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Corporate Responsibility Report 2008

Q&As

Here we respond to questions raised by our stakeholders

Is your goal to cure disease or to find treatments for ongoing, chronic use?
Ideally we want to cure disease. Our antibiotics help to treat diseases caused by bacterial infection and our anti-parasitic medicines help prevent and treat prevalent diseases such as lymphatic filariasis and malaria.

Unfortunately, there is no known cure for most diseases. Our medicines help reduce symptoms and may need to be taken for long periods. These medicines are still valuable because they may enable the patient to have a more normal lifestyle, for example remaining in work or looking after their family. In many cases we are continuing research to find a cure.

Ideally we want to prevent a disease from occurring in the first place, which is where vaccines have an important role.

What factors do you consider when prioritising your R&D efforts?
There are three main interrelated factors – science, patient need and commercial potential.

We assess scientific opportunities to determine how advances in scientific and disease understanding may lead to innovative new ways to treat or prevent disease. In 2008, we used the outcome of a systematic Therapy Area Review looking at the scientific understanding in 17 therapy areas to refocus our research effort. We continually evaluate the scientific information we obtain on our compounds to help us predict whether they can be developed into effective and well-tolerated medicines.

Assessing patient need is fundamental to R&D at GSK. This ranges from looking for medicines that will treat diseases for which there are no current effective treatments, to the development of medicines that improve on existing treatments in terms of safety, efficacy or ease of use.

Our assessment of the commercial potential of possible new treatments includes: how our product would be differentiated from those of our competitors; the size of the potential market for any new treatment; and the range of conditions it may be suitable for treating.

The better able we are to meet patient needs, the more likely it is that a product will be commercially successful. However, it is not always possible to achieve a return on investment, for example when developing treatments for diseases that are prevalent in the developing world. In some cases, where commercial potential is limited but patient need is high, we may seek ways to share the costs and risks associated with drug development.

Are you researching drugs to treat serious diseases?
Our pipeline and product range includes products against most of the major causes of mortality and morbidity (disease).

Our product launches in 2008 included Promacta for treatment of idiopathic thrombocytopenic purpura and Volibris for pulmonary arterial hypertension. Our top-selling products in 2008 treat asthma and chronic obstructive pulmonary disease, epilepsy and bipolar disorder, diabetes, herpes and migraine.

Our vaccines portfolio includes vaccines to prevent influenza, hepatitis, rotavirus and Human Papillomavirus infection which can cause cervical cancer. We also make vaccines to prevent many childhood illnesses such as measles and rubella.

How do you measure R&D productivity?
The ultimate measure of our productivity is the delivery of new medicines to meet patients’ needs. In 2008, GSK launched three products based on new chemical or biological entities, six new vaccines and a number of product line extensions that benefit patients. Our target is to sustain a late-stage pipeline of around 30 key assets. However, given that research and development can take longer than ten years, we measure productivity in a number of ways during the R&D process, including:

• The number of compounds in our pipeline, and the emerging risks and benefits of these compounds
• Our success at progressing compounds in our pipeline through clinical trial phases l, ll and lll and to market registration
• The speed of progress through our pipeline, which is an indication of the efficiency of our R&D processes

Is it true that research productivity is falling in large pharmaceutical companies? How is GSK managing this?
Investment in pharmaceutical R&D has risen while the number of new medicines gaining regulatory approval has remained relatively constant or decreased. We believe there are many reasons for this, including:

• An increasing focus on R&D into chronic degenerative diseases such as Alzheimer’s which are scientifically challenging, require longer clinical trials and have increased failure rates
• Significant investment by industry in new technologies which will help deliver innovative medicines in the longer term, for example systems biology tools, genome-wide association scans, new in vitro and in vivo models and sophisticated imaging equipment
• More extensive requirements from regulators and healthcare payers, including the need to conduct larger clinical studies to evaluate the long-term outcome of treatment with a medicine, as well as higher hurdles for approval
• The effectiveness of existing treatments for some conditions, so that demonstrating improved safety or efficacy of a new treatment is increasingly difficult

Our approach is to focus on meeting patients’ needs and increasing the effectiveness and efficiency of R&D. For example, in 2008 we established 35 Discovery Performance Units (DPU) within our established Centres of Excellence for Drug Discovery. DPUs are small groups of scientists focused on a specific disease or molecular pathway, and structured to be as efficient as possible. These organisations combine the entrepreneurial approach of a small company with the resources and reach of a larger organisation.

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