PDF (14.14 MB) - Boehringer Ingelheim Annual Report 2012

Value through Innovation 

Corporate Magazine 2012

corporate magazine 2012 

content 

value through innovation 

6 PERSPECTIVES FOR LASTING SUCCESS 

perspectives for boehringer ingelheim 

8 EMPLOYEES’ PHOTO CONTEST 

corporate responsibility 

14 COMPANY WITH A HUMAN FACE 

18 NEW WAYS OF IMPROVING HEALTH 

24 PERSPECTIVES FOR ENVIRONMENT, 

HEALTH AND SAFETY 

28 OUTSTANDING BASIC RESEARCH 

30 PERSPECTIVES FOR THE SOCIETY OF TOMORROW 

32 NEW STIMULI IN RESEARCH 

34 SHAPING THE FUTURE OF RESEARCH 

36 KNOWLEDGE TRANSFER BETWEEN ACADEMIA 

AND INDUSTRY 

research & development 

42 RESEARCH PARTNERSHIPS WITH ACADEMIA 

AND INDUSTRY 

44 ACCELERATING THE DEVELOPMENT OF NEW MEDICINES 

45 PHARMACOEPIDEMIOLOGY - A RISING FIELD 

48 PIONEERING TREATMENTS FOR CANCER 

52 HIGH DISEASE BURDEN OF HEPATITIS C 

55 INDUSTRY-LEADING DEVELOPMENT 

OF ORAL ANTIDIABETES DRUGS 

58 MOVING RESPIRATORY FORWARD 

60 THE FUTURE OF OUR RESEARCH AND DEVELOPMENT

our businesses 

66 [ prescription medicines ] 

67 CARDIOVASCULAR DISEASES 

70 REDUCING STROKE RISK IN ATRIAL FIBRILLATION 

73 CONTROLLING HYPERTENSION AND 

CARDIOVASCULAR PROTECTION 

76 LIVING BETTER WITH DIABETES 

79 THE TRUE FACE OF COPD 

82 PERSPECTIVES ON INNOVATIVE BUSINESS 

MODELS 

84 MARKET ACCESS FOR NEW MEDICINES 

86 PASSIONATELY ENABLING GROWTH 

88 [ consumer health care ] 

89 STAY HEALTHY TO ENJOY YOUR FREEDOM 

90 FROM PRESCRIPTION TO SELF-MEDICATION 

92 [ biopharmaceuticals & biosimilars ] 

93 BIOPHARMACEUTICALS – 

MEDICINES FOR THE FUTURE 

94 INNOVATION DRIVERS IN BIOPHARMACEUTICALS 

97 BIOSIMILARS – PERSPECTIVES FOR PATIENTS 

98 [ animal health ] 

99 COMPREHENSIVE ANIMAL HEALTH MANAGEMENT 

101 FRONT LINE RESEARCH 

104 GLOBAL PERSPECTIVES IN ANIMAL HEALTH 

106 A FUTURE FOR VULTURES IN INDIA 

production network 

112 MANAGING QUALITY 

114 SECURE SUPPLY CHAINS GUARANTEED 

our markets 

120 EUROPE - MARKETS IN TRANSITION 

124 USA - FUNDAMENTAL REFORMS 

126 JAPAN - HEALTHCARE FINANCING UNCLEAR 

CONTENT

VALUE THROUGH 

INNOVATION 

We perceive ourselves as the patient ̒s partner, 

providing innovative medicines for better health. 

We thereby create Value through Innovation.


extracts from our ‘leitbild’ 

EXTRACTS FROM OUR 

Leitbild * 

Boehringer Ingelheim has been a successful, family-owned business 

for more than 125 years and intends to remain so for the second 

century of its existence. Although it is impossible to predict the future 

precisely, we are actively and creatively facing the changing tasks and 

challenges, building on our experiences and achievements. This gives 

us the strength, direction and confidence to shape our future. 

We have committed ourselves to the goal of serving humankind 

through research into diseases and the development of new drugs and 

therapies. In this endeavour, the future of our company will depend 

on its innovative capability. 

In all our activities, we safeguard our employees, facilities and the 

environment from harmful influences, conserve natural resources and 

promote environmental awareness. Parallel to pursuing these goals, 

we seek to foster economic and social well-being in the countries and 

communities where we do business. 

In order to realise our goals, we must be financially successful, be 

willing to make the necessary changes, and be critically receptive 

to new ideas and developments. Maintaining and improving the 

performance of the company take precedence over maxi mising 

earnings in the short term. 

* Guiding principles 

Extracts from our Leitbild 5

PERSPECTIVES FOR 

LASTING SUCCESS 

We stand for a successful, multinational company with 

an open, human face. We are a respected partner that 

cares both about the interests of patients, physicians and 

business partners as well as those of our employees. 

Christian Boehringer, Chairman of the Shareholders’ Committee, and 

Andreas Barner, Chairman of the Board of Managing Directors. 

6 Boehringer Ingelheim annual report 2012


perspectives for lasting success 

Perspectives for lasting success 

7

EMPLOYEES’ PHOTOS FOR THE ANNUAL REPORT 

PERSPECTIVES 

New perspectives are necessary and important for Boehringer Ingelheim 

in order to remain successful – especially in an ever faster changing 

environment. 

Boehringer Ingelheim invited its employees to take part in a worldwide 

photo competition entitled “Perspectives”. The company wanted to 

know what new perspectives mean to them, personally and what inspires 

them. It could be places or everyday situations. And, particularly, had 

they already had an experience that changed their perspectives or gave 

them new ideas. 

Employees from around the globe submitted a broad range of pictures. 

A selection is published on the opening pages of each chapter in this 

year’s Annual Report. 

ketchikan, alaska 

[ p.108 ] 

taipei city, taiwan 

[ p.96 ] 

antelope canyon, usa 

[ p.88 ] 

apo, philippines 

[ p.62 ] 

see more perspectives online: 

annualreport.boehringer-ingelheim.com 

or on ipad, 

android and kindle 


perspectives for boehringer ingelheim 

employees’ photo contest 

glencoe, scotland 

[ p.10 ] 

sant cugat, spain 

[ p.98 ] 

kleinich, germany 

[ p.66 ] 

biberach, germany 

[ p.92 ] 

sicily, italy 

[ p.116 ] 

swakopmund, namibia 

[ p.38 ] 

Employees’ photos for the annual report 

9

56° 40' 59" N, 5° 6' 14" W 

glencoe, scotland


perspectives for society 

nadezhda chetvertnykh 

medical representative 

st. petersburg, russia 

read more about read the more perspective about 

the photographers’ of scientist mustermann 

perspective

56° 40' 59" N, 5° 6' 14" W 

glencoe, scotland


nadezhda chetvertnykh 

medical representative 

st. petersburg, russia 

read more about the perspective 

of scientist mustermann


SOCIETY 

In all our activities we safeguard our employees, facilities and the environment 

from harmful influences, conserve natural resources and promote environmental 

awareness. In this way we seek to foster economic and social well-being in the 

countries and communities where we do business. 

OUR CORPORATE RESPONSIBILITY INCLUDES THE TOPICS: 

BUSINESS 

ETHICS 

EMPLOYEES / HUMAN 

RESOURCES 

ENVIRONMENT, HEALTH 

AND SAFETY 

CORPORATE 

CITIZENSHIP 

We are guided by the 

Our employees are the 

Our environmental 

We regard our involvement 

company’s stated core 

guarantors of our innovative 

protection, energy efficiency 

in public-private partner- 

principles (Leitbild) and 

capability. They form the 

and carbon footprint 

ships and foundations as 

the vision Value through 

core of our unique corporate 

continue to be important 

active citizenship, as service 

Innovation. 

culture as family-owned 

issues to work on. 

to society. 

company that lives out its 

responsibility and builds 

on mutual respect and 

fairness. 

OUR EMPLOYEES 

[ worldwide ] 

ENVIRONMENT, HEALTH AND SAFETY 

[ co2 reductions ] 

46,228 100,000 t 

More than 46,000 employees work 

at Boehringer Ingelheim. 

During the last ten years we could save 

more than 100,000 tons of CO2 emissions 

at our sites. 




contents 

14 COMPANY WITH A HUMAN FACE 

18 NEW WAYS OF IMPROVING HEALTH 

24 PERSPECTIVES FOR ENVIRONMENT, 


28 OUTSTANDING BASIC RESEARCH 

30 PERSPECTIVES FOR THE SOCIETY OF TOMORROW 

32 NEW STIMULI IN RESEARCH 

34 SHAPING THE FUTURE OF RESEARCH 

36 KNOWLEDGE TRANSFER BETWEEN ACADEMIA 

AND INDUSTRY 

“MAKING MORE HEALTH” INITIATIVE 

[ youth projects ] 

“MAKING MORE HEALTH” INITIATIVE 

[ social entrepreneurs ] 

>100 

50 

More than 100 youth teams are 

supported in the “Making More 

Health” initiative. 

50 social entrepreneurs will 

be identified in the initiative. 

Perspectives for society 

13

50 NATIONS 

People from around 50 nations work at Boehringer Ingelheim 

worldwide. Different cultures and nationalities make it 

possible to provide customer-specific offerings globally. 

Differing markets can also be evaluated much better. 

COMPANY WITH A HUMAN FACE 

Boehringer Ingelheim has a distinctive company culture that 

fosters innovation, drives high performance and encourages 

diversity, collaboration and mutual respect. The four values 

(respect, trust, empathy and passion) characterise the very 

nature of Boehringer Ingelheim. 

The essence of a company is expressed 

in its culture, which is created and sustained 

by its employees. As a more than 

127 year-old, privately-held company, 

Boehringer Ingelheim has a deep-rooted 

distinctive company culture. 

In 2012, Boehringer Ingelheim highlighted 

four values of this culture: 

respect, trust, empathy and passion, 

which characterise the very nature 

of Boehringer Ingelheim’s human face. 

Together, all employees will further develop 

Boehringer Ingelheim’s culture, 

its most distinctive character, at the 

same time its most important competitive 

advantage, enabling the company 

to realise its vision: Value through Innovation. 

International mobility 

Talent management has proven to be 

instrumental in enabling Boehringer 

Ingelheim’s business strategy and will 

remain a key driver in creating a competitive 

workforce. Through talent management, 

the company strives to ensure 

sustained employability for all employees, 

ensure performance management 

and development of the employees as 

well as secure robust succession planning 

globally with a clear focus on strategic 

positions. 

The globalisation of Boehringer 

Ingelheim’s businesses requires consistent 

alignment of employee development 

with business needs. It is crucial 

to truly foster the development of em- 




“I advanced my leadership and 

enlarged my network by participating 

in the Regional Leadership Development 

Programme (RLDP). The immersion experience 

in Moscow was eye-opening 

and changed my view on emerging 

markets.” 

andreas henrich 

information systems 

germany 

“When my supervisor in China talked to 

me about a two-year assignment working for 

Corporate Communications at the headquarters 

in Ingelheim, I felt amazed as in many companies 

only senior management has the opportunity to 

do this. Every day in Germany, I learn some thing 

new, no matter if it’s about work or about 

another culture.” 

linda ling, 

corporate communications, 

formerly china, now germany 

ployees, first within their organisation, 

and then to prepare employees for 

leading teams in a globalised environment. 

Boehringer Ingelheim therefore 

develops through experiential learning 

in a new environment over a medium 

or longer period of time. To accelerate 

the development of talents, the company 

invests in various kinds of shorterand 

longer-term international assignments. 

Boehringer Ingelheim uses short-time 

assignments outside the employee’s 

home country to support a project or to 

temporarily fill a position. In addition 

to addressing business needs, shorttime 

assignments are increasingly leveraged 

to further develop talents within 

Boehringer Ingelheim’s global talent 

management approach. A short-time 

assignment offers participants unique 

opportunities to adapt to and deliver 

results in new and challenging environments, 

as well as broaden their international 

network. 

Diversity and inclusion 

Diversity and inclusion have been part 

of our commitment, as visibly demonstrated 

by the company Leitbild (guiding 

principles). The company is convinced 

BOEHRINGER INGELHEIM’S VALUES 

RESPECT TRUST EMPATHY PASSION 

Respect means that all 

employees treat people 

and everything in their 

environment with respect. 

Trust is the mindset 

with which everyone 

approaches each other. 

Empathy means the 

employees care – about 

their colleagues, about 

the customers, about 

society, about healthcare 

workers, about patients 

and their families. 

Passion is our desire to 

improve and succeed. 

We believe that we can 

only be successful if we 

pursue our objectives 

with passion. 

Company with a human face 

15

“RLDP journey: a great learning opportunity, 

that was enhanced by the sharing 

of different experiences on how leaders 

can change teams by translating the 

company vision into their own work unit 

and inspiring employees to strive for that 

vision.” 

For the success of our business, it is crucial to truly 

foster the development of employees, first within their 

organisation, and then to prepare employees for 

leading teams in a globalised environment. 

mohammed al-tawil 

business head 

middle east & near east region 

dubai 

RLDP 

The Regional Leadership 

Development Programme (RLDP) 

is a major step in the process 

of building leadership capability 

that is grounded in the values 

and focused on enabling the 

company to deliver Value through 

Innovation. 

that the effective integration of diverse 

views, different experience and the 

knowledge of all employees make a significant 

difference when it comes to understanding 

global and complex markets 

and customer needs. 

In order to be successful, it is essential 

to have the right people at the right 

place with the appropriate skills and 

experience, with diverse personal and 

professional backgrounds enabling 

them to contribute in their entirety. 

Boehringer Ingelheim wants to encourage 

everybody to develop their talents, 

knowing that their individual characteristics 

and distinctive backgrounds 

are an asset to the company. 

The company has strengthened an understanding 

of the value of diversity 

and inclusion. For diversity and inclusion 

to become a genuine part of how 

Boehringer Ingelheim conducts business, 

we will integrate diversity and inclusion 

within all processes in our businesses 

and functions to leverage its 

value and benefit. 

Leadership development 

Leadership development enables the 

successful execution of the Boehringer 

Ingelheim strategy and ensures a succession 

of well-prepared leaders to support 

the sustained growth and independence 

of the company. 

Overall, the leadership development 

framework will support leaders by providing 

appropriate development based 

on their individual needs and the different 

stages in their leadership career, 

with tailored programmes for the needs 

of senior executives, middle managers 

and team managers. 

Boehringer Ingelheim’s operating 

environment is undergoing extensive 

and rapid change. Power is shifting to 

payers, regulation is intensifying and 

new competitors are appearing in 

unexpected places, while new markets 

are opening across the globe. In this 

competitive situation, Boehringer 

Ingelheim has made significant 

changes to its global strategy and 

its operating model. 




“I have experienced that 

people matter and have seen 

many examples whereby our 

company has reached out to help 

employees. For me, this makes 

Boehringer Ingelheim a very 

personal place to work.” 

anne-marie jennings 

animal health 

formerly usa, now germany 

SPECIAL PRIZE FOR INCLUSION 

In Germany, Boehringer Ingelheim has been awarded a special prize for the 

exemplary employment of severely disabled people by the Rhineland-Palatinate 

State Office for Social Affairs, Youth and Care. Boehringer Ingelheim was the 

first company in Germany to draw up its own action plan for implementing the 

United Nations Convention on the Rights of Persons with Disabilities in 2012. 

Concrete targets and activities will translate the provisions of the convention 

into binding action 

The company recognises that welltrained 

leaders at all levels are critical 

to meeting the challenges of this competitive 

environment and to fulfilling 

the company’s vision. The Regional 

Leadership Development Programme 

(RLDP) is a major step in the process of 

building leadership capability that is 

grounded in the values and focused on 

enabling the company to deliver Value 

through Innovation. 

management participate in the twomodule 

training held in cities, such as 

New York, Moscow, Singapore, Shanghai 

and Istanbul. The modules cover 

topics such as self-awareness, coaching 

and feedback, strategy implementation, 

leading change, leading global 

teams and innovation. 

A programme has been designed to 

train and support more than 1,000 

senior leaders across three geographical 

regions. Boehringer Ingelheim has 

partnered with Duke Corporate Education 

(Duke CE) of Duke University. 

Duke CE has been ranked Number 1 in 

the world for ten consecutive years by 

the Financial Times and Business 

Week. Together, Boehringer Ingelheim 

and Duke have designed a unique 

learning experience tailored to the 

company’s competitive challenges. 

All leaders who are responsible for a 

business and/or function in middle 

WORKING MOTHER BEST 

COMPANY AWARD 

In 2012, Boehringer Ingelheim 

was granted an award for the top 

100 best companies for working 

mothers in the USA. 

This time, particular weight was 

given to child care, flexible scheduling 

options and advancement 

programmes. 

Company with a human face 

17

SHONA MCDONALD, SHONAQUIP 

[ south africa ] 

her idea: designing wheelchairs for children 

who cannot afford any or cannot use the 

standard models. 

her approach: building strong wheelchairs and 

providing appropriate assistive devices that 

effectively reduce the development of secondary 

health complications in disabled children. 

The vision of the “Making More Health” 

initiative is to identify new and better ways 

of improving health globally. 

NEW WAYS OF IMPROVING 

HEALTH 

Since 2010, Boehringer Ingelheim and the non-governmental 

organisation Ashoka have been working together in a global 

partnership, “Making More Health”. Its vision is to identify new 

and better ways of improving health globally. The objectives 

are to source social innovation around the world, to explore 

unconventional partnerships and business models, and to 

include and develop Boehringer Ingelheim employees. 

By supporting social entrepreneurs (see 

right) in the field of health, Boehringer 

Ingelheim aims to provide better health 

beyond its core business. 

With Ashoka, the company wants to 

prepare for 21st century challenges of 

health access by understanding trends 

in key areas, including healthcare delivery, 

the globalisation of health issues, 

the changing face of healthcare providers 

and the patient’s role, especially in 

low-income populations. 

20 new social entrepreneurs were elected 

“Making More Health” fellows by 

Boehringer Ingelheim and Ashoka in 

2012 (see examples in grey boxes above. 

More online). 

“Youth Venture” 

By the end of 2013, “Making More 

Health” will be supporting 50 social 

entrepreneurs and numerous youth 

projects. The “Youth Venture” programme, 

designed to grant every young 

person the opportunity to be a changemaker, 

supports 12 – 24 year olds in 

launching their own changemaking 

projects. These ventures address and 

improve local problems in the field of 

health in the areas of nutrition, sports, 

environment, social cooperation or 

totally different areas associated with 

health in the broadest sense. 

Through the “Youth Venture” initiative, 

young people shall develop an early 

understanding of empathy, teamwork, 

problem solving and leadership behaviour 

and take responsibility for their 

own actions. The overall objective is to 




1 In Shona McDonald’s project, appropriate wheelchairs for 

children are designed. 

2 Participants of the Indonesian “Youth Venture” project. 

SAM AGUTU, CHANGAMKA 

[ east africa ] 

his idea: making health insurance accessible for 

people working outside of formal employment. 

his approach: using a technology-based 

approach pairing mobile phones with health 

insurance smart cards to be available for 

purchase in any grocery store throughout 

the country. 

1 2 

create a strong network of changemakers 

– people who drive change, one 

of the basic ideas of “Making More 

Health”. Boehringer Ingelheim employees 

actively support the youth in the 

programme by serving as mentors or 

coaches. These employees pass on their 

knowledge, network and experience. 

Seven countries are engaged in the 

“Youth Venture” initiative – Indonesia, 

Argentina, Germany, the USA, Mexico, 

Brazil and Spain – and have supported 

more than 100 youth teams. Examples 

include a “Changemaker Weekend”, 

which took place in Germany in November 

2012. Two projects will be implemented 

during the coming months. 

One project, “BE Integrated – Azubis 

helfen Azubis” (BE integrated – apprentices 

help apprentices) aims to foster 

networking between apprentices at the 

Ingelheim site in Germany, primarily in 

order to make it possible for them to get 

a better start in their professional lives. 

In the longer term, Ante Jonjic and 

Nathalie Kastello, themselves apprentices 

and leaders of the project, want to 

cooperate with other sites also offering 

apprenticeships. The positive power of 

networks and partnerships is a key part 

of what “Making More Health” is all 

about. With the project “Gesundheitsbewusstsein 

– make it real” (Health 

awareness – make it real), Benjamin 

Gmeiner and Susanne Kulzer, apprentices 

from Biberach, Germany, will provide 

information to children and young 

people between eight and 15 years of 

age with the goal of generating greater 

awareness for healthy, sound living. 

SOCIAL ENTREPRENEURS 

The term social entrepreneur 

is much more than a professional 

description. Being a 

social entrepreneur is rather a 

state of mind committed to 

the goal of making positive 

social change for the future. 

Like the classical commercial 

entrepreneur, the social entrepreneur’s 

qualities include 

the will to succeed, creativity, 

pragmatism, entrepreneurial 

spirit and vision. Social entrepreneurs 

add to these qualities 

the drive to make a positive 

change in society for the 

long term. 

The social entrepreneur 

solves pressing social problems 

sustainably for example, 

in fields like combating poverty, 

education, family, integration, 

human rights and 

environmental protection. 

They are innovative, think 

systematically and develop 

concepts with measurable 

outcomes. The goal is not implementation 

at a specific 

location, but to implement 

the concept wherever it is 

needed. Social entrepreneurs 

do not provide their services 

free of charge, but try as 

much as possible to achieve 

income. If they earn money 

and become profitable, they 

reinvest their profits in developing 

their social business 

model further. 

New ways of improving health 

19

SEHNAZ LAYIKEL, RUSIHAK 

[ turkey ] 

her idea: improving access to mental 

healthcare in Turkey. 

her approach: deconstructing the top-down 

medical approach that continues to 

dehumanise individuals with mental 

disabilities in Turkey. Improved 

living conditions for mental health 

patients, including better meals 

and more recess time. 

Boehringer Ingelheim employee Dr Thomas 

Franke supports the institution Fundación 

Educational, which focuses on nutrition 

education in Latin America. 

The Argentinian “Youth Venture” 

project, “Distensionáte”, provides training 

in domestic electrical installation to 

socially vulnerable youth, who find 

themselves at high risk of accidents due 

to insecure electrical conditions. This 

vital training programme aims to combat 

the problem of dangerous and nontrained 

electrical installation as well as 

increase legitimate, worthwhile job opportunities 

for participants. 

At the heart of the Indonesia-based 

“Youth Venture” project, “Maestro Green 

Radio”, is a radio show promoting environmental 

awareness. The programme is 

on air twice a day and delivers a variety 

of messages about environmental preservation. 

“Boehringer Ingelheim Executive 

in Residence” 

Boehringer Ingelheim employees support 

young changemakers and also established 

social entrepreneurs and 

their businesses in various ways. Employee 

engagement with social entrepreneurs 

directly calls on the employees’ 

talent to bring about lasting 

change in the field of health. This aspect 

of “Making More Health” forms a 

bridge between Boehringer Ingelheim’s 

expertise and competence and the innovative 

capabilities of the social entrepreneurs. 

An element of the “Making More Health” 

commitment to bring employees and 

social entrepreneurs together is the 

“Boehringer Ingelheim Executive in 

Residence” programme (see right). This 

places employees in the field with the 

social entrepreneurs so they may directly 

support the social entrepreneurs’ 

business for a certain period. 

While the employees are providing specific 

business skills, they are also learning 

and developing valuable leadership 

competencies during the experience 

with the social entrepreneur. The social 

projects Boehringer Ingelheim employees 

support are critical to the business 

of the social entrepreneur and expand 

the businesses impact to individuals 

and communities where it is most criti- 




HEIDI WANG, NOEN 

[ norway ] 

her idea: supporting dementia sufferers and their 

families to improve long-term care. 

her approach: helping families map the collective 

story of a dementia sufferer’s life through a twiceweekly 

at-home activity programme. Families also 

receive legal advice and guidance on dementia 

care. An app allows users to input data on personality 

changes, physical markers and other personal 

information. 

1 2 

1 At the first “Making More Health” convention 

at corporate headquarters in Ingelheim, Germany, 

Rajeev Sukumaran and Mukteshwari Bosco presented 

the first results of their work for Healing Fields 

Foundation. 

2 During his time in India, Rajeev Sukumaran helped 

to scale up a project that created a mini-insurance 

system in several Indian villages. 

cally needed. This programme is available 

to Boehringer Ingelheim’s Global 

Management Development Programme 

(GMDP) participants. 

Rajeev Sukumaran is Boehringer Ingelheim’s 

first employee to have taken part 

in “Boehringer Ingelheim Executive in 

Residence”. He was granted professional 

development time away from his 

full-time job in Information Systems 

in Ridgefield (USA) for three months in 

which he actively worked alongside the 

female social entrepreneur Mukteshwari 

Bosco, who founded Healing Fields 

Foundation in India. 

“My overall goal was to gain more 

exposure in the area of health,” he 

says in an interview. “Moreover, I 

wanted to be involved in doing social 

good. This project gave me the opportunity 

to do both. The goal of Healing 

Fields is to make quality healthcare 

available to people who cannot afford 

it – especially in regions with extremely 

limited or no facilities, like doctors or 

hospitals.” 

Healing Fields Foundation created a 

business model, which ultimately led to 

a mini-insurance system inside the village, 

linked with the next hospital. Sukumaran 

helped to scale up the project 

and also gained valuable people skills 

in the process. With thanks to Sukumaran 

and his contributions, the Healing 

Fields model has now been rolled out to 

5,000 other villages in India. 

Educational campaign 

Additional Executives in Residence started 

in October 2012. Dr Thomas Franke, 

who works in the Information Systems 

Department at Boehringer Ingelheim in 

Ingelheim, Germany, joined Maria Ana 

Angeleri de Schwartz, elected “Making 

“BOEHRINGER INGELHEIM EXECUTIVE IN RESIDENCE” 

The “Executive in Residence” 

programme by Ashoka is a 

leadership development opportunity 

available to Boehringer 

Ingelheim’s Global 

Management Development 

Programme (GMDP) participants 

– therefore often also 

called “Boehringer Ingelheim 

Executive in Residence”. It 

allows Boehringer Ingelheim 

employees to work with an 

Ashoka fellow for several 

months on a project. The 

main focus of GMDP is leading 

oneself and others. It has 

been designed as an experiential 

development opportunity 

built on project work and integrated 

with leadership skills 

training. Through this experience, 

participants will build 

key leadership competencies 

that will enable them to lead 

themselves and their teams to 

success. 


21

Thalita Guimaraes joins the “Boehringer 

Ingelheim Executive in Residence” programme 

and works together with “Making 

More Health” fellow Krystian Fikert. 

ELISABETH RAITH-PAULA, 

MFM-PROJECT 

[ germany ] 

her idea: improving body confidence and 

self-awareness in children. 

her approach: teaching body competence, 

self-awareness, cross-gender understanding 

and informed decision-making for young 

people in workshops. Parents and 

teachers receive training to be able 

to answer questions and improve 

children’s knowledge about sexuality. 

CHANGEMAKER COMPETITIONS 

... are an aspect of the “Making 

More Health” initiative that 

invites innovative, sustainable 

ideas from the public with the 

potential to transform health 

and increase well-being. 

