UPDATE 1-Affymax: independent committee positive on anemia drug

Mon Jul 20, 2009 8:53am EDT

* Independent committee recommends drug trial to continue

* Still sees NDA filing in 2010

July 20 (Reuters) - Affymax Inc (AFFY.O) said an independent data monitoring committee recommended the continuation of the company's late-stage trials of its experimental drug to treat anemia in chronic renal failure patients.

The biotechnology company, which is co-developing the drug Hematide with Japan's Takeda Pharmaceutical Co Ltd (4502.T), said the committee informed Affymax that safety data from two late-stage studies, called EMERALD and PEARL, support continuation of the studies.

Last August, Affymax and Takeda said they would stop developing the drug for the treatment of chemotherapy-induced anemia due to uncertain regulatory landscapes.

Hematide, a synthetic drug that would compete with biologic anemia medicines that have faced restrictions over safety and potential overuse concerns, is administered just once a month.

That could be a major advantage over current standard treatments from Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N), which are given with dialysis about three times a week.

Affymax said it still expects to file for regulatory approval of the drug in 2010.

Shares of the company closed at $18.30 Friday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Aradhana Aravindan)

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