FDA Approvals of 2012

8 of 39


Drug: Omontys
Generic molecule: peginesatide
Company: Affymax
Approval date: March 27

The scoop: This anemia drug is the first competition for Amgen's ($AMGN) Epogen drug for kidney patients on dialysis, and analysts think it could capture a $700 million slice of that market by 2018. But to get it, Affymax will have to scramble. It has a marketing deal with Japan's Takeda and its drug is given once a month, compared with the three times a month for Epogen. But the two are priced similarly and Amgen has had two decades to establish loyalty. To that end it inked an exclusive, 7-year deal with the leading dialysis provider, DaVita, and a three-year, nonexclusive arrangement with Fresenius, which happens to have participated in clinical trials of Omontys.