The second Changemaker Competition 

entitled “Transforming 

Health Systems: Gamechanging 

Business Models” was launched 

in January 2013. It is intended to 

generate new ideas and business 

models with the potential, for 

example, to improve access to 

healthcare services or to support 

patients. Those submitting the 

best ideas will, in addition to 

prize money, also receive support 

from Boehringer Ingelheim and 

thereby be able to realise their 

business models. 

www.changemakers.com/ 

healthbiz 

More Health” fellow in 2011, in her institution 

Fundación Educacional, which 

focuses on nutrition education in Latin 

America. So far, Franke’s work with the 

team on location in Buenos Aires, Argentina, 

has been to analyse the organisation’s 

situation, determine its goals and 

work out strategies for implementation. 

The main focus of Franke’s work is directed 

toward broadening the working 

model of Fundación Educacional. Besides 

the manpower and cost-intensive 

measures by which the organisation’s 

employees currently educate school children, 

Fundación Educational is working 

with Franke to make supplementary use 

of digital technologies that make it possible 

to reach children in remote schools. 

In concrete terms, implementation will 

consist of the development of future 

working models, the actual implementation 

of e-trainings and remote cooperation 

tools. To turn this into reality, the 

team from Fundación Educacional seeks 

to enlist the support of potential cooperation 

partners from industry. 

“With all of these ideas, one should, 

however, never lose sight of the actual 

circumstances at the location, such as 

provision of the school with computers, 

DVD drives or the internet. Long-term 

feasibility calls for no deployment of 

complicated technology, for keeping 

costs low and for ensuring that equipment 

can be looked after and maintained,” 

commented Franke on the 

challenges of the project. 

Setting up the business 

For half a year, Michael Döll from 

Boeh ringer Ingelheim’s Purchasing 

Department, is supporting the scale up 

of the organisation “Discovering Hands”. 

Its founder, Dr Frank Hoffmann, was 

selected as a “Making More Health” 

fellow in 2011. Among other things, 

Döll is helping to further develop the 

strategy to globally expand the innovative 

system behind “Discovering 

Hands” – using blind and visually impaired 

women in breast cancer diagnosis 

and prevention. 




GISELA SOLYMOS, CREN 

[ brazil ] 

her idea: addressing the psychological effects of 

poverty to alleviate malnutrition. 

her approach: different types of service, 

including individual clinic consultations, 

group activities with physical 

education teachers and nutrition 

workshops. 

Michael Döll is working with “Making More Health” fellow Dr Frank 

Hoffmann. Among other things, Döll is helping to further develop the 

strategy to globally expand the innovative system behind “Discovering 

Hands” – using blind and visually impaired women in breast cancer 

diagnosis and prevention. 

Additional responsibilities Döll has in 

his assignment are setting up the business 

of the orientation stripes used by 

the blind medical tactile examiners 

(MTEs) to localise tissue alterations, 

identifying medical partners, seeking 

investors and recruiting new MTE candidates. 

“This initiative is a perfect 

combination of an innovative method 

of early breast cancer detection and the 

inclusion of visually impaired women,” 

enthuses Döll about the project. 

Structuring the business 

Thalita Guimaraes is working as a 

product manager for Respiratory Brands 

Management at Boehringer Ingelheim 

in São Paulo, Brazil. She joined the 

“Boehringer Ingelheim Executive in 

Residence” programme and is working 

together with “Making More Health” fellow 

Krystian Fikert. His organisation, 

MyMind, in Ireland, is a social enterprise 

which provides affordable and 

easily accessible psychological counselling 

services to those suffering from depression, 

anxiety or other mental health 

problems. 

“My challenge in the MyMind project is 

to support them in structuring their 

business and to develop their online 

services (free support online and Skype 

sessions),” Guimaraes describes her 

task. “At MyMind, every day is time to 

do something for people in need of 

help,” she says. 

Several improvements could be observed 

such as the launch of a new 

website, connected with social media 

or mobile phones. A new business plan 

was developed, and a Facebook and 

radio campaign was created to increase 

popular awareness about MyMind, to 

name only a few things. 

FOR MORE INFORMATION SEE 

www.makingmorehealth.org 

corporateresponsibility. 

boehringer-ingelheim.com 

www.youthventure.org 

www.ashoka.org 


23

When handling chemicals, employees must protect 

themselves in special ways. Employee protection is a 

crucial part of the BE SAFE initiative at Boehringer 

Ingelheim. 

PERSPECTIVES FOR ENVIRONMENT, 


Protecting the environment, conserving natural resources and 

promoting environmental awareness are valued principles at 

Boehringer Ingelheim, which are anchored in our Leitbild 

(guiding principles) and in the Boehringer Ingelheim 

Environment, Health and Safety (EHS) policy. 

country to country and even over a 

certain time period. 

• Emissions of CO 2 have to be reduced 

wherever technically feasible and 

meaningful. 

• Water usage has to be reduced without 

negative environmental impact 

from other substances, e. g. usage of 

organic solvents. 

In order to make products out of starting 

materials, the usage of energy resources, 

air and water is a precondition. 

To protect resources and to fulfil the 

targets from Boehringer Ingelheim’s 

Leitbild, there are several aspects to 

consider. For example: 

• Sourcing and use of energy have to 

be optimised. Energy losses have to 

be avoided as far as possible. The usage 

of renewable energy has to be 

considered. Boehringer Ingelheim 

has to find the optimal energy mix, 

which may vary from site to site, 

• Wastewater has to be treated according 

to regulatory requirements and 

industry standards. The impact of 

pharmaceuticals in the environment 

has to be analysed and, where scientifically 

reasonable, remediated. 

• Waste to landfill has to be reduced 

and balanced in relation to waste 

burning, according to the national 

legal and regulatory requirements. 

In many cases, reduction strategies 

have to be tailor-made for individual 

problems. The right environmental 

mindset is key to solving problems. No 




ENVIRONMENTAL IMPACT ALONG THE PHARMACEUTICAL VALUE CHAIN 

[ supply chain ] 

energy 

efficiency 

[ production ] 

[ product ] 

air 

energy 

losses 

gas 

air/ 

climate 

water 

energy 

resources 

starting 

materials 

manufacturing 

process & 

infrastructure 

emissions/ 

co2 

waste 

water 

use & 

disposal 

pie* 

waste 

surface water 

groundwater 

soil 

product & 

process design 

waste/ 

landfill 

historical old processes 

brownfields 

* Pharmaceuticals in the environment. 

energy-saving measure is so unimportant 

that it can be neglected in the scientific-technical 

evaluation. 

BE GREEN – new environmental 

activities 

Various projects for improving our environmental 

efficiencies, such as reducing 

energy consumption and greenhouse 

gases, have been locally implemented at 

several sites, which has led to savings 

during the last ten years of more than 

100,000 tons of CO 2 emissions. 

The BE GREEN initiative will further 

contribute to Boehringer Ingelheim 

being an organisation, in which sustainability 

in EHS is truly a value, in 

line with the company’s Value through 

Innovation principles. In order to achieve 

sustainability, all our employees are 

asked to take a more proactive role in 

protecting natural resources and in implementing 

environmentally-conscious 

processes. This means making decisions 

that support the implementation of strategic 

goals and proj ects to continuously 

reduce environmental impact. 

Energy efficiency and CO 2 

emission reduction 

Boehringer Ingelheim has actively 

saved energy for years. This topic will 

be significantly reinforced further by 

new, company-wide projects within the 

BE GREEN initiative. Further reduction 

of CO 2 emissions will be achieved in future, 

for instance due to increased inclusion 

of new savings potentials, such 

as logistics, travel and car fleet. 

CO 2 cut for company cars in Germany 

At the German sites, the upper limit for 

CO 2 emissions from company cars was 

lowered by 6.2% from 177 g in 2011 to 

166 g/kilometre. This corresponds to a 

reduction of about 11 tons of CO 2 per 

million kilometres driven. 

Infrastructure innovation in Italy 

At our Italian site in Milan, various innovations 

were introduced to site infrastructure 

in order to significantly reduce 

energy consumption. For example, 

the air compressors for the site were exchanged, 

resulting in energy saving of 

15%. Furthermore, all sanitary facilities 

“20 BY 20” – 

THE BE GREEN KEY GOAL 

To achieve a 20% reduction in 

company carbon dioxide emissions 

globally by 2020 – using 

2010 emissions as a baseline – is 

a key goal of BE GREEN. To meet 

this ambitious target, we will address 

our culture, behaviour and 

processes in a sustainable way. 

Perspectives for environment, health and safety 

25

1 

1 With its own wastewater treatment plants here in Ingelheim, 

Germany, Boehringer Ingelheim is able to clean wastewater 

arising from production. 

2 The whole treatment plant process is tested continuously 

(picture: online measurement devices for testing water quality). 

This way, the company ensures that only cleaned water is 

returned to the environment – an active contribution to environmental 

protection. 

NEW REPORTING SYSTEM 

OPERATIONAL 

To support the management of 

EHS performance within Boehringer 

Ingelheim, Sustainability 

Performance Management (SuPM) 

reporting has been established. It 

was enhanced in 2012 by the introduction 

of new reporting software 

in order to increase the quality 

and integrity of reported data. 

Furthermore, the new system provides 

a company-wide database, 

is easy to use, means less work for 

all stakeholders and is prepared 

for future reporting requirements. 

at the site were equipped with motion 

detectors to automatically turn lights on 

and off. Additionally, a facility automation 

system was also implemented to 

optimise infrastructure maintenance, 

leading to further optimisation of energy 

consumption. 

New lighting systems in Spain 

Our San Cugat site in Spain undertook 

a comprehensive renewal of its 

lighting systems. The switch from 

conventional lighting to modern systems 

leads to an annual energy saving 

of some 194,000 kWh. This roughly 

corresponds to the annual consumption 

of 473 housing units. The energy 

saving is associated with an annual 

reduction of around 106 tons of CO 2 

emissions. 

Improved operation of buildings in 

Germany 

Various optimisation measures in the 

operational technology of the Pharmaceutical 

Research and Development 

buildings at the site in Biberach, Germany, 

achieved an annual reduction in 

CO 2 emissions of around 400 tons. This 

corresponds to an energy saving of 

some 20%. This only involved changes 

to operational procedures in the buildings 

and no additional investment was 

made. 

Soil clean-up at our Ingelheim site 

For over 25 years, environmental protection 

has been an integral part of 

Boehringer Ingelheim’s corporate culture. 

This includes not only projects on 

wastewater treatment, air pollution prevention 

and resource protection but 

also evaluation and clean-up of contaminated 

deposits. 

In past years, we started an extensive 

project under our own initiative for the 

inspection and clean-up of contaminated 

deposits in the soil at our corporate 

headquarters site at Ingel heim, Germany, 

where active ingredients and medicines 

have been produced for more 

than 127 years. We have set ourselves 

the target of identifying and cleaning 

up contamination of the soil at and in 

the vicinity of our production sites. 




NEW LIGHTING SYSTEMS 

A switch from conventional lighting to modern systems 

leads to a significant energy saving. With the renewal 

of the lighting systems (left: new lights, right: old lights) 

at the site in San Cugat, Spain, some 194,000 kWh can 

be saved annually. 

[ new ] [ old ] 

2 

Back in the 1980s, protective boreholes 

were installed in agreement with the 

authorities in order to extract groundwater 

that is treated in the site wastewater 

treatment plant and then returned 

in clean condition. 

In past years, Boehringer Ingelheim has 

intensified measures worldwide to identify 

and clean up contaminated deposits. 

Clean-up measures at the Ingelheim 

site, our largest production site worldwide, 

are part of this overall process. 

Due to technical progress and increased 

knowledge, new and deeper insights 

into the problems are possible more so 

today than before. For example, groundwater 

flows over a prolonged period can 

be depicted and projected with computer 

support. In addition, external experts 

in geochemistry, environmental 

toxicology and engineering sciences are 

continuously involved as consultants in 

order to implement measures for individual 

clean-up projects. 

BE SAFE – NEW DEVELOPMENTS IN 2012 

The aim of our worldwide 

initiative for improving safety 

culture, BE SAFE – Zero by 

Choice, is to encourage all 

employees to proactively take 

on the responsibility of their 

own well-being and to also 

look out for others working 

around them. 

The roll-out ensures that all 

functions go through a workflow 

comprising various steps, 

such as setting up specific 

improvement plans. By the 

end of 2012, the roll-out of 

BE SAFE – Zero by Choice 

had been started in Germany, 

the USA, China, Austria, Spain, 

France, Italy, Mexico, the countries 

of Central and Eastern 

Europe, Russia and Brazil. 

In 2013, the roll-out is planned 

to continue in several more 

countries. The BE SAFE initiative, 

which has been rewarded 

by the German Chemical 

Association with the local 

Responsible Care Award, will – 

in parallel – be extended to 

smaller Marketing & Sales 

sites in order to involve the 

local field force in the new 

safety approach. 

Perspectives for environment, health and safety 

27

2 

1 Dr Carolyn R. Bertozzi received the Heinrich Wieland 

Prize 2012 for her research on the biological functions 

of cellular sugars. 

2 The Heinrich Wieland Prize honours outstanding research 

on biologically active molecules and systems and their 

clinical impact in chemistry, biochemistry and physiology. 

1 

OUTSTANDING BASIC 

RESEARCH 

Promoting basic research is essential for our research and 

development mission and an integral part of our social 

responsibility. Central to success in research and development 

(R&D) are scientists who can bridge basic research and 

science in the pharmaceutical industry. 

The search for new therapeutic options 

is the cornerstone of Boehringer Ingelheim’s 

R&D. Alongside a continuing 

commitment to our own R&D projects, 

we focus on working together with 

others to contribute to therapeutic progress 

by developing tomorrow’s medicines 

from today’s science. 

In our constant quest for pharmaceutical 

innovation, we have successful ongoing 

collaborations and are actively 

seeking new collaborations with external 

partners, ranging from academic 

institutions to biopharmaceutical enterprises 

and start-up companies. 

Honouring scientific work 

Boehringer Ingelheim supports, 

awards and sponsors several scientific 

activities conducted by curiosity-driven 

scientists. The Boehringer Ingelheim 

FENS Research Award recognises 

young European scientists for outstanding 

research in the field of neuroscience. 

The international Heinrich Wieland 

Prize honours outstanding research on 

biologically active molecules and systems 

and their clinical impact in chemistry, 

biochemistry and physiology. The 

prize is named after the Nobel laureate 

Heinrich Otto Wieland (1877 – 1957), 

who was professor of chemistry in 

Munich for many years. Wieland 

maintained close relations to Boehringer 

Ingelheim and played an important 

part in setting up the company’s 

research activities. 

Heinrich Wieland Prize 2012 

Dr Carolyn R. Bertozzi, Professor of 

Chemistry and Professor of Cell and 

Molecular Biology at the University of 




3 Ilka Diester won the Boehringer Ingelheim’s 

FENS Award 2012 for exceptional research in 

Neuroscience. 

3 

California at Berkeley, received the 

Heinrich Wieland Prize 2012 for 

her research on the biological functions 

of cellular sugars, especially 

the sugar modifications associated 

with cancer, inflammation and infection. 

She focuses on glycans, a group 

of sugar chains fulfilling vital functions 

in humans and other living 

beings. 

Her novel methodological design, 

bio orthogonal chemistry, helps to 

differentiate healthy from diseased 

cells by monitoring their sugar codes, 

thereby tracking tumor development 

and growth. She alters the respective 

sugar codes by uniquely attaching 

so-called bioorthogonal reporters or 

labels. 

These small molecules are chemically 

synthesized and then specifically inserted 

into different classes of glycans 

by the cell itself. These bioorthogonal 

biomarkers have led to a new technology 

for the development of novel 

protein drugs. 

The chemist’s breakthrough method 

can pave the way for new therapies, 

e.g. against cancer. 

FENS Award 2012 

In 2012, Dr Ilka Diester of Stanford 

University’s Department of Bioengineering 

was honoured with the FENS 

Award for her research into the neural 

mechanisms that are used to control 

movements, particularly the differences 

in neural connectivity that 

exist between various species of 

mammals. 

The work of the scientist uses optogenetics 

– a novel method using genetic 

and optical techniques – to investigate 

complex behaviours in rodents 

and rhesus monkeys to dissect the 

neural circuits underlying movements. 

Diester’s work could contribute to 

revolutionising the understanding of 

the complexities of the mind and 

propel forward medical developments. 

Nerve cells (neurons) are responsible 

for passing information around 

the central nervous system (CNS) 

and from the CNS to the rest of the 

body. This information is transmitted 

as electrical impulses. A nerve 

cell comprises a central nerve cell 

body surrounded by numerous extensions. 

Outstanding basic research 29

PERSPECTIVES FOR THE SOCIETY 

OF TOMORROW 

In the Research Institute of Molecular Pathology (IMP) in Vienna, Austria, 

and the Institute of Molecular Biology (IMB) in Mainz, Germany, Boehringer 

Ingelheim and the Boehringer Ingelheim Foundation are supporting two 

basic research institutes. One of the questions which drives us is what can 

we do today in order to be able to offer innovative solutions to the then most 

pressing diseases in 15 to 20 years time. 

COOPERATION BETWEEN ACADEMIC 

AND INDUSTRIAL RESEARCH 

[ in conversation with ] [ and ] 

Andreas Barner, 

Chairman of the Board of 

Managing Directors, 

Boehringer Ingelheim 

Dr Jan-Michael Peters, 

Acting Director Science, 

Institute of Molecular Pathology, 

Vienna, Austria 

Prof. Christof Niehrs, 

Founding Director, 

Institute for Molecular Biology, 

Mainz, Germany 




For more information about 

IMB and IMP: 

see following pages 

andreas barner: Through our 

cooperation with basic research we 

want to create new opportunities for 

diagnoses and therapies. For this it is 

necessary to have broad access to newly 

emerging therapeutic concepts and 

new technology platforms. These alliances 

enable Boehringer Ingelheim, 

in cooperation with the scientific community, 

to integrate outside innovations 

into the company in a reliable 

and trusting partnership. 

Invention and innovation – What does 

basic research mean 

jan-michael peters: Invention 

and innovation and, I would add, discovery, 

are the core of science. That 

applies for technological development 

that often determines how much we investigate, 

and are thereby able to understand, 

as too for the field of biology. 

The freedom of basic research is required 

for discoveries, which ultimately 

depend on the idea or intuition 

of individuals. Planning and predicting 

cannot deliver them. New stimuli 

for developing medicines or other 

medical progress also come from independent 

basic research. That is one 

of the many sound reasons to promote 

them on a broad front, even when their 

usability is not always immediately 

evident. 

And what does discovery and innovation 

mean for our research-driven pharmaceutical 

company 

andreas barner: Our researchers 

realise innovations in human and veterinary 

pharmaceuticals in our own 

network of research and development 

sites. Here substances are developed 

into medications. Examples are the medications, 

such as pradaxa®, spiriva® 

or trajenta®. We are guided by the 

idea of researching therapies for diseases 

with great medical need. Research 

and development is an integral 

element of our family-owned company 

Boehringer Ingelheim. 

What advantages come from 

cooperations between the two 

worlds of research 

christof niehrs: The pharmaceutical 

industry also needs welleducated 

scientists and they come from 

high-performance universities. These 

are, however, frequently underfinanced. 

Industry’s commitment can play an 

important role in order to make a basic 

research location perform better and 

be more attractive. 

jan-michael peters: Very much 

so! Where industry and academic research 

cooperate, ideas and discoveries 

are tested early on for their possible 

applications, sometimes even before 

academic researchers are aware of them. 

Conversely, basic research can in many 

different ways benefit from, for example, 

the development of active ingredients 

that open up new experimental 

opportunities. 

What will successful research look like 

in the future 

christof niehrs: Research will 

increasingly be conducted in large 

networks. The trend is clearly towards 

large-scale projects, as in physics. All 

manner of consortia, as in genomics, 

are an example of this. This trend will 

continue and grow stronger. Furthermore, 

methods will be increasingly 

specific and complex. In the past, a 

laboratory was able to cover only some 

fields, such a biochemistry, developmental 

biology or physiology. 

Today, scientific work bridges an everlarger 

span from the biochemistry of 

phosphorylated proteins to knock-out 

mice, from signal transduction analysis 

to their bioinformatic simulation 

and analysis. 

andreas barner: Successful 

research takes place when we absorb 

new ideas and develop therapeutic 

options beyond current scientific, 

metho dical and institutional boundaries. 

Perspectives for the society of tomorrow 

31

The opening ceremony of IMB: 

Interaction between public sector and 

private foundation 

NEW STIMULI IN RESEARCH 

The Germany-based Institute of Molecular Biology (IMB), opened 

2011 in Mainz, is a research centre funded by the Boehringer 

Ingelheim Foundation, a charity with a long tradition in promoting 

outstanding research in medicine, biology, chemistry and pharmaceutical 

science. Researchers concentrate on developmental biology, 

epigenetics, DNA repair and related areas, and hope, thereby, to 

decisively advance understanding of fundamental biological 

processes. 

IMB is a non-profit company but operates 

like an academic research centre. 

This status allows it to implement flexible 

management structures and to remunerate 

its staff with competitive salaries. 

Hierarchies are deliberately flat 

and the research groups enjoy full independence. 

The groups cover a broad range of expertise 

and include leading biochemists, 

geneticists, cell and developmental biologists 

who study the molecular mechanisms 

of the development, ageing and 

disease of embryonic cells. Furthermore, 

bioinformaticians and systems 

biologists analyse high throughput data 

sets and model regulatory gene networks, 

alongside applied physicists who develop 

groundbreaking super-resolution 

microscopes. 

International PhD programme 

The education of the next generation of 

leading scientists is also an important 

part of IMB’s activities. In its doctoral 

programme, “Dynamics of Gene Regulation, 

Epigenetics and DNA Damage 

Response”, PhD students from all over 

the world are conducting research in 

innovative projects. 

International Summer School 

In addition, an International Summer 

School (ISS) was held in 2012 for undergraduates 

and PhD students at IMB. 

This six-week programme offered 12 

students the opportunity to acquire 

practical skills and hands-on training 

from leading scientists in molecular biology. 

The ISS has a unique profile that 

provides students with interdisciplinary 

education in the fields of epigenetics, 

gene regulation, DNA repair, functional 




NEW SCIENTIFIC DIRECTORS 

1 

morphology of the nucleus and systems 

biology as well as bioinformatics. 

Exciting findings, surprising insights 

Scientists at the IMB have identified 

a protein essential for initiating the 

development of male sex organs. Research 

carried out in the laboratory of 

IMB director Christof Niehrs revealed 

that the deletion of just one gene, 

GADD45g, results in complete sex 

reversal in male mice, making them 

appear female. The researchers furthermore 

showed that GADD45g exerts its 

effect by regulating signalling cascades 

that control the gene SRY. For male sex 

organs to develop correctly, it is essential 

that the gene SRY is expressed at 

high levels within a very narrow time 

frame in the embryo. 

2 

Interaction between public sector and 

private foundation 

The IMB is a prime example of successful 

collaboration between public 

authorities and a private foundation. 

In 2010, the Boehringer Ingelheim 

Foundation dedicated EUR 100m for a 

period of ten years to cover the scientific 

running costs of IMB. The state of 

Rhineland-Palatinate provided EUR 

50m for the construction of a modern 

building to house IMB. Intensive networking 

with the most important biological 

research institutions strengthens 

innovative research in Mainz. 

1 In September 2012, IMB appointed 

the molecular biologist René Ketting 

as its second scientific director. He is 

conducting research on non-coding 

RNA (ncRNA), which he has shown to 

play a key role in embryonic development. 

Furthermore, errors in the control 

of gene activity by ncRNAs con tribute 

to major diseases, such as cancer and 

heart failure. 

2 In January 2013, the third scientific 

director Helle Ulrich, an internationally 

leading expert on DNA damage response, 

joined IMB. Ulrich is investigating 

the involvement of two small 

proteins, ubiquitin and SUMO, in the 

regulation of DNA repair. These proteins 

function by attaching themselves 

to other proteins and thus changing 

their properties. 

This study both identifies a new role for 

GADD45g and suggests a novel signalling 

pathway that could have important 

implications for research into disorders 

of sexual development. The research 

has been published in the high-impact 

journal Developmental Cell. 


IMB: 

www.imb-mainz.de 

New stimuli in research 33

CIRCUIT MECHANICS OF EMOTIONS 

Understanding how the brain works is one of science’s greatest 

challenges. Traditional methods to explore the nervous system are 

of limited resolution in time and space. Advanced technologies in 

circuit genetics will close this gap and open up new perspectives 

for studying brain function and treating disorders. 

SHAPING THE FUTURE 

OF RESEARCH 

Deepening scientific knowledge is a central issue for Boehringer 

Ingelheim. This is why we are the main sponsor of the the Research 

Institute of Molecular Pathology (IMP) in Vienna (Austria). This 

fundamental biomedical research centre is one of the European 

“hot spots” for research in the area of molecular biology. 

WULF HAUBENSAK 

Neurobiologist and IMP researcher 

Wulf Haubensak pursues the goal 

of understanding how emotions, 

such as fear or pleasure, are generated 

in the brain. A Starting 

Grant by the European Research 

Council (ERC), which was awarded 

to him in 2012, will substantially 

support his project. 

Research at the IMP spans a wide 

range of topics, broadly organised 

into four themes: life at the molecular 

and cellular levels, information 

processing and storage in neural circuits, 

mechanisms of organismal development 

and disease, and interdisciplinary 

approaches that bring ideas 

and methods from other fields to 

bear on biological questions. 

The common goal in all of these areas 

is to elucidate the mechanisms and 

principles that underlie complex biological 

processes. 

Circuit neuroscience 

For over a century, neuroscientists relied 

on functional-anatomical studies 

of the brain to gain a rough understanding 

of its workings. Observation 

of patients with brain lesions and of 

the effects this had on their behaviour 

offered the only clue to the functional 

connectivity of the brain, but it 

was a random and unpredictable 

method. And it could not tackle the 

questions that modern neurobiology 

seeks to answer: what are the molecular 

mechanisms that process and 

store information within neural circuits 

And how do activity patterns 

in neural circuits give rise to perception 

and behaviour 

Questions like these are addressed by 

research groups at the IMP. Exploiting 

genetic tools, they identify, describe 

and manipulate the specific circuits 

and molecules that are relevant for a 

certain behaviour, aiming at the 

smallest functional units of the brain. 

When emotions arise, multiple brain 




2 

1 

1 Together with Max F. Perutz Laboratories (MFPL), the 

Institute of Molecular Biotechnology (IMBA), the Gregor 

Mendel Institute (GMI) of the Austrian Academy of 

Science and several biotech companies, and the IMP 

form the Campus Vienna Biocenter. 

2 Mouse oocytes. 

areas are involved: the neocortex, the 

brain stem and the amygdala, an almond-shaped 

region in the limbic system. 

Together, these components form 

a complex network of neuronal circuits 

whose detailed structure and 

function are not yet understood. 

Optogenetics 

A particularly powerful and versatile 

tool available to neuroscience is called 

optogenetics, a combination of genetic 

and optical methods. It allows the targeted 

and fast control of precisely defined 

events in living organisms. The 

technology has changed the perspective 

on solving some of the most intriguing 

puzzles in neurobiology. 

At the IMP, the technology has quickly 

been adopted and ideally complements 

electro-physiological and pharmacogenetic 

methods to study how 

and where emotions are generated. As 

models for these studies, the researchers 

use mice that carry a light-sensitive 

algal protein that is expressed in specific 

neurons. Upon exposure to light, 

these neurons become depolarised and 

fire off an electrical signal. Light can 

thus be used as an on-off switch to remotely 

control neuronal circuits and, 

consequently, behaviour. The IMP scientists 

also address the question of 

how genes and pharmaceutical substances 

affect the activity of neuronal 

circuits and influence emotions. They 

hope to gain valuable insights into 

emotional dysfunctions, such as posttraumatic 

stress or anxiety disorders. 

