AstraZeneca will assume operational and cost responsibility for all development and regulatory activities on behalf of the collaboration.
Bristol-Myers Squibb and AstraZeneca expanded a 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 evaluated in several Phase III trials, including one to assess its efficacy and safety as a once-daily treatment for type 2 diabetes.
In January 2007, Bristol-Myers Squibb and AstraZeneca entered into a global collaboration, excluding Japan, to enable the companies to research, develop, and commercialize dapagliflozin. The companies now have agreed to co-develop dapagliflozin in Japan with AstraZeneca having 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. Bristol-Myers Squibb will manufacture dapagliflozin and also book sales. Dapagliflozin is currently being studied in Phase II clinical trials in Japan.
“Bristol-Myers Squibb and AstraZeneca 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, evp and COO, Bristol-Myers Squibb.