Eli Lilly is establishing a dedicated diabetes research center in Shanghai, and has pledged about $2.5 million to support a new partnership with the Chinese Diabetes Society (CDS) and European Foundation for the Study of Diabetes (EFSD). The new Shanghai facility, due to open in the second half of 2011, will focus on the discovery and development of antidiabetics with novel mechanisms of action, along with treatments that target co-morbid conditions such as cardiovascular disease and obesity.
The aim is to discover therapies that target the molecular basis of diabetes in Chinese and other Asian populations. In parallel, Lilly aims to work in partnership with the CDS and EFSD to promote collaborative diabetes research by Chinese and European academic organizations.
Lilly says the incidence of diabetes in China has reached epidemic proportions. The firm cites recently published figures suggesting the disease affects about 10% of the Chinese population, equivalent to 92 million people.
“Given key differences in the molecular basis of diabetes in Chinese and other Asian populations, a major focus at this center will be on discovering therapies that target critical aspects of the disease,” remarks David Moller, M.D., vp of endocrine and cardiovascular research and clinical investigation at Lilly.
“By establishing a diabetes research center in China, Lilly will be better able to discover medicines that are well suited to the particular needs of patients with diabetes in China,” adds Jacques Tapiero, svp and president of Lilly’s emerging markets business. The Shanghai diabetes center will employ about 100 scientists, headed by international diabetes expert Bei Betty Zhang, Ph.D., who acts as vp of research for Lilly Research Laboratories in China.
Lilly says it has been building its organization in China since the early 1990s. With its Chinese R&D operations based in Shanghai, the firm also has manufacturing facilities in Suzhou, and over 300 offices throughout the territory. It claims to be the only global pharmaceutical company to have created a venture capital fund focused on the Chinese biopharma industry. Lilly Asian Ventures was established in 2007.
Lilly’s U.S.-marketed diabetes portfolio includes products for both type 1 and type 2 disease, headed by the Humalog® and Humulin® product families for type 1 disease, and Byetta® and Actos®, for treating type 2 diabetes. The firm’s global pipeline includes products at all stages of clinical development.
It has not been all smooth running for pivotal-stage products, unfortunately. Just last month Lilly and partner MarcoGenics announced they were suspending enrollment into ongoing clinical studies with the humanized anti-CD3 monoclonal antibody teplizumab, due to disappointing Phase III results. A planned analysis of one-year safety and efficacy data from the Protege study by the trial’s independent Data Monitoring Committee (DMC) found that teplizumab therapy did not meet its primary composite endpoint of insulin usage and HbA1c levels, in patients with recent-onset type 1 diabetes.
The teplizumab trial data was reported just a day after Lilly, Amlyn, and Alkermes confirmed that FDA had requested additional trial data on the type 2 diabetes drug Bydureon™, before it could consider approving the therapy. An NDA for Bydureon had been submitted to the agency in May 2009. FDA’s complete response letter to the firms requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of Bydureon. The drug is a once-weekly formulation of exenatide, the active ingredient of Byetta injection.