GPC Biotech of Germany is withdrawing its marketing application in the USA for the experimental cancer drug satraplatin after the company received a negative response from the regulator’s advisory committee.
The company had filed a New Drug Application filed for accelerated approval of satraplatin for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. However a vote last week 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.
GPC said that overall survival results from the SPARC trial, which is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with prostate cancer, should be available within six months but “this timing is based on an extrapolation of death rates in the trial and may change”. Chief executive Bernd Seizinger said that “while we were very surprised and disappointed by last week’s ODAC outcome, we need to move forward. Thus, we are focusing our efforts on the overall survival results from the satraplatin SPARC trial and integrating these data into the strongest possible NDA submission”. He added that if these data are positive, “we plan to submit an NDA to the FDA as quickly as possible.”
GPC licensed the rights to satraplatin from Spectrum Pharmaceuticals in 2002 and is responsible for development and regulatory costs, while partner Pharmion Corp has the European rights to the drug. GPC recently announced a licence agreement with Yakult Honsha Co for satraplatin in Japan.
Lawsuit filed over ‘false’ satraplatin claims
The news comes just as the German firm revealed that it has been sued in the US District Court for the Southern District of New York, in a class action lawsuit on behalf of everyone who purchased or acquired securities of GPC between December 5, 2005 and July 24, 2007. The complaint alleges that GPC Biotech violated US federal securities laws by making false public statements relating to the prospects of satraplatin, and thereby artificially inflated the share price.