Affymax gets $10 million milestone from Takeda on peginesatide NDA acceptance

California, USA-based Affymax (Nasdaq: AFFY) says it has received a $10 million development milestone payment from Takeda Pharmaceutical (TYO: 4502), Japan’s largest drugmaker, as part of the companies’ exclusive global agreement to develop and commercialize peginesatide (formerly known as Hematide), Affymax’ investigational drug for the treatment of anemia in chronic renal failure patients.

The payment was triggered by the acceptance and filing of the New Drug Application for peginesatide by the US Food and Drug Administration. The NDA was filed with the agency in May (The Pharma Letter June 1). If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent (ESA) available for the treatment of anemia associated with chronic kidney disease (CKD) patients on dialysis in the USA.

Under the terms of the agreement signed in 2006, which was established with an upfront fee of $122.0 million, the US company is eligible to receive up to $345.0 million in developmental and regulatory milestones from Takeda, which has commercialization rights for the drug outside the USA. In addition, Affymax will be paid $150.0 million if the drug is successfully commercialized. The US firm last year received a $30 million development milestone (TPL June 23, 2010).