Celgene retracted application for satraplatin because CHMP’s review suggested that the drug could not be approved.
GPC Biotech’s satraplatin franchise suffered another defeat when its European partner deciding to withdraw the MAA for the cancer drug. European approval was one of GPC’s last remaining hopes to make money on satraplatin in the near term.
GPC sold European marketing rights to Pharmion, which is now part of Celgene. Celgene decided to retract the application after EMEA’s advisory panel suggested that the compound is not currently approvable. The MAA covered the use of satraplatin plus prednisone for hormone-refractory prostate cancer in patients whose chemotherapy had failed.
This decision was based on a list of outstanding issues received following review by the Committee for Medicinal Products for Human Use. The committee’s opinion was that the application is currently not approvable based on the information provided.
Under the terms of the deal with Pharmion, GPC would have received royalties on satraplatin once sanctioned in Europe. Last year GPC itself withdrew the NDA for the drug in the U.S. after an FDA committee advised that the agency wait for more survival information. The application was for accelerated approval in the same indication.
GPC has since gone through a few rounds of restructuring, losing 253 employees, or 80% of its workforce. The firm is now looking to be acquired. Its value dropped from almost $32 per share to $13.35 the day after the U.S. advisory panel made its review to within the $2.5 to $7 range in the last eight months.
