Affymax Moves for Approval

Affymax, a company based in Palo Alto, CA, and its partner, Takeda Pharmaceuticals of Osaka, Japan, are making a bid for U.S. Food and Drug Administration (FDA) approval of the drug peginesatide, used to treat anemia in patients with advanced chronic kidney disease.

The companies have submitted a new drug application to the FDA. The drug is a synthetic PEGylated peptidic compound that binds to and activates the erythropoietin receptor. It acts like an erythropoiesis-stimulating agent.

This move won’t come without a fight, however. Johnson & Johnson may block that bid with a patent suit to protect its interests.

The Affymax drug was studied in patients with chronic kidney failure who were not receiving dialysis. Although the drug met its goals in that study, the side effects were more severe for patients who were not receiving dialysis.

According to Forbes magazine, the companies face a potential challenge from a relative giant, Johnson & Johnson, whose drug Procrit, another type of erythropoietin drug, is used to treat anemia in patients who are receiving dialysis for kidney failure or who are being treated for cancer. In October, an arbitrator ruled that Johnson & Johnson was the owner of a group of patents on those drugs.

Affymax said that it thinks the patent is invalid and doesn’t apply to Procrit or peginesatide. Nevertheless, the ruling could allow the sole owner, Johnson & Johnson, to sue Affymax for patent infringement. If Affymax asks a federal court to overturn the decision, this could apply to current patents and applications in the United States, Canada, Australia, Japan, and Europe.

August 2011 (Vol. 3, Number 8)