In the future, this could lead to the 

development of specific “circuit therapies” 

to treat psychiatric disorders 

more selectively and with fewer side 

effects. 

THE RESEARCH INSTITUTE OF 

MOLECULAR PATHOLOGY (IMP) 

The IMP is a fundamental biomedical 

research institute located 

at the Campus Vienna Biocenter 

(Austria). The IMP’s scientists are 

passionately committed to scientific 

discovery, seeking to unlock 

some of life’s fundamental mysteries. 

The institute is supported by 

Boehringer Ingelheim and through 

research grants from national and 

international funding agencies. 


IMP: 

www.imp.ac.at 

Shaping the future of research 35

BIBERACH UNIVERSITY OF APPLIED 

SCIENCE 

Newly-qualified professionals from 

Biberach University of Applied Science 

enter the world of pharmaceutical 

biotechnology. 

Source: HBC 

KNOWLEDGE TRANSFER BETWEEN 

ACADEMIA AND INDUSTRY 

Since 2006, a for Germany unique degree course – biopharmaceutical 

biotechnology – has been available at the Biberach University of 

applied sciences, provided in cooperation with, amongst others, 

Boehringer Ingelheim. The growing importance of pharmaceutical 

biotechnology in economic and research development led to the 

establishment of the biotechnology faculty, which in the meantime 

has 13 professors and 21 staff. 

INVESTMENT IN THE FUTURE OF 

BIOTECHNOLOGY 

A course of study offering excellent 

professional opportunites 

that supports the region’s strong 

pharmaceutical industry with a 

highly educated new generation 

of academics – this is the motivation 

for strengthened cooperation 

between practice and science, 

industry and university in the field 

of pharmaceutical biotechnology. 

The biotechnology cluster Ulm- 

Laupheim-Biberach-Ravensburg, 

which is unique in Europe, offers 

excellent conditions here. 

Almost 300 young men and women 

are meanwhile studying at the university, 

with the goal of being able to 

work, either at home or abroad, in 

the many areas of biotechnological, 

pharmaceutical and biomedical industry. 

Pharmaceutical biotechnology 

The bachelor of science programme 

Pharmaceutical Biotechnology is specifically 

focused on the development 

and production of biopharmaceuticals. 

Biberach University held its first 

graduation ceremonies in 2010, with 

a total of 56 biotechnologists receiving 

their bachelor of science degrees. 

Additionally, the study course “Industrial 

biotechnology” has been 

established at the university in 2011. 

Masters degree and doctorate 

Graduates can now also pursue further 

qualification in their dicipline. 

In a cooperation with Biberach University 

and Ulm University, a joint 

masters programme in pharmaceutical 

biotechnology was established in 

2010. Based on a good bachelor degree 

foundation in, for example, 

pharmaceutical biotechnology, biochemistry 

or molecular biology, students 

can receive tuition of a more 

research-orientated nature. 

Since 2011, those obtaining an outstanding 

masters qualification can also 

study for a doctorate. A PhD course – 

pharmaceutical biotechnology – has 

been established at the University of 

Ulm and Biberach University. 




1 

1 Unique in Germany: the degree course in pharmaceutical 

biotechnology offered by Biberach University of Applied Science 

in cooperation with industry. Source: HBC/Stefan Sättle 

2 Simon Fischer, a Biberach University student, graduated with a 

bachelor‘s degree in pharmaceutical biotechnology and also 

gained a masters degree in biomedical engineering. Subsequently, 

he received a stipendium for the cooperative PhD course at 

Biberach University. He is investigating the effects on growth of 

the Chinese hamster ovary (CHO) cell – the most frequently used 

cell in biopharmaceutical production. Source: HBC 

2 

Exciting professional fields 

The interdisciplinarity of research at 

universities and in industry is an important 

precondition for being able to 

do justice to the future challenges to 

medical substances regarding safety 

and efficacy at reasonable cost. Pharmaceutical 

biotechnology addresses 

the development of strategies for the 

rapid and efficient transfer of the latest 

medical and pharmacological 

findings into safe and efficacious 

pharmaceutical products. It thus operates 

on the dividing line between 

(bio)chemistry, medicines and biotechnology, 

thereby bringing together 

many aspects of modern life sciences. 

Important professional fields, depending 

on the choice of focus area, 

are, for example, in biotechnological 

and pharmaceutical research and industry, 

in biotechnology, in pharmaceutical 

plant construction, in quality 

management and in the quality control 

for the pharmaceutical and biotechnological 

industries. 

BOEHRINGER INGELHEIM ULM UNIVERSITY BIOCENTER (BIU) 

Agreed in 2011, the cooperation 

between Boehringer 

Ingelheim and the University 

of Ulm, Germany, has intensified. 

In a first round in May, a total 

of 11 projects was approved. 

A second round call for applications 

yielded six further 

funded projects in October. 

With this the total funding 

volume has been assigned to 

six projects in cardiometabolic 

diseases, five projects in respiratory 

diseases and six 

projects in CNS diseases. 

All approved projects have 

been initiated. 

Knowledge transfer between academia and industry 

37

22° 41' 0" S, 14° 32' 0" E 

swakopmund, namibia

esearch & development 

perspectives for medical innovation 

eckhard burbach 

retiree (formerly head of 

talent management germany) 

ingelheim, germany 

read more about 

the photographers’ perspective

22° 41' 0" S, 14° 32' 0" E 

swakopmund, namibia

eckhard burbach 

retiree (formerly head of 

talent management germany) 


perspectives for medical innovation


MEDICAL INNOVATION 

Boehringer Ingelheim’s commitment to emerging science as a basis 

for new medicines grows ever stronger. 

We therefore focus on studying human disease, the subsets of each 

disease and establishing target-disease relationships which enable 

us to ask the right questions. 

Our aim to help patients by treating diseases in areas of high unmet 

medical need both in our current therapeutic area focus and in new 

emerging disease areas. 

Our R&D activities include both small molecules and biotherapeutics, 

thereby allowing us to choose the most appropriate approach for 

each therapeutic concept. 

RESEARCH AREAS 

[ in focus: six major areas ] 

THE BOEHRINGER INGELHEIM PIPELINE 

[ compounds in development, total 94 ] 

respiratory 

diseases 

central nervous 

system diseases 

cardiometabolic 

diseases 

immunology 

oncology 

infectious 

diseases 

17 

respiratory 

diseases 

9 

immunology 

10 

cns diseases 

3 

infectious 

diseases 

24 

oncology 

31 

cardiometabolic 

diseases 




contents 

42 RESEARCH PARTNERSHIPS WITH ACADEMIA 

AND INDUSTRY 

44 ACCELERATING THE DEVELOPMENT 

OF NEW MEDICINES 

45 PHARMACOEPIDEMIOLOGY - A RISING FIELD 

48 PIONEERING TREATMENTS FOR CANCER 

52 HIGH DISEASE BURDEN OF HEPATITIS C 

55 INDUSTRY-LEADING DEVELOPMENT 


58 MOVING RESPIRATORY FORWARD 

60 THE FUTURE OF OUR RESEARCH AND DEVELOPMENT 

OUR RESEARCH AND DEVELOPMENT SITES 

[3 major and 3 specialized sites ] 

RESEARCH & DEVELOPMENT FACTS 

[ 2012 ] 

2 

1 

3 

5 

4 

6 

2,795m 

[ eur ] 

Investments in research and 

development of new drugs 

1 ridgefield, usa 

2 laval, canada 

3 biberach and 


4 vienna, austria 

5 milan, italy 

6 kobe, japan 

7,492 

An average of more than 7,400 

employees worked in R&D. 

Status 31.12.2012 

Perspectives for medical innovation 

41

RESEARCH PARTNERSHIPS WITH 

ACADEMIA AND INDUSTRY 

Our research teams can only tackle some of the most important 

challenges in medicine today if we work together with scientists and 

physicians outside our organisation. We cooperate with academic 

institutions, non-profit research centres and external industry 

partners. Together, we strive for excellence in both small molecules 

and biotherapeutics and turn discovery into clinical practice. 

COOPERATIONS 

IN DIABETES 

In order to develop new insights 

into the causes of diabetes, 

Boehringer Ingelheim has entered 

into cooperations with universities. 

Cooperations in diabetes 

Boehringer Ingelheim and GWT, a 

company of the Technische Universität 

Dresden AG (TUDAG) and the Department 

of Me dicine of the Technische 

Universität Dresden (TU Dresden – 

Technical University Dresden) signed a 

five-year research collaboration agreement 

in 2012 to develop new insights 

into the causes of diabetes and the link 

between excessive blood glucose, the 

hallmark of diabetes, and the serious 

complications of the disease that can 

affect many organ functions. 

We have initially defined six research 

projects, which range from exploring 

the causes of insulin-producing beta 

cell destruction to the cells and molecules 

triggering diabetic complications 

in organs, such as the eye (diabetic 

retinopathy), which can lead to blindness, 

kidney (nephropathy), nerves 

(neuropathy) or skin (ulcerations). 

In 2012, Boehringer Ingelheim also entered 

into a four-year collaboration 

with the Institute of Molecular Health 

Science and the Institute of Food, Nutrition 

and Health, Eidgenössische 

Technische Hochschule Zürich (ETH 

Zurich) to achieve new insights into the 

development of diabetes and obesity. 

This joint collaboration effort will focus 

on investigating three cell types 

that may contribute to the onset of diseases, 

such as obesity and diabetes, because 

of their dominant role in metabolic 

homoeostasis. 




COOPERATIONS IN DRUG 

DISCOVERY 

As our understanding of human disease improves, 

it has become clear that some molecular targets that have 

been considered “undrug able” in the past can today be 

addressed with more unconventional chemical structures. 

Cooperations in drug discovery 

We have entered into several strategic 

partnerships in the area of small molecule 

drug discovery. These collaborations 

provide access to innovative 

screening approaches as well as novel 

chemical libraries covering uncharted 

chemical territory for therapeutic concepts 

of interest. 

Global strategic partnerships 

Nuevolution A/S is applying its proprietary 

Chemetics® technology to identify 

novel small molecule lead structures 

against drug targets of interest. The 

Chemetics® platform uses innovative 

DNA labelling to allow fragmentbased 

drug screening of hundreds of 

millions of diverse small molecules. 

In our collaboration with Polyphor 

Ltd, the MacroFinder® drug discovery 

platform will be applied to find effective 

modulators for complex biological 

targets, again including protein-protein 

interactions. 

With EnsembleTherapeutics, we will 

apply new drug discovery platforms, 

including its Ensemblin collection 

(a class of new macrocycles synthesised 

using DNA-programmed chemistry) 

for around five million compounds 

to discover and advance novel drug 

candidates. 

GLOBAL PARTNERSHIPS 

Boehringer Ingelheim has entered 

into several partnerships in the 

area of small molecule drug discovery. 

Our collaboration with FORMA Therapeutics 

will focus on researching small 

molecule drugs for oncology-relevant 

protein-protein interactions. This includes 

screening with the MAPPIT 

screening technology as well as optimising 

any resultant hit compounds. 

Research partnerships with academia and industry 43

collaborate innovate accelerate 

TRANSCELERATE: COOPERATION WITH THE GLOBAL RESEARCH AND DEVELOPMENT COMMUNITY 

[ regulatory, public, government and industry-based entities are engaged. ] 

industry 

initiatives 

regulatory 

bodies 

transcelerate 

biopharma inc. 

research and 

cro community 

health 

advocacy 

ACCELERATING THE DEVELOPMENT 

OF NEW MEDICINES 

Clinical study execution has been identified 

as the initiative’s initial focus area. 

Five projects have been selected for 

funding and development, including: 

Boehringer Ingelheim and nine other leading biopharmaceutical 

companies have formed TransCelerate BioPharma Inc., a non-profit 

organisation to accelerate the development of new medicines. 

GLOBAL INDUSTRY ALLIANCES 

TransCelerate’s work builds on 

existing industry collaborations 

which closely align with project 

activities. We will involve industry 

alliances, including Clinical Data 

Interchange Standards Consortium 

(CDISC), Critical Path Institute 

(C-Path), Clinical Trials Transformation 

Initiative (CTTI) and Innovative 

Medicines Initiative (IMI), 

regulatory bodies, including the 

US Food and Drug Administration 

(FDA) and the European Medicines 

Agency (EMA), and contract 

research organisations (CROs). 

TransCelerate BioPharma Inc. was 

launched to identify and solve common 

drug development challenges, with the 

goals of improving the quality of clinical 

studies and bringing new medicines 

to patients faster. 

Shared research and solutions 

TransCelerate aims to collaborate across 

the global research and development 

community and share research and solutions, 

which will eliminate inefficiencies 

that drive up R&D costs as well as 

simplify and accelerate the delivery of 

new medicines for patients. 

• Development of a shared user interface 

for investigator site portals 

• Mutual recognition of study site qualification 

and training 

• Development of risk-based site monitoring 

approach and standards 

• Development of clinical data standards 

• Establishment of a comparator drug 

supply model 




THE GLOBAL EPIDEMIOLOGY TEAM 

The global epidemiology team at Boehringer Ingelheim is 

growing and actively working to attract and to retain talent. 

The team is highly motivated, engaged and innovative. It 

works interdisciplinarily and globally to help respond to challenging 

public health questions using real-world data. 

PHARMACOEPIDEMIOLOGY – 

A RISING FIELD 

Pharmacoepidemiology contributes substantially to drug 

development and to the advancement of public health by 

answering clinically relevant questions that provide physicians 

and patients with information to ensure healthier lives. 

The main tasks of pharmacoepidemiology 

at Boehringer Ingelheim are to: 

• Inform the planning, design and 

conduct of clinical studies 

• Study the use, safety and effectiveness 

of drugs in large populations 

• Determine the benefit-risk profiles of 

our drugs 

Integration into drug development 

To develop drugs and to address patients’ 

needs, it is important to integrate 

epidemiological data early and consistently 

into the drug development process. 

A newly established process will 

ensure that epidemiological data are 

available when: 

• Decisions are made on unmet medical 

needs and target patient populations 

in order to configure clinical 

development programmes to best address 

current healthcare needs 

• Potential adverse effects are evaluated 

and need to be put into perspective 

in relation to the background 

risk in the target population 

• New treatments are to be monitored 

for their safety and effectiveness 

DEFINITION 

Pharmacoepidemiology is the 

application of epidemiological 

knowledge and methods to study 

the effects, beneficial and adverse, 

of drug products in human populations. 

It evaluates who the 

patients are and how the patients 

respond to treatments. 

Pharmacoepidemiology – a rising field 

45

GLORIA-AF® 

Registry programme for patients 

with atrial fibrillation 

56,000 

56,000 patients in over 

50 countries 

2,200 

Around 2,200 sites will contribute 

data to assess the comparative 

effectiveness of new oral 

anticoagulants. 

Epidemiological studies 

Epidemiological studies based on realworld 

data are critically important. 

They are often requested by authorities 

and are also increasingly used to determine 

whether and how well therapies 

are covered by public and commercial 

health insurers. Boehringer Ingelheim 

is keen to learn more about how treatments 

work in real-world settings. 

Epidemiological studies may be based 

on newly collected or on existing data. 

While the former type allows exact assessment 

of all clinically relevant data, 

they can be time and cost intensive. In 

contrast, existing healthcare data (e. g. 

claims, electronic medical records – 

EMR) represent the routine care of all 

patients and are less resource-intensive, 

but often lack detailed clinical information 

and the necessary quality. 

Impact of epidemiological studies 

Both types of studies, based on newly 

collected as well as on existing data, 

have their advantages and complement 

each other. Together, they contribute 

to the totality of evidence. Two examples 

related to pradaxa® help to elucidate 

this. 

Collecting new data – GLORIA-AF® 

The Registry Programme on Long- 

Term Oral Antithrombotic Treatment 

in Patients with Atrial Fibrillaiton 

(GLORIA-AF®) was initiated by 

Boehringer Ingel heim and is scheduled 

to collect data from up to 56,000 patients 

in over 50 countries. Around 2,200 sites 

will contribute data to assess the comparative 

effectiveness of new oral anticoagulants. 

Until data become available, 

additional database studies will give initial 

insights into pradaxa® treatments 

in real-world settings. 

Analysis of existing data 

Before pradaxa® was launched, a 

study based on electronic medical 

records was undertaken to better understand 

the target population, their 

characteristics and comorbidities. This 

provided important insights into the 




COOPERATION WITH UNIVERSITIES 

2 

4 

Since well-trained pharmacoepidemiologists 

are difficult to find, Boehringer Ingelheim finds 

itself in an international competition for talent. 

1 

We are actively working to address this by 

committing to long-term investment in training 

programmes and by working closely with a 

network with academic institutions. 

A network with academic partners, including 

Harvard University, McGill University, University 

of Stellenbosch and Hannover Medical 

School, has been established and collaborative 

teaching programmes are now underway. 

3 

1 harvard university 

2 mcgill university 

3 university of stellenbosch 

4 hannover medical school 

profiles of the patients currently being 

treated with and without anticoagulant 

therapy. 

to build high-quality analytic capabilities 

to assess the value of our products 

in routine care. 

Subsequently, a long-term active monitoring 

system has been set up in collaboration 

with Harvard Medical School, 

designed to collect information about 

the use of pradaxa® and other oral anticoagulants 

based on electronic healthcare 

data. 

To analyse data from millions of patients, 

appropriate technology and software 

needs to be in place that allows 

our epidemiologists to complete studies 

timely, accurately and reproducibly. 

Boehringer Ingelheim is continuing to 

build such capabilities. 

Opportunities with increasing 

data sources 

The increasing availability of claims 

and electronic medical record (EMR) 

data requires pharmaceutical companies 

to ensure capabilities for expeditiously 

accessing, analysing and interpreting 

real-world data. 

Direct access to large claims and EMR 

databases has become a key success factor 

and the foundation for proactive 

drug monitoring. Boehringer Ingelheim 

is expanding the number of strategically 

selected databases and is continuing 

Pharmacoepidemiology – a rising field 47

BOEHRINGER INGELHEIM ONCOLOGY FRANCHISE 

[ overview of compounds in development ] 

head and neck cancer [ scchn ]* 

AFATINIB PHASE III 

acute myeloid leukaemia [ aml ]* 

VOLASERTIB PHASE III 

breast cancer [ bc ] 


non-small cell lung cancer [ nsclc ]* 


NINTEDANIB PHASE III 

ovarian cancer[ oc ] 

NINTEDANIB PHASE III 

liver cancer [ hcc ]* 

NINTEDANIB PHASE II 

colorectal cancer [ crc ]* 


renal cell cancer [ rcc ]* 


* Can affect both males and females. AML source is bone marrow/spinal cord. 

PIONEERING TREATMENTS 

FOR CANCER 

Boehringer Ingelheim is applying scientific discoveries and research 

advances in cancer biology to develop a wide range of novel therapies 

in areas of unmet medical needs in both solid tumours and haematological 

malignancies. We are committed to the clinical development 

of pioneering treatments for cancer. 

Our oncology pipeline is evolving and 

demonstrates the company’s continued 

commitment to advance in this disease 

area. The current focus of clinical research 

includes compounds in three 

areas: signal transduction inhibition, 

angiogenesis inhibition and cell-cycle 

kinase inhibition. 

Afatinib 

Afatinib is an irreversible ErbB family 

blocker which inhibits signal transduction 

of all kinase receptors from the 

ErbB family, which is known to play a 

critical role in the growth and spread 

of the most pervasive cancers and cancers 

associated with high mortality, 

lung, breast, and head and neck cancers. 

Afatinib is currently in phase III 

development in non-small cell lung 

cancer (NSCLC), head and neck cancer, 

and breast cancer. 

Lung cancer 

Lung cancer is the most common and 

most deadly form of cancer in the world: 

it accounts for 1.6 million new cases in 

Europe annually. Because of its poor 

prognosis, 1.38 million deaths each year 

are attributable to lung cancer. 

Most patients with advanced or metastatic 

lung cancer are treated with 

chemotherapy regimens. Due to unsatisfactory 

treatment results in patients 

with advanced non-small cell lung cancer, 

research and development projects 

are accelerating the identification of 

new treatment strategies for this disease. 

LUX®-Lung 3 trial 

LUX®-Lung 3 is a large, randomised, 

open-label, phase III registration study 

comparing afatinib to a combination 

of two chemotherapy agents, peme- 




PATIENT IDENTIFICATION 

In collaboration with QIAGEN N.V., a companion 

diagnostic (Thera-Screen® EGFR RGQ) was developed. 

It allows identification of those patients with an 

EGFR mutation positive tumour who are eligible for 

targeted therapy with afatinib. 

AFATINIB – POTENTIAL PERSONALISED TREATMENT 

OPTION FOR LUNG CANCER 

Afatinib in NSCLCs has demonstrated unprecedented 

efficacy as a first-line treatment for patients with EGFR 

mutations. Because of its specific benefit for those EGFR 

positive, mutation status patients, it is a personalised 

approach. 

We believe that health systems will acknowledge a personalised 

approach using biomarkers to identify patients 

benefiting from therapy with afatinib. 

trexed and cisplatin, as first-line treatment 

for patients with stage IIIb or 

IV NSCLC harbouring an epidermalgrowth-factor-receptor 

(EGFR) mutation. 

disease-related symptoms, such as dyspnea 

(shortness of breath), cough and 

chest pain. Afatinib also significantly 

delays the deterioration of these symptoms 

compared with chemotherapy. 

The LUX®-Lung 3 results, presented 

in 2012, showed that lung cancer patients 

taking afatinib as a first-line 

treatment lived for almost one year 

before their tumour started to grow 

again (progression-free survival – PFS 

of 11.1 months) versus just over half a 

year (PFS of 6.9 months) for those on 

standard chemotherapy (pemetrexed / 

cisplatin). 

Importantly, patients taking afatinib 

with the most common EGFR mutations 

(del19 and L858R, accounting for 

90% of all EGFR mutations) lived with 

afatinib for well over a year without 

progression (PFS of 13.6 months) versus 

just over half a year (PFS of 6.9 months) 

for those in the comparator arm. 

In addition, a standard questionnaire 

assessing the quality of life of lung cancer 

patients revealed that afatinib treatment 

translated into an improved quality 

of life. 

Submission of afatinib 

A marketing authorisation application 

for afatinib as a treatment for EGFR 

(ErbB1) mutation positive NSCLC has 

been submitted to the European Medicines 

Agency (EMA) for Europe as well 

as in the USA , Canada, Asia, Japan and 

other countries. 

The delay in disease progression was 

also associated with an improvement of 

Pioneering treatments for cancer 

49

AFATINIB BLOCKS THE ERBB RECEPTORS 

ErbB Family receptors (such as EGFR and 

HER2) are frequently overexpressed on cancer 

cell surfaces. These have been associated 

with a variety of tumour types and are associated 

with poor prognosis and advancedstage 

cancer. 

An irreversible inhibition of all receptors of 

the ErbB family may provide a more successful 

blockade of the signalling pathway. 

cell 

wall 

MODE OF ACTION OF AFATINIB* 

[ targeting the erbb family ] 

egfr 

[erbb1] 

egfr 

erbb3 

egfr 

her2 

[erbb2] 

egfr 

erbb4 

her2 

proliferation – invasion – metastasis 

her2 

erbb3 

her2 

erbb4 

Afatinib* acts on all ErbB family receptors, 

therefore blocking the key pathways 

involved in cell growth. 

* Afatinib acts on all ErbB family receptors, therefore 

blocking the main pathways involved in cell growth. 

AFATINIB – ORALLY APPLICABLE 

The development of a pharmaceutical 

dispensing form for 

afatinib that can be used to administer 

the active ingredient to 

patients in different dosages and 

in an oral application form were 

challenges which had to be 

solved. 

As afatinib can be applied orally, 

development of film-coated tablets 

in various dosages was chosen. 

The sensitivity of afatinib to 

moisture represented a challenge 

for formulation, process and 

packaging development of the 

product. 

This was resolved through targeted 

selection of the auxiliary tablet 

materials, optimisation of the 

manufacturing process and use of 

moisture-protective packaging. 

Head and neck cancer 

Head and neck cancer is the term 

used to describe malignant tumours 

originating in the upper aerodigestive 

tract, including the oral cavity, larynx, 

pharynx and nasopharynx. The vast 

majority (90%) of head and neck cancers 

are squamous cell carcinomas 

(HNSCC) arising from the epithelial 

membranes of these regions. More than 

50% of locally advanced head and 

neck cancer will recur and there is an 

urgent need for better treatment options 

besides current systemic chemotherapy. 

Patients with recurrent or metastatic 

head and neck cancer still have a poor 

prognosis, with a median survival of 

only 6–10 months. 

Overexpression of the epidermal 

growth factor receptor (EGFR), also 

referred to as ErbB1, is found in at 

least 90% of head and neck cancers 

and strongly correlates with poor 

prognosis and survival. 

LUX®-Head and Neck 1 and 2 

The clinical study LUX®-Head & Neck 1 

evaluates if afatinib can prolong 

progression-free survival (primary 

endpoint) and improve overall survival 

in patients with recurrent/metastatic 

head and neck cancer who 

progress in comparison with intravenous 

methotrexate. LUX®-Head & 

Neck 2 evaluates whether afatinib can 

prevent the recurrence of the disease 

and improve overall survival in patients 

with locally advanced disease 

after radiochemotherapy. 

Breast cancer 

Breast cancer is the leading cause of 

cancer deaths in women globally. 

HER-2 positive breast cancer is an 

aggressive form of this disease. It is 

thought that in approximately 30% of 

advanced breast cancer cases, women 

overexpress the HER-2 protein. 

LUX®-Breast 1 trial 

LUX®-Breast 1 is an open-label randomised 

phase III trial to investigate 




AFATINIB – SYNTHESIS OF ACTIVE PHARMACEUTICAL INGREDIENT 

Due to the high number of large-scale 

international clinical studies with more 

than 3,500 patients, supplying afatinib 

film-coated tablets, various reference 

preparations and co-medications was a 

logistical challenge for the global Clinical 

Trial Supplies Unit (CTSU) and the 

manufacturing units. 

To safeguard the extensive clinical programme 

and to ensure market supply 

post-approval, a standalone oncological 

production facility was set up in Ingelheim. 

This was established in order to 

meet the special safety requirements 

for afatinib. At this dedicated facility, 

all necessary manufacturing steps for 

afatinib can be covered, from the 

initial weighing of the substance 

through dry granulation and tabletting 

to tablet film-coating and packaging. 

1 Synthesis of active pharma ceutical 

ingredients for afatinib in Ingelheim. 

1 

the safety and efficacy of afatinib plus 

vinorelbine compared with trastuzumab 

plus vinorelbine in patients with 

metastatic HER-2 positive breast cancer 

who received prior treatment with 

trastuzumab. 

Volasertib 

Volasertib is an investigational inhibitor 

of polo-like kinase (Plk), an enzyme 

that regulates cell division (mitosis). 

This inhibition is intended to 

result in prolonged cell cycle arrest 

and ultimately cell death (apoptosis). 

Acute myeloid leukaemia (AML) 

AML is one of the most common types 

of leukaemia in adults, accounting for 

25% of all adult leukaemias in the 

western world. AML has one of the 

lowest survival rates of all leukemias. 

