It has been one of the most lucrative monopolies of all time, yielding the biotechnology company Amgen roughly $40 billion in sales over 23 years.
Now it appears to be over. The FDA approved an alternative to Amgen’s drugs for use in increasing red blood cell levels in anemic patients receiving kidney dialysis.
The new drug, developed by a small company called Affymax, works the same way in the body as Amgen’s anemia drugs do. But it is different enough chemically that it is expected to avoid the patent infringement lawsuits that Amgen has wielded successfully to defend its turf.
The new drug, Omontys, could provide a less expensive alternative for dialysis providers and for Medicare, which pays for most dialysis, even for those under 65 years old.
“We have suffered under a monopoly now for many years, and Amgen has done pretty much whatever they’ve pleased,” said Dr. John H. Sadler, chief executive of the Independent Dialysis Foundation, a small nonprofit dialysis provider in Baltimore.
The prices dialysis providers negotiate with Amgen help determine their profitability, he and other dialysis industry executives say. Without competition, Amgen has been free to set prices and recently raised them significantly, according to some of the executives.
Affymax is entering the market as use of the anemia drugs is declining because of safety concerns and a new Medicare payment system. Sales of Epogen, Amgen’s main drug for dialysis, dropped to $2 billion in 2011 from $2.5 billion in 2010.
Amgen has also taken steps to lock Affymax out of the market, signing contracts with the two big dialysis chains that together treat around two-thirds of the nation’s roughly 400,000 dialysis patients, virtually all of whom have anemia.