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 cancer. This unique product eliminates the need for chemical solvents and allows for higher doses of paclitaxel without compromising safety and tolerability."
Rakesh Bamzai, President- Marketing at Biocon, said, "The launch of ABRAXANE reiterates our belief in strategic licensing partnerships to advance therapeutics in the UAE, and we take great pride in providing oncologists in the UAE with the latest treatment in breast cancer."
Neil Desai, Ph.D., Vice President of Research and Development at Abraxis BioScience, said, "ABRAXANE is the first nanotechnology based anti-cancer drug that is administered as albumin-bound particles of approximately 130 nanometers and takes advantage of albumin, a natural protein that acts as the body's key transporter of nutrients and other water-insoluble molecules and accumulates in tumor tissues. The drug has demonstrated superiority in progression free survival over both Taxol® Injection and Taxotere® Injection in recent randomized clinical trials. The initial clinical trials for ABRAXANE were conducted in India and we are very satisfied to be able to bring this drug to the UAE patients through our partner NeoBiocon."
Sumit Bhanot, Head-Operations and Marketing at NeoBiocon, said, "Cancer rates in the UAE are lower than those seen in Western countries, but are rising with increasing life expectancy and changing lifestyles. The breast is the second most common site of cancer in women after the cervix uteri."
In August 2007, Abraxis established a licensing agreement with Biocon for the commercialization of ABRAXANE in India. Under the terms of the agreement, Biocon has the right to market ABRAXANE in India, Pakistan, Bangladesh, Sri Lanka, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. Subsequently, Abraxis received approval in October 2007 from India's Drug Control General to market ABRAXANE in India.
ABRAXANE is approved for marketing in 35 countries. Abraxis has several pending patent applications in India relating to ABRAXANE. In the Asia-Pacific region, ABRAXANE is approved for marketing in China and Korea in addition to India. ABRAXANE is under regulatory review for the treatment of breast cancer by the Therapeutic Goods Administration (TGA) in Australia, the Federal Authority for Healthcare and Social Development Regulation in Russia, and the Ministry of Health, Labour and Welfare in Japan.