Biocon and Abraxis BioScience launch ABRAXANE in India for breast cancer
http://www.forbes.com/businesswire/feeds/businessw [2008-7-21]
Tag : natural paclitaxel
Biocon Limited, India's pioneering biotechnology company, andAbraxis BioScience, Inc. (NASDAQ:ABII), a fully integratedbiotechnology company, today announced the launch of ABRAXANE(R)(paclitaxel protein-bound particles for injectable suspension)(albumin-bound) in India for the treatment of breast cancer afterfailure of combination therapy for metastatic disease or relapsewithin six months of adjuvant chemotherapy. ABRAXANE is nowavailable in India as a single-use 100 mg vial (as a lyophilizedpowder, to be reconstituted for intravenous administration).
In October 2007, ABRAXANE was approved by the Drug ControllerGeneral of India. The approval was based on the clinical trial datathat was the basis of approval in the United States. The Phase IIIclinical trial in the U.S. demonstrated that ABRAXANE nearlydoubled the response rate, significantly prolonged time toprogression, and significantly improved overall survival in thesecond-line setting versus solvent-based Taxol(R) in the approvedindication.
In the U.S. pivotal head-to-head trial, the overall response rateof ABRAXANE was 33% vs. 19% compared to Taxol (P = .001), andABRAXANE achieved a 25% percent improvement in time to tumorprogression (23.0 weeks vs. 16.9 weeks; hazard ratio = 0.75; P =.006) when compared to Taxol. Furthermore, patients receivingABRAXANE in the second-line setting had a significantly prolongedsurvival by an additional 27% compared to solvent-based Taxol (56.4weeks vs. 46.7 weeks; P = 0.24). The tolerability with ABRAXANE andTaxol was comparable, despite the 50% greater dose of paclitaxeladministered as ABRAXANE.
Biocon Limited, India's pioneering biotechnology company, andAbraxis BioScience, Inc. (NASDAQ:ABII), a fully integratedbiotechnology company, today announced the launch of ABRAXANE(R)(paclitaxel protein-bound particles for injectable suspension)(albumin-bound) in India for the treatment of breast cancer afterfailure of combination therapy for metastatic disease or relapsewithin six months of adjuvant chemotherapy. ABRAXANE is nowavailable in India as a single-use 100 mg vial (as a lyophilizedpowder, to be reconstituted for intravenous administration).
In October 2007, ABRAXANE was approved by the Drug ControllerGeneral of India. The approval was based on the clinical trial datathat was the basis of approval in the United States. The Phase IIIclinical trial in the U.S. demonstrated that ABRAXANE nearlydoubled the response rate, significantly prolonged time toprogression, and significantly improved overall survival in thesecond-line setting versus solvent-based Taxol(R) in the approvedindication.
In the U.S. pivotal head-to-head trial, the overall response rateof ABRAXANE was 33% vs. 19% compared to Taxol (P = .001), andABRAXANE achieved a 25% percent improvement in time to tumorprogression (23.0 weeks vs. 16.9 weeks; hazard ratio = 0.75; P =.006) when compared to Taxol. Furthermore, patients receivingABRAXANE in the second-line setting had a significantly prolongedsurvival by an additional 27% compared to solvent-based Taxol (56.4weeks vs. 46.7 weeks; P = 0.24). The tolerability with ABRAXANE andTaxol was comparable, despite the 50% greater dose of paclitaxeladministered as ABRAXANE.
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