Affymax Hires New CEO, Former Genentecher, to Complete FDA Push With Anemia Drug

1/6/11Follow @xconomy

Affymax (NASDAQ: AFFY), the Palo Alto, CA-based developer of an experimental anemia drug, said today it has hired John Orwin as its new CEO, to replace Arlene Morris. Orwin was formerly the senior vice president of marketing and sales for Genentech before he joined Affymax last April as president and chief operating officer.

Morris, who became Affymax’s CEO in 2003, will continue to consult to the company until September. She leaves after a year in which Affymax stock took a big hit. Affymax, along with its partner Takeda Pharmaceuticals, said in June that clinical trials showed their anemia drug peginesatide (Hematide) was associated with a higher rate of heart-related adverse events, such as congestive heart failure and unstable angina, if patients had chronic kidney disease that hadn’t yet required dialysis.

The stock fell almost 70 percent on that news, and didn’t really recover from there, even though the company said the overall package of results was still encouraging enough for the company to seek FDA approval in a sicker patient population—kidney patients who are on dialysis.

I quoted one analyst back in August who said Affymax is “not dead yet.” Affymax confirmed in November that it planned to go ahead and seek FDA approval of its anemia drug candidate in the first half of 2011. That will be one of Orwin’s main objectives this year, no doubt. If Affymax can get its drug cleared for sale in the U.S., it will be in a position to compete with Amgen’s multi-billion dollar franchise drug, epoetin alfa (Epogen).

“We are now in final preparations of our new drug application and are on track to submit this application to the Food and Drug Administration in the second quarter of 2011,” Orwin said in a statement. “We believe we are well positioned to commercialize peginesatide upon potential approval for the treatment of anemia in dialysis patients, and look forward to our transition to a commercial organization.”

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