Not a slam dunk as once thought by many investors.
SPPI-UPDATE 1-US drug reviewers question GPC Biotech cancer drug
Fri Jul 20, 2007 10:30AM EDT
By Lisa Richwine
WASHINGTON, July 20 (Reuters) - U.S. drug reviewers have questioned GPC Biotech AG's (GPCG.DE: Quote, Profile, Research) study of a proposed prostate cancer pill and will ask an advisory panel if officials should wait for final survival data before acting on the company's application, a summary released on Friday said.
Food and Drug Administration staff raised five issues with GPC's application for the drug Orplatna, known generically as satraplatin. Among them, the FDA reviewers asked whether one of the main goals in a GPC study was acceptable for marketing approval, and whether pain measurements were reliable.
Shares of Germany-based GPC Biotech fell 39 percent in German trading. Shares of Spectrum Pharmaceuticals (SPPI.O: Quote, Profile, Research),which licensed the drug to GPC, dropped 22 percent, while shares of Pharmion Corp. (PHRM.O: Quote, Profile, Research) slid nearly 9 percent.
Spectrum has the option to co-promote Orplatna in the United States. Pharmion owns rights to sell the drug in Europe and some other territories.
GPC Biotech spokeswoman Laurie Doyle said the company had no comment on the FDA staff summary.
"We do remain convinced of the strength of satraplatin data," she said.
reuters.com |
