78, 92, 

94, 100, 102, 115, 119, 155, 163, 

169 

Organ transplantation, 13, 21–22, 33, 

63, 103, 108 

Orphan drugs, 105 

Osteoporosis, 20, 56, 94, 105 

174 

P 

Packaging, 90, 107, 123 

Palo Alto, 107, 133, 136, 141 

Parent company, 24–25, 30, 108, 133 

Patents, 6, 44, 66, 85, 108, 135, 155, 

159 

Patient self-monitoring kits, 109 

PCR, 15, 30, 50, 60, 68, 77, 109, 111, 

114 

Pediatric pharmaceuticals, 109 

Pegasys, 15, 29, 68, 77, 122, 142, 159, 

167 

Penzberg, 26, 70, 74, 111, 122, 133 

pH value, 94 

Pharmaceutical formulation, 73 

Pharmaceuticals, 51, 66, 71, 78, 83, 94, 

104, 107–109, 111–112, 122, 133, 

138–139, 159 

Pharmaceuticals, Division, 51, 71, 76, 

78, 107–108, 111, 122, 133, 

138–139 

Pharmacoeconomics, 112 

Pharmacogenetics, 112, 150 

Pharmacogenomics, 113, 150 

Pharmacokinetics, 113, 161 

Pharmacology, 113, 158, 161 

Phelophepa, 113, 151 

Plasmid, 114 

Platelets, 29–30 

Pleasanton, 95, 114 

Point of Care Testing, 115 

Polymerase chain reaction (PCR), 49, 

68, 95–96, 100, 109, 115, 130, 145, 

155 

Predisposition, 76, 118 

Prevention, 82, 118 

Prices, 118 

Prix Galien, 63, 86, 119 

Product distribution, 120 

Product safety, 9, 120

Production, biotechnological, 29, 33, 

85, 121 

Production, chemical, 122 

Production construction projects, 123 

Production, pharmaceutical, 123 

Production sites, 86, 125 

Professional Diagnostics, 9, 39, 49, 56, 

78, 81–82, 105, 115, 125, 130, 142 

Profit, 126 

Protease, 126 

Proteins, 7, 12, 21, 26, 29, 35, 38, 46, 

52, 61, 64, 66, 68–69, 85, 111, 121, 

126–127, 130, 136, 141 

Proteomics, 17, 26, 50, 127, 139 

Psychotropic drugs, 25, 119, 128, 151 

Pulmozyme, 46, 68 

Q 

Quality assurance, 71–72, 121, 129, 160 

Quality control, 9, 71, 121–122, 129, 

134 

R 

Randall, Lowell, 25 

Rapid diagnostic tests, 130 

Rating, 152 

Reagents, diagnostic, 130, 143, 157 

Receptors, 5, 126, 131, 141 

Recombination, 131 

Recycling, 59, 131 

Reflotron, 130 

Regio, 132 

Registration, 35, 56, 60, 72, 108, 111, 

132, 162 

Research, 7, 25, 71, 76, 86, 108, 112, 

126, 133–134 

Research expenditure, 7, 134 

Research, genetic, 139 

Restriction enzymes, 135 

Retention tanks, 135 


Rheumatism, 22, 38, 135 

Rhine, 74, 92, 132, 136 

Ribonucleic acid, 52, 64, 138 

Ribosome, 136 

Risk management, 136 

Risk management planning, 137 

RNA, 26, 68, 136, 138, 145, 154, 166 

Rocephin, 16, 29, 34, 122, 138 

Roche, 85, 138 

Roche Biomarker Programme, RBP, 

139 

Roche Charter on Genetics, 139 

Roche Commissions, 44–45 

Roche Connect, 140 

Roche Forum Buonas, 140, 160 

Roche Foundation for Anemia 

Research, 63 

Roche Holding AG, 30, 74, 81, 108, 

149–150 

Roche Institute of Molecular Biology, 

85, 141 

Roche ’n’ Jazz, 45 

Roche Organ Transplantation 

Research Foundation (ROTRF), 

63 

Roche Research Foundation, 63 

Roche Sample Repository, RSR, 141 

Roferon-A, 30, 67, 77, 85, 103, 113, 

141, 167 

Rohn, Roland, 19 

Rotkreuz, 142 

Rx, 112, 143 

S 

Index 

Safety, 56, 60, 76, 102, 136, 144 

Safety data sheet, 144 

Salvisberg, Otto R., 18–19, 44 

Sapac Corporation, Ltd., 144, 149 

Science and Ethics Advisory Group, 

(SEAG), 140 

175

Index 

Screening, 76, 145 

Sepsis test, 145, 157 

Sequencing, 50, 145 

Serology, 131 

Seveso, 146 

Shanghai, 134, 147 

Share capital, 74, 79, 81, 145, 149 

Sirolin, 80, 139, 150 

SNPs, 150 

Social benefits, 150 

Social responsibility, 5, 8, 114, 

151–152 

Stem cells, 10, 151 

Sternbach, Leo Henryk, 25, 98, 151 

Studies, clinical, 152 

Supply Chain Management, 90 

Sustainability, 8, 56, 152 

Synthesis, 152, 154 

Systems biology, 152 

T 

Tablets, 35, 107, 111, 123, 125 

Tamiflu, 16, 60, 84, 154, 167 

TaqMan, 95, 117, 142 

Taq (Thermus aquaticus) polymerase, 

154 

Tarceva, 103, 155, 163 

Technology transfer, 124, 155 

Tender, 156 

Test strips, 69, 82, 115, 143, 156 

Tests, diagnostic, 9, 26, 139, 156 

Thymine, 52 

Tinguely, Jean, 46, 157 

Tonegawa, Susumu, 13, 82, 99–100 

Toxicology, 7, 9, 12, 72, 102, 113, 121, 

130, 158, 161 

Trademarks, 6, 25, 44, 78, 80, 85, 139, 

159 

Training and development, 140, 160 

Transfer prices, 160 

176 

Transformation, 68 

Traub,Max Carl,79 

Trial, clinical, 33, 54, 66, 71, 74, 78, 85, 

87, 121, 132, 141, 152, 154, 161 

Trial, experimental, 72, 87, 94, 162 

Tumour markers, 56, 103, 163 

Tyrosine kinase inhibitor, 103, 155, 

163 

T cells, 4–5, 21, 30, 163–164 

T lymphocytes (T cells), 21, 30, 34, 

91, 163 

U 

Ultra-High-Throughput Screening, 

UHTS, 165 

Uracil, 138 

USAN, 65 

V 

Valcyte, 15, 104, 108 

Valium Roche, 25, 151–152 

Viracept, 15, 166–167 

Viruses, 4, 13–14, 28, 67, 69, 82, 84, 

86, 154, 166 

W 

Waste, 6, 28, 58–59, 88–89, 122, 131, 

138 

Wastewater treatment, 59, 168 

WHO, 44, 65, 71, 73, 76, 99, 101, 168 

Wieland-Zahn, A., 30 

X 

Xeloda, 62, 102, 148, 169 

Xenical, 101, 111 

Z 

Zenapax, 68, 104

Roche from A to Z Serving health

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