Bristol-Myers Squibb and AstraZeneca have expanded their worldwide collaboration to include the development and commercialization of dapagliflozin in Japan. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in Phase III clinical trials in several countries, including the U.S., to assess its efficacy and safety as a once-daily treatment for type 2 diabetes.

BMS and AZ entered into a global R&D and commercialization collaboration in January 2007, but it excluded Japan. The companies now have agreed to co-develop dapagliflozin in Japan with AZ covering operational and cost responsibility for all development and regulatory activities on behalf of the collaboration. The two companies will jointly market the product in Japan, sharing all commercialization expenses and activities and splitting profits/losses equally. BMS will manufacture dapagliflozin and also book sales. Dapagliflozin is currently being studied in Phase II clinical trials in that market.

“BMS and AZ have been working together to develop dapagliflozin for type 2 diabetes for nearly two years; this inclusion of Japan was a natural progression of our collaboration and an important strategic step in our relationship,” said Lamberto Andreotti, executive vice president and chief operating officer, BMS. “Our companies have a shared vision for these diabetes treatments, and this agreement will help ensure we can successfully launch and maximize the potential of dapagliflozin for the more than six million people in Japan living with type 2 diabetes.”

“Last year, the cost of treating and preventing type 2 diabetes and its complications in Japan was more than $18.4 billion, which is a significant cost to Japanese society,” said Bruno Angelici, executive vice president, International Sales and Marketing Organization, AZ. “We have a long-standing presence in Japan, and our agreement with BMS to bring a potentially important type 2 diabetes treatment to market in the region will not only help reduce this cost burden, but also reduce the impact this disease has on the country’s health.”