Exciting development-stage drugmaker GPC Biotech (NASDAQ:GPCB) announced yesterday that its marketing partner Pharmion (NASDAQ:PHRM) had filed for approval of its lead cancer-fighting drug in the European Union.
GPC's oral chemotherapeutic drug Satraplatin performed very well in a phase 3 study last year. Therefore, the drug will likely gain regulatory approval in the EU since the medical authorities are already familiar with the class of drugs of which Satraplatin is a part.
EU countries like Germany and France are some of the world's largest markets for pharmaceutical drugs. Nonetheless, even if Satraplatin can achieve EU regulatory approval next year, Pharmion and GPC will still have to wait to negotiate reimbursement of the drug with the governments in each country before meaningful sales will ramp up. Consequently, investors shouldn't expect to see consequential royalties from the drug's sales in the EU until late 2008 or the beginning of 2009 at the earliest.
GPC is already awaiting word from the FDA on Satraplatin in the U.S. The day by which the FDA is expected to make its decision is Aug. 15. An advisory panel meeting of experts is scheduled for July.
GPC is flush with approximately $165 million in cash (at current exchange rates) to support its U.S. sales force build-out if Satraplatin gains regulatory approval.
GPC and Pharmion won't have an easy time competing against Sanofi-Aventis' (NYSE:SNY) Taxotere and other chemotherapeutic agents as a treatment for late-stage prostate cancer. But at least the companies have started the countdown on possible EU marketing 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.
