Shares of GPC Biotech (NASDAQ:GPCB) have nearly doubled off of its 52-week lows, following the announcement of successful phase 3 results and anticipation of FDA approval for its lead compound .
GPC's lead drug is the oral chemotherapy agent Satraplatin. To date, the compound has been tested in more than 1,500 patients in its clinical trials. In a pivotal phase 3 study as a treatment for late-stage prostate cancer, Satraplatin produced statistically significant improvements in rates of progression-free survival versus non-Satraplatin treated patients.
Due to the highly positive efficacy results with the drug and the FDA's historical actions, I believe Satraplatin will become the first late-stage prostate cancer treatment since the agency approved Sanofi-Aventis' (NYSE:SNY) Taxotere in 2004. The Satraplatin PDUFA date is August 15, but an advisory panel meeting to debate the compound is scheduled for July, so investors should know before its PDUFA date whether the drug will likely gain approval or not.
GPC is also testing Satraplatin in other indications like non-small cell lung cancer (NSCLC), but it might not be long until on- and off-label competition from other oral chemotherapeutics arrives. Two weeks ago, GlaxoSmithKline (NYSE:GSK) filed for U.S. marketing approval of its oral chemotherapeutic Hycamtin as a treatment for NSCLC.
The other upcoming risk for GPC involves an arbitration panel hearing in July with Spectrum Pharmaceuticals (NASDAQ:SPPI), from whom GPC licensed the rights to Satraplatin. The companies have been bickering over milestone payments and other issues relating to the drug. GPC's management says that a negative decision from the arbitration panel is highly unlikely, but investors should be aware of the risk nonetheless.
GPC's market cap is less than a billion dollars. With a novel cancer compound that should be on the market by the end of the year, and full U.S. marketing rights to Satraplatin, GPC deserves a look from investors in search of the next new cancer treatment to gain regulatory approval.
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Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
