Keryx Biopharmaceuticals cancer drug candidate gets faster regulatory review by FDA

Keryx treatment gets faster FDA review

NEW YORK — Keryx Biopharmaceuticals Inc. and AEterna Zentaris Inc. said Wednesday the Food and Drug Administration granted the potential cancer treatment Perifosine a fast-track review process.

The designation allows the agency to conduct a faster review of a drug candidate intended for a serious disease. Drug developers can submit their applications to the FDA piece by piece instead of having to file all the paperwork at once.

The company expects to begin a late-stage study on the drug candidate, focusing on multiple myeloma, by the end of 2009.

Perifosine already 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.

Keryx and AEterna Zentaris are partnering on the perifosine in North America. AEterna Zentaris has the rights to the drug in the rest of the world excluding South Korea.

Shares of Keryx rose 37 cents, or 14 percent, to $3.02 in afternoon trading after rising as high as $3.14 earlier in the session. That approaches the high end of its 52-week trading range of 9 cents to $3.33 a share. AEterna Zentaris shares gained 5 cents, or 5 percent, to $1.05 and peaked at $1.13, earlier in the trading day.