roche.jpgNovember 14, 2007. Rockville, MD. The FDA passes Roches’s Mircera, long-acting erythropoiesis-stimulating agent for the treatment of anemia associated with chronic renal failure in adults.

But this is just the first of hurdles for Roche as they are in a legal battle with Amgen over the product. Amgen claims that Mircera infringes upon six US patents it has for their anemia product: Epogen (epoetin alfa).

The case is in federal court at the time of publishing and hearing is not expected until early 2009.

Epoetin alfa (r-HuEPO) is a recombinant form of the renal hormone erythropoietin (EPO) and belongs to a class of drugs known as erythropoiesis-stimulating agents (ESAs). Erythropoietin (EPO) is a protein that regulates the production of red blood. Epoetin alfa has the same activity as EPO. In adults, almost 90% of EPO is produced in the kidney with the remainder produced by the liver. People with kidney damage loose the ability to make new EPO and create new red blood cells and cause anemia, and hence these products being targeted in those patients.