Takeda Pharmaceutical Co and partner Affymax have submitted peginesatide, a potential rival to the existing EPO treatments, to the US Food and Drug Administration.
The drug, which was formally known as Hematide, has been filed for the treatment of anaemia associated with chronic renal failure (CRF) in adults on dialysis. Peginesatide is a synthetic, PEGylated peptidic compound that acts as an erythropoiesis stimulating agent, the same class as Amgen’s treatments Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and Johnson & Johnson's Procrit/Eprex (epoetin alfa).
The New Drug Application includes data from two Phase III studies (EMERALD 1 and 2) which suggested that once-monthly peginesatide was similar to epoetin in maintaining haemoglobin levels in kidney failure patients on dialysis with anaemia with a similar adverse event rate. Azmi Nabulsi, president of Takeda Global R&D Center based in the USA, noted that “to date, limited options for treating anemia in CRF patients on dialysis exist" and the peginesatide NDA "represents an important step in the evaluation of a potentially new treatment".
How new the treatment is disputed by J&J. In October last year, an arbitration panel reviewing Affymax's dispute with the healthcare giant determined that they were co-owners of certain intellectual property related to erythropoietin receptor agonists. However the ruling also stated that J&J is sole owner of another US patent and related applications in Europe, Japan, Canada and Australia.
At the time of the ruling, Affymax-then chief executive Arlene Morris, said "we continue to believe that these patents and patent applications do not encompass Hematide and that we can manufacture and sell the product upon approval".
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