BioWorld International Correspondent

Following its recent failure to obtain accelerated approval from the FDA for its prostate cancer drug satraplatin, GPC Biotech AG has responded by cutting 46 positions at its Princeton, N.J., site, which represents approximately 15 percent of its payroll.

The Martinsried, Germany-based company is also conserving its cash by freezing spending on external research and on internal development. The two most prominent programs to be affected include 1D09C3, a monoclonal antibody undergoing a Phase I clinical trial, which is in development for treatment of non-Hodgkin's Lymphoma, and a series of cell cycle inhibitors in development for various cancer indications.

The job cuts in Princeton affect personnel working in the company's commercialization, drug development and general and administrative groups. The company is not planning any further redundancies.

"At the moment there are no other plans. We are hoping, of course, this will be it," GPC Biotech spokeswoman Sandra Mills told BioWorld International.

The company will retain more than 130 employees at its clinical development site in Princeton. Earlier this year, it closed a drug discovery site at Waltham, Mass., a move that cut 16 percent, or around 60 members, of its workforce at that point. When the latest lay offs are completed, the company will have some 270 people on its payroll.

GPC's fortunes are riding on its orally available platinum therapy satraplatin, for which it had hoped to gain accelerated approval this year, based on a progression free survival endpoint. The company withdrew its NDA in the wake of a 12-0 recommendation by the FDA's Oncologic Drugs Advisory Committee (ODAC) not to approve that application. It plans to resubmit a dossier using overall survival data from its 950-patient Phase III clinical trial of the drug. (See BioWorld International, Aug. 1, 2007.).

The data are expected by around the year end, and the company is not planning to make any major moves until then. "This is not long to go, so we think it makes sense to wait and see what the data look like," Mills said.

The company also named Martine George as the successor to Marcel Rozencweig in the role of senior vice president, drug development and chief medical officer. Rozencweig will continue as senior vice president, clinical science and drug evaluation and will be responsible for identifying new in-licensing opportunities.