Affymax approval breaks Amgen's long anemia monopoly

Amgen's anemia-drug sales have been losing altitude for the past couple of years. Now that FDA has approved a new, independent competitor, will Amgen's versions plummet? That's the billion-dollar question.

Yesterday, the U.S. agency gave its final blessing to Omontys, an alternative to Amgen's ($AMGN) Epogen drug for kidney patients on dialysis. Developed by Affymax ($AFFY) and marketed with Japan's Takeda, the once-a-month injection may not have a significantly different sticker price from Epogen, which is given three times a week, The New York Times reports. But Affymax figures on discounts, rebates, and lower administration costs to sway dialysis providers its way. It's staffing a sales force of up to 80 reps over the next 30 to 60 days to help support the rollout.

Amgen has been preparing for competition, however, from new meds like Omontys and from future biosimilar versions of its own brands. The company inked an exclusive, 7-year deal with the leading dialysis provider, DaVita, and a 3-year, non-exclusive arrangement with Fresenius (which happens to have participated in clinical trials of Omontys, also known as peginesatide). Affymax CEO John Orwin expects bigger dialysis providers to sample Omontys in a few facilities first, before committing to large-scale use.

But small- and medium-sized dialysis companies are still a significant market. "There's a group of people who are very anxious to talk to us," Orwin told the Times.

Piper Jaffray analyst Ian Somaiya agreed, saying he's looking at peak sales for Omontys of $700 million by 2017. "We're dealing with a monopoly right now and that's not ideal because it's occurred for two decades," Somaiya told Bloomberg. "Small and medium dialysis centers are price sensitive. Peginesatide would be the choice for these dialysis providers."

- see the release from FDA
- read the NYT piece
- get more from The Wall Street Journal
- check out the Bloomberg story