Spectrum Pharma (SPPI) Tops Q4 EPS by 25c
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Spectrum Pharmaceuticals Reports Robust Clinical Data and Strong 2014 Financial Results
March 13, 2015 7:00 AM EDTDevelopment Highlights: 2 Near-term NDAs and 2 Potential Blockbusters
SPI-2012, a novel long-acting GCSF, demonstrated non-inferiority to pegfilgrastim at the 135 µg/kg dose (p= 0.002), and superiority at the 270 µg/kg dose (p= 0.023) in a randomized Phase 2 Study. Phase 3 protocols are being finalized following productive meetings with regulatory agencies in the U.S. and Europe. Poziotinib, a novel pan-HER inhibitor, showed promising Phase 1 data (ORR= 60%) in heavily pretreated breast cancer patients who had failed multiple other HER2-directed therapies. Captisol-Enabled Melphalan, a propylene-glycol free formulation with... More