GSK Annual Report 2002

Product approvals
Country/Region
Product (Approval Date) Description
Description of business GlaxoSmithKline 19
In 2002, approvals were received for a number of new products, including several significant new indications and formulations for existing
products, as summarised in the table below.
Augmentin XR USA (October) extended release formulation of amoxicillin (a beta-lactam antibiotic)
and clavulanate (a beta lactamase inhibitor) for adult respiratory tract
infections
Avandamet USA (October) fixed dose combination of Avandia and metformin for type 2 diabetes
Avodart USA (October) 2 year data on dutasteride, a 5-alpha reductase inhibitor for the
treatment of benign prostatic hypertrophy (BPH)
Avodart Europe (July) dutasteride, for the treatment of BPH
Epivir USA (October) once daily dosing with lamivudine, a reverse transcriptase inhibitor, for
HIV
Flixotide Europe (October) lower age limit for fluticasone, an inhaled corticosteroid for asthma
Flonase USA (May) intranasal fluticasone for nasal symptoms
Flutide Japan (October) fluticasone in a CFC-free inhaler
Lotronex USA (June) reintroduction of alosetron for irritable bowel syndrome (IBS)
Paxil CR USA (February) paroxetine, a selective serotonin re-uptake inhibitor for panic disorder
Pediarix USA (December) combined diphtheria, tetanus, pertussis, hepatitis B and polio vaccine
for children
Serevent Diskus USA (March) dry powder formulation of salmeterol (a long-acting beta blocker) for
COPD
Serevent MDI and Diskus Japan (April) salmeterol in both metered dose and dry powder inhalers for asthma
Sultanol Diskus Japan (March) the short-acting beta blocker salbutamol in a dry powder device for
asthma
Twinrix 2 dose Europe (September) combined vaccine for hepatitis A and B
Valtrex USA (September) valaciclovir, a DNA polymerase inhibitor for the treatment of cold sores
Wellbutrin SR USA (June) additional strength of bupropion for depression
Zovirax cream USA (December) aciclovir, a DNA polymerase inhibitor for the treatment of cold sores
Zyloric tablets Japan (March) allopurinol, a xanthine-oxidase inhibitor, for the treatment of gout
R&D Processes – Discovery, Commercialisation & Delivery
Genetics
Research
Discovery
Research
Intellectual property
validated targets
and leads
Centres
of Excellence
for Drug Discovery
"CEDDs"
Pre-clinical
Development
New Product
Development
Drugs Products
New
Medicines
of Proven
Value
R&D processes
In line with GlaxoSmithKline's strategic intent to become the
indisputable leader in the industry, R&D has set itself the goal of
becoming the industry’s most productive R&D organisation. Steps
to achieve this have included initiatives to both reduce the time
taken in all phases of the discovery and development chain; and
also to gain earlier understanding of candidate molecules,
increasing the probability of making a new medicine available to
treat patients as soon as possible.
R&D measures this productivity not just by the number and
innovation of the products it creates, but also by the
commercial value of the product's ability to address the unmet
needs of healthcare customers including patients, healthcare
professionals, budget holders and regulators; each with their
own perspective on what constitutes a valuable new product.
R&D is now positioned to ensure that it generates the right
safety, efficacy and quality information to respond to these
different perspectives through data demonstrating the overall
social benefits of the new medicine; increased length or quality
of life, and increased workplace productivity.
One of the historical contradictions in the pharmaceutical
industry has been the need to lever the advantages of a large
organisation without losing the creative spirit of the research
environment. In GlaxoSmithKline, R&D has been structured to
balance the areas that benefit from large scale with those that
take advantage of being small to enhance their productivity.
The key areas that benefit from being large are those that are
capital intensive or high throughput activities such as
compound screening; those that require scarce skills; and
those that are highly regulated, mainly at the later end of the
development chain. Other areas flourish to their best
advantage if the structural unit remains small: the units can
respond quickly to the changing environment; the opportunity
for scientists to interact is optimised; and the need for return
on investment is focussed through the fostering of an
entrepreneurial, accountable culture.