Bangalore, India and Los Angeles, California:
July 18, 2008
Biocon Limited, India's pioneering biotechnology company, and Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced the launch of 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).
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.
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 Indian patients through our partner Biocon."
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.
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.
ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nabTM technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Because solvents are eliminated, ABRAXANE allows for the delivery of a 49% higher dose compared to solvent-based paclitaxel (Taxol®) without compromising safety and tolerability. ABRAXANE is administered in 30 minutes (as compared to three hours for solvent-based paclitaxel).
ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, and gastric. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. For the full prescribing information for ABRAXANE, including Boxed Warning, please visit www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience and is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca.
About Biocon Limited
Biocon Limited is India's pioneer biotechnology enterprise established in 1978. Biocon and its two subsidiaries, Syngene and Clinigene form a fully integrated biotechnology enterprise, with specialized focus on biopharmaceuticals, contract research and clinical research. Strategic international acquisitions, such as acquiring a majority in the German pharmaceutical company, AxiCorp, have given Biocon wider global access and greater market penetration. Many of our products have USFDA and EMEA acceptance.
Biocon's proprietary technologies have been used effectively in diabetology, oncology, cardiology, nephrology and other therapeutic treatments. The company's robust drug discovery pipeline offers novel therapies on a platform of affordable innovation. Biocon launched the world's first recombinant human insulin, INSUGEN® in November 2004 using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFR™ in September 2006.
About Abraxis BioScience
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nabTM platform. The first FDA approved product to use this nabTM platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the launch of ABRAXANE in India. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE; the need for additional data or clinical studies for ABRAXANE; regulatory developments (domestic or foreign) involving the company’s manufacturing facilities; the market adoption and demand of ABRAXANE, the costs associated with the ongoing launch of ABRAXANE; the impact of pharmaceutical industry regulation; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; the ability to successfully manufacture products in a time-sensitive and cost effective manner; the acceptance and demand of new pharmaceutical products; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2007 and in other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
Taxol® is a registered trademark of Bristol-Myers Squibb Company.
Taxotere® is a registered trademark of Sanofi-Aventis.