March 31, 2008
Last week, development-stage drugmaker GPC Biotech (Nasdaq: GPCB ) released its year-end financial results after a 2007 in which the FDA depth-charged its lead drug.
GPC is best known for its oral chemotherapy drug candidate Satraplatin. Before this year, Satraplatin was in phase 3 testing for treatment for late-stage prostate cancer. After showing what GPC described as a successful interim progression-free survival benefit with the drug in phase 3 testing, it filed for FDA and European Union marketing approval for the drug last year.
Shares of GPC biotech zigged significantly lower later in the year, after an FDA advisory panel recommended that the drug not be approved until overall survival results from its ongoing phase 3 study came through. Shares of GPC zagged even lower three months later, when those overall survival results came back negative (after showing a previously positive trend).
Based on these events, GPC pulled its FDA marketing application for the drug and cut its workforce significantly to reduce cash burn. GPC isn't giving up on Satraplatin yet, though. A European Union marketing application for the drug from partner Celgene (Nasdaq: CELG ) is still awaiting a European Medicines Agency decision, which GPC guided to come in the second half of this year. GPC also plans on testing Satraplatin in multiple phase 1 studies in a range of cancer indications as well.
GPC is trying to rise from the dead, even though its share price (trading just above its cash level) is indicating a less than enthusiastic level of investor sentiment toward the drugmaker. It still has around $100 million in cash on its balance sheet and GPC has (somewhat unrealistically) forecast that this will last it another three years. In the meantime, the company will work on Satraplatin and other oncology drug candidates like its kinase inhibitor that's expected to enter the clinic this year.