December 2, 2009 / 2:35 PM / 8 years ago

UPDATE 2-FDA fast tracks Aeterna, Keryx cancer drug

* Cancer drug receives fast track approval

* Perifosine in Phase 3 late-stage trial

* Aeterna shares up 7.6 pct, Keryx shares up 9.4 pct (Adds analyst’s comments. In U.S. dollars)

TORONTO, Dec 2 (Reuters) - Canadian drugmaker Aeterna Zentaris AEZ.TO said on Wednesday that its experimental cancer drug KRX-0401 has received fast track approval from U.S. health regulators, a move that could clear a quick path to final approval for the multiple myeloma treatment.

Quebec-based Aeterna is developing the drug, also known as Perifosine, with partner and licensee Keryx Biopharmaceuticals (KERX.O) in the United States, Canada and Mexico.

Aeterna shares were up 7.6 percent at C$1.13 on the Toronto Stock Exchange. Keryx shares were up 9.4 percent at $2.90 in New York.

“This is a positive and just suggests that the FDA is viewing the potential of this drug positively,” said Neil Maruoka, an analyst at Canaccord Adams. “This could potentially shorten the time lines to approval.”

Perifosine is currently in Phase 2 mid-stage clinical development for multiple tumor types, and a Phase 3 late-stage trial for multiple myeloma is set to begin.

Fast track approval is often awarded to new drugs intended to treat serious or life-threatening conditions.

Earlier this year the drug received orphan drug designation from the FDA, which is reserved for new treatments that are being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States, and which grants the drug developers seven years of market exclusivity. ($1=$1.05 Canadian) (Reporting by Scott Anderson; editing by Peter Galloway) ((scott.anderson@reuters.com; +1 416 941 8106; Reuters Messaging: scott.anderson.reuters.com@reuters.net))

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