July 21, 2008 — Biotechnology companies ,Biocon Limited and Abraxis BioScience, Inc., have launched nanotechnology-based ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy. ABRAXANE is now available in India as a single-use 100 mg vial — as a lyophilized powder, to be reconstituted for intravenous administration.
“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,” said Neil Desai, Ph.D., vice president of research and development at Abraxis BioScience. “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 Indian patients through our partner Biocon.”
In October 2007, ABRAXANE was approved by the Drug Controller General of India. The approval was based on the clinical trial data that was the basis of approval in the United States. 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 India 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 India, 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.”
“This launch provides breakthrough therapeutics to cancer patients in India,” 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. The launch of ABRAXANE reiterates our belief in strategic licensing partnerships to advance therapeutics in India, and we take great pride in providing oncologists in India with the latest treatment in breast cancer.”
Ms. Mazumdar-Shaw noted that ABRAXANE is an important addition to Biocon’s Oncotherapeutics portfolio, which has already seen the successful launch of its proprietary antibody, BIOMAb EGFR for the treatment of head and neck cancers.
Rakesh Bamzai, president marketing, Biocon, said, “Presently, more than 100,000 new cases of breast cancer occur in Indian women every year. Breast cancer is the second largest cause of death among women diagnosed with cancer in India. With the launch of ABRAXANE through Biocon’s innovation led Oncotherapeutics division and the growing need for this drug in the country, we look forward to attaining market leadership in this segment.”
Cancer rates in India are lower than those seen in Western countries, but are rising with increasing migration of rural population to the cities, increasing life expectancy and changing lifestyles. The breast is the second most common site of cancer in women after the cervix uteri. In the metropolitan cities of New Delhi and Mumbai, it is the most common kind of cancer in women. The annual age-adjusted rate (AAR) varies between the urban and rural areas. In the urban areas, the AAR is 21.9 to 28.3 per 100,000, whereas in rural areas, it is 8.6 per 100,000.