Spectrum Announces Positive Phase 3 Trials for Prostate Cancer Drug
Spectrum Pharmaceuticals (SPPI) announced late on Sunday that the company's phase 3 clinical trials for Satraplatin in patients with Hormone-Refractory Prostate Cancer has met its primary endpoint.
Satraplatin is being co-developed and marketed by GPC Biotech AG (GPCB) of Germany, and Spectrum stands to recieve $20 million upon certain approval requirements in the U.S. and Europe, with further royalties on sale milestones.
The company is anticipating to file a New Drug Application (NDA) in the U.S. at the end of 2006, and the European application in the first half of 2007. Satraplatin had already recieved fast track designation from the FDA, and if it is approved could be marketed in the U.S. in the second half of 2007.
Look for SPPI shares to open up higher on heavy volume, with another spike upwards later on around noon eastern standard time as the company holds its conference call.
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Spectrum Pharmaceuticals (SPPI) announced late on Sunday that the company's phase 3 clinical trials for Satraplatin in patients with Hormone-Refractory Prostate Cancer has met its primary endpoint.
Satraplatin is being co-developed and marketed by GPC Biotech AG (GPCB) of Germany, and Spectrum stands to recieve $20 million upon certain approval requirements in the U.S. and Europe, with further royalties on sale milestones.
The company is anticipating to file a New Drug Application (NDA) in the U.S. at the end of 2006, and the European application in the first half of 2007. Satraplatin had already recieved fast track designation from the FDA, and if it is approved could be marketed in the U.S. in the second half of 2007.
Look for SPPI shares to open up higher on heavy volume, with another spike upwards later on around noon eastern standard time as the company holds its conference call.
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posted by Nico at
11:56 PM
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