Takeda Halts TAK-379 Development
Takeda is discontinuing clinical development of diabetes agent TAK-379 because it does not meet internal criteria to support further development. An insulin sensitizer, TAK-379 was in phase II trials in the United States and Europe and in phase I in Japan. A Takeda spokeswoman said the impact of the discontinuation would be minimal since TAK-379 is considered an early-stage compound. The halt came after the Food and Drug Administration told the company in March that it would apply its December 2008 guidelines on cardiovascular risk assessment for type 2 diabetes drugs in its review of Takeda's DPP-4 inhibitor alogliptin, despite the fact that the company submitted its new drug application prior to the published guidance. The agency informed Takeda that the amount of existing alogliptin clinical data was not sufficient to meet statistical requirements.
Novocell Awarded Grants
Novocell Inc., a stem cell engineering company, has been awarded two grants totaling $6.2 million from the California Institute for Regenerative Medicine. The grants will help fund research into methods for delivery and safety monitoring of human embryonic stem cell (hESC)-derived pancreatic cells for diabetes cell therapy. Novocell stated that it has developed methods of generating pancreatic, insulin-producing cells from hESCs. The CIRM grants will assist Novocell in finding ways to detect teratoma-forming cells remaining in product preparations derived from hESCs. “Developing methods to deliver cells and to reduce contamination of hESC-derived product preparations are major concerns impacting the development and application of stem cell therapies,” said Emmanuel Baetge, Ph.D., senior vice-president and chief scientific officer of Novocell.
Sanofi R&D Plan Announced
French pharmaceutical company Sanofi-Aventis has begun releasing details from its revised research and development plan. The new structure will involve smaller, more independent units similar to those of competitors. Sanofi signaled that staff changes will accompany the shift in strategy, including a reduction in employees and a change in recruitment, with emphasis on promising researchers. The company is closing up to 8 of its 27 R&D sites, mostly by combining divisions located throughout France. There is a plan for voluntary departures.
Joslin Opens Dubai Affiliate
Joslin Diabetes Center has opened an affiliate in Dubai. “Dubai has a huge diabetes problem,” said Dr. Antoine Kaldany, director of international programs at Joslin. “According to the World Health Organization, the United Arab Emirates, of which the city-state of Dubai is part, has the second highest rate of diabetes in the world.” About 40% of the UAE's health care budget is spent on diabetes. The new affiliate, opened under an agreement with the Dubai government, is on the campus of Al Wasl Hospital. It will focus on prevention, education, lifestyle management, podiatry, and early detection of complications in adults. A pediatric division also is planned. The staff includes four U.S.-board-certified endocrinologists, seven diabetes educators, a podiatrist, a physiotherapist and a mental health counselor.
Insulet's OmniPod Gets CE Mark
Insulet Corporation has received the CE Mark approval for its OmniPod tube-free insulin pump. “We are very pleased to have received the CE Mark for the OmniPod System,” Carsten Boess, Insulet's vice president of international, said in a statement. Insulet is in discussions about international distribution options for the OmniPod System. The company indicated that the product will likely be available to a limited extent in selected markets in 2009, and will have broader availability in 2010.
—From staff reports
Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.