Singapore, Dec 19, 2011: Takeda Pharmaceutical and Affymax, biopharmaceutical companies committed to develop novel drugs, have announced that Takeda has decided not to commercialize peginesatide in Japan. Peginesatide is an investigational therapy for use in the treatment of patients with anemia due to chronic kidney disease (CKD). Takeda and Affymax will explore other options for the commercialization rights for this product in the Japanese market, including potentially licensing it out to a third party.

Takeda had been reviewing the business opportunity for peginesatide in Japan in view of its product portfolio and also further concentration into its core therapeutic areas and reached the conclusion that commercialization in the territory is not strategically optimal. Takeda and Affymax will continue closely collaborating in the development and commercialization of peginesatide outside Japan, including preparing for potential U.S. approval and launch and regulatory filing in Europe.

In Japan, the majority of phase II and phase III clinical trials are completed, and the findings to date suggest that peginesatide can become a promising treatment option for Japanese renal anemia patients. Accordingly, the companies are pursuing options that will take the program forward with a regulatory submission and commercialization in Japan.

Takeda and Affymax entered into two agreements signed in 2006 for development and commercialization of peginesatide, one for Japan and another for the rest of the world. In the US, a New Drug Application of peginesatide is under FDA review with a scheduled action date of March 27, 2012. In the European Union, Takeda expects to submit a Marketing Authorization Application during the first quarter of calendar year 2012.

Source:BioSpectrum Bureau