That $50 million is in addition to a $5 millionmilestone payment the company received from Takeda that was triggered by theEuropean Medicines Agency (EMA) acceptance of the Marketing AuthorizationApplication (MAA) for the drug in February.
The deal goes back to 2006, when Affymax andTakeda entered into an exclusive global agreement to collaborate on thedevelopment and commercialization of Omontys. Both companies are workingtogether to co-commercialize Omontys in the United States, while Takeda holdsan exclusive license to develop and commercialize the product outside the UnitedStates.
Based on the acceptance of an MAA submitted byTakeda, peginesatide is currently under review by the European Medicines Agency(EMA) for the treatment of symptomatic anemia associated with CKD in adultpatients on dialysis.
Takeda and Affymax are exploring options for thecommercialization rights for peginesatide in the Japanese market, includingpotentially licensing to a third party.
The U.S. Food and Drug Administration approvedOmontys to treat anemia in adult dialysis patients who have chronic kidneydisease (CKD). Omontys is a new erythropoiesis-stimulating agent (ESA) thataids in the formation of red blood cells. Administered as a once-a-monthinjection, the drug works by stimulating the bone marrow to produce more redblood cells and reduce the need for transfusions in patients with CKD.
"Omontys represents the first new FDA-approved andmarketed ESA for this condition since 2001," said Dr. Richard Pazdur, directorof the Office of Hematology and Oncology Products in the FDA's Center for DrugEvaluation and Research, when the drug was approved. "This new drug offerspatients and health care providers the convenience of receiving ESA therapyjust once per month instead of more frequent injections."
According to the FDA, two randomized,active-controlled, open-label, multi-center clinical trials demonstrated thesafety and efficacy of Omontys in patients with CKD who were on dialysis. Thetrials randomly selected a total of 1,608 patients with hemoglobin levelsinitially stabilized by ESA to receive either Omontys once monthly or tocontinue their current ESA (epoetin) treatment. Results showed Omontys was assafe and effective as epoetin in maintaining hemoglobin levels within thestudies' pre-specified range of 10 to 12 grams per deciliter.
The most common side effects observed in 10percent or more of dialysis patients treated with Omontys were diarrhea,vomiting, hypertension and joint, back, leg or arm pain.
Omontys reportedly should not be used in patientswith CKD who are not receiving dialysis or in patients with cancer–relatedanemia, according to the FDA-approved labeling. It also should not be used as asubstitute for red blood cell transfusions in patients who require immediatecorrection of anemia. Omontys has not been shown to improve symptoms of anemia,physical functioning or health-related quality of life in patients with CKD ondialysis.
