PALO ALTO, Calif.—Affymax has received a $50 million milestone payment from Takeda Pharmaceutical linked to U.S. Food and Drug Administration (FDA) approval of Omontys Injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. The drug was given the go-ahead on March 27.
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 the medication in the U.S., while Takeda holds an exclusive license to develop and commercialize the product outside the U.S.
Takeda’s MAA was accepted for review by the EMA in February. That triggered a $5 million milestone fee to Affymax. In Japan the companies said they are looking for a partner after Takeda announced last December that it would not engage in commercialization activities in that country. Phase II and III trials in Japan reportedly suggest that Omontys “can become a promising treatment option for Japanese renal anemia patients,” Takeda said in December 2011.
Omontys marks Affymax’ first approved drug. It was discovered by Affymax and is a synthetic pegylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an erythropoietin stimulatin agent.
Affymax and Takeda are also evaluating the drug as a treatment for anemia in dialysis and nondialysis patients with pure red cell aplasia (PRCA). A Phase II study in this indication is ongoing outside the U.S. PRCA occurs when the body produces neutralizing antibodies to the recombinant human erythropoietin, thus seriously reducing the production of red blood cells by the bone marrow.