GPC Biotech of Germany’s stock has collapsed on the news that the firm’s late-stage prostate cancer drug satraplatin has failed to meet its primary goal of overall survival.
The Martinsried-based company and US partner Pharmion Corp announced data from the SPARC Phase III trial which involved 950 patients, which evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment with hormone-refractory prostate cancer. The companies reported that the trial did not achieve the endpoint of overall survival as the median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group.
GPC chief executive Bernd Seizinger said “we are extremely disappointed with the findings” and the firm is currently discussing the plans for the future development of the drug with Pharmion and Yakult, the Japanese firm which signed a licensing deal with GPC for satraplatin in June. The negative news did not come as a massive surprise however, given that July saw the German firm withdraw its marketing application in the USA for the drug after it received a negative response from the US Food and Drug Administration’s Oncologic Drugs Advisory Committee.
The uncertainty surrounding the future of satraplatin forced Germany’s GPC Biotech into a restructuring programme a month later, which will result in a 15% reduction in its workforce. The job cuts will affect 46 workers in the USA.
GPC’s stock has been struggling for some time but the announcement of the negative data has left it in tatters and another attempt to file in the USA is now highly unlikely. The firm’s shares closed at 4.79 euros, a fall of just over 58% and brokers downgraded the stock in droves – down to ‘sell’ from ‘neutral’ at Goldman Sachs, ‘hold’ to ‘sell’ at Deutsche Bank and ‘overweight’ to ‘underweight’ at Lehman Brothers. The latter’s
Peter Welford noted that GPC has to cut costs and reduce its R&D spending significantly but “without further investment in satraplatin clinical trials to pursue the drug in other cancers, we see limited future prospects for the company".
All this has also had a negative effect on Pharmion, whose European marketing application for satraplatin is currently under review. The US firm submitted the filing in June using progression-free survival data and was hoping to add the overall survival results to the file. Chief executive Patrick Mahaffy said “these results are clearly disappointing” and will impact the review, adding that “the key for our European submission now will be to conduct the pre-specified subset analyses and particularly to focus on the impact of prior Taxotere (docetaxel; Sanofi-Aventis’ cancer drug) use, which we know is very important to the European Medicines Agency”.
Also suffering was Spectrum Pharmaceuticals, which licensed the global rights to the drug to GPC in 2002. Its shares fell nearly 8.5% to $3.79.