GPC Biotech Shares Fall on FDA's Vote on Cancer Drug

GPC Biotech AG shares fell as much as 42 percent, a record, after a U.S. panel recommended delaying a decision on the company's experimental prostate cancer drug.

The decline wiped 226 million euros ($310 million) from GPC's market value after a panel of advisers to the Food and Drug Administration voted 12-0 yesterday to wait for more data on the treatment, called satraplatin. GPC, the company leading the drug's development, said it doesn't expect to have a survival analysis from its 950-patient study for another year.

Shares of Martinsried, Germany-based GPC fell 4.62 euros, or 32 percent, to 9.94 euros at 2:15 p.m. in Frankfurt. The stock had already lost 37 percent of its value after the FDA staff suggested on July 20 that available data wouldn't be enough to secure approval for the medicine by next month. Spectrum Pharmaceuticals Inc. would receive a portion of the drug's sales under a licensing accord with GPC.

``It would be a huge blow to GPC if satraplatin is not approved at all,'' said Isabella Zinck, an analyst at UniCredit in Munich. ``Right now, the product hasn't been rejected, it has just lost the chance of having an accelerated review. We can't say this is the end of GPC.''

The panel advising the FDA recommended a delay until there is more data on whether satraplatin helped men with prostate cancer live longer. The FDA usually follows the recommendations of its advisers, although it isn't required to do so.

Better Than Narcotics?

``I'm not certain that satraplatin is better than narcotics'' in treating pain and improving quality of life, FDA panel member Otis Brawley, an oncology professor at Emory University in Atlanta, said yesterday. ``I do believe that satraplatin will meet that survival endpoint, but I think we need'' the data to be sure.

GPC Chief Executive Officer Bernd Seizinger said on a conference call today that he was disappointed with the FDA panel's recommendation.

The agency ``has the full range of options available to it,'' Seizinger said. ``It could issue an approvable letter, it could also issue a non-approvable letter.''

Spectrum shares fell 9.4 percent to $4.80 yesterday. The Irvine, California-based company has had a licensing agreement for satraplatin since 2002.

Regulators were scheduled to make a decision by Aug. 15 under an expedited review program for new compounds that serve an unmet need or represent significant improvements over existing drugs. The treatment, which is for use in men who haven't responded to chemotherapy, would be sold under the brand name Orplatna.

Enough Cash

Interim data from the clinical test submitted by GPC doesn't prove the drug helps prostate cancer patients live longer, the advisory committee said. The panel, which met in Rockville, Maryland, also questioned how the company did its analysis of disease progression and pain reduction in the study.

A slowdown in the death rate of patients on the trial means overall survival data won't be available for another six months, later than expected.

GPC has ``sufficient cash to get to the final survival analysis,'' said Martin Braendle, head of investor relations.

GPC said patients who took satraplatin in combination with steroids had a 33 percent lesser risk of cancer spreading than those taking steroids alone. Side effects from the drug were mostly mild and included nausea and fatigue.

``Without additional clinical trials, positive survival data appear to be the only way the drug will ever make it onto the market,'' Friedman Billings Ramsey analyst Robert Uhl wrote today in a note to investors. Uhl cut his rating on Spectrum to ``market perform'' from ``outperform,'' and reduced his price target for the stock to $5.50 from $12.25.

Drug Side Effects

Satraplatin would become the first oral chemotherapy agent with platinum as the active ingredient if it eventually wins regulatory approval. Similar therapies, such as Sanofi-Aventis SA's Taxotere, must be given intravenously.

Taxotere is now the only approved treatment shown to improve survival in prostate cancer patients who have stopped responding to hormones. The injections extended lives by a median of 2.4 months in a clinical trial, although doctors representing GPC told the panel that the benefits of such drugs are limited by the potential for serious side effects.

``This is a rapidly progressing, debilitating and ultimately fatal disease,'' said Nicholas Vogelzang, of the Nevada Cancer Institute. ``There is an urgent need for effective and well-tolerated therapies.''

Almost 219,000 U.S. men will be diagnosed with prostate cancer this year, and 27,050 men will die from the disease, according to the National Cancer Institute in Bethesda, Maryland.

source : www.bloomberg.com