THOUSAND OAKS, Calif. ― Moving to protect a lucrative monopoly against impending competition, Amgen has reached an agreement that will preserve its status as the main supplier of anemia drugs to one of the nation’s two large kidney dialysis chains.The dialysis chain, DaVita, agreed that Amgen’s drug, Epogen, will account for at least 90 percent of its purchases of that type of anemia drug through the end of 2018. DaVita will get discounts and rebates on the drug, Amgen said in a regulatory filing Friday morning.
Amgen has had a monopoly on providing this type of anemia drug to American dialysis clinics since 1989, when Epogen was approved. Sales have been about $2.5 billion annually, though they are now declining because of safety concerns and a change in how Medicare pays for dialysis.
The new contract comes as Amgen might finally face competition. Affymax, a Silicon Valley biotechnology company, has a drug that will come up for a review by an F.D.A. advisory committee on Dec. 7 and might be approved early next year. The Japanese drug maker Takeda would help sell it. And by 2015 or so, companies should be able to introduce near-generic versions of Epogen.
Amgen apparently decided to help lock up sales to DaVita, which treats about one-third of American patients on dialysis. And DaVita apparently decided to leverage the impending competition to get itself a better deal.
Dialysis clinics are under pressure to cut how much they spend on drugs because Medicare this year began paying a set fee for the complete dialysis treatment, including the drugs being used.
Before that, dialysis clinics billed for the drugs like Epogen separately. Critics, including various members of Congress, had said that the system encouraged Epogen to be overused to improve dialysis company profits. That inflated medical bills, they said, and potentially put patients at risk, because some studies have now shown that the drugs can raise the risks of heart attacks and blood clots.
Five years ago, Amgen reached a similar supply agreement with the other large dialysis provider, Fresenius.
At that time, Roche was preparing to enter the market with an anemia drug similar to Epogen. But Amgen eventually prevailed in litigation defending its patents, keeping Roche out of the American market.
At least one analyst had questioned whether the deal between Amgen and Fresenius would raise antitrust scrutiny. It is possible the new deal with DaVita could raise similar concerns.