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R&D Update

Alongside the Q2 results, at a presentation to investors in London today, GSK sets out the new approach it will take to Research and Development (R&D).

Emma Walmsley, Chief Executive Officer, GSK said:

“Innovation is the first of our three long-term strategic priorities I set out for GSK last year. Improving the performance of our Pharmaceuticals business and strengthening our R&D pipeline is fundamental to this. Today, we have announced the start of a new approach to R&D which aims to capitalise on the assets we have in our promising early-stage pipeline and build the next wave of growth for GSK.

“Under Hal Barron’s leadership, we are reallocating resources to support this new R&D approach, and savings realised from the new major restructuring programme will be used to help fund targeted increases in R&D spending as well as support new products. We believe the R&D approach outlined today will deliver the value we see in our pipeline for the benefit of patients and shareholders.”

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said:

“GSK has a long history of developing novel medicines that provide significant benefits for patients and today we are describing the next phase of innovation in R&D that will strengthen our pipeline and deliver a new generation of medicines and vaccines. At the core of this new approach is identifying new medicines by focusing on ways to modulate the immune system, leveraging the vast amounts of human genetic data now being generated, analysing this complex data with machine learning and creating an accountable culture where smart risk-taking is rewarded. This combination of science, technology and culture will generate new insights, improve our probability of success, enable us to focus and, most importantly, create new medicines that will have important benefits for patients.”

New R&D approach

Our understanding of the science related to the immune system in the development of human disease is rapidly advancing, suggesting a much broader clinical and commercial opportunity for novel immune modulatory therapies. In addition, access to large databases derived from carefully genotyped and phenotyped patient populations, coupled with technological advances in data analytics, now offer the opportunity to direct drug discovery and development to a new generation of targets with significantly increased probability of success.

Science

Going forward, GSK’s Research will have an even greater focus on the basic biology of the immune system as well as targets that have a high degree of validation based on human genetics. Medicines targeting mechanisms of action with strong human genetic validation have a higher (2-fold) probability of success. This means a shift to a genetics-driven (vs genetics-supported) portfolio.

GSK’s Pharmaceutical and Vaccines businesses have a deep history of developing novel and competitive assets targeting the immune system. The company currently has 27 immunomodulatory NMEs (new molecular entities) in the clinic, representing 60% of the total clinical pipeline. Of these 27 assets, more than half are potential first-in-class therapy options for a range of different diseases. In Oncology, GSK is developing a number of assets using different immune-based approaches: cell therapy, epigenetic modulators and antibodies targeting immune cells (agonists and antagonists).

Access to databases that can be used to assess the impact of genetic variation on human disease offers significant opportunities to improve drug development. Today GSK announced a major advance in this capability with the formation of a new collaboration with 23andMe, the world’s leading consumer genetics and research company. This collaboration offers GSK a transformational opportunity to utilise 23andMe’s database and statistical analytics to identify disease-relevant genes and novel targets. 23andMe currently has 5 million customers and growing, making it the world’s largest genetic and phenotypic resource. GSK will also be able to benefit from 23andMe’s ability to identify patients with specific gene variations in specific diseases, helping significantly accelerate recruitment for new clinical studies. This new collaboration complements GSK’s existing investments in the EBI/Sanger Open Targets consortium, Altius Institute, and the UK Biobank.

Technology

Investing in advanced technology platforms, such as machine learning, to support interpretation of genetics data will be an important part of enabling the new R&D approach. In addition, the Group will be investing in functional genomics to validate potential targets, applying techniques for gene modification such as CRISPR technology. GSK will also invest in computational design, automation and new capabilities to assess the indication potential, selection, sequencing and management of evidence generation for new assets over the lifecycle. These investments will supplement GSK’s existing strengths in other technologies, including a leading position in Cell and Gene Therapy.

Culture

Execution of this new approach will require investing in, and changing the culture within GSK R&D. A critical element of this will be through effective collaboration with external partners, investment in new talent and development of people. GSK also intends to promote a culture of increased accountability and smart risk-taking. This will include redefining success and fostering a culture of truth-seeking versus progression-seeking, and optimised portfolio decision-making, alongside implementation of a new robust governance model. Targeted business development to strengthen the Group’s pipeline and technology capabilities will also be part of the new R&D approach.

Pipeline

GSK currently has over 40 NMEs in its pharmaceutical pipeline and expects a significant number of critical data readouts in 2018-2020. The Group has potential assets expected to launch in this period, including two new dual therapy treatments for HIV, dolutegravir+lamivudine and cabotegravir+ripilvirine, and GSK’s most advanced new oncology treatment, 2857916 (BCMA antibody-drug conjugate), for treatment of multiple myeloma. Beyond 2020, GSK expects to launch multiple medicines from its promising, early-stage and highly innovative R&D portfolio. Further details and updates on GSK’s R&D pipeline are presented on page 37.

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