Affymax, Inc. (AFFY) said Monday that it has received a $50 million development milestone payment from Takeda Pharmaceutical Co. as part of the companies' exclusive global agreement to develop and commercialize OMONTYS Injection.
The milestone was triggered by the U.S. Food and Drug Administration approval of OMONTYS on March 27.
This is in addition to the $5 million milestone payment the company received from Takeda that was triggered by the European Medicines Agency acceptance of the Marketing Authorization Application in February.
In 2006, Affymax. and Takeda entered into an exclusive global agreement to collaborate on the development and commercialization of OMONTYS. Both companies are working together to co-commercialize OMONTYS in the U.S., while Takeda holds an exclusive license to develop and commercialize the product outside the U.S.
Based on the acceptance of a Marketing Authorization Application (MAA) submitted by Takeda, peginesatide is currently under review by the European Medicines Agency for the treatment of symptomatic anemia associated with chronic kidney disease in adult patients on dialysis.
Takeda and Affymax are exploring options for the commercialization rights for peginesatide in the Japanese market, including potentially licensing to a third party.
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