Drug Companies Advance Diabetes Strategies

Bristol-Myers Squibb and AstraZeneca together will advance what they hope might be effective small-molecule therapies against diabetes. Meanwhile, Novo Nordisk, a leading insulin producer, is returning to its roots and will work only on protein-based drugs.

Although insulin injections have been the primary diabetes treatment for decades, drug developers have begun introducing small-molecule drugs that can be administered orally (C&EN, Jan. 8, page 30). BMS and AstraZeneca, which both halted late-stage diabetes programs in 2006, will jointly develop two compounds discovered by BMS.

One is saxagliptin, one of a class of dipeptidyl peptidase-4 inhibitors that reduce blood glucose. It is in Phase III clinical development, and the companies hope to file for U.S. regulatory approval in the first half of 2008. The other is dapagliflozin, a sodium-glucose cotransporter-2 inhibitor that improves glucose control, currently in Phase IIb development.

AstraZeneca will pay BMS $100 million up front and fund the majority of development costs until 2009. BMS may also receive up to $650 million contingent on achieving development and regulatory milestones. It could get another $300 million per product if eventual sales goals are reached. BMS will manufacture the drugs. The companies will share commercialization expenses and any profits or losses worldwide, except in Japan. In late 2006, BMS sold Japanese rights for saxagliptin to Otsuka Pharmaceutical.

"Diabetes is a disease reaching almost epidemic proportions in many regions throughout the world," says AstraZeneca CEO David Brennan. The company has been looking to fill its pipeline, and the deal, he says, "gives us access to two strategically important late-stage compounds in an area of high unmet medical need."

Novo Nordisk, however, has decided to focus all its R&D resources on protein-based pharmaceuticals for diabetes, hemostasis, growth disorders, and other diseases. It will discontinue activities and divest programs in small-molecule drugs for diabetes.

"Our core competences lie within therapeutic proteins, and it is within this area that we can make the greatest difference in terms of patient outcomes and company growth," says Mads Krogsgaard Thomsen, chief science officer and executive vice president. Novo anticipates being able to offer jobs to about half of the 180 employees, mostly scientists, impacted by the cutback.