The most common treatment approach 

is intensive remission induction 

therapy. However, many patients 

over 65 years of age are ineligible for 

this approach, which involves large 

doses of chemotherapy over a period 

of five to seven days. 

Clinical trial results in AML 

Positive phase II results from an interim 

analysis of the randomised 

phase I/II study involving volasertib 

in newly diagnosed patients with 

acute myeloid leukemia (AML) considered 

ineligible for intensive remission 

induction therapy were published. 

In this study, higher rates of 

objective response and an improvement 

in event-free survival were observed 

in patients treated with volasertib 

in combination with low-dose 

cytarabine (LDAC) compared with 

patients treated with LDAC alone. 

Based on these positive results, a 

phase III study, POLO-AML-2, with 

volasertib in combination with LDAC 

was initiated. 

LIFE WITH LUNG CANCER 

PATIENT PORTAL 

The portal is a comprehensive online 

resource for individuals coping with a 

diagnosis of lung cancer, and for family 

and friends providing support and 

care for their loved ones. It focuses on 

engaging and empowering patients 

suffering from cancer and puts the 

individual’s own journey at the heart 

of its navigation. 

www.lifewithlungcancer.info 

For more information go to: 

www.thewhiteroom.info 

www.youtube/oncology 

Pioneering treatments for cancer 

51

HEPTATIS C VIRUS (HCV) INFECTION 

HCV infection represents a significant global burden with 

high prevalence and death rates. 

Estimated chronic HCV 

infections in 2012 

200 

Most HCV infections 

become chronic 

Infections often go unnoticed due to 

a lack of symptoms but, if left untreated, 

complications can be fatal. 

150,000,000 

100 

disease can progress with few 

symptoms for many years 

2012 

0 

acute 

can be resolved 

within six months 

4 OUT OF 5 BECOME 

CHRONIC 

chronic 

can last a lifetime 

and needs treatment 

severe liver inflammation with 

long-term complications 

liver failure and potential 

transplant 

HIGH DISEASE BURDEN 

OF HEPATITIS C 

Despite recent treatment progress, the burden of hepatitis C virus 

(HCV) infection on patients and physicians remains huge. Boehringer 

Ingelheim is researching a better HCV medication that reduces the 

challenge and the burden for the patient. 

HEPATITIS C VIRUS 

(HCV) 

Hepatitis C virus is a small 

enveloped virus containing a 

positive-strand RNA genome. 

HCVerso clinical trial programme 

We maintain a rigorous HCV clinical 

trial programme, HCVerso, designed 

to find solutions to the challenges of 

this disease. 

Our clinical research extends to diverse 

HCV patient populations across the 

world, including HIV co-infected patients 

and those who have previously 

failed treatment. The aim is to improve 

cure rates, shorten treatment and eliminate 

interferon, which is the backbone of 

current HCV treatment and is associated 

with severe side effects, including heart 

failure, blood poisoning, white blood cell 

reduction, depression and vision loss. 

Our HCV portfolio 

The portfolio is directed towards advancing 

inhibitors that target essential 

viral enzymes, such as the HCV serine 

protease and RNA polymerase. We are 

investigating the two direct-acting antivirals 

(DAA) faldaprevir and BI 207127. 

Faldaprevir 

Faldaprevir, a potent investigational 

next-wave once-daily HCV NS3/4A 

protease inhibitor, is designed to target 

the viral reservoir within the liver and 

inhibit viral replication. The compound 

is optimised to target genotype 1 HCV, 

the most difficult type to effectively 

cure with current therapy. 

Phase III trial programme 

STARTVerso 

The nearly completed multistudy phase 

III trial programme, STARTVerso, 

evaluates faldaprevir combined with 

pegulated inferon/ribavirin in both 

treatment-naïve, experienced and HIV 

co-infected patients with chronic genotype 

1 HCV. 




STAGES OF LIVER DISEASES 

Enduring inflammation of the liver by hepatitis C can lead to 

liver fibrosis. The next stage of the disease can be liver cirrhosis. 

Hepatitis C is also the main cause of liver cancer. 

healthy 

liver 

liver 

fibrosis 

liver 

cirrhosis 

liver 

cancer 

The study programme is in progress at 

more than 350 sites in 15 countries and 

includes more than 2,000 patients. The 

study programme evaluates sustained 

viral response (SVR) as the primary 

clinical endpoint, which is considered 

to be the viral cure. Results from the 

phase III studies are expected in the 

first half of 2013. 

SOUND-C2 trial 

SOUND-C2 is an open-label, randomised, 

phase IIb study that enrolled 

362 treatment-naïve HCV genotype 1 

patients into one of five treatment arms. 

The study evaluated the safety and efficacy 

of the interferon-free polymodal 

therapy of faldaprevir and BI 207127, 

with and without ribavirin. 

BI 207127 – A potent polymerase 

inhibitor 

BI 207127 is an investigational nonnucleoside 

NS5B RNA-dependent 

polymerase inhibitor that has the potential 

to eliminate interferon from 

HCV treatment when combined with 

faldaprevir and ribavirin/RBV. 

BI 207127 works by blocking a specific 

step in the viral lifecycle, targeting a site 

of this polymerase enzyme and consequently 

preventing HCV from replicating. 

Phase II trials of this interferonsparing 

regimen (SOUND-C2) have 

been completed and phase III HCVerso 

trials investigating this regimen have 

been initiated. 

Final data from this trial in phase IIb 

(SOUND-C2) show high viral cure rates 

in genotype 1 patients. When looking at 

all patients collectively, including the 

most challenging to cure, a viral cure 

was achieved for 70%. 

NEWSHOME 

Our website is the one-stop shop 

for clear, concise and easy to 

understand information about 

hepatitis C. 

www.NewsHome.com 

High disease burden of hepatitis C 

53

1 

viral entry 

rna 

release 

rna 

translated 

into proteins 

[+] rna 

2 

3 

DIRECT-ACTING ANTIVIRAL AGENTS (DAA) 

6 

[+] rna [–] rna 

The hepatitis C virus is a small enveloped virus 

that contains a positive-strand RNA genome 

that encodes a polyprotein that is processed by 

host and viral proteases into 10 proteins that 

are required for RNA virus replication. 

assembly 

and release 

rna 

replication 

polyprotein 

processing 

bi 207127 

ns5b polymerase 

inhibitor 

faldaprevir 

ns3/4a polymerase 

inhibitor 

BI 207127 – 

NS5B POLYMERASE INHIBITOR 

The HCV NS5B polymerase is an 

essential viral enzyme that catalyses 

virus genome replication and has 

attracted research interest since 

inhibition of polymerase activity offers 

an opportunity for therapeutic 

intervention. Boehringer Ingelheim 

has led the optimisation of a class of 

non-nucleoside NS5B inhibitors exemplified 

by BI 207127. 

The NS5B inhibitors that have recently 

progressed in clinical trials are expected 

to become an important component 

for a more effective and better 

tolerated anti-HCV regimens. A recent 

paradigm shift towards the development 

of interferon-sparing therapies 

using combinations of DAAs with 

complementary modes of action, such 

as NS3 protease inhibitors in combination 

with NS5B inhibitors, is envisaged 

to provide efficacy with improved 

safety and tolerability while 

minimising the emergence of resistant 

virus. 

FALDAPREVIR 

NS3/4A PROTEASE INHIBITOR 

The NS3/4A protease is one of the 

essential viral proteins and pioneering 

research at Boehringer Ingelheim to 

discover inhibitors of this viral enzyme. 

It led to the first clinical trial 

with the NS3 protease inhibitor BILN 

2061 (ciluprevir) that clinically validated 

the NS3 protease as an attractive 

direct antiviral target. 

Potent second wave NS3 protease inhibitors 

such as Boehringer Ingelheim’s 

faldaprevir, currently in phase 3 clinical 

trials in combination with PegIFN/RBV, 

may be expected to provide simplified 

dosing regimens and a further improvement 

in treatment options. 

FDA fast-track designation 

The US Food and Drug Administration 

(FDA) granted fast-track designation for 

the interferon-based development programmes 

for faldaprevir in combination 

with PegIFN/RBV for genotype 1 

patients and the interferon-free regimen 

of faldaprevir and BI 207127 plus 

ribavirin/RBV. 

This process is selected by the authority 

when drugs to treat serious diseases 

with high unmet medical need should 

be developed. Patients with HCV 

should receive important new medications 

as in an attempt to get important 

new drugs to people with HCV as soon 

as possible. 




TYPE 2 DIABETES MELLITUS 

Type 2 diabetes results from an imbalance 

between insulin sensitivity and insulin secretion 

due to an impaired beta cell function in the 

pancreas. The picture shows the pancreas. 

INDUSTRY-LEADING DEVELOPMENT 


Diabetes mellitus, literally translated, means “honey-sweet flow”. 

But there is nothing sweet about it. It leads to a plethora of damage 

in the body, particularly with regard to the small and large blood vessels, 

resulting, for example, in peripheral artery disease, myocardial infarction, 

stroke, chronic renal failure, blindness and premature death. 

An estimated 371 million people suffer 

from diabetes. This is expected to rise to 

552 million within the next 20 years. 

Each year, around four million people die 

from diabetes. 90% - 95% of these have 

type 2 diabetes, which is a chronic and 

progressive condition characterised by 

impaired insulin secretion from the pancreas 

and insulin resistance of tissues. 

A growing global trend in obesity is one 

of the key causes of this rise in diabetes 

prevalence. 

High unmet medical need 

Several medicines are available for the 

treatment of diabetes, but most of them 

further increase body weight in the 

long run, reinforcing a vicious cycle. 

For some of them, the so-called sulfonylurea 

drugs, treatment lowers blood 

sugar, but nevertheless the range of 

blood sugar variations remains high. 

Better treatments are urgently needed 

and they need to be tested as to whether 

they actually improve patients’ lives 

in the long run and allow patients to 

live longer. 

40% 

At diagnosis, approximately 

40% of type 2 diabetes patients 

already exhibit some form of 

pre s ent with some form of tissue 

damage resulting from elevated 

blood glucose levels, such as 

heart disease, stroke, renal impairment 

and nerve damage. 

Industry-leading development of oral antidiabetes drugs 

55

1 

2 

THE MAIN COMPLICATIONS OF DIABETES 

3 

The risk of stroke in newly diagnosed 

type 2 diabetes is more than doubled. 

4 

Microvascular damage to the retina from 

diabetes (diabetic retinopathy). 

People with diabetes are two to four times 

more likely to have cardiovascular disease. 

Damage to the kidney filtering systems from 

diabetes (diabetic nephropathy). 

Damage to the nerves from diabetes 

(diabetic neuropathy) is a leading cause of 

foot wounds and ulcers. 

TRAJENTA® AND JENTADUETO® 

Both drugs are labelled for the 

treatment of type 2 diabetes. 

5 

Diabetes Alliance – Boehringer Ingelheim 

and Eli Lilly & Company 

Based on its own research programmes, 

Boehringer Ingelheim has identified 

several drug candidates from multiple 

new drug classes with promising characteristics. 

We are clinically developing them in 

an alliance with Eli Lilly & Company. 

The first result from this pipeline is linagliptin 

(trajenta®), which was first 

launched in 2011, also as the single-pill 

combination linagliptin and metformin 

(jentadueto®), which was first launched 

in 2012. The second compound is empagliflozin, 

which will be filed for registration 

in 2013. 

TRAJENTA® – linagliptin 

Linagliptin belongs to the drug class of 

DPP4-inhibitors. 

trajenta® has been approved very rapidly 

in all major markets and approval 

for fixed-dose combinations with metformin 

(jentadueto®), or as add-on to 

insulin treatment, was obtained in 

2012. It can also be administered 

without dosage adjustment in patients 

with impaired renal function, which 

frequently occurs in diabetic patients. 

CAROLINA® trial 

In an unprecedented effort to determine 

the long-term benefit in cardiovascular 

complications, Boehringer 

Ingelheim has performed a large outcome 

study versus a representative of 

the sulfonylurea drug class, glimepiride, 

the CAROLINA® study. 

Linagliptin is currently the only DPP4- 

inhibitor which is compared to an active 

comparator in a large outcome 

study, and the CAROLINA® study has 

completed enrollment. Large outcome 

studies will determine the beneficial 

effects of linagliptin with a level of 

certainty not available for any other 

oral antidiabetic drug. 

Empagliflozin 

Empagliflozin represents a novel class 

of antidiabetic drugs, the SGLT2-inhibitors. 




LINAGLIPTIN DEVELOPMENT PROGRAMME 

EMPAGLIFLOZIN DEVELOPMENT PROGRAMME 

phase ιιι 

25 studies 

approx. 5,000 patients 

phase ιιι 

11 studies 


phase ιι 

5 studies, 


phase ι 

51 studies 


cardiovascular outcome study 

carolina® 

6,000 patients for approx. 6 years 

phase ιι 

8 studies, 


phase ι 

26 studies 

approx. 800 patients 

cardiovascular 

outcome study 

empa-clarity 


for approx. 5 years 

2004 2006 2008 2010 2012 2014 2016 2018 2004 2006 2008 2010 2012 2014 2016 2018 

In contrast to all other drugs, these do 

not slow glucose uptake from the gut 

or change its disposition within the 

body, but promote its excretion via the 

kidneys, turning the former diagnostic 

measure of sugar in the urine into a 

therapeutic approach. 

change in HbA1c from baseline compared 

to placebo, was met. Filing for 

regulatory review in the USA, Europe 

and Japan is expected in 2013. 

Weight loss and blood 

pressure lowering 

Pooled data from the phase II studies 

have demonstrated that empagliflozin 

treatment not only avoids weight gain, 

but actually causes some weight loss 

and additionally some blood pressure 

lowering, addressing multiple important 

contributors to overall health. 

SGLT2-INHIBITORS - MECHANISM OF ACTION 

Empagliflozin in phase III studies 

Its efficacy and safety is determined 

in 12 multinational phase III studies 

with over 14,500 patients, including 

a cardiovascular outcome study that 

is one of the largest of its kind. 

In the four completed phase III clinical 

trials for empagliflozin, the primary 

efficacy endpoint, defined as significant 

glucose 

sglt2- 

inhibitor 

proximal 

tubule 

glucose 

urinary glucose excretion, 

loss of calories 

SGLT2-inhibitors do not slow 

glucose uptake from the gut or 

change its disposition within the 

body, but promote its excretion 

via the kidneys, turning the 

former diagnostic measure of 

sugar in the urine into a therapeutic 

approach. 

Industry-leading development of oral antidiabetes drugs 

57

ASTHMA 

Asthma is a chronic disease characterised by 

airway inflammation and bronchoconstriction. 

Symptoms include recurring periods of coughing, 

chest tightness, shortness of breath and 

wheezing. 

The air passages become 

inflamed, mucus-filled 

and narrowed, making it 

difficult to breathe. 

As many as 300 million people worldwide have 

asthma. Epidemiological data have shown that 

many adults with asthma remain symptomatic, 

despite current treatment options and have 

asthma exacerbations (attacks). 

normal open 

airways 

inflamed airways 

during an asthma 

attack 

mucus 

MOVING RESPIRATORY FORWARD 

narrow airways 

because of 

inflammatory 

airway swelling 

Boehringer Ingelheim has a long history and a leadership position in 

the field of respiratory diseases and has an ongoing commitment to 

help patients suffering from respiratory diseases with the development 

of new medications. 

PHASE III TRIAL PROGRAMME 

The phase III trial programme in 

respiratory includes: tiotropium in 

asthma, tiotropium + olodaterol 

fixed-dose combination in COPD 

and nintendanib in idiopathic 

pulmonary fibrosis. 

Tiotropium in asthma 

A significant proportion of asthma 

patients remain symptomatic, despite 

current treatment options, and may 

have asthma exacerbations. Tiotropium 

is a long-acting anticholinergic 

bronchodilator, which helps to keep 

the airways open. 

Data from the PrimoTinA-Asthma 

phase III studies presented in 2012 

show that tiotropium delivered via the 

respimat® Soft Mist Inhaler (SMI) 

device increases the time to first severe 

asthma exacerbations in patients who 

remain symptomatic despite treatment 

with at least inhaled corticosteroids/ 

long-acting beta agonists (ICS/LABA). 

Tiotropium also significantly improved 

lung function in symptomatic asthma 

patients on ICS/LABA. 

The PrimoTinA-Asthma studies are 

part of our comprehensive ongoing 

phase III trial programme named 

UniTinA-Asthma, which was 

designed to establish the efficacy 

and safety of tiotropium respimat® 

in patients with symptomatic asthma. 

UniTinA-Asthma includes a number 

of clinical studies in adults, adolescents 

and children with symptomatic asthma 

across the spectrum of asthma severity. 

These studies involve over 4,000 patients 

in more than 150 sites worldwide. 




IDIOPATHIC PULMONARY FIBROSIS 

Idiopathic pulmonary fibrosis results in a progressive 

loss of lung function, associated with a 

clear deterioration in quality of life for patients. 

There is a high unmet need for effective new 

treatments which may substantially change the 

clinical course of this deadly disease. Important 

goals are to influence the deterioration in 

lung function and to reduce the rate of exacerbations. 

normal 

ipf 

O 2 

O 2 

O 2 

O 2 

O 2 

O 

O 2 

2 

O 2 

O 2 

AFFECTS AS MANY AS 

14-43 

out of 

100,000 

PEOPLE 

common symptoms 

And is seen more 

frequently in men. 

Resultant scarring/honeycombing 

in the lung restricts breathing and 

oxygen exchange. 

shortness 

of breath 

chronic 

dry cough 

finger 

clubbing 

Tiotropium + olodaterol for COPD 

The TOviTO phase III trial programme 

is evaluating the potential benefits of 

tiotropium and olodaterol in a oncedaily 

fixed-dose combination using the 

respimat® Soft Mist Inhaler (SMI) device. 

The pivotal one-year registration 

programmes for tiotropium and olodaterol 

fixed-dose combination are on 

track, with expected publication of results 

in 2014. 

Olodaterol is a complementary bronchodilator 

that has been studied extensively 

and developed as an ideal partner 

to tiotropium in order to provide maximum 

brochodilation for COPD patients. 

The scheduled announcement of the 

phase III clinical trial results for olodaterol 

is scheduled for 2013. 

options available to date. Approximately 

50% of patients with IPF die from 

the disease within two to five years after 

diagnosis. There is a high unmet clinical 

need for effective licensed agents. 

Phase II data from the TOMORROW 

trial show that nintedanib 150 mg bid 

has the potential to reduce disease progression 

by slowing the annual decline 

of lung function, reducing acute exacerbations 

and preserving quality of life. 

Nintedanib is currently in phase III 

clinical development. Two identical 

trials (INPULSIS-1 and INPULSIS-2) 

have been initiated and the last patient 

was included in September 2012. This 

trial is being carried out in 24 countries 

in Europe, the Americas, Asia and 

Australia. 

NINTEDANIB IN IPF 

Nintedanib is an investigational 

small molecule tyrosine kinase 

inhibitor (TKI) in development for 

IPF. It targets the growth factors: 

the vascular endothelial growth 

factor receptor (VEGFR), fibroblast 

growth factor receptor (FGFR) and 

platelet-derived growth factor receptor 

(PDGFR). These receptors 

have been shown to be potentially 

involved in pathomechanisms 

of pulmonary fibrosis. By blocking 

these signalling pathways that are 

involved in fibrotic processes, it is 

believed that nintedanib has the 

potential to reduce disease progression, 

slowing the decline of 

lung function. 

Nintedanib in idiopathic 

pulmonary fibrosis 

Idiopathic pulmonary fibrosis (IPF) is a 

progressive and severely debilitating 

lung disease with high mortality, for 

which there are only limited treatment 

Moving respiratory forward 

59

THERAPEUTIC AREA (TA) REVIEW CORE TEAM 

The TA Review core team, which worked for over nine months in a 

cross-functional effort on the development of the Disease Map 

2025 defining potential future focus areas for our R&D+M efforts. 

THE FUTURE OF OUR RESEARCH 

AND DEVELOPMENT 

We remain strongly committed to creating real value for patients 

by constantly developing medicines in areas of high unmet medical 

need. We continuously review the focus of our Prescription Medicines 

business at the disease and indication level in oder to chart our 

direction in a rapidly changing external environment. 

Disease Map 2025 

The Disease Map 2025 defines goals 

and key areas in research, development 

and medicine (R&D+M) in which we 

want to develop our Prescription Medicines 

(PM) business. While the adjustment 

of our research focus is ongoing, 

we at the same time make investments 

in R&D+M that are above the industry 

average. 

GOAL: BRINGING NEW 

MEDICINES TO PATIENTS 

The Disease Map 2025 will help 

us to achieve our goal of bringing 

new medicines to patients. In order 

to effectively and efficiently 

enable this, we have defined specific 

actions for our established 

therapeutic areas as well as areas 

of cross-TA opportunities. 

A cross-functional team reviewed our 

future aspirations in the PM business 

division by considering patients’ and 

societal needs for better medicines. 

Emphasis was placed on fundamental 

trends, unique opportunities and 

special challenges for our established, 

emerging and potential new research 

areas. 

The results of this review have helped 

us to draft the Disease Map 2025, 

which provides recommendations 

on our future direction. 

By assessing a large number of diseases, 

we were able to prioritise the most attractive 

opportunities for our portfolio. 

These include diseases that are already 

part of our current R&D focus as well 

as new diseases. For both current and 

new diseases, the target product profiles 

(TPPs) are very ambitious, with a strong 

emphasis on disease modification over 

symptomatic treatment. 

Disease-modifying approaches 

Within the therapeutic areas the emphasis 

will be placed on disease-modifying 

approaches in larger and established 

indications. Furthermore, we will 

continue to focus on accessing external 




CHANGING PHARMACEUTICAL ENVIRONMENT 

[ challenges for boehringer ingelheim ] 

R&D + M at Boehringer Ingelheim faces the 

challenge of identifying and address high 

unmet medical needs as well as identifying 

synergies in disease and technology clusters. 

discovery 

development 

on-market 

Lower sales 

expectations 

(price, price 

cuts) 

Access, reimbursement 

and pricing increasingly 

a challenge 

Earlier and 

more aggressive 

competition 

by generics 

HIGH UNMET 

MEDICAL 

NEEDS 

Higher 

development 

costs 

Lower 

probability 

of success 

Incremental innovation 

not recognised any 

more 

Risk-adjusted cash flows (cumulative) 

Nominal cash flows (cumulative) 

innovation for novel drug concepts and 

emerging technologies. In addition, we 

will focus on smaller indications with a 

high unmet medical need. 

Disease clusters 

Synergies in researching diseases 

should be exploited in the future by 

identifying groups of diseases from one 

or more therapeutic areas which could 

be targeted by the same mechanism 

(disease cluster). 

Technology clusters 

In addition to the TA-specific aspects, 

the company worked on general topics 

with the primary goals of identifying 

technology clusters. Such clusters will 

enable drug discovery by complementing 

our technical approaches, thereby 

enlarging the exploitable target space 

and increasing the chances of therapeutic 

advance. 

Such technologies could include therapeutic 

vaccines, gene therapy, regenerative 

medicine and new biotherapeutic 

technologies. 

FOCUS ON CREATIVITY AND 

GLOBAL SCIENCE NETWORK 

We count on the creativity of 

our employees to respond to 

the challenges of the future. 

Our goal is to bring together 

unprecedented science in the 

context of a global network to 

help us define the attractive 

drug concepts of the future. 

Potential advantages of such disease 

clusters are a fast path to clinical proof 

of concept with an increased probability 

of success by starting clinical development 

in indications with the strongest 

concept-to-disease link. For all disease 

clusters, potential synergies in research 

and development can be leveraged. 

The future of our research and development 

61

6° 59' 15" N, 125° 16' 15" E 


Boehringer Ingelheim annual report 2012

esearch our businesses & development 

perspectives for medical better health innovation 


the photographers’ perspective 

Chapter

icardo f. solitaria 

district manager 

manila, philippines 

6° 59' 15" N, 125° 16' 15" E 




perspectives for medical better health innovation 

Chapter


BETTER HEALTH 

Boehringer Ingelheim drives progress in the form of medicines, 

technologies and solutions that help people. 

We also evaluate innovative models of a healthcare provision and 

opportunities for cooperative innovation through pilot programmes, 

partnerships and investments in the field of integrated healthcare 

solutions that deliver greater health benefit for patients. 

Here we are always led by people’s medical needs. Boehringer 

Ingelheim is the patients’ partner that makes available innovative 

medicines for better health. 

GROUP SALES 


GROUP SALES BY REGION 

[ in eur million ] 

14,691m 

[ eur ] 

+ 11.5 % 

2012 2011 

% of 

group 

sales 

AMERICAS 6,905 6,087 47 % 

EUROPE 4,194 4,037 29 % 

ASIA, AUSTRALASIA, AFRICA (AAA) 3,592 3,047 24 % 



perspectives for better health 

contents 

66 [ prescription medicines ] 

67 CARDIOVASCULAR DISEASES 

70 REDUCING STROKE RISK IN ATRIAL FIBRILLATION 

73 CONTROLLING HYPERTENSION AND CARDIOVASCULAR PROTECTION 

76 LIVING BETTER WITH DIABETES 

79 THE TRUE FACE OF COPD 

82 PERSPECTIVES ON INNOVATIVE BUSINESS MODELS 

84 MARKET ACCESS FOR NEW MEDICINES 

86 PASSIONATELY ENABLING GROWTH 

88 [ consumer health care ] 

89 STAY HEALTHY TO ENJOY YOUR FREEDOM 

90 FROM PRESCRIPTION TO SELF-MEDICATION 

92 [ biopharmaceuticals & biosimilars ] 

93 BIOPHARMACEUTICALS – MEDICINES FOR THE FUTURE 

94 INNOVATION DRIVERS IN BIOPHARMACEUTICALS 

97 BIOSIMILARS – PERSPECTIVES FOR PATIENTS 

98 [ animal health ] 

99 COMPREHENSIVE ANIMAL HEALTH MANAGEMENT 

101 FRONT LINE RESEARCH 

104 GLOBAL PERSPECTIVES IN ANIMAL HEALTH 

106 A FUTURE FOR VULTURES IN INDIA 

OUR TOP THREE PRODUCTS 


[ spiriva® ] 

[ micardis® ] [ pradaxa® ] 

[ eur ] 

3,562m 

[ eur ] 

1,623m 

[ eur ] 

1,108m 

Perspectives for better health 

65

“My photo shows Frau Röhrig 

from a small village in the 

Hunsrück upland (Kleinich). 

The lady is over 90 years old 

and radiates a great joy of 

living. That’s a perspective that 

many people would wish for 

themselves, living an active 

and healthy life in old age.” 

andreas weber 

technical assistant 


49° 53' 12" N, 7° 11' 85" E 

kleinich, germany



#3.1 

PRESCRIPTION MEDICINES 

CARDIOVASCULAR 

DISEASES 

Boehringer Ingelheim has for decades offered a wide 

range of medications for the treatment and prevention 

of cardiovascular diseases. 

88 % 

ischaemic 

stroke 

STROKE TYPES AND 

INCIDENCE 

12 % 

haemorrhagic 

Cardiovascular knowledge 

Boehringer Ingelheim offers medications 

for the treatment and prevention of: 

• Thrombo-embolic diseases with a 

focus on acute and recurrent stroke 

• Acute myocardial infarction 

• Hypertension, with focus on cardioprotection 

Stroke prevention 

The acute phase is not the only stage of 

a stroke that has to be managed. Stroke 

prevention, whether primary or secondary, 

is extremely important. 

