WASHINGTON—For more than 20 years, Amgen Inc. (AMGN) has been the only option for anemia-treatment for patients with loss of kidney function. Affymax Inc. (AFFY) changed that today as the Food and Drug Administration cleared Omontys, also known as peginesatide, for patients with chronic kidney disease on dialysis.
The treatment will be Palo Alto, California-based Affymax’s first marketed product.
Approval of the drug -- intended to be used once a month instead of as often as three times a week for Amgen’s Epogen --may potentially save money for Medicare, the federal health program for the elderly and disabled. Peginesatide may generate as much as $700 million in peak sales by 2017, Ian Somaiya, an analyst at Piper Jaffray & Co. in New York, said in a telephone interview.
“We’re dealing with a monopoly right now and that’s not ideal because it’s occurred for two decades,” Somaiya said of Epogen. “Small and medium dialysis centers are price sensitive. Peginesatide would be the choice for these dialysis providers.”
Dialysis removes toxins from the blood when kidneys can’t.
Amgen’s Epogen, approved in 1989, generated $2 billion in sales last year, down 19 percent from 2010, according to data compiled by Bloomberg. Peginesatide may compete to a lesser extent with Thousand Oaks, California-based Amgen’s Aranesp, which is primarily used on non-dialysis kidney patients. Aranesp had $2.3 billion in sales last year.