Aeterna Zentaris Stock Rises After Study Reviewed
From Associated Press (April 15, 2010)
Shares of AEterna Zentaris Inc. soared Thursday as the Canadian drug maker said it received encouraging feedback from the European Medicines Agency regarding a late-stage study of the potential cancer treatment perifosine.
The company said it asked the agency for scientific advice on the acceptability of the trial, which is being sponsored by Keryx Biopharmaceuticals Inc. It said the agency indicated the study is sufficient "to provide all data necessary to support a marketing authorization of perifosine" with another multiple myeloma treatment, Velcade.
AEterna Zentaris said it believes its North American clinical program will support an application for marketing authorization in Europe and the rest of the world.
Perifosine also is being studied as a colorectal cancer treatment. Earlier this month, AEterna Zentaris and Keryx said the U.S. Food and Drug Administration gave perifosine a "fast track" designation, which allows for a faster review of a potential treatment intended for a serious or life-threatening disease.
In December, perifosine received a fast-track review designation as a potential multiple myeloma treatment.
Perifosine also has orphan drug status, which is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits.
U.S.-traded shares of AEterna Zentaris climbed 34 cents, or 24.6 percent, to $1.72 in afternoon trading. The stock has ranged from 75 cents to $3.25 over the past year.
Posted: April 2010