Risk factors for stroke 

The most important modifiable risk 

factors for stroke are high blood pressure 

and atrial fibrillation. 

Other modifiable risk factors include 

high blood cholesterol levels, diabetes, 

smoking, heavy alcohol consumption 

and drug use, lack of physical activity, 

as well as obesity and unhealthy diet. 

Interventions to prevent stroke 

The best medical interventions should 

be primarily aimed at weight reduction, 

promotion of regular exercise, reducing 

alcohol consumption or stopping 

smoking. Nonetheless, medication 

is the most common method of stroke 

prevention and offers a scientifically 

proven benefit for patients in terms of 

stroke preventing. 

Stroke treatment and prevention 

A stroke is defined as an acute loss of 

neurological function due to an interruption 

in the blood supply to a part of 

the brain. Strokes can be ischaemic 

(reduced blood and oxygen supply to 

an area of the brain) or haemorrhagic 

(caused by bleeding). 

Ischaemic strokes occur when there is 

a blockage in a vessel by one of the following: 

a blood clot in a vessel, atherosclerotic 

plaques or an embolus from 

another vessel. 

OUR PORTFOLIO IN STROKE 

PREVENTION AND TREATMENT 

Acute treatment of stroke: 

actilyse® (alteplase) 

Prevention of stroke in patients 

with atrial fibrillation: 

pradaxa® (dabigatran etexilate) 

Secondary prevention of stroke: 

aggrenox® (dipyridamol/ASA) 

Prevention of stroke (organ 

protection), treatment of 

hypertension: 

micardis® (telmisartan) 

micardisplus® (telmisartan/HCT) 

Cardiovascular diseases 67

OUR CARDIOVASCULAR PORTFOLIO 

aggrenox® 

Secondary prevention of stroke, 

1998 in EU, 1999 in USA 

metalyse® 

Acute myocardial infarction, 

2000 in USA, 2001 in Europe 

pradaxa® 

2008 approval for 

primary prevention of 

venous thrombo-embolism 

pradaxa® 

2010 approval for 

stroke prevention in 

atrial fibrillation 

actilyse® 

1987 acute myocardial infarction, 

1996 in USA, 2002 in Germany, 

acute stroke treatment 

micardis® 

1998 hypertension, 

2008 cardioprotection 

micardisplus® 

2002 hypertension 

twynsta® 

2009 hypertension 

1987 1998 2000 

2002 

2008 2009 2010 

Ischaemic core 

(brain tissue 

destined to die) 

Penumbra 

(salvageable 

brain area) 

An untreated patient loses 

approximately 1.9 million 

neurons every minute in the 

ischaemic area 

TREATMENT OF ACUTE 

ISCHAEMIC STROKE 

Option to reduce neurological 

damage by thrombolytic 

reperfusion 

Reperfusion offers 

the potential to 

reduce the extent of 

ischaemic injury 

Haemorrhagic strokes occur when 

a blood vessel ruptures or leaks into 

the brain tissue or subarachnoid 

space. 

Time is brain – act fast 

It is imperative that a stroke is recognised 

early, the stroke patient is taken 

directly to a stroke unit, and diagnosis 

and reperfusion treatment follow as 

quickly and efficiently as possible. 

The earlier treatment is initiated, the 

better the outcome. International 

guidelines recommend a door-toneedle 

time (DTN) of 1 hour or less. 

Acute stroke management – ACTILYSE® 

actilyse® (alteplase or recombinant 

tissue plasminogen activator, rt-PA), is 

a registered intravenous thrombolytic 

for the treatment of an acute ischaemic 

stroke. 

The use of intravenous actilyse® 

revolutionised the approach to the 

treatment of acute ischaemic stroke 

15 years ago. 

Patients should be treated within the 

4.5-hour treatment window. Time-totreatment 

with actilyse® is an important 

determinant of 90-day and oneyear 

functional outcomes in acute 

ischaemic stroke. The earlier that 

actilyse® is given in the therapeutic 

window to eligible ischaemic stroke 

patients, the better their outcomes. 

Reducing door-to-needle times 

Reducing door-to-needle (DTN) times 

and increasing the portion of eligible 

acute ischaemic stroke patients who are 

treated are important goals. In numerous 

clinical studies, providing feedback 

on clinical performance indicators has 

been shown to improve clinical performance 

and patient outcomes. 

QUICK initiative 

Boehringer Ingelheim’s QUICK (QUality 

Improvement of aCute Ischaemic 

stroKe patient management) initiative 

aims to help hospitals improve their 

acute stroke patient management process 

by significantly reducing delays all 

along the management process, from 

68 




OUR PORTFOLIO IN STROKE TREATMENT 

AND PREVENTION 

[ actilyse® ] [ aggrenox® ] [ pradaxa® ] 

F.A.S.T. 

The F.A.S.T (Face, Arms, Speech, 

Time) algorithm is a quick method 

for assessment of a potential stroke: 

• Asymmetry of the face – facial 

droop on one side 

• Weakness on one side of the 

body – typically, unable to raise 

both arms in parallel 

• Slurred speech – or inability to 

understand or formulate speech 

• Other problems, including 

confusion, visual disturbance, 

dizziness etc. 

the onset of symptoms to potential 

treatment. 

Secondary prevention of stroke 

Survivors of a transient ischaemic attack 

or stroke have an increased risk of 

another stroke, which is a major source 

of increased mortality and morbidity. 

AGGRENOX® 

aggrenox®/asasantin®retard (extended 

released dipyridamole + acetyl 

salicylic acid (ASA)) is indicated to reduce 

the risk of secondary stroke in patients 

who have had a TIA or completed 

ischaemic stroke due to thrombosis. 

PROFESS®, the world’s largest trial in 

recurrent stroke prevention, included 

more than 20,000 patients. The study 

compared aggrenox® with clopidogrel, 

while also analysing whether telmisartan, 

on top of other standard 

therapy, would further reduce the risk 

of recurrent stroke when compared 

with placebo. In the two antiplatelet 

regimens, the patients had a comparable 

risk for stroke as well as for myocardial 

infarction or vascular death. 

QUICK INITIATIVE 

To improve the efficiency of the 

stroke patient management process, 

the quick project is divided 

into four major phases for each 

participating hospital. 

Reassessment 

Check up 

of the stroke 

units 

Implementation 

of the action 

plan 

Development 

of action 

plan 

Trials in stroke prevention 

The prevention of stroke was speci fically 

investigated in PROFESS® and 

stroke was also included in the primary 

endpoint of ONTARGET and 

TRANSCEND®. 

Analysis on structure and 

time management 

Stakeholders to 

decide on actions 

Reduce door-toneedle 

time 

Ensure 

continuity 

Cardiovascular diseases 

69

HOW ATRIAL FIBRILLATION (AF) 

LEADS TO STROKE 

AF leads to serious secondary diseases. 

Blood clots (thrombi) can form in the 

atria that can dislodge and travel in 

the bloodstream, potentially blocking 

blood vessels in the brain and leading 

to ischaemic stroke. 

5 

4 

1 Embolus (clot) forms 

2 Atrial fibrillation in the left atrium 

3 Embolus (clot) enters blood stream 

and travels towards brain 

4 Embolus blocks blood flow to part 

of the brain 

5 Brain starved of oxygen leading 

to stroke and brain damage 

3 

2 

1 

REDUCING STROKE RISK IN 

ATRIAL FIBRILLATION 

For patients with the cardiac arrhythmia atrial fibrillation (AF) anticoagulation 

therapy is essential for stroke prevention. pradaxa® 

(dabigatran etexilate) belongs to a new generation of oral anticoagulants, 

which are fundamentally reshaping the medical landscape 

by significantly reducing thrombo-embolic events. 

Strokes happen in AF when pools of 

blood form in the heart due to failure 

of the atria to contract properly. Blood 

sticks together in the atria and forms 

clots, which can travel through the 

bloodstream and block blood flow to the 

brain, causing a stroke. Approximately 

92% of AF-related strokes are ischaemic. 

They tend to be severe, with an increased 

probability of death and disability. 

A stroke can change everything in a 

moment for patients and their families. 

The best protection against stroke is 

knowledge of the disease and appropriate 

treatment. Anticoagulation therapy 

is essential for stroke prevention in AF 

patients. 

Atrial fibrillation and stroke – 

an unholy alliance 

The most common cardiac arrhythmia 

atrial fibrillation increases the risk of 

stroke by a factor of five. AF causes the 

heart to beat too fast, too slow or with 

an irregular rhythm. 

Up to three million people worldwide 

suffer strokes related to AF each year. 

Appropriate anticoagulation therapy 

can help to prevent AF-related strokes 

and improve overall patient outcomes. 

Over one million patient-years 

Clinical experience of pradaxa®, an anticoagulant 

from the class of the direct 

thrombin inhibitors, is considerable and 

continues to grow, reaching over one 

million patient-years in the year 2012 

(including all licensed indications in over 

80 countries), and provides the greatest 

body of clinical experience for pradaxa® 

of all novel oral anticoagulants. 

70 




PRADAXA®-DEVELOPMENT AT BOEHRINGER INGELHEIM 

Lead molecule in the direct 

oral thrombin inhibitor 

project works in vivo. 

Dabigatran 

etexilate is 

selected for 

development. 

Phase II studies 

in about 2,300 

patients. 

First patients 

are enrolled 

in RE-LY®. 

European approval for dabigatran 

for the prevention 

of VTE after hip or knee 

replacement surgery. 

Research on a direct 

oral thrombin inhibitor 

begins. 

The dabigatran 

molecule is 

discovered. 

First batch of 

dabigatran 

successfully 

synthesised. 

Innovative 

capsule 

developed. 

RE-VOLUTION® 

clinical trial 

programme 

started. 

FDA approves 

pradaxa® for stroke 

risk prevention in 

patients with AF. 

pradaxa® approved 

in the EU 

for stroke prevention 

in AF. 

1992 1996 1997 2002 2004 2005 2008 2010 

2011 

Sustained, long-term protection 

Data from the RELY-ABLE® study presented 

in 2012 supports the long-term 

safety profile and efficacy of pradaxa®. 

Highly consistent with the findings 

from the landmark RE-LY® trial, the results 

observed during the additional 

follow-up demonstrate the sustained 

protection over a treatment duration of 

more than four years and support the 

benefit of both doses for tailored patient 

treatment. 

Safety confirmed 

In 2012, the positive risk-benefit profile 

of pradaxa® has been confirmed by independent 

regulatory appraisals of realworld 

data led by the US Food and Drug 

Administration (FDA) as well as the European 

Medicines Agency (EMA), which 

highlight that the drug offers important 

benefits to patients. 

Further research 

Boehringer Ingelheim remains dedicated 

to advancing science and ensuring that 

physicians have all the tools they may 

require to effectively manage patients, including 

in critical situations. Boehringer 

Ingelheim is therefore currently developing 

a specific antidote to the anticoagulation 

effect of pradaxa® to add to 

the existing reversal strategies already 

available in clinical practice. 

Unprecedented insights 

We continue to collaborate with regulatory 

authorities worldwide. In Germany, 

we have taken the unprecedented step 

of actively and regularly sharing safety 

data with physicians – achieving a new 

level of transparency and openness. 

Furthermore, unique insights have been 

provided through the development of 

‘Finding the right molecule’, a book 

guiding readers through the innovative 

development journey of pradaxa®. 

Challenges of reimbursement 

pradaxa® addresses the demands for 

an effective treatment option, providing 

sustained and reliable stroke prevention. 

At the same time, health care systems 

worldwide face increasing cost 

restrictions, providing a challenging 

environment for reimbursement. Still, 

PRADAXA®, PRADAXAR®, 

PRAZAXA® 

is a novel reversible oral direct 

thrombin inhibitor that blocks the 

activity of thrombin, the central 

enzyme in clot formation. It is 

approved for the primary prevention 

of venous thrombo-embolism 

(VTE) in adults who have undergone 

elective total hip or knee 

replacement surgery and was the 

first new anticoagulation therapy 

in over 50 years to be approved 

for the prevention of stroke and 

systemic embolism for adult 

patients with non-valvular atrial 

fibrillation who are at risk of 

stroke. 

Reducing stroke risk in atrial fibrillation 

71

FINDING THE RIGHT MOLECULE 

“Finding the right molecule”, a book 

that guides readers through the 

innovative development journey 

of pradaxa®. 

Find out more here: 

www.heartofstroke.com 

most reimbursement agencies have concluded 

that pradaxa® is a cost-effective 

use of health care resources. 

1 Mission 1 Million 

In cooperation with leading medical 

and patient organisations, such as the 

World Heart Federation and the Atrial 

Fibrillation Association, the 1 Mission 

1 Million initiative has continued to 

raise awareness of AF and its link to 

stroke around the world. Communitybased 

action is at the heart of this global 

initiative, and during 2012 the 

foundations of phase 2 were launched 

to ensure ongoing engagement in 2013 

with key stakeholders – patients, 

healthcare professionals and third 

party groups. 

1 Mission 1 Million – three approaches 

• Supporting projects around the world 

that aim to help prevent AF-related 

stroke. 

• The petition calls upon people to help 

save lives from potentially disabling 

or fatal AF-related strokes. The global 

petition calls upon health organisations 

around to world to fully recognise 

AF as a serious condition and as 

a risk factor for stroke through better 

management, stroke prevention and 

education. 

• Encouraging people directly affected 

by AF to share their unique stories 

and experiences. 

72 





BEYOND BLOOD PRESSURE CONTROL 

[ brain 

] 

Ultimate goal – prevention of stroke, 

heart attack, kidney failure 

[ kidney ] 

CONTROLLING HYPERTENSION AND 


[ heart ] 

Controlling blood pressure is one of the most important factors to 

reduce cardiovascular events. The primary cardiovascular concern of 

physicians is treating high blood pressure. The goal is also to prevent 

the life-threatening events of stroke, heart attack or kidney failure 

that can result from complications of high blood pressure. 

micardis® (telmisartan) is an angiotensin 

receptor blocker (arb) registered 

for the treatment of hypertension and 

the reduction of cardiovascular morbidity 

and mortality. This was achieved as 

a result of a vast and robust body of research, 

including the ONTARGET 

study, one of the most ambitious and 

far-reaching research programmes ever 

conducted with an arb. 

Evolution of the global brand 

micardis® was discovered and developed 

by Boehringer Ingelheim and 

was launched in 1998. The product is 

currently registered in 112 countries 

and marketed in 104 countries worldwide. 

It is the foundation for the telmisartan 

franchise, which also includes 

micar dis plus® and twynsta®. 

Organ protection and cardiovascular 

prevention 

Historically, the point of difference for 

micardis® was “full 24-hour blood 

pressure protection”, which included 

cover for the risky early morning hours, 

where other medicines can wear off. In 

2006, this shifted to its “powerful 24- 

hour blood pressure lowering effect”, 

which was felt to be more meaningful 

by doctors. 

MICARDIS® 

For the treatment of hypertension. 

For the reduction of cardiovascular 

morbidity in patients with manifest 

atherothrombotic cardiovascular 

disease (history of coronary heart 

disease, stroke or peripheral arterial 

disease) or type 2 diabetes 

with documented target organ 

damage. 

Controlling hypertension and cardiovascular protection 

73

PATIENTS AT CARDIOVASCULAR RISK 

Most hypertensive patients need more 

than just simple blood pressure control. 

Preserving vascular health and protecting 

vital end organs is essential too. 

micardis®, micardisplus® and twynsta® 

are indicated for the management of 

patients at added risk of cardiovascular 

events. These include patients with 

obesity, diabetes, uncontrolled hypertension 

and metabolic syndrome. 

obesity 

diabetes 

uncontrolled 

hypertension 

metabolic 

syndrome 

TWYNSTA®/MICAMLO® 

(telmisartan / amlodipine) 

Add-on therapy in adult patients 

with not adequately controlled 

blood pressure on amlodipine and 

replacement therapy in adult patients 

receiving telmisartan and 

amlodipine from separate tablets. 

24-hour control of blood pressure is an 

important feature. micardis® aims further 

to protect of end-organs, such as 

the brain, heart and kidneys. 

In 2008, Boehringer Ingelheim completed 

the ONTARGET study – a large 

and comprehensive clinical trial designed 

to investigate the direct cardioprotective 

effect of micardis® beyond 

the effects resulting from the lowering 

of blood pressure. 

This landmark trial gave clinical proof 

for micardis® to prevent stroke, myocardial 

infarction (MI) and cardiovascular 

death and led to the indication for 

cardiovascular prevention beyond 

blood pressure control. 

Reducing cardiovascular risk 

micardis® is labelled for patients 

with hypertension, as well as those at 

risk of cardiovascular events. It is an 

angio tensin receptor blocker (ARB) 

that is clinically proven to prevent 

stroke, mi and cardiovascular death 

and is indicated for cardiovascular 

prevention beyond blood pressure 

control. 

Single-pill combinations 

Treatment guidelines recognise that at 

least two-thirds of patients need two 

antihypertensive agents to effectively 

control blood pressure; a figure that 

rises to nine out of ten in patients with 

co-morbidities, such as obesity, diabetes 

and metabolic syndrome, which are all 

cardiovascular risk factors. Single-pill 

combinations (SPCs) that are effective 

and well-tolerated offer a major benefit 

for these patients. 

MICARDISPLUS® 

micardisplus® is labelled for hypertensive 

patients at risk of cardiovascular 

events who need blood pressure control 

and will benefit from adding a diuretic, 

e. g. the elderly and where oedema is often 

a problem. micardisplus® delivers 

an efficacy that lasts for a full 24 hours. 

It contains telmisartan, the only arb 

with a cardiovascular prevention indication 

and the diuretic hydrochlorothiazide 

(HCTZ). 

74 




MICARDIS® PROFILE 

[ unique chemical structure ] 

[ telmisartan ] 

micardis® is different to other ARBs 

as it also contains a non-tetrazole 

carboxylic acid ring, shown in red 

(in chart right). The distinctive 

groupings in the structure of 

micardis® give it properties that 

make it different from all other ARBs. 

TWYNSTA®, MICAMLO® 

twynsta® is labelled for hypertensive 

patients who require intensified blood 

pressure control. twynsta® delivers the 

effective and prompt blood pressure reductions 

needed to help patients reach 

their goal, and the power of twynsta® 

lasts for a full 24 hours. twynsta® contains 

telmisartan, the only ARB with a 

cardiovascular prevention indication 

and the calcium channel blocker amlodipine. 

The TEAMSTA® switch study 

TEAMSTA® switch has been a 12-week, 

open-label, multi-centre study, which 

forms part of the telmisartan plus amlodipine 

phase III/IV clinical trials programme. 

The results from the TEAMSTA® 

switch study, presented in 2012, showed 

that twynsta® delivers prompt blood 

pressure control in the majority of patients 

with uncontrolled hypertension 

on renin-angiotensin system (RAS) 

blocker monotherapy and provides further 

confirmation of its excellent efficacy 

in controlling high blood pressure. 

These latest findings add to a robust evidence 

base, confirming that twynsta® 

is a valuable treatment option for patients 

with hypertension and is highly 

effective in helping patients who are 

uncontrolled to reach their blood pressure 

goals. 

OUR LANDMARK TRIALS 

micardis® (telmisartan) has been 

investigated in the most ambitious 

and far-reaching research programme 

conducted with an arb. 

In the clinical trial programmes 

ONTARGET, PROTECTION and 

PROFESS®, over 58,000 patients 

were enrolled to investigate the 

efficacy and cardiovascular protective 

effects of telmisartan. 

micardis® (telmisartan) is one of 

the most studied antihypertensives 

in clinical trials and is widely used 

with a total of more than 40 million 

(including micardisplus®) 

patient-years since approval. 

Controlling hypertension and cardiovascular protection 

75

TRAJENTA® / TRADJENTA® 

trajenta® is a prescription 

medicine that is used along with 

diet and exercise to lower 

blood sugar in adults with type 2 

diabetes. The once-daily tablet 

is used along with diet and 

exercise to improve glycaemic 

control. 

A STRONG ALLIANCE FOR DIABETES TREATMENT OPTIONS 

In January 2011, Boehringer Ingelheim and Eli Lilly and Company 

have formed an alliance in the field of diabetes that centres on four 

pipeline compounds representing several of the largest treatment 

classes. 

We understand the ongoing need to research and develop newer, 

targeted medications that are specifically designed not only to provide 

effective, long-term reductions in blood sugar levels but also 

avoid the limitations and tolerability issues of the current treatments. 

trajenta® / tradjenta® and jentadueto® are the first products 

marketed under the alliance. 

LIVING BETTER WITH DIABETES 

Managing diabetes is a life-long job for patients. Increasing awareness 

about the importance and benefits of diabetes control is therefore 

the key objective of strategies for a better life with this chronic disease. 

Beyond our focus on drug treatments for diabetes, we are eager 

to establish tools and programmes that can help patients to make lifestyle 

and behaviour changes. 

371 million 

PEOPLE HAVE DIABETES 

An estimated 371 million people 

worldwide have diabetes, a serious 

chronic condition that occurs 

when the body either does not 

properly produce, or use, the hormone 

insulin. 

Type 2 diabetes is the most common 

type, accounting for an estimated 

90% to 95% of all cases. The 

number of diabetes cases is expected 

to grow considerably in the 

coming years due to unhealthy 

lifestyles. 

Living with type 2 diabetes requires 

that patients develop a range of competencies 

that allow them to take greater 

control over the treatment of their disease. 

This includes: 

• Education and support for selfmanagement 

(including reduction 

of lifestyle risk factors). 

• Effective drug treatment strategies for 

maintaining normal blood glucose 

and lipid levels, and normal blood 

pressure. 

• Effective surveillance for early detection 

and treatment of complications. 

The most important aspect is that the 

patients stick to a chosen regimen and 

properly manage their lifestyle change. 

Steps towards better health 

In future, patients with certain diseases, 

especially chronic ones, should be treated 

with a more holistic approach beyond 

drug treatment. This requires education 

with the explicit aim of enhancing active 

involvement of patients so that they become 

partners in their healthcare process. 

Boehringer Ingelheim is therfore 

concentrating on new business models 

and healthcare innovation. 

Need for educational tools 

Ever more patients with type 2 diabetes 

have comorbidities and new treatments 

options have raised expectations and redefined 

the standards for treatment success. 

In particular, the close link between 

type 2 diabetes and the onset and 

progression of nephropathy presents a 

common – and often underestimated 

and misunderstood – treatment challenge. 

In order to meet this task effectively, 

practitioners need answers to sev- 

76 




JENTADUETO® 

jentadueto® is a twice-daily combination 

of two diabetes medicines, linagliptin and 

metformin. It can be used along with diet 

and exercise to help control blood sugar in 

adults with type 2 diabetes when treatment 

with both compounds is appropriate. 

Our Diabetes Health Lounge: 

The website combines educational videos 

and games, research tools and information 

on type 2 diabetes. 

For more information see: 

www.diabeteshealthlounge.com 

eral questions. How many patients with 

diabetes have some degree of renal impairment 

What is their prognosis How 

does it impact their quality of life And 

lastly, what are the consequences for the 

doctor, in terms of treatment approaches 

Diabate © website 

Sponsored by an unconditional educational 

grant from Boehringer Ingelheim, 

Diabate © is a resource for all medically 

qualified practitioners with an interest 

in the treatment of diabetes. It brings 

together experts in diabetes, diabetic 

renal impairment and cardiovascular 

disease in an ongoing programme to 

review, discuss and understand the latest 

scientific developments relevant to 

the overall topic of diabetes and renal 

disease. 

Web, smartphone and type 2 diabetes 

We have partnered with the digital 

health management company Healthrageous, 

Inc. to study a web and smartphone-based 

lifestyle behaviour modification 

programme. The goal is to use 

technology to produce an easier and 

more effective way for patients to selfmanage 

their diabetes and improve 

their health status. Study participants, 

who must have been diagnosed with 

type 2 diabetes for at least six months, 

experience a digital technology intervention 

combining digital coaching and 

a wireless glucose meter transmitting 

data to clinical monitors. 

My Well Planner 

In 2012, Boehringer Ingelheim and Eli 

Lilly and Company introduced the My 

Well Planner lifestyle improvement 

programme in the USA. The free, comprehensive 

resource offers customised 

educational content to help adults with 

type 2 diabetes make simple lifestyle 

changes to improve their health. Sample 

topics include general information 

about type 2 diabetes, better eating habits, 

building physical activity into daily 

life, taking medication and communication 

strategies. 

The programme also creates progress 

reports, which patients can print out 

DIABATE © WEBSITE 

It brings together diabetes experts 

in an ongoing programme to 

review, discuss and understand 

the latest scientific developments 

relevant to the overall topic of 

diabetes and renal disease. 

For more information see: 

www.diabate.tv 

Living better with diabetes 

77

WORLD DIABETES DAY 

World Diabetes Day (WDD) is celebrated every year on 14 November 

It engages millions of people worldwide in diabetes advocacy and 

awareness. The campaign draws attention to issues of paramount 

importance to the diabetes world and keeps diabetes firmly in the 

public spotlight. In 2012, Boehringer Ingelheim for the fourth consecutive 

year supported the Life for a Child programme by donating 

the proceeds of a 3km employee run that was held at the company’s 

headquarters. A total of EUR 20,000 was donated to the programme 

initiated by the International Diabetes Federation (IDF). 

and take to their healthcare providers 

to discuss during visits. 

A day to raise awareness 

On each World Diabetes Day (WDD) on 

14 November, Boehringer Ingelheim 

conducts a number of diabetes awarenessraising 

activities among its employees. 

In 2012, an internal communication 

campaign designed to increase the 

understanding of the global diabetes epidemic 

promoted healthy diet and active 

lifestyle. Special lunchtime menus were 

offered with the opportunity to let employees 

test their blood sugar levels. 

10,000 children with diabetes in developing 

countries through fundraising 

and monetary contributions. 

The financial support that Boehringer 

Ingelheim provided in 2012 will go directly 

to diabetes centres in these countries, 

enabling them to provide the ongoing 

clinical care and diabetes education 

that children need to stay alive. 

MY WELL PLANNER 

My Well Planner is designed to 

help adults with type 2 diabetes 

and their healthcare providers 

work together to set small lifestyle 

goals at their own pace, building 

toward bigger goals in the future. 

Patients in the USA can register 

and create their own “My Well 

Planner” account at: 

www.mywellplannerinfo.com. 

Support for the “Life for a Child” 

programme 

Over 450 employees participated in a 

3km run with the knowledge that each 

kilometer completed would be converted 

into a financial contribution to the 

“Life for a Child” programme initiated 

by the International Diabetes Federation 

(IDF). 

This international aid programme provides 

life-saving support to more than 

78 




CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) 

triggers include 

people experience 

physical and emotional impact 

pollutants and 

noxious particles 

cigarette 

smoke 

breathlessness 

coughing 

copd 

exacerbations 

socially 

isolated 

work 

absenteeism 

wheezing 

limited 

physical 

activity 

increased 

sputum 

production 

scared 

depressed 

THE TRUE FACE OF COPD 

Chronic obstructive pulmonary disease (COPD) has a lot of 

frightening aspects. You can’t breathe, you’re finding yourself 

gasping for air after climbing a few stairs and are not able to 

accomplish simple activities. 

COPD is caused by the long-term inhalation 

of pollutants, most commonly 

cigarette smoke, that progressively 

and permanently reduces the ability of 

adults to breathe well and maintain 

active lives. 

