Germany’s GPC Biotech has posted a 56% net loss for the second quarter as the firm counts the cost for preparing the launch of its experimental cancer drug satraplatin which has now been delayed.
Revenues were down 10.5% to 3.4 million euros and the firm’s loss reached 23.7 million euros while its general and administrative costs leapt 114% to 12.4 million euros, due mainly to the formation of a sales and marketing force in the USA for satraplatin. The company had filed a New Drug Application for accelerated approval of the compound for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed, but a negative response from US regulators means those plans have been put firmly on hold.
A vote in July by the US Food and Drug Administration’s Oncologic Drugs Advisory Committee recommended that the agency should wait for the final survival analysis of the firm’s Phase III SPARC trial before deciding whether satraplatin is approvable, a move which led to GPC pulling the plug on its NDA just a week after. The company is also facing a class action lawsuit in New York which alleges that GPC violated US federal securities laws by making false public statements relating to the prospects of satraplatin, and thereby artificially inflated the share price.
Despite these woes, the firm remains upbeat. Partner Pharmion Corp submitted a marketing authorisation application to the European Medicines Agency for satraplatin in combination with prednisone in June and since then GPC has signed a licensing deal with Japan’s Yakult for the drug.
Chief financial officer Mirko Scherer said that "despite the recent setback, we remain in a solid financial position and believe we have sufficient cash under current expectations to carry us through to a potential regulatory submission based on the overall survival analysis". He added that "with our recent cost-cutting measures alone and anticipated revenues and expenses for the rest of the year, we expect to end 2007 with approximately 60 million euros in cash and equivalents."
GPC concluded by noting that revenues for the year should be in the range of 17-19 million euros.