Affymax Inc., a biopharmaceutical company, has received a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide.

This milestone is triggered by the European Medicines Agency (EMA) acceptance of the Marketing Authorization Application (MAA) for the investigational compound peginesatide for the treatment of anaemia associated with chronic kidney disease (CKD) in adult patients on dialysis.

“We are delighted with Takeda's execution on the European front and are encouraged by the EMA acceptance of the MAA,” said John Orwin, president and CEO of Affymax. “While we are concurrently preparing for potential commercialization of peginesatide in the United States, we are pleased that progress is being made to potentially make the product available outside the US.”

Peginesatide was discovered by Affymax, and if approved, will be co-marketed by Affymax and Takeda in the United States. Takeda has commercialization rights in the European Union. In the United States, the scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27.

Peginesatide is a synthetic PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA). The peginesatide phase III clinical programme was the largest to support the new drug application of an ESA in the treatment of anaemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events. The compound was discovered by Affymax and is being co-developed by Affymax and Takeda. If approved, peginesatide may be the first once-monthly product for anaemia in CKD for dialysis patients available in the United States.

Anaemia is a common complication in CKD that impacts the overall health and well-being of CKD patients and is associated with increased rates of hospitalization and mortality. ESAs are medications commonly prescribed to treat anaemia and stimulate red blood cell production. Research has shown that there may be challenges with anaemia management due to factors such as, haemoglobin (Hb) variability and stability, among other concerns.