SPIRIVA® – over 31 million patientyears 

in clinical use 

The year 2012 signifies an important 

ten-year milestone for the COPD medication 

spiriva® (tiotropium) since 

launch of the HandiHaler® in 2002. 

31 million 

In clinical use for over 31 million 

patient-years, once-daily spiriva® 

is the most prescribed COPD 

maintenance treatment worldwide. 

COPD, ranked fourth globally among 

the leading causes of death, is characterised 

by breathlessness (dyspnoea), 

coughing, wheezing and increased sputum 

production. Due to its progressive 

nature, the early diagnosis and treatment 

of COPD is essential to prevent 

and/or reduce potential complications 

and exacerbations (worsening of symptoms) 

associated with the disease. 

In clinical use for over 31 million patient-years, 

once-daily spiriva® is the 

most prescribed COPD maintenance 

treatment worldwide. This position is 

rooted in the wealth of clinical trial 

data available to prove the clinical efficacy 

of spiriva® in reducing breathlessness 

(dyspnoea) and the risk of exacerbations, 

as well as in improving 

patients’ quality of life. 

The true face of COPD 79

SPIRIVA®: 10 YEARS AND MORE OF CLINICAL INNOVATION AND COMMITMENT TO COPD PATIENTS 

Global Initiative for Chronic 

Obstructive Lung Disease 

(GOLD) is formed. 

spiriva® for the treatment of 

COPD delivered via the Handi- 

Haler® device is launched in 

European and Asian countries 

spiriva® HandiHaler® 

receives US FDA approval 

Development of tiotropium 

bromidefor 

COPD began. 

GOLD releases its first report: 

Global Strategy for the 

Diagnosis, Management, 

and Prevention of COPD. 

International guidelines recommend 

inhaled long-acting bronchodilators 

as first-line maintenance 

therapy for COPD. 

spiriva® becomes the 

world’s most-prescribed 

COPD maintenance 

treatment. 

1985 1997 2001 2002 2003 

2004 

2005 

SPIRIVA® 

spiriva® is delivered via the Handi- 

Haler®, a breath-actuated, singledose 

dry powder inhaler, or by 

spiriva® respimat® Soft Mist 

inhaler, a propellant-free, new 

generation inhaler that combines 

innovative technology with the 

proven efficacy of spiriva®. 

Over the years, more than 175 clinical 

trials with the active ingredient tiotropium 

in COPD have been conducted 

investigating a broad range of patients 

in studies of up to four years. 

spiriva® has an established efficacy and 

tolerability profile, as demonstrated in 

multiple clinical trials and extensive 

real-world experience spanning over 

ten years. 

spiriva® provides proven efficacy in a 

broad range of COPD patients, ranging 

from maintenance-naïve patients and 

across varying severities of airflow 

limitation (GOLD 2 to 4) to those patients 

with or without concomitant respiratory 

therapy, including long-acting 

beta-antagonists. 

Reflected in global COPD guidelines 

The Global Initiative for Chronic Obstructive 

Lung Disease (GOLD) recognises 

that some of the key goals of 

treatment are to alleviate the impact 

of symptoms, including breathlessness, 

and reduce the risk of adverse health 

events, such as exacerbations. 

In its report Global Strategy for Diagnosis, 

Management, and Prevention of 

COPD from 2011, GOLD extensively 

revised the COPD assessment aspects 

with the addition of the individualised 

evaluation of symptoms and exacerbation 

risk. This assessment now not only 

includes spirometry tests but also a 

combination of a patient’s severity of 

symptoms and a history of exacerbations. 

The 2011 GOLD report recommends 

long-acting anticholinergics such as 

spiriva® for every patient requiring 

maintenance therapy (first choice for patient 

groups B – D and second option for 

patient group A) . This recommendation 

was solely based on data for the longacting 

anticholinergic spiriva®. The recent 

2013 update of the GOLD’s Global 

Strategy for the Diagnosis, Management, 

and Prevention of COPD, reflects the 

same choice recommendations on the 

use of long-acting anticholinergics as 

proposed in the 2011 GOLD Report. 

80 




spiriva® respimat® Soft Mist Inhaler, 

which delivers tiotropium via a soft mist 

cloud, successfully secures European 

registration in 25 member states. 

GOLD update recommends longacting 

anticholinergics such as 

spiriva® for every patient requiring 

maintenance therapy. 

spiriva® has over 31 million 

patient-years of 

extensive real-world 

experience. 

UPLIFT® demonstrates that 

spiriva® sustains lung function 

improvements over four years and 

improves survival rate. 

POET-COPD® study results demonstrate 

the superiority of spiriva® 

over salmeterol in reducing the risk 

of COPD exacerbations. 

spiriva® is currently available 

in over 120 countries and continues 

to be the most widely 

prescribed maintenance therapy 

for COPD worldwide. 

2007 2008 2009 2010 

2011 

2012 and beyond 

Confirmed value to the patient 

Among external institutions conducting 

health technology assessments 

(HTAs), the German IQWiG (Institute 

for Quality and Efficiency in Health 

Care) has examined whether spiriva® 

offers a perceptible benefit to patients 

compared with placebo and other COPD 

drugs. The IQWiG considers it proven 

that, in comparison with the group of 

long-acting beta-agonists (salmeterol, 

formoterol and indacaterol), tiotropium 

delivered via the HandiHaler® exhibits 

additional benefit in terms of both exacerbation 

frequency and the need for 

hospitalisation as a result of exacerbation. 

A “proof” of evidence is the highest 

IQWiG evidence grading possible. 

COMBIVENT® RESPIMAT® in the USA 

Following FDA approval in 2011, 

combivent® respimat® was launched 

in the US market in 2012. This marks 

an important milestone, as it is the first 

product to be delivered in the propellant-free 

and innovative respimat® inhaler. 

The respimat® inhaler is a new 

generation inhaler with a unique delivery 

mechanism, which is preferred by 

patients. It is the platform for our future 

respiratory products. 

COMBIVENT® RESPIMAT® 

The launch of combivent® 

respimat® for COPD in 2012 

was the first introduction of the 

respimat® inhaler on the 

US market. 

The IQWiG assessment was largely 

based upon the head-to-head POET- 

COPD® study, comparing the effects on 

acute worsening of the disease (exacerbations) 

of two long-acting bronchodilators 

spiriva® and salmeterol. The study 

showed significantly better outcomes 

with spiriva® in reducing COPD exacerbations 

compared with salmeterol. 

The true face of COPD 81

BEHAVIOUR CHANGE IN 

TYPE 2 DIABETES 

The goal of the Healthrageous’ internetbased 

diabetes programme is to leverage 

technology in a way that makes the 

personalised journey of self-managing 

diabetes easier and more effective. 

PERSPECTIVES ON INNOVATIVE 

BUSINESS MODELS 

More complex technologies are able to 

screen and provide medical care from 

the patient’s own home, facilitating access 

to our ever aging population. 

Healthcare is changing. Over the next decade, the focus will switch 

from products towards integrated solutions and service offerings. 

Beyond medications it means combining numerous solutions into 

a healthcare provision model that addresses the needs of patients 

and healthcare providers alike. 

HEALTHRAGEOUS, INC. 

Digital coaching and a wireless 

glucose meter transmitting data 

to clinical monitors. 

New healthcare business models are focusing 

towards innovative integrated 

solutions that seek to support patients 

in prevention, and through the treatment 

and management of their disease. 

These can include simple solutions that 

allow a patient to monitor their condition 

from home, providing them a more 

accurate view of the effectiveness of 

their actions and motivating them to 

follow their treatment plan and activities 

to achieve better results. 

The emerging alliance between medicine 

and technology will lead to more 

predictive, personalised and effective 

medical care. These measures aim to 

remove obstacles and encourage patients 

and healthcare providers down a 

common path where quality of life and 

healthcare outcomes are improved. 

The shift towards integrated healthcare 

models can be seen as an evolution towards 

highly effective holistic treatment 

solutions. Boehringer Ingelheim 

has a department called Business Model 

& Health Care Innovation (BM&HCI), 

in order to further shape these changes 

and to improve knowledge, competencies 

and capabilities in this area. 

82 




MAKING SELF-MANAGEMENT OF TYPE 2 DIABETES 

EASIER AND MORE EFFECTIVE 

Wireless blood glucose 

Internet-based clinical monitoring 

A B C 

measurement 

+ digital coaching 

Intervention on changes in 

lifestyle behaviours 

reporting 

on self 

tracking 

messages, 

reminders and 

alerts 

Supporting the patient 

The department is looking at supporting 

the entire patient journey. This includes 

imaging, diagnostics and predictive 

analytics, that help identifying 

patients early on. It also comprises consumer 

sensors, devices or monitors, 

codified and standardised protocolbased 

pathways, as well as behaviour 

modification tools that leverage science 

and economics. 

BM&HCI has been tasked with exploring 

opportunities for collaborative innovation 

through pilot programmes 

and partnerships, which drive superior 

health benefits for patients, while facilitating 

the delivery of improved care by 

providers. 

BM&HCI works to extensively network 

within the company to assess potential 

needs and uncover ideas for potential 

projects early on. 

Simultaneously, via external partnerships 

with academia and a variety of 

different industry partners, the department 

is building knowledge and relationships, 

including with partners not 

typically associated with the healthcare 

industry. 

In all, we are working to find and evaluate 

the best solutions and business 

models from a variety of sources. 

Cooperation with Healthrageous, Inc. 

Boehringer Ingelheim and Healthrageous, 

Inc., a digital health management 

company, will evaluate in a pilot 

study a lifestyle behaviour modification 

programme to improve the health status 

of people with type 2 diabetes. 

Study participants will experience a 

digital technology intervention combining 

digital coaching and a wireless glucose 

meter transmitting data to clinical 

monitors. The internet-based tool will 

allow an evaluation of the intervention 

on changes in lifestyle behaviours, glucose 

control, additional medical parameters 

and medication adherence. 

DIGITAL COACHING AND 

BIOMETRIC FEEDBACK 

In the first phase 200 adults diagnosed 

with type 2 diabetes for at 

least six months will have access 

to Healthrageous’ digital diabetes 

self-management programme. 

The web and smartphone delivered 

programme will include a personalised 

action plan with health 

behaviour improvement goals, biometric 

feedback to demonstrate 

goal achievement and milestones, 

digital coach interaction, recognition 

and incentives for progress, 

supply and strip refill ordering and 

medication reminders. 

If the results show the expected 

benefits, the programme will be 

expanded to encompass up to 

one thousand patients in several 

countries. 

Perspectives on innovative business models 

83

Rapid progress in global healthcare generates 

demand for innovative medicines. 

MARKET ACCESS FOR 

NEW MEDICINES 

Rapid progress in global healthcare systems today continuously 

generates demand for urgently needed innovative medicines. However, 

in many cases, innovations in medicines and technology result in 

increased healthcare expenditure, at least in the short term. Healthcare 

budgets are under severe pressure and cost-consciousness among 

healthcare providers has increased. 

BENEFIT FOR PATIENTS 

AND SOCIETY 

We at Boehringer Ingelheim are 

convinced that our new and 

innovative products offer significant 

additional medical benefit 

to patients and economic benefit 

to society. 

The market access environment for 

medications has changed structurally, 

driven by the limited affordability of 

healthcare for the public health sector 

in growing and aging societies. The 

impact on the pharmaceutical industry 

is that the regulatory requirements, 

such as demonstrating efficacy, safety 

and quality of products, are no longer 

sufficient when bringing new medicines 

to the market. Additionally, medical 

and economic benefit have to be demonstrated 

when new medicines are 

brought to the market. 

Innovation – risk-adequate incentives 

Boehringer Ingelheim is guided by the 

aspiration to provide a sustainable contribution 

to the improvement of the 

health of society with innovative medications. 

As a research-driven company, 

we can, however, only continue to invest 

in our own research and development 

of innovative medications, if we 

are risk-adequate incentivised and rewarded 

for our entrepreneurial risk and 

innovation. Cost-benefit calculations of 

the public sector for sole cost control 

are falling short related to the sustained 

improvement of public health. 

Our market access organisations 

To find a solution for the divergent goals 

of society and Boehringer Ingelheim, 

we have built up corporate and local 

market access structures and processes, 

which have helped to achieve and sustain 

access and reimbursement of our 

products in most markets. 

However, market access activities for 

our two new innovative products, 

pradaxa® and trajenta®, have identi- 

84 




REQUIREMENTS FOR PRODUCT APPROVAL 

The pharmaceutical industry, including Boehringer 

Ingelheim, is facing increasing difficulties to achieve 

market access, i.e. reimbursement for the labelled 

portfolio of new innovative products. 

budget 

impact 

THREE TRADITIONAL REQUIREMENTS 

Provision of evidence to demonstrate 

safety, efficacy and quality for purposes of 

registration and reimbursement of new 

medications. 

value and costeffectiveness 

FOURTH REQUIREMENT: 

VALUE AND COST-EFFECTIVENESS 

quality 

efficacy 

safety 

three traditional requirements 

fourth 

requirement 

fifth 

requirement 

Healthcare providers’ expenses for treatments 

are covered or reimbursed by a payer. 

This payer must be convinced of the 

additional clinical, as well as the economic 

benefit of the product to be willing to pay 

for it. 

fied a difference in stakeholders’ and 

customers’ value perception of external 

market access compared with our conviction 

about the innovation and medical 

need of the two products. 

Unlike in previous years, we also noted 

a mismatch between rather positive 

health technology assessment (HTA) 

outcomes and the finally implemented 

reimbursement and pricing decisions – 

most likely driven by payers’ increasing 

healthcare budget constraints. As a result, 

physicians and patients often had 

to wait longer than expected to get access 

to pradaxa® or trajenta®. 

Market access embedded 

Therefore, our market access group is 

an integrated part of committees in 

R&D, Marketing and Regulatory to 

align evaluations and decisions with a 

sufficient focus on market access in the 

preparation of research and development 

milestone decisions. 

Progressive market access models 

Faced with fast-changing healthcare 

systems, we have started to explore and 

develop non-traditional market access 

models, such as risk-sharing agreements 

and outcome/performance-based agreements 

with some payers. Tiered pricing, 

i.e. pricing in accordance with the ability 

of societies to generate income per 

capita, might be a way to bring new 

medicines to a wider group of eligible 

patients in emerging markets. 

Every market is different and we need 

to clearly understand each payer’s 

needs and ability to finance new medicines, 

whether the payer is a third party 

(i.e. health insurer) or the actual patient. 

Budget constraints are expected 

to continue in many markets and each 

market needs a different solution. 

Demonstrating the overall benefit of a new 

product, i.e. in the form of so-called costbenefit 

models, has to be cleared by the 

research-driven pharmaceutical industry. 

Payers are assessing the benefits of any 

new medicine before granting access to 

the respective healthcare systems. 

FIFTH REQUIREMENT: 

BUDGET IMPACT 

Addressing the budget impact is the ultimate 

challenge for gaining market access 

at national, regional and local levels. 

Market access for new medicines 

85

KEY GOALS OF GLOBAL BUSINESS SERVICES 

improving 

productivity 

improving quality 

and compliance 

adding business 

value 

enabling business 

growth 

attracting talented 

employees 

Leveraging standardisation, 

automation and 

economies of scale. 

Leveraging innovative 

technology, transparency 

and globally 

bundled expertise. 

Businesses and functions 

to focus on their 

core processes. 

Greater efficiencies 

through agility and 

standards. 

Attractive work environment, 

modern ways of 

working, good development 

opportunities. 

PASSIONATELY 

ENABLING GROWTH 

Global Business Services (GBS) is a programme, a system, an 

orga nisation. GBS is one of the largest and most significant 

transformation initiatives that Boehringer Ingelheim has invested 

in to date. It embraces services, standards and systems. 

Scope of GBS 

The scope of GBS covers more than 

rolling out new software technologies 

and business enterprise platforms to 

automate commercial transactional 

functions. 

GBS especially aims to target both 

direct and indirect resource creation 

through faster delivery of quality information 

using standardised, transparent 

and compliant processes and harmonised 

systems. 

The mission of GBS is to deliver optimal 

internal global services from 

within the organisation with the aim 

of operating more efficiently and effectively. 

Hence, GBS plays a significant 

role in ensuring that the company 

remains in a strong commercial 

position. 

GBS has moved rapidly from a traditional 

back-office function-based 

role to become a strategic partner to 

the organisation. 

GBS evaluates three key topics to find 

out whether a service can be subject to 

a GBS target. If it can be standardised, 

internationalised or industrialised on a 

large scale, it is likely that GBS, together 

with the respective business and 

function, develops global standards. 

Interconnected systems 

To run such services, globally harmonised 

standards in processes and content 

have to be in place. Having defined 

services, content and processes, a smart 

global architecture of information sys- 

86 




G LOBAL BUSINESS SERVICE CENTER 

Globally standardised procedures 

are executed by a central service 

center, the Global Business Services 

Center (GBSC), and create 

global synergies. 

The implementation of GBS is 

focused on accountabilities and 

service excellence aiming at 

increasing service quality and 

allowing for continuous improvement 

of processes. 

improvement and strategic evolution 

purposes at globally standardised 

sites, global governance is 

improved and complexities are 

reduced in all business process 

areas. 

Overall, GBS is enabling Boehringer 

Ingelheim to achieve cost 

containment and sustain growth 

and success well into the future. 

As information is centrally available 

for monitoring, continuous 

tems is established to enable and empower 

GBS. In fact, it is a number of 

interconnected systems that allows 

Boehringer Ingelheim to run these 

services and processes, be they commercial 

or production-re lated. 

Organisational dimension 

Additionally, GBS also has an organisational 

dimension: to govern, develop, 

deploy and to run services. Together 

with the partners, particularly in its 

functions Operations and Information 

Systems, Boehringer Ingelheim rapidly 

deploys the new set-up to all its subsidiaries. 

Global business standards 

New global business process standards 

are rolled out in partnership with corporate 

businesses and functions and the 

subsidiaries to create and refine stateof-the-art 

business processes that will 

enable Boehringer Ingelheim to manage 

key assets with greater ease. 

invoices to suppliers and receiving payments 

from pharmaceutical distributors 

and wholesalers. 

It also covers many front-end processes 

and interfaces, including customer relationship 

management, for the sales and 

medical teams across the company. 

Operations also pursues a compatible 

harmonisation approach closely aligned 

with the GBS initiatives to streamline 

and deploy the very best manufacturing 

processes to manage production logistics, 

operations planning, and ensure 

manufacturing plants are running efficiently 

and producing the highest quality 

medicines possible. 

Importantly, the GBS initiatives allow 

employees in hundreds of different job 

functions globally to focus more on 

their most important core business 

functions. 

BUILDING UP GBS 

Global Business Services (GBS) 

were successfully introduced until 

2012, initially in some European 

countries (UK, Ireland, Italy) and 

in Brazil. 

With this global proof of concept, 

we will now migrate additional 

units worldwide to new standards 

and platforms. In 2013, further 

introductions are scheduled in 

Europe, Asia and the Americas. 

The GBS initiatives cover commercial 

business functions, such as payments of 

Passionately enabling growth 87

“The perspectives that open up 

unexpectedly in the canyon, which 

is about 1.5 km long, are so varied, 

because of the different lighting, 

colours and forms. So every step 

turns into an experience, generating 

curiosity, excitement and fascination.” 

(Antelope Canyon, Arizona, 

USA) 

klaus fleischmann 

project leader 


36° 51' 27" N, 111° 22' 19" W 

antelope canyon, arizona, usa



#3.2 

FUTURE PROSPECTS FOR CONSUMER HEALTH CARE (CHC) 

STAY HEALTHY TO ENJOY 

YOUR FREEDOM 

Nowadays, people live longer due to better living conditions and 

better public and private healthcare systems. To contribute to 

improving the health of an ageing society, we implemented an 

innovation programme and understand better the quality of 

life needs of people between 50 and 65 years old, the so-called 

“young-timers”, and bring new solutions for them. 

People born in the 1950s and 1960s 

form a large demographic group together 

with the baby boomers, and represent 

the largest demographic group in most 

developed countries. They also hold a 

very large part of many countries’ economic 

wealth. 

Health and lifestyle solutions 

People live longer and want to maintain 

their health and quality of life for as 

long as possible. Retirement is probably, 

together with family and health-related 

topics, one of the major concerns for 

this age group. It can completely change 

people’s habits from one day to another, 

impacts incomes and can be life-changing. 

Some people face it with enthusiasm 

and others with fear. 

Their biggest needs and demands include 

health and lifestyle services especially 

designed for them. Boehringer 

Ingelheim is de veloping specific health 

and lifestyle solutions and services for 

people aged 50 and over. 

Mobility 

Part of our current innovation programme 

for “young-timers” is related 

to their mobility. 

The most common mobility ailments 

are back pain (sciatica or slipped disc), 

joint ache (arthritis, arthrosis, bursitis, 

tendinitis or gout), osteoporosis or 

conditions like varicosis or haemorrhoids. 

Through our innovation programme, 

we are working with experts who have 

pointed out the importance of being 

proactive when mobility problems appear. 

New solutions also need to be 

more personalised, more preventive and 

offer clear guidance on how to manage 

problems. 

MOBILITY – “YOUNG-TIMERS” 

Mobility is part of our innovation 

programme for “young-timers”, 

people between 50 and 65 years 

of age. 

Stay healthy to enjoy your freedom 89

OUR GLOBAL SWITCH TEAM 

The Switch unit is focused on switching medicines with 

expired patents to over-the-counter medications. The team 

is working on global switch opportunities, thus offering 

consumers new self-care solutions. 

FROM PRESCRIPTION TO 

SELF-MEDICATION 

A switch is a process whereby a drug, previously available as prescription 

medicine only, is approved as safe and effective for selfmedication 

use without a doctor’s prescription. Switches increase 

access to treatment options, reduce overall healthcare costs and 

can significantly increase the awareness of the respective health 

condition. 

ALESION® JAPAN 

A number of targeted campaigns 

made alesion® one of the best 

OTC launches, surpassing a 

market share of 11% during the 

first season after launch. 

Many consumers want to be responsible 

for their own health and prefer greater 

access to self-medication. In addition, 

undertreatment of many common medical 

conditions is a well-recognised 

public health problem and easing the 

access to necessary drug therapies provides 

improved health outcomes. 

Thus, governments and regulatory authorities 

show an increased willingness 

to make medications more accessible 

and affordable through a switch and to 

avoid unnecessary doctor’s visits and 

healthcare costs. Given the current financial 

constraints and burden combined 

with a rapidly ageing population, 

we see a huge potential to relieve physicians’ 

offices and to unburden the 

healthcare systems by releasing medicines 

from prescription. 

An expert team for switches 

Based on these trends and in alignment 

with its Consumer Health Care (CHC) 

growth strategy, Boeh ringer Ingelheim 

set up a dedicated switch unit. 

The unit is focused on switching medicines 

with expired patents of Boehringer 

Ingelheim, thus offering consumers 

new self-care solutions. 

Furthermore, the unit uses the reputation 

as a leading global over-the-counter 

(OTC) company to become a partner 

of choice. The global strength of CHC 

makes it an attractive partner for other 

companies with switch candidates. 




2 

1 Consumer campaign for the alesion® 

switch in Japan 

2 Health expert campaign of the alesion® 

switch in Japan 

1 

Highlights 2012 

While switches are complex and timeconsuming 

endeavours, and many 

activities are going on around the globe, 

the year 2012 showed some compelling 

success stories. 

ALESION® – new OTC treatment 

option for hayfever in Japan 

After the switch of alesion® 10 (epinastine), 

CHC Japan launched it on to the 

Japanese OTC rhinitis market. alesion® 

10 provides effective relief from hayfever 

symptoms, such as runny nose, with a 

convenient once-a-day dosing. Furthermore 

alesion® 10 causes less drowsiness 

than other products – a key differentiator 

in the market. 

The Japanese team, in cooperation with 

the global Switch team, is working on 

further switch opportunities for the 

Japanese OTC market. 

expert panel (Expert Advisory Committee 

for Prescription-Only Issues) in 2012. 

One is a new mono substance in the indication 

of acute diarrhoea, which will 

strengthen the gastro-intestinal franchise 

of CHC. The other is a combination 

product, which will extend the presence 

in the cough and cold segment to the 

cold and flu sector – a huge and fastgrowing 

market segment. 

Both switches were given approval by 

the German Upper House (Bundesrat) 

to change the law and to complete the 

switch. Both products will offer considerable 

growth opportunities for the 

German self-medication business. Furthermore, 

both options will be launched 

in additional countries. 

EVOLUTION IN 

SWITCHES 

Evolving technology and communication 

capabilities will help to 

support self-diagnosis and extend 

self-medication to new areas, including 

selected chronic conditions 

and even symptomless ailments. 

Consumers will in the near future 

combine internet with their own 

records and be able to monitor 

key metrics like blood pressure 

and blood sugar. 

Our switch activities anticipate 

the future, when consumers will 

be able to take responsibility for 

maintaining and improving their 

own health, measure their progress 

and partner with their healthcare 

professional. 

Switch opportunities for Germany 

Two switches were given a positive 

switch recommendation by the German 

From prescription to self-medication 91

“For me, the photo shows that 

the indirect view produces 

more interesting perspectives 

on things and people than a 

sober examination of the facts. 

It brings details to light that 

we would otherwise never have 

discovered.” 

wilhelm von heyking 

head of development coordination 

biberach, germany 

48° 5' 53" N, 9° 47' 19" E 

biberach, germany



#3.3 

BIOPHARMACEUTICALS 

BIOPHARMACEUTICALS – 

MEDICINES FOR THE FUTURE 

Boehringer Ingelheim was a pioneer in the field of biotechnology 

and is now one of the leading companies for the development and 

manufacture of biopharmaceuticals. New biological entities (NBEs) 

and biosimilars are and will continue to be among the main drivers 

of growth in the pharmaceutical industry in the mid to long term. 

1 

2 3 

New biologic entities 

Our Biopharmaceuticals business is 

committed to supporting research and 

development (R&D) of new biological 

entities. 

Biopharmaceuticals is an integral part 

of in-licensing activities and identification 

of potential new products. It continuously 

scouts for innovative process 

and product technologies. These activities 

foster the development of cuttingedge 

NBEs in the respective therapeutic 

areas. 

Boehringer Ingelheim markets the 

four biopharmaceuticals actilyse®, 

metalyse®, imukin® and beromun® 

produced in cell culture or from microbial 

fermentation. 

Boehringer Ingelheim BioXcellence 

We aspire to maintain our position as 

one of the world’s largest contract manufacturers 

of biopharmaceuticals, providing 

the entire production technology 

chain from DNA to fill and finish. We 

have brought 22 new biopharmaceutical 

products (or NBEs) together with our 

customers to the market (i. e. cell-line 

development to registered product). 

The contract manufacturing business of 

Boehringer Ingelheim is now represented 

by its new brand Boehringer Ingelheim 

BioXcellence, which stands for 

excellence, quality and reliability in the 

market. 

Our biosimilars 

In addition, we decided to expand our 

current Biopharmaceuticals business 

for the development and manufacture 

of new and innovative biopharmaceuticals 

into developing biosimilars. 

With our expertise and world-class 

technology, we are well-placed to 

create, develop and manufacture highquality 

biosimilars. 

