Takeda Pharmaceutical has decided not to commercialize Affymax’ peginesatide for anemia 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 an investigational therapy for use in patients with anemia due to chronic kidney disease (CKD). Last week, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with 1 abstention, that peginesatide demonstrated a favorable benefit/risk profile in this indication.
In Takeda’s review of its pipeline and portfolio priorities, however, the firm decided that commercialization in Japan is not strategically optimal for it. The majority of Phase II and Phase III trials in this country have been completed, though. Findings to date suggest that peginesatide can become a promising treatment option for Japanese renal anemia patients, according to Affymax and Takeda.
Takeda and Affymax say that they are pursuing options that will take the program forward with a regulatory submission and commercialization in Japan. The firms will continue to work together on development and commercialization of peginesatide outside Japan, however, including preparing for potential U.S. approval and launch as well as regulatory filing in Europe.
In the U.S., FDA is expected to make a decision by March 27, 2012. In the EU, Takeda anticipates submitting an MAA during the first quarter of calendar year 2012.
Peginesatide is a synthetic PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The compound was discovered by Affymax and is being co-developed by Affymax and Takeda under two agreements inked in 2006, one for the U.S. and the other for the rest of the world.