Affymax and Takeda file peginesatide NDA for anemia associated with chronic renal failure in dialysis patients

USA-based Affymax (Nasdaq: AFFY) and Japan’s largest drugmaker, Takeda Pharmaceutical (TSE: 4502) have filed a New Drug Application with the US Food and Drug Administration for the investigational agent peginesatide (formerly known as Hematide) for the treatment of anemia associated with chronic renal failure (CRF) in adult patients on dialysis.

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 (The Pharma Letter June 23, 2010).

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA). The agent is being co-developed by Affymax and Takeda. The NDA includes data from two Phase III studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels), in maintaining hemoglobin (Hb) levels. In the studies, CRF patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was similar to epoetin in maintaining Hb levels in CRF patients on dialysis with anemia with a similar adverse event rate.