OUR BIOPHARMACEUTICALS 

NETWORK 

1 fremont, usa 

2 biberach, germany 

3 vienna, austria 

Biopharmaceuticals – medicines for the future 93

2 Disposable single use bioreactor 

with sensors attached that help 

control pH and dissolved oxygen 

during cell culture. 

1 2 

INNOVATION DRIVERS 

IN BIOPHARMACEUTICALS 

Innovation in biopharmaceuticals will not only be driven by new 

products, but by availability of new technologies. Boehringer Ingelheim 

is well-prepared to deliver innovation in biopharmaceuticals by 

provision of innovative products and technologies. 

INNOVATIVE BIOLOGICS 

PRODUCTS 

Looking at the early phase product 

portfolio, antibodies will continue to 

dominate the biologics market. Also 

Scaffolds, antibody fragments and 

more complex antibody-derived molecules 

are also on the increase. We are 

well-prepared to develop and manufacture 

these types of molecules and 

have conducted more than 30 feasibility 

studies in the scaffold area. 

Global disposable network 

Personalised medicine will be far 

more prominent in future, resulting 

in smaller quantities of material and 

leading to flexibility of scale becoming 

a necessity. This is one reason why 

we are establishing a global disposable 

network. 

Experience with disposable systems 

Over the last few years, Biopharmaceuticals 

has been gaining experience with 

disposables and an extensive experience 

dataset has been collated to date. 

Now we have made a commitment to 

set up production facilities using disposable 

systems for biopharmaceuticals 

in both facilities in Biberach, Germany, 

and in Fremont, USA. Here we 

will be able to seamlessly transfer processes 

as we apply the same technology 

at all our sites. 

Disposable systems – high quality 

The quality standards will remain the 

same regardless of whether disposable 

or stainless steel systems are used. Media 

and buffer solutions come into 

contact with the product during the 

process, or even become part of the 

end product. Thus, studies and risk 

analyses are carried out regarding the 

adsorptive and leachable properties of 

the disposable materials used. 

We have shown for a large number of 

processes that the yield, along with the 

product quality and purity of the disposable 

process, match that of a conventional 

process. In future, it is likely 

that disposable systems will be state of 

the art, replacing conventional stainless 

steel-based systems for early clinical 

production. 




4 

3 

1, 3 + 4 With its new equipment and laboratories in 

process development, Boehringer Ingelheim 

provides an expanded service offering for its 

customers along the whole biopharmaceutical 

process chain. Process science laboratories in 

Vienna, Austria. 

New processes and technologies 

High production costs and technical 

difficulties in large-scale production 

led to sophisticated technological developments 

and improvements. This 

fledgling area of biopharmaceuticals 

will also in future be shaped by innovative 

technology developments in 

future. 

Since production titers for standard 

monoclonal antibodies (mAbs) are going 

beyond 4 g/l, which is pushing chromatography 

beyond its physical and economic 

limits, we are working on columnfree 

processes. In addition, the generation 

of new molecule formats and non-mAb 

proteins cause problems in capturing 

with standard affinity materials. 

In column-free processes, large amounts 

of protein are manageable and all kinds 

of biomolecules are feasible as this 

process technique is mainly independent 

of protein design. Automation will also 

play a significant role in this area. 

DATA-DRIVEN DRUG 

DEVELOPMENT 

Through our automation in all areas of 

chemistry, manufacturing and controls 

(CMC) development, we are able to 

better understand the processes. 

High throughput and miniaturised 

assay provide the data to drive early 

decisions, which have a significant 

impact on cost and timelines. This 

now allows us to gain a holistic view 

of biopharmaceutical processes early 

on. The process knowledge is based 

on a much broader data set and allows 

early decisions to be made on 

the right molecule format. 

The realisation of a new purification 

platform process from pre-harvest to 

bulk is the goal based on approved technologies 

such as aqueous two phase extraction 

(ATPE) and controlled precipitation 

and filtration processes. 

Innovation drivers in biopharmaceuticals 

95

“The hard-working bees 

successfully transformed the 

life of the Lotus. It takes 

two to tango.” 

grace wu 

internal communications manager 

taipei city, taiwan 

23° 58' 0" N, 120° 58' 0" E 

taipei city, taiwan



#3.4 

BIOSIMILARS 

BIOSIMILARS – 

PERSPECTIVES FOR PATIENTS 

The proportion of the population over 65 years old is growing across 

the globe. This means that in coming years the demand for high-quality 

medical care will rise, as will treatment costs. At the same time, 

healthcare systems are subject to more stringent cost controls. With 

biosimilars we can help to meet the challenge. 

With more than 30 years of experience 

in biopharmaceutical research and development 

and with a sophisticated 

technological infrastructure, we are 

well-positioned to enter the biosimilars 

market. 

Doing the same in a different way 

A biosimilar is a very close but nonidentical 

re-creation of an approved biological 

medicine that has lost patent 

protection or exclusivity. Biosimilars 

are derived from the same gene sequence 

as the original, but the cell lines and 

process steps differ from one manufacturer 

to another. Unlike generics, a biosimilar 

is not an exact chemical copy, 

but a similar-as-possible re-creation of 

the originator product. 

A patient-orientated pipeline 

The biosimilars pipeline at Boehringer 

Ingelheim is aligned to patients’ needs 

for various indications in which biopharmaceuticals 

play a role. In particular, 

our focus is on monoclonal antibodies 

for oncology and immunology. 

We have three mono clonal antibodies 

in clinical development: adalimumab, 

bevacizumab, and rituximab. 

OUR BIOSIMILARS PIPELINE 

We are currently conducting studies 

in adalimumab (pictured above), 

bevacizumab and rituximab. 

Bringing better health to more people 

Biosimilars create better perspectives 

for patients, and also for physicians and 

for payers in the healthcare sector. They 

offer the same standard of care as the 

originator products, but with a lighter 

burden on healthcare budgets. 

Biosimilars – perspectives for patients 97

“There are many things and experiences 

that can change the perspective of your life. 

One of these, and the most important for 

me, has been my son Biel. This picture makes 

me think about how his perspective of life 

can be, how happy and enthusiastic he is 

with his two and a half years. We should 

all try to keep a little bit of this enthusiasm 

in the course and in the different aspects 

of our lives …” 

roser anglarill lozano 

marketing assistant 

spain 

41° 28' 29" N, 2° 5' 12" E 

sant cugat, spain



#3.5 

PERSPECTIVES IN ANIMAL HEALTH 

COMPREHENSIVE ANIMAL 

HEALTH MANAGEMENT 

Health and nutrition are very important topics for the well-informed 

consumer. Boehringer Ingelheim cares about the modern consumer’s 

requirements. High-quality protein, less residues and adequate animal 

housing are relevant themes which are relevant. 

Sustainable healthcare for pigs 

Animal Health strives to foster the 

health and wellbeing of mankind 

by contributing to an adequate 

supply of safe, nutritious food and 

by promoting the emotional and 

physical benefits arising from the 

human-animal bond. 

Sustainability and holistic health management 

for farm animals is one of the 

perspectives of our Animal Health business. 

“Prevention is better than cure” is 

the central concept in the field of swine 

vaccines. Systematic use of vaccines can 

reduce the use of antibiotics. 

Comprehensive health management is 

thus the key. A combination of several 

measures makes it possible for the 

farmer to keep animals in good condition. 

Close interaction between the 

veterinarian and the farmer is the 

foundation of integrated farm animal 

health management. Regular visits 

and close monitoring of data on housing, 

nutrition and the hygienic situation 

on the farm form the basis, help 

obtain an overview and offer the opportunity 

to intervene in time and before 

illness occurs. 

Highly effective vaccines 

With a wide range of highly effective 

vaccines, our Animal Health business 

addresses a number of threatening respiratory, 

reproductive and enteric diseases 

which can occur on a farm at any 

time. These diseases can be life-threatening 

to pigs and result in economic 

loss for farmers. 

A leading company in chronic care 

In a changing demographic and social 

environment, pets and horses are increasingly 

assuming the role of companions 

and family members. Consequently, 

they are more frequently given 

the best healthcare and treatment, resulting 

in a longer and happier life. We 

have set standards for innovation in 

many areas, for instance in heart failure 

and arthritis in dogs. 

Intensive research activities and stateof-the-art 

technologies form the backbone 

of the Animal Health business. 

In our global R&D centres, researchers 

VACCINE FLASK 

INGELVAC MYCOFLEX® 

The 22nd Congress of the International 

Pig Veterinary Society (IPVS), 

held in South Korea, attracted more 

than 3,000 participants from 60 

countries. Boehringer Ingelheim 

organised a symposium focusing 

on swine respiratory disease. 

A major success was the launch 

of our latest innovation, the 

ingelvac mycoflex® vaccine flask 

Headspace bottle, which has been 

developed to simplify the mixing 

of ingelvac circoflex® and 

ingelvac mycoflex®. Customers 

had the opportunity to see the new 

flask at our booth and experience 

live vaccine mixing themselves. 

Comprehensive animal health management 99

OUR GLOBAL SCIENTIFIC NET WORK 

IN ANIMAL HEALTH 

1 fort dodge, usa 

2 ames, usa 

3 st. joseph, usa 

4 guadalajara, mexico 

5 ingelheim, germany 

6 hannover, germany 

7 tokyo, japan 

8 shanghai, china 

4 

2 

3 

1 

6 

5 

8 

7 

INNOVATIVE VACCINES – 

MILESTONES IN SWINE HEALTH 

This is a selection of the swine 

vaccines with which we inspired 

new perspectives in animal health 

management. 

Healthy animals are the precondition 

for healthy meat. Any contribution 

to the well-being of farm animals is 

therefore also an important contribution 

to consumer protection. 

are working on innovative solutions 

to best serve our customers. Unmet 

medical needs are challenges for the 

researchers and their ambition is to 

find innovative and effective solutions. 

The numbers of newly emerging diseases 

are expected to rise in an increasingly 

globalised economy and due to 

climate change. Timely provision of 

vaccines in response to these diseases 

will be a key factor in keeping animals, 

and thereby humans, healthy. 

Global manufacturing – focus 

on reliable supply 

Close cooperation between our Operations 

and Research and Development is 

crucial in the supply chain. It usually 

takes 180 days to produce a vaccine 

product. As diseases and epidemics occur 

in waves, it is important to maintain 

delivery at all times and have sufficient 

capacity to react quickly. Our goal is a 

reliable supply situation to be achieved 

in several stages. 

This year, we enlarged capacities in our 

Animal Health business. Acquisition of a 

production facility for vaccines in Weesp, 

the Netherlands, provides higher flexibility 

for manufacturing in Europe. We 

also invested at our other international 

manufacturing sites, in state-of-the-art 

technology contributing to the needs of 

our global, successful business. 




ANIMAL HEALTH GLOBAL R&D – 

SEARCH FOR LEADING SOLUTIONS 

In our global R&D centres, colleagues are 

working on innovative solutions to serve our 

customers best. 

FRONT LINE RESEARCH 

Teams of scientists from all over the world conduct advanced 

level research at eight major R&D centres to preserve and improve 

the health of animals. 

High investment rate in R&D 

Approximately 450 scientists and 

support staff in R&D worked in the 

Animal Health area at Boehringer 

Ingelheim. This business continually 

invests 11% of its revenues in R&D, 

which is one of the highest rates in 

the industry. In 2012, this amounted 

to EUR 115 million. 

Vaccines and chronic care 

the focus of R&D 

R&D at Animal Health focuses on two 

main areas: improved vaccines for the 

prevention of infectious diseases in all 

species and development of treatments 

for chronic diseases in companion animals. 

While the former aims at preventing 

disease and suffering in all animals, 

the latter has the goal of improving the 

quality of life and enhancing the humananimal 

bond. In 2012, two major milestones 

were reached in treating epilepsy 

and chronic renal diseases in companion 

animals. 

Epilepsy in dogs 

Epilepsy is a common disease in dogs 

and occurs frequently in the first year 

of life. The disease leads to the animal 

having seizures (whole body cramps) 

and is highly stressful for the animal 

and its owner. Previously, only few 

treatment options were available and 

for many decades veterinarians have 

used phenobarbital and potassium 

bromide to reduce the number of seizures. 

EUR 115m 

Boehringer Ingelheim Animal 

Health continually invests 11% 

of its revenues in R&D, which is 

one of the highest rates in the industry. 

In 2012, this amounted 

to EUR 115 million. 

Front line research 101

2 3 

1 Scientists in Hannover working in the laboratories 

of the new Boehringer Ingelheim Veterinary R&D 

centre. 

2 Epilepsy is a common disease in dogs and occurs 

frequently in the first year of life. 

3 Chronic kidney disease is a frequent diagnosis 

in aging cats. 

1 

INNOVATION – FROM THE IDEA 

TO THE FINAL PRODUCT 

At all R&D centres, we conduct 

vaccine research and development, 

from the idea to the final 

product and marketing authorisation, 

using the latest technology. 

Many of our R&D centres are near 

academic research institutions 

and close cooperation between 

academic or biotech basic research, 

on the one hand, and applied 

drug development at Animal 

Health, on the other, has proven 

to be the most efficient way of 

bringing innovation to the veterinarian 

and the animal owner. 

While these treatments lead to the desired 

reduction in events, the drugs are 

associated with a number of unwanted 

effects, including tiredness and negative 

effects on the liver. Animal Health has 

recently obtained approval for a novel 

treatment (imepitoin), which reduces 

the number of events, while having a 

significantly improved safety profile. 

This active ingredient binds to a different 

receptor than the currently approved 

treatments and thus has a different 

mode of action. 

Kidney disease in cats 

Chronic kidney disease in cats is a frequent 

diagnosis in ageing cats. In many 

cases, this disease is associated with 

fatigue and a reduced quality of life in 

the affected animals. A hallmark of 

this disease is that the kidneys become 

leaky and excrete proteins that are 

normally not found in the urine. 

In addition, this disease is often associated 

with a high blood pressure in 

these animals, which contributes to 

the progression of the disease. In many 

cases, animals die from the long-term 

effects of this disease. We have recently 

obtained the approval for a novel 

treatment (telmisartan) to reduce the 

protein leakage in the kidneys. 

This drug belongs to a class that is new 

to veterinary medicine, but has been 

one of the first line options in humans 

for treating high blood pressure and 

some forms of kidney disease. These 

angiotensin receptor antagonists prevent 

the detrimental effect of angiotensin 

II on cells by selectively blocking 

its binding to one of the receptors. 

Preventing disease with vaccines 

Vaccination against infectious diseases 

is one of the most effective measures to 

maintain the health of livestock and 

companion animals. Boehringer Ingelheim 

has a global network of vaccine 

R&D and manufacturing sites to serve 

global as well as regional needs. 

This includes US sites in the Midwest 

(Missouri and Iowa). In Hannover, Ger- 




4 Scientific work in the lab requires 

patience and care. 

5 Modern technology in the labs is 

essential to perform high level 

science. 

5 

4 

many, Boehringer Ingelheim invested 

more than EUR 40 million in a new research 

and development for vaccines. 

Supply of safe and healthy food is also 

gaining in importance in Asia, especially 

in China. 

We have therefore opened the Asian 

Veterinary R&D centre in Shanghai, 

China, where by the end of 2012 more 

than 30 scientists were working on improved 

vaccines for China and Southeast 

Asia. Finally, R&D centres in Guadalajara, 

Mexico, and Tokyo, Japan, also 

contribute to our global R&D activities 

and ensure access to the important markets 

of Latin America and Japan. 

ANIMAL HEALTH CENTRES OF EXCELLENCE 

While Boehringer Ingelheim 

Animal Health R&D centres 

in all regions conduct vaccine 

research as well as 

clinical and product development, 

a network of centres 

of excellence ensures 

accessibility to special 

technology for the entire 

R&D organisation. 

These centres include genomics 

(Ames), immunology 

(Hannover), tolerability 

acceptance studies (St 

Joseph) and pharmaceutical 

product development 

(Ingelheim). 

Front line research 

103

“Living and working on a different 

continent is certainly a challenge, 

but it offers many opportunities at 

the same time.” 

elisabeth kamphuis 

head of r&d 

guadalajara, mexico 

“I enjoy working for a leading 

company in the animal health 

business and in an excellent 

global team.” 

jiang haifeng 

business development 

manager, shanghai, china 

GLOBAL PERSPECTIVES IN 

ANIMAL HEALTH 

Having the right people in the right place and position is a key 

success factor for a leading company. Boehringer Ingelheim Animal 

Health offers chances for those looking for exciting professional 

careers in a successfully growing international business. Working 

with people from many nations is great fun and offers good potential 

for learning. 

Flexibility 

An international career is one of the 

desired goals university graduates 

strive for. Within Animal Health, colleagues 

obtain the chance to gain experience 

working in projects in another 

country. Several options offer 

shorter or longer work experience in 

one of the countries in which we have 

sites. 

Edgar Sandoval from Mexico, gaining 

international experience in St Joseph, 

Missouri, USA, says: “It is rewarding 

for me to contribute to the success of 

our Animal Health business and be 

part of a great team.” 

Responsibility 

From the beginning, colleagues are 

trained to take over responsibility for 

their projects and, at times, a team. 

Elisabeth Kamphuis, Head of R&D 

in Guadalajara, explains: “Since June 

2012, I have been working in Guadalajara, 

Mexico. In my new position, I can 

move things forward for my team as 

well as for the whole operating unit. 

I can bring in my professional experience 

and knowledge of the field. It is 

very exciting and pleasant to implement 

changes and also to see them 

bear fruits of it.” 

Aspiration 

Of course, we need to adapt to changing 

working environments and market 

situations, but we offer interesting opportunities 

to those who are interested. 

“I worked for other international organisations 

before,” says Jiang Haifeng, 

Business Development Manager at 

Boehringer Ingelheim China. “My superior 

works at Corporate Headquarters 

in Ingelheim, Germany, and I am 

based in Shanghai, China. My projects 




“I especially value the opportunity 

to work on real products that will 

bring benefit to our customers.” 

yali zhang 

bioprocess development 

manager, shanghai, china 

“My incorporation to the US 

operations team has allowed me 

to grow professionally by being 

part of major projects, like the 

Fort Dodge technology transfer.” 

edgar sandoval 

group leader 

st joseph, usa 

are progressing very well though, as we 

have frequent review video meetings 

on my work progress, in addition to occasional 

meetings in person. Excellent 

supervising and coaching is critical for 

me to be able to contribute to the success 

of our business and to achieve my 

professional goals.” 

Networking 

Internal development programmes offer 

ample opportunities for ambitious 

colleagues to get to know the company 

well and develop their talent and personality. 

Short- or mid-term exchange 

programmes are a fruitful opportunity 

to work in different teams and cultures, 

which is perceived as highly rewarding. 

Future leaders need to know as much as 

possible about the company before they 

take up a position where they assume 

responsibility for important projects 

and people alike. 

The real experience 

From the beginning, young employees 

work in projects which are part of the 

regular business plan. They are involved 

in the business cycle, according 

to the position they obtain. Yali Zhang, 

Bioprocess Development Manager in 

Shanghai, states: “Here at the Asian Veterinary 

Research and Development 

Centre, we are researching and developing 

vaccine solutions for the Asian 

countries. I especially value the opportunity 

to work on real products that will 

bring benefit to our customers.” 

3,100 

EMPLOYEES WORLDWIDE 

worked in Boehringer Ingelheim’s 

Animal Health business in 2012. 

Global perspectives in Animal Health 105

1 Phoenix, the first captive-bred 

Oriental White Back Vulture. 

2 Jürgen Dämmgen and the team 

visiting an Indian village. 

1 

2 

A FUTURE FOR 

VULTURES IN INDIA 

Millions of vultures used to be part of the fabric of India, just like 

rickshaws, fakirs and the Taj Mahal. In the late 1990s, ornithologists 

started to discover that vultures were dying with no obvious cause and 

raised the first alarm bells. Jürgen Dämmgen is Boehringer Ingelheim 

Animal Health’s ambassador for coordinating the company’s support. 

CHEMICAL STRUCTURE 

OF MELOXICAM 

Meloxicam, the active ingredient 

of metacam © , is a nonsteroidal 

anti-inflammatory drug (NSAID). 

Its chemical structure and biological 

characteristics are different 

from diclofenac. 

What consequence did the dying 

vultures have for India 

jürgen dämmgen: For religious 

reasons, cows are sacred creatures in 

India. That is the reason why cattle having 

died in old age sanctuaries (panjarapoles) 

are disposed of carcass dumps, 

where they used to be eaten by carioneating 

vultures. Meanwhile, this role of 

vultures has been partly taken over by a 

rising number of feral dogs, increasing 

the risk for humans of being attacked 

and infected with rabies. Since 2007, 

Boehringer Ingelheim Animal Health 

has been supporting an initiative that is 

trying to help improve the situation. 

Has the root cause for this 

catastrophy been discovered 

jürgen dämmgen: After a frustrating 

initial search for infectious agents, 

a groundbreaking discovery was made 

by detecting residues of diclofenac, the 

well-known nonsteroidal anti-inflammatory 

drug (NSAID), in cattle carcasses. 

This drug turned out to be extremely 

toxic for vultures. 




VULTURE SAFE ZONES 

1 corbett 

2 dudhwa 

3 nepal 

4 jharkhand 

5 assam 

6 madhya prades 

7 maharashtra 

8 gujarat 

8 

7 

1 

6 

2 

3 

4 

5 

3 4 

3 Ornithologist Richard Cuthbert collecting vulture 

nestlings in India. 

4 Schoolchildren in the countryside learn more about 

the role of vultures in Indian culture and how to protect 

them by means of entertaining puppet shows. 

Many children had never been in contact with vultures 

before. Moreover, children could take home 

the message and share this with their parents. 

Several vulture safe zones are being established in 

India and Nepal. 

Which measures have been taken 

jürgen dämmgen: Quickly, this 

observation resulted in a ban of the use 

of diclofenac in veterinary medicine in 

the Indian subcontinent. metacam® 

(meloxicam) was iden tified as a replacement 

for di clofenac. Boehringer Ingelheim 

helped the situation by dropping 

its patent rights for injectable metacam® 

(meloxicam) in India. 

In addition, we started an information 

and awareness campaign together with 

the British Royal Society for the Protection 

of Birds and the Bombay Natural 

History Society, visiting pharmaceutical 

production sites in India. Today, meloxicam 

is the leading anti-inflammatory 

drug for cattle in India. 

What is the long-term perspective 

of the engagement 

jürgen dämmgen: Animal Health 

has committed itself to helping by providing 

both financial and technical 

support. Currently, it is sponsoring a 

captive breeding programme to reestablish 

a viable population of vultures in 

the future as well as creating vulture 

safe zones, allowing these animals to 

live without the risk of being poisoned 

by diclofenac. 

PROJECT PARTNERS: 

CAPTIVE BREEDING STATION 

Every day, the scientists are excited 

about what is happening with 

the baby vultures being raised in 

Pinjore, one of four captive breeding 

centres in India. Techniques 

and methods for breeding had to 

be established from scratch. 

boehringer ingelheim 

animal health 

rspb royal society for 

the protection of birds 

A future for vultures in India 107

55° 21' 0" N, 131° 40' 24" W 

ketchikan, alaska


perspectives for quality in operations 



scott zhang 

strategic effectiveness analyst 

burlington, canada 

55° 21' 0" N, 131° 40' 24" W 

ketchikan, alaska

perspectives for quality in operations


QUALITY IN OPERATIONS 

Operations at Boehringer Ingelheim ensure that patients can rely 

on receiving high quality medicines. 

From simple precursors and intermediates handling through 

manufacturing the active pharmaceutical ingredient and producing 

and delivering the final drug product, it is the responsibility of 

operations to ensure a smooth process. 

INVESTMENT IN GERMANY 

[ respimat® production ] 

SECURE SUPPLY CHAINS 

[ third-party management ] 

163m 

3PM 

[ eur ] 

We invest EUR 163m to increase and 

double capacity of the respimat® to 

44 million packaging units by 2015. 

The Third Party Management (3PM) network 

currently includes more than a hundred 

contract manufacturing organisations on 

different continents. It is essential for 

analysing and securing Boehringer Ingelheim’s 

supply chains. 




contents 

112 MANAGING QUALITY 

114 SECURE SUPPLY CHAINS GUARANTEED 

INVESTMENT IN THE USA 

[ high containment operations ] 


[ supply chain integrity ] 

50m 

SCI 

[ usd ] 

In Columbus USD 50m were invested 

in a state-of-the-art facility for the 

development and manufacturing of 

oncology and other high-potency 

products. 

To ensure secure supply of safe 

medicines we have integrated the 

supply chain integrity (SCI) initiative 

into our supply chain strategy. 

Perspectives for quality in operations 

111

With the quality risk management system, certain 

processes, such as production or packaging processes 

(here: technical testing of empty pradaxa® capsules 

using an optical length gauge), are evaluated, thereby 

ensuring their robustness and quality. 

MANAGING QUALITY 

As Operations at Boehringer Ingelheim has to ensure every day 

that patients can count on receiving high quality medicine. 

In 2012, the focus was on risk and compliance management. 

PERFECTION AIM FOR ALL 

PRODUCTS 

The Operations network is responsible 

for global supply of 

Boehringer Ingelheim products. 

This requires knowledge of manufacturing 

flexibility and the local 

requirements of each region. In 

its “Launch Excellence initiative”, 

Boehringer Ingelheim is seeking 

continuous expansion and implementation 

of robust manufacturing 

processes with special focus 

on the quality engineered into the 

products and processes. 

The highest standards demanded by the 

medicine authorities worldwide form 

the essential working basis in the research, 

development and manu facture 

of medicines. In 2012, we implemented 

a series of quality initiatives on different 

topics. In the area of risk management, 

we continually improve our processes 

and reduce risk accompanying the 

business. For this reason, a quality risk 

management system was developed that 

can be deployed at Operations sites. 

Process evaluation 

With the quality risk management system, 

certain processes, such as production 

or packaging processes, are evaluated, 

thereby ensuring their robustness 

and quality. Furthermore, each site is 

subjected to risk analysis. 

The project initiative in 2012 evaluated 

whole business processes in departments, 

cross-functionally between departments, 

or for the overall production 

site. Managing and evaluating risk on 

this business process level means to 

mitigate and control identified risks. 

Together with managerial review, this 

ensures that a high quality level can be 

supported and guaranteed long-term. 

This combination of several management 

elements then becomes a quality 

system. 

Focus on compliance management 

As we are committed to ensuring patient 

and product protection, we integrate 

brand protection and other services 

for our patients into our business 

model. 

Looking at the end-to-end supply chain, 

from the starting materials to the final 

medicinal product in the hands of the 

patient, compliance management plays 

a pivotal role and is receiving increasingly 

more focus. Consequently, as a 

global cooperation we focus on compli- 




2 

1 

1 The site at Columbus, Ohio (USA), was expanded in 2012 and 

money was invested in its high-containment operations to include 

a new, state-of-the-art facility for the development and 

manufacture of oncology and other high-potency products. 

2 Increased patient needs are raising demand for the respimat® 

Soft Mist Inhaler. 

ance along the entire chain from development 

and sourcing to manufacturing 

and distribution of our medications. 

As compliance hurdles worldwide continue 

to evolve, all products have to 

pass not only all levels of our existing 

quality standards, but also anticipated 

future requirements. Our goal is to 

continuously analyse and improve 

our end-to-end processes. Any topic 

affecting or compromising our quality 

or reliability along the medicinal 

product chain will be subject to receive 

rigorous scrutiny. 

