Takeda Pharmaceutical Company Limited, a research-based global company,  announced that the company has decided not to commercialize peginesatide, an investigational therapy for use in the treatment of patients with anaemia due to chronic kidney disease (CKD) in Japan. 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.

Peginesatide is a synthetic PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The peginesatide phase 3 clinical programme was the largest to support the new drug application of an ESA in the treatment of anaemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events. The compound was discovered by Affymax and is being co-developed by Affymax and Takeda. If approved, peginesatide may be the first once-monthly product for anaemia in CKD for dialysis patients available in the United States.

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 US approval and launch and regulatory filing in Europe.

In Japan, the majority of phase 2 and phase 3 clinical trials are completed, and the findings to date suggest that peginesatide can become a promising treatment option for Japanese renal anaemia 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.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions.