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re: GPCB/SPPI

GPC Biotech Shares Plunge on FDA Concern
Friday July 20, 10:24 am ET
GPC Biotech Shares Dive on FDA Committee Concerns Over Prostate Cancer Drug Application


NEW YORK (AP) -- Shares of GPC Biotech AG nosedived Friday after a Food and Drug Administration advisory committee questioned the methods GPC used to test and study its prostate cancer drug candidate Orplatna, or satraplatin.
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The Oncology Drugs Advisory Committee, in a brief ahead of a July 24 meeting with the company, raised several issues and pondered whether the FDA should wait on making a decision until final data from a late-stage study is available. That survival data isn't expected until the end of the year.

GPC shares plummeted $13.15, or 41.4 percent, to $18.65 in morning trading. The stock has traded between $13.53 and $37.79 over the last 52 weeks. Development partner Pharmion Corp., which has exclusive European rights, also saw shares fall $2.13, or nearly 8 percent, to $25.02 on more than quadruple average volume.

The committee questioned the measurements in the study that GPC used to determine the drug's effectiveness, including a main goal defined as a "composite endpoint". The committee said the FDA has no prior experience with that type of endpoint, an issue which was "clearly communicated" to GPC Biotech.

Also, two independent reviewers disagreed on the progress made by 39 percent of patients in the study, raising the issue of whether the main goal of the study could be reliably assessed.

The committee said a final issue is whether the FDA should wait for final survival analysis before taking action.

The company said it will hold a conference call on July 25 to discuss the outcome of the FDA meeting.



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