Amgen Inc., aiming to secure future sales of its flagship anemia drug Epogen as potential competition emerges, has reached new supply contracts with the two largest operators of U.S. kidney dialysis clinics.
The Thousand Oaks biotechnology company said in a regulatory filing Friday that it had signed a seven-year contract to provide clinic operator DaVita Inc. with at least 90% of its anemia drug needs.
Amgen also entered into a multiyear agreement, starting in January, to supply Epogen on a nonexclusive basis to Fresenius Medical Care, according to Amgen spokeswoman Christine Regan.
Fresenius has a U.S. dialysis market share of about 33%, while DaVita's share is about 26%.
Both contracts include discounts and rebates.
"Amgen has effectively locked in two-thirds of its Epogen customer base with these DaVita and Fresenius contracts," Stifel Nicolaus analyst Maged Shenouda said.
Epogen sales, which totaled $2.52 billion in 2010, have waned in recent years because of safety concerns. But Amgen still holds a virtual monopoly on the market for drugs used to boost red blood cell levels in kidney dialysis patients.
That could change as generic, or "biosimilar," versions of such erythropoiesis-stimulating agents reach the market and competitors such as Roche Holding start selling similar drugs.
Another potential rival is Affymax Inc., which is seeking U.S. regulatory approval for its experimental drug, peginesatide, as a treatment of anemia in kidney dialysis patients.
A panel of expert advisors to the U.S. Food and Drug Administration is set to review the drug, developed by Affymax and Takeda Pharmaceutical Co., on Dec. 7, with a final decision from the agency expected by March 27.
Should it win approval, Affymax is expected to price its product below Epogen.
The Medicare federal health insurance program began this year to reimburse dialysis clinics based on a fixed amount for each patient, rather than the previous method of simply marking up from costs — which critics argued led to overuse of drugs, including Epogen.
Medicare, which traditionally covers just elderly and disabled Americans, provides coverage for all those with end-stage renal disease under a decades-old law.
Amgen shares fell 34 cents to close at $55.57.