INVESTING IN INNOVATION 

New market launches in our respiratory 

portfolio and increased patient 

needs are raising demand for 

the respimat® Soft Mist Inhaler. 

We will therefore invest EUR 163m 

to increase and double capacity 

to 44m packing units by 2015. 

The inhaler system is manufactured 

at Boehringer Ingelheim 

microParts GmbH in Dortmund, 

Germany, and the cartridges with 

the active ingredient at the Ingelheim 

site. Production planning 

in Dortmund was adapted to the 

required capacity and additional 

resources created in 2012. Furthermore, 

new employees were 

hired and trained. 

The site at Columbus, Ohio (USA), 

was also expanded in 2012 and 

USD 50m was invested in its highcontainment 

operations (HCO) to 

include a state-of-the-art facility 

for the development and manufacture 

of oncology and other 

high-potency products. 

The new capacity includes product 

and analytical development areas, 

quality control laboratories, active 

pharmaceutical ingredient filling, 

manufacturing and packaging 

units and a finished goods warehouse. 

A unidirectional work flow 

and state-of-the-art containment 

avoidance technology means reduced 

possibility for cross-contamination. 

In addition, the manufacturing 

suites are designed for 

flexibility and quick changeovers. 

In Columbus, Boehringer Ingelheim 

manufactures a broad range 

of products. Through investment, 

global capacity for handling and 

manufacturing potent compounds 

is increasing, thereby making the 

Columbus site into a HCO center 

of excellence for the global Boehringer 

Ingelheim network. 

Thanks to the new HCO facility 

and the cutting-edge technologies 

employed, we will also be in a position 

in the future to continually 

broaden its product portfolio in 

order to offer even more highgrade 

and affordable medicines. 

Small and large-scale manufacturing 

capacitities support both 

clinical provision and commercial 

production, and will enable us to 

take timely advantage of future 

market opportunities. 

Managing quality 113

In order to ensure patient safety, it is crucial that 

Boehringer Ingelheim knows and controls all 

products that pass through its supply chains. 


GUARANTEED 

One of the greatest challenges for the healthcare system is ensuring 

the supply of secure or counterfeit-proof medicines. For this reason, 

Boehringer Ingelheim has integrated the initiative Supply Chain 

Integrity (SCI) as an important cornerstone in its operational supply 

chain strategy. 

MINIMISING RISK 

Transparent, end-to-end supply 

chains – from feedstock to medicine 

supply to patients – provide 

a better understanding of the 

risks, as well as their minimisation, 

and enable rapid, determined 

intervention. Current industry 

standards for inspecting 

product authenticity are based on 

mass serialisation combined with 

original seal technology. 

Third Party Management Group 

To be successful as a company, all participants 

in the supply chain have to 

work together – from sourcing to sales. 

Boehringer Ingelheim takes extensive 

precautions to analyse and secure its 

supply chain, irrespective of whether it 

concerns contract manufacturers, externally 

or internally produced products 

(see box, right). 

A good example is Boehringer Ingelheim’s 

Third Party Management Group 

(3PM). This monitors a network of 

contract manufacturing organisations 

(CMOs) and for patients worldwide ensures 

a reliable and competitive supply 

of prescription medicines and over-thecounter 

medications for patients worldwide. 

The 3PM network currently includes 

more than one hundred CMOs 

on different continents. 

Continuous development of the 3PM 

network supports operational strategies 

at many levels. It eliminates unrewarded 

complexity, optimises the risk profile 

and improves the overall competitiveness 

and robustness of the supply 

chain. It develops tailor-made solutions 

for production and supply activities for 

overcoming barriers to market access 

and identifies new geopolitical developments 

and takes them into consideration. 

It seeks flexible openings for new 

business opportunities, either within 

the existing 3PM network or by deliberately 

including new CMOs. 

The regional operational 3PM units 

ensure that Boehringer Ingelheim 

standards for supply chain integrity are 

implemented for every CMO in the network. 

This is achieved by means of a 




VALUE AND DISTRIBUTION CHAIN 

[ chemical synthesis ] [ pharmaceutical production ] [ distribution ] 

starting 

material 

final 

api 

tablet/ 

capsule 

packaging 

transportation 

distribution 

market place/ 

customer 

quality assurance agreement in which 

we stipulate our expectations regarding 

the supply chain transparency of CMOs, 

supplier management standards and 

measures to safeguard against counterfeiting. 

CMO approval process 

An additional Boehringer Ingelheim 

monitoring function for securing continuous 

regulatory, legal and financial 

compliance for the 3PM network is the 

CMO approval process. The process is 

used for every CMO that is to join and 

includes, for example, qualification audits 

on site and thorough and detailed 

assessment of the supply chain. 

An example of a special SCI initiative 

that has already been implemented at 

one of our most important CMOs is 

based on the serialising and aggregation 

requirements recently issued by 

the Chinese authorities. A tailor-made 

IT solution, as well as alterations to the 

CMO’s packaging system, delivers an 

unambiguous identification number 

for every packaging unit that is supplied 

to the Chinese market and enables 

inspection for counterfeiting. 

External partners, such as customs or 

other authorities, can also take part in 

the extensive investigations of divergences 

that lead to impairment of supply 

chain integrity. This allows improvement 

at the weak points in the 

process chain and criminal offences can 

be selectively pursued. Only through 

transparency in communication and 

the exchange of best practices with internal 

and external stakeholders is it 

possible to create an environment for a 

more secure supply of medicines. 

SAFE MEDICINES IN FOCUS 

Authorities worldwide regularly 

issue updates to their regulations. 

Currently, the secure supply of 

medicines is centre stage. From 

pharmaceutical manufacturers, 

the authorities demand that they 

know and control the products 

that pass through their supply 

chains in order to ensure patient 

safety. 

Boehringer Ingelheim is also improving 

the integrity of its supply 

chain. The system embraces all 

processes that are required for ensuring 

supply chain integrity, such 

as global supplier management, 

relevant internal and external production 

processes, global sales 

management, protection against 

counterfeiting, serialisation and 

supply chain risk management 

and transparency. 

Secure supply chains guaranteed 115

37° 34' 48" N, 14° 16' 34" E 

sicily, italy

esearch our markets 

& development 

perspectives for medical established innovation markets 



37° 34' 48" N, 14° 16' 34" E 

sicily, italy 

dr hansjörg hagels 

head of phyto center 

ingelheim, germany


perspectives for medical established innovation markets


ESTABLISHED MARKETS 

In contrast to emerging markets, mature markets are showing 

modest economic growth or stagnation. Their industry has to 

a great extent matured. 

Healthcare systems are also undergoing change, primarily due 

to aging populations that are increasingly dependent on innovative 

medicines. At the same time, cost savings must be made. 

Increasing pressure on prices and market access difficulties 

for medicines present challenges for the research-driven 

pharmaceutical companies in particular. 

BOEHRINGER INGELHEIM IN GERMANY 


BOEHRINGER INGELHEIM IN GREECE 


13,103 45 

Boehringer Ingelheim has 13,103 

employees (mean headcount 2012) 

in Germany. 

Boehringer Ingelheim’s Greek 

pro duction site produces for 

export to over 45 countries. 


our markets 

perspectives for established markets 

contents 

120 EUROPE – MARKETS IN TRANSITION 

124 USA – FUNDAMENTAL REFORMS 

126 JAPAN – HEALTHCARE FINANCING UNCLEAR 

BOEHRINGER INGELHEIM IN THE USA 


BOEHRINGER INGELHEIM IN JAPAN 


10,855 2.11bn 

[ eur ] 

In the USA Boehringer Ingelheim 

has 10,855 employees 

(mean headcount 2012). 

Boehringer Ingelheim has had sales in 

Japan of EUR 2,11 bn. 

Perspectives for established markets 

119

Spain is one of the countries struck by the debt crisis. 

Not only are all administration levels in debt – communities, 

regional authorities, central government – but 

also the bulk of private households. Public sector cost 

cuts have also had an impact on healthcare spending. 

EUROPE – MARKETS IN 

TRANSITION 

Europe is a region of diverse significance for Boehringer Ingelheim, 

with the corporate headquarters in Germany and important research, 

development and manufacturing centres in the region. In addition, 

Europe makes a significant contribution to company turnover in 

Prescription Medicines. 

But markets are currently changing. 

Due to the economic and financial crisis, 

the states of Europe are under enormous 

pressure to reform. In order to reduce 

new indebtedness, or bring down 

accumulated debt, countries are also 

having to lower their expenditure. This 

pressure to consolidate, which is burdening 

many European countries, leads 

to savings in public sector budgets, also 

including spending on healthcare. The 

costs are rising steadily, not least due to 

demographic change. The saving measures 

have an immediate impact on 

the market situation for medicines that 

qualify for reimbursement. 

The effects are varied: 

• Market access for new medicines has 

become discernibly more difficult. 

New medicines are frequently taken 

up by European states only after 

long delays, even though they can 

demonstrate distinct clinical advantages 

and cost-effectiveness. 

• In the course of cost reduction measures, 

prices for prescription medicines 

qualifying for reimbursement 

are lowered in many countries. These 

price cuts are, as a rule, unilateral 

political decisions in which a company 

has no influence. 

• Many countries determine their prices 

by means of a regular comparison 

with prices in other countries (international 

reference price). In combination 

with the aforementioned 

price cuts, this reference price system 

leads to a downward spiral effect 

for innovative medicine prices 

through extra ordinary cost-containing 

measures. 


our markets 


BOEHRINGER INGELHEIM IN GERMANY 

Boehringer Ingelheim has 

13,103 employees (mean 

headcount 2012) in Germany. 

In 2012, it achieved a turnover 

of EUR 1.03bn. 

The assessment and price formation 

introduced within the 

framework of the German law 

on the reorganisation of the 

pharmaceutical market 

(Arzneimittelmarktneuordnungsgesetz 

– AMNOG) 

presents new challenges for 

the pharmaceutical industry 

and Boehringer Ingelheim in 

Germany. Germany is, nevertheless, 

Boehringer Ingelheim’s 

most important research 

and production location: 46% 

of its worldwide investment 

and 60% of its global research 

expenditure benefits German 

sites – most recently, the expansion 

of respimat® production 

in Dortmund. 

These figures document the 

company’s commitment to 

this location, despite the difficult 

healthcare policy conditions. 

In September 2012, the 

Boehringer Ingelheim Veterinary 

Research Center (BIVRC) 

was inaugurated in Hannover, 

making it the company’s fourth 

German site. 

dortmund 

ingelheim 

hannover 

biberach 

Numerous challenges 

Boehringer Ingelheim faces numerous 

challenges due to this situation. On the 

one hand, it still wishes to offer products 

already introduced in the respective 

markets, despite this difficult environment. 

On the other hand, launches 

of new Boehringer Ingelheim products 

are of the greatest importance. 

The divide must be bridged between 

constructively pursuing savings measures 

in crisis-hit countries and ensuring 

supply for patients in affected countries. 

Frequently, patients receive prescriptions 

for innovative medicines because 

there is no therapeutic alternative. For 

this reason, the pharmaceutical industry 

has where necessary accepted prices 

that are barely economically reasonable. 

The effects of the crisis are particularly 

pronounced in Greece. Beyond what is 

a special situation in the country, all 

other European markets are also undergoing 

transition. Several countries are 

THE SITUATION IN GERMANY 

The significance of Boehringer 

Ingelheim for Germany as a 

location is made clear in a 

new study (WifOR) on the 

pharmaceutical industry as 

an economic factor. In Germany, 

Boehringer Ingelheim 

generates more than 11% of 

the total pharmaceutical value 

added (status 2010) and 

employs almost 10% of the 

pharmaceutical industry’s 

workforce in Germany. Over 

35,000 jobs are either directly 

or indirectly secured by company 

activities. 

Our total tax and social insurance 

contributions amount 

to almost EUR 1.2 billion – a 

significant contribution to 

financing public sector budgets. 

Nearly two thirds of all 

business turnover is generated 

from a high and steadily 

growing export quota that is 

above the average for the 

whole economy. 

Furthermore, Boehringer 

Ingelheim, with its high, aboveaverage 

level of investment, 

supports Germany overall as a 

business location and supports 

it as a location for cutting-edge 

technology with well 

above-average investment in 

research and development. 

Healthcare is already today 

the largest business sector in 

the German economy today, 

with a rising growth trend. Its 

share of the total economy is 

11%. Every seventh employed 

person works in healthcare: 

8.5 million jobs are attributable 

directly or indirectly to 

healthcare. 

Europe – markets in transition 

121

2 

1 View of Athens. 

2 Production site in Koropi, 

Greece. 

1 

increasing regionalisation. For example 

in Italy, and recently also in Spain, 

where the national, regional and even 

local authorities are now also deciding 

to release new medicines for use in particular 

regions or hospitals. 

This can take place via lists of authorised 

medicines (i.e. all medicines that 

doctors may prescribe placed on a list) 

or through medical guidelines which 

dictate when a drug should be used. 

More and more countries, for example 

Germany and Portugal, are turning to 

the method of setting medicine budgets 

for physicians which, if exceeded, 

can have negative economic consequences 

for the physicians. 

Ways to solutions 

Governments and the pharmaceutical 

industry are currently going through a 

phase in which both sides are learning 

to understand the other side in a changing 

environment and are beginning to 

accommodate one another. In several 

countries, for example at a national level 

in Greece and Portugal, or at a regional 

level in Italy and Spain, work is already 

being undertaken to find ways that allow 

both sides to achieve their goals. 

Such solutions can differ totally. 

Agreements between the respective 

payers in healthcare systems and pharmaceutical 

companies are playing a 

growing role. 

For the research-driven pharmaceutical 

industry in Europe, this trend means 

that it is becoming increasingly difficult 

for an innovative substance to reach patients 

after registration, and that this 

process takes longer and longer. 

Agreements on additional services, 

such as promoting preventative 

measures or supporting patient programmes, 

or even public-private joint 

ventures in patient care, make a wholly 

new form of cooperation possible. 


our markets 


BOEHRINGER INGELHEIM IN GREECE 

In spite of the financial crisis and 

the consequent difficult situation 

on the pharmaceutical market, 

Boehringer Ingelheim remains 

com mitted to its Greek production 

site. 

Boehringer Ingelheim Ellas has 

342 employees (mean headcount 

2012) and sales of EUR 100 million. 

It is currently the only international 

pharmaceutical company 

with a manufacturing facility in 

Greece, a fact which reinforces 

the role of the local subsidiary in 

Greek industry. The company’s 

plant produces pharmaceuticals 

for the domestic market, but 

mainly produces for export to over 

45 countries in Eastern Europe, 

the Balkans, Asia, North Africa 

and the Middle East. Income from 

exports amounted to EUR 156 

million in 2012, accounting for 

1% of the Greek gross domestic 

product. 

Investments of EUR 10 million in 

2012 now make it possible that 

also trajenta® can be produced in 

Greece and exported from there. 

Boehringer Ingelheim’s share of 

the Greek exports is therefore 

anticipated to continue to rise. 

Boehringer Ingelheim Ellas 

succeeded in raising its position 

ranking in the domestic pharmaceutical 

market from the 13th 

with a market share of 2.6% 

in 2011 to the 9th position with 

a market share of 3.2% in 2012, 

despite constant healthcare 

reforms and medicine price reductions 

resulting from the government’s 

aim to contain pharmaceutical 

expenditure. 

elliniko 

koropi 

The pharmaceutical industry commands 

many competencies, which go 

beyond researching and developing 

new medicines. Competencies, for example, 

in the field of data analysis, 

further education in medicine, or logistics, 

can be used to modernise and 

improve patient care in the countries 

of Europe through a cooperative approach 

between healthcare systems 

and pharmaceutical companies to the 

benefit of patients. 

THE SITUATION IN GREECE 

The crisis in Greece has made it 

necessary for the Greek state to 

make savings in all areas. And the 

memorandum with the “Troika” 

(the European Commission, the 

International Monetary Fund and 

the European Central Bank) commits 

the Greek government to 

lowering public sector medicine 

expenditure. That is forcing massive 

structural adjustments precisely 

at a time of economic recession. 

The measures arising 

from the pressure to adjust, such 

as price cuts for numerous medicines, 

a formulary that limits the 

number of medicines reimbursed 

by social insurance and a higher 

generics share of the pharmaceutical 

market, are only some of the 

measures having an enormous 

impact on the Greek pharmaceutical 

market. In addition, pharmaceutical 

companies are obliged to 

give clawbacks and rebates, i. e. 

they must return part of their 

sales income to the government, 

if Greek state expenditure on 

medicines exceeds the budget 

foreseen for it. 

These rigid measures and bad 

payments practice in the Greek 

healthcare system – the debts to 

the pharmaceutical industry of 

the EOPYY, the Greek state health 

service, together with those of the 

public sector hospitals, amount to 

more than EUR 2 billion – as well 

as the uncertainty as to the extent 

to which Greece will be in a financial 

position to include innovative 

new medicines in reimbursement, 

create an extremely volatile and 

difficult market environment. 

Europe – markets in transition 123

1 View of San Francisco, the leading financial and cultural 

centre of Northern California. 

2 The increasing diversity in the US population (age, 

ethnicity, technology access/adoption, socioeconomic 

strata) requires targeted solutions and approaches 

to meet specific patient and physician groups’ needs. 

1 2 

USA – FUNDAMENTAL REFORMS 

The USA spends more on healthcare per capita than any other 

developed country, however increasing costs are no longer 

sustainable in the context of the economic challenges and the 

need to significantly reduce the federal deficit. The magnitude 

of the funds to be identified is such that healthcare programmes 

(Medicare, Medicaid) are being targeted for spending cuts in 

addition to other areas, such as defence. 

collaboration between payers, plans 

and providers. With mounting pressure 

from employers and government and a 

growing lower margin in Medicare and 

Medicaid business, the insurance sector 

and healthcare providers are continually 

consolidating to achieve efficiencies, 

and making strategic decisions. 

Definitions are blurring between payers 

and providers as new entities merge 

and emerge. 

PATIENT PROTECTION AND 

AFFORDABLE CARE ACT (ACA) 

The ACA will make significant 

reforms to the healthcare system. 

ACA puts in place comprehensive 

health insurance reforms that will 

roll out over many years. One of 

the primary elements is providing 

coverage to the uninsured due to 

start in 2014. In addition, the 

Medicaid health programme for 

low-income Americans will be 

expanded. The ACA also imposes 

new fees and rebates on the healthcare 

sector (pharmaceutical, health 

plans, hospitals) to fund the expansion 

in coverage. 

Besides insurance coverage, the new 

Affordable Care Act (see left) encourages 

value-based health system delivery 

by providing incentives for healthcare 

providers to form Accountable 

Care Organisations (ACOs), which will 

be incentivised to coordinate care 

across settings, improve quality, prevent 

disease and reduce hospital admissions. 

Unlike the current ‘fee for 

service’ system, organisations with the 

best outcomes will be paid more than 

those that perform poorly on quality 

measures. One of the most fundamental 

changes the law may incent is the 

substantial increase in the levels of 

Enduring implications 

The combination of factors driving significant 

change in the US healthcare 

environment has critical implications 

for the pharmaceutical industry. Recognition 

of the necessity of change, and 

the planning and execution of effective 

strategies to meet the needs of the market 

will define success. Some examples 

of areas of focus are: 

• Increased burden of proof will be required 

for market access. With blockbuster 

medicines losing patent exclusivity, 

there are many generics with 

strong profiles. Payers are seeking 


our markets 


BOEHRINGER INGELHEIM IN THE USA 

Boehringer Ingelheim has 

been represented in the USA 

since 1971. In 2012, the company 

had 10,855 employees 

(average 2012) and turnover 

of EUR 5.55 billion. 

Boehringer Ingelheim Pharmaceuticals, 

Inc., headquartered 

in Ridgefield, Connecticut, 

is the largest US subsidiary. 

Other sites are located in the 

states Ohio, Iowa, Missouri 

and California. Boehringer 

Ingelheim Roxane, Inc., based 

in Columbus, Ohio, is, for 

example, one of Boehringer 

Ingelheim’s production and 

launch sites. 

In Fremont, California, biopharmaceutical 

products have 

been manufactured since 2011. 

The Animal Health business is 

also represented in the USA 

by three sites, St Joseph, Fort 

Dodge and Ames. 

fremont 

fort dodge 

st joseph 

columbus 

ames 

bedford 

ridgefield 

petersburg 

demonstration of value of brands 

versus generic standards of care, 

medical cost savings and defined and 

reproducible health outcomes. 

• Cooperation between payers, plans 

and organised providers will grow in 

importance. New and different groups 

continue to be formed. Diversity in 

the make up and focus of these 

groups will mean that the industry 

will need to be flexible in its approach. 

Different competencies and 

account management skills are being 

developed. 

• The traditional detailing model to 

physicians is facing challenges. Payer 

influence, laws and regulations and 

provider consolidation, have impacted 

traditional detailing models. New 

engagement models with healthcare 

providers are being developed, particularly 

where representative access 

is restricted. 

• Empowered consumers and physicians 

require multi-channel communication, 

decision support and behaviour 

management tools. 

ACCESS, AFFORDABILITY 

AND QUALITY 

US healthcare reform is centred 

on the core issues of access, affordability 

and quality of care. 

Transformation in healthcare to 

meet these needs is dynamic. 

Boehringer Ingelheim is focused 

on the planning and execution 

of effective go-to-market and external 

collaboration strategies, 

adopting new business priorities 

and capturing the current and 

future business opportunities. 

• Personalised medicines, the approach 

of tailoring medicines to the individual, 

is no longer confined to research 

laboratories. The last decade 

has seen an increasing number of 

targeted therapies brought to market, 

improving the predictability of 

outcomes. Boehringer Ingelheim 

will be entering the field of personalised 

medicines in 2013 with entry 

into oncology and with the launch 

of afatinib. 

USA – fundamental reforms 

125

2 

1 

1 View of Tokyo with Japan’s highest mountain, 

Mount Fuji. 

2 A low birthrate and a long life expectancy are 

trends in the Japanese population. 

3 Boehringer Ingelheim in Tokyo 

JAPAN – HEALTHCARE 

FINANCING UNCLEAR 

According to an estimate by the government in Tokyo, Japan’s population 

will undergo enormous contraction and ageing in the coming 

years. Against this background, what the financing of the healthcare 

system will look like in the years ahead remains unclear. 

low birth rate, coupled with long life 

expectancy, hardly any industrialised 

society is ageing as fast as Japan. It is 

forecast that, in 2060, the average age 

will be over 84 for a man and almost 

91 for a woman. 

ADAPTATION OF LIFESTYLE 

The lifestyle of the Japanese is 

adapting increasingly to that of 

western societies. The result is an 

increase in chronic diseases, most 

of all cardiovascular diseases. 

The country currently has 128 million 

inhabitants. In the coming 50 years 

or so, it will, however, lose a third of 

its population, according to estimates 

by the Japanese Social Affairs Ministry. 

As a share of the total population, 

Japanese people over 65 years of age 

will by then have almost doubled to 

40%, while the under 15s will have 

more than halved, amounting to almost 

eight million. 

It is presumed that the low birth rate 

of 1.39 children per couple will fall to 

an average of 1.35 by 2060. Due to its 

Financing of the healthcare system 

The health insurance administration 

sees itself confronted by a deficit in 

order to be able to treat increasing 

numbers of patients with Alzheimer’s 

disease, cancer and lifestyle diseases, 

such as diabetes and cardiovascular 

diseases. The healthcare deficit, especially 

for the elderly, is particularly 

large as it generally has higher medical 

expenditure. Overall reform of the 

system is now under discussion. The 

key focus has been on the balance between 

cost reduction and retaining 

continuous provision of high quality 

medical services. 


our markets 


BOEHRINGER INGELHEIM IN JAPAN 

In Japan, the company has a 

total of 2,652 employees (mean 

headcount 2012). In the 2012 

financial year, total turn over of 

EUR 2.11 billion was generated 

in the country. 

As a result of the accelerated 

registration process, pradaxa® 

(brand name in Japan prazaxa®) 

was launched on the Japanese 

market in 2011, a year earlier 

than expected. trajenta® (trazenta®) 

was also introduced in 

2011. 

Japan is the largest market for 

micardis® in the Boehringer 

Ingelheim group of companies. 

The product has been marketed 

for over ten years in cooperation 

with the company Astellas. 

Cooperations between western 

and Japanese companies are 

much favoured and widespread. 

Japanese companies are thereby 

able to improve access to western 

innovations, while the western 

companies receive valuable 

support on the Japanese market. 

yamagata 

3 

kobe 

tokyo and narita 

Promotion of generics 

Japan has traditionally been a pharmaceutical 

market with limited generic 

penetration (around 20%). This is 

mainly attributable to the loyalty of 

the Japanese to branded medicines. 

In order to reduce state healthcare expenditure, 

generics are projected to 

account for a 30% share of the total 

market for prescription medicines in 

the coming years. 

The Japanese pharmaceutical market 

nevertheless remains attractive for innovative 

products and is expected to 

continue to grow. In 2010, the Chuikyo 

(Japan’s Central Social Insurance 

Medical Council) on a test basis introduced 

a form of incentive scheme for 

patent-protected products. Products 

that still have no generic equivalent 

on the market are exempted from the 

usual biannual price reductions. This 

leads to prices on the Japanese pharmaceutical 

market being quite stable 

compared with the trends in western 

countries. 

In order to remove the drug lag, i. e. 

the delayed registration of innovative 

medicines on the Japanese market 

which has lasted for years, various initiatives 

have been taken. In the past, 

the Japanese authorities demanded 

extensive clinical data from participants 

in studies in Japan. The cost was 

in part excessively high for pharmaceutical 

companies and the Japanese 

market was denied innovations on occasions 

as a consequence. This situation 

has improved somewhat in the 

meantime. Data are generated in western 

populations now also more readily 

accepted in Japan. 

THERAPEUTIC AREAS 

The medicines with the largest 

turnover on the Japanese pharmaceutical 

market are drugs to treat 

for cardiovascular diseases. In 

second place are alimentary and 

metabolic drugs. 

Japan – healthcare financing unclear 127

IF YOU HAVE ANY QUERIES OR COMMENTS, 

PLEASE CONTACT US. 

Boehringer Ingelheim GmbH 

Binger Strasse 173 

55216 Ingelheim 

Germany 

Telephone + 49 6132 77-0 

Fax + 49 6132 72-3000 

Contact 

Corporate Division Communications 

E-mail webmaster@boehringer-ingelheim.com 

Internet www.boehringer-ingelheim.com 

Issued by 

Boehringer Ingelheim GmbH 

Design and layout 

mpm · Corporate Communication Solutions 

www.digitalagentur-mpm.de 

Photos 

dieth + schröder Fotografie (p. 6, 30) 

dpa Picture-Allianz GmbH (p. 126), Fotolia (p. 55, 77, 124), Getty Images (p. 58, 82, 93, 120, 122, 126), 

iStockphoto (p. 102), plainpicture (p. 114, 120), Sciencephoto (p. 29, 52, 67, 97) 

Printed by 

Süddeutsche Verlagsgesellschaft, Ulm 

Copyright 

© 

Boehringer Ingelheim GmbH, 2013 

All rights reserved. No part of this Annual Report 2012 may be reproduced or transmitted 

in any form or by any means, electronic or photocopy, without permission in writing from 

Boehringer Ingelheim GmbH. Figures from third parties used in the annual report are based 

on data available at the time the financial statement was drawn up.

www.boehringer-ingelheim.com 

annualreport.boehringer-ingelheim.com

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