Keryx Biopharmaceuticals Inc. (KERX) said the U.S. Food and Drug
Administration has given fast-track designation to perifosine, its
drug for treating colorectal cancer.
Shares of the biopharmaceutical company jumped 25% to $3.43 in
recent trading, while U.S.-traded shares of Keryx's Canadian
partner Aeterna Zentaris Inc. (AEZ.T, AEZS) were recently up 23% to
99 cents.
Drugs given fast-track designation are intended to treat serious
or life-threatening conditions and that demonstrate the potential
to address unmet medical needs, Keryx said. They usually qualify
for expedited review from the FDA.
"We believe that commercialization of perifosine in this
indication could potentially commence by mid-2012," said Chief
Executive Ron Bentsur.
Keryx said it expects to begin Phase III testing of the drug in
the second quarter of this year, and it expects to complete the
study in the second half of 2011.
Keryx in December received fast-track status from the FDA for
perifosine for the treatment of multiple myeloma. The treatment is
licensed by Keryx from Aeterna for the U.S., Canada and Mexico.
-By Nathan Becker, Dow Jones Newswires; 212-416-2855;
nathan.becker@dowjones.com;