* 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 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
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