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Abu Dhabi, October 9: : NeoBiocon, a recently established biotechnology company and Abraxis BioScience, Inc, a fully integrated biotechnology company, today announced the launch of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in the UAE for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
NeoBiocon is a joint venture between Dr. B.R. Shetty, Managing Director & CEO of Abu Dhabi based company Neopharma and Ms. Kiran Mazumdar-Shaw, Chairman & Managing Director of India’s Biocon Ltd.
ABRAXANE is currently available in the UAE as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration).
The Phase III clinical trial in the U.S. demonstrated that ABRAXANE nearly doubled the response rate, significantly prolonged time to progression, and significantly improved overall survival in the second-line setting versus solvent-based Taxol in the approved indication.
In the U.S. pivotal head-to-head trial, the overall response rate of ABRAXANE was 33% vs. 19% compared to Taxol (P = .001), and ABRAXANE achieved a 25% percent improvement in time to tumor progression (23.0 weeks vs. 16.9 weeks; hazard ratio = 0.75; P = .006) when compared to Taxol. Furthermore, patients receiving ABRAXANE in the second-line setting had a significantly prolonged survival by an additional 27% compared to solvent-based Taxol (56.4 weeks vs. 46.7 weeks; P = 0.24). The tolerability with ABRAXANE and Taxol was comparable, despite the 50% greater dose of paclitaxel administered as ABRAXANE.
"The launch of ABRAXANE in the UAE represents a major strategic step in our plan to provide safer and more effective cancer treatments on a global scale,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “In addition to the UAE, our marketing agreement with Biocon covers more than ten countries, and we are working closely with national authorities throughout the region to receive regulatory approvals and commence marketing activities as soon as practicable.”
Dr. B.R. Shetty, MD and CEO, NMC group remarked, "It gives us immense pleasure to introduce world-class pharmaceutical biotech products, to the United Arab Emirates.” He added, "NeoBiocon is committed to developing a range of products for debilitating disease segments and will offer products that cater to lifestyle disorders and oncology."
“This launch provides breakthrough therapeutics to cancer patients in the UAE,” said Kiran Mazumdar-Shaw, Chairman & Managing Director of Biocon. “ABRAXANE is a significant advance in taxane therapy for the treatment of breast...
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