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UPDATE 1-Affymax, Takeda see anemia drug filing in early 2011
August 5, 2010 / 4:57 PM / 7 years ago

UPDATE 1-Affymax, Takeda see anemia drug filing in early 2011

* Cos plan prelim U.S. registration strategy for Hematide

* To continue further analysis of drug trials

* Shares jump as much as 25 percent

Aug 5 (Reuters) - Affymax Inc AFFY.O and its Japanese partner Takeda Pharmaceutical Co Ltd (4502.T) said they plan to continue the registration process for their experimental anemia drug, and hope to file for U.S. marketing approval in the first-half of 2011.

Shares of Affymax soared as much as 25 percent on Thursday, recovering some of the losses the stock suffered after it touched a life-time low in June on safety concerns over the drug.

The late-stage trials of the drug had met their main goal but showed a higher rate of cardiovascular events, including death and stroke, in patients who were suffering from chronic renal failure but were not on dialysis. [ID:nSGE65K0EH]

In a joint statement, the companies said they would continue to conduct further analysis of the late-stage studies, evaluating the efficacy and safety of the drug Hematide.

The companies plan to discuss the registration strategy for the drug with the U.S. Food and Drug Administration by 2010.

“Subject to feedback from the FDA, the plan is to pursue a new drug application for treatment of anemia in dialysis patients, while continuing to evaluate the non-dialysis indication,” the companies said. Shares of Affymax were trading up about 23 percent at $7.93 Thursday afternoon on Nasdaq. They touched a high of $8.01 earlier in the session. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Roshni Menon)

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