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FDA delay forces cutbacks at GPC Biotech

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Struggling to overcome FDA hurdles for its cancer drug satraplatin, Germany's GPC Biotech says it will slash its staff by 15 percent and ratchet down research and development costs. An FDA advisory committee opted to delay approval until the company can deliver final data on patient survival, which GPC has estimated would take six months. To survive the delay, the biotech is handing out 46 pink slips among its 316 employees. GPC licensed satraplatin five years ago, agreeing to take on development and regulatory costs. As part of the restructuring, GPC says it will slow down--for a while anyway--its work on its 1D09C3 monoclonal antibody and cell cycle inhibitors. 

As part of a planned succession, Dr. Martine George is succeeding Dr. Marcel Rozencweig as senior vice president of drug development and chief medical officer. Dr. Rozencweig will remain with the company in the new role of senior vice president, clinical science and drug evaluation.

- check out the release

Related Articles:
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Shares surge as satraplatin succeeds in Phase III. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report


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More stories about 1D00C3   Drug Development   FDA   chief medical officer   monoclonal antibody   Darmstadt Germany   Cancer Drugs   development costs   GPC Biotech   satraplatin   job cuts   FDA regulation