Biocon teams up with Abraxis BioScience, launches breast cancer drug Abraxane in India

"ABRAXANE is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration)," a press release issued by Biocon said.

"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," it said.

"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 CEO, 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."

"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," said Neil Desai, Ph.D., vice president (research and development), Abraxis BioScience.

"This launch provides breakthrough therapeutics to cancer patients in India," said Kiran Mazumdar-Shaw, chairman and managing director, 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."

ABRAXANE is an important addition, Mazumdar-Shaw said, 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.

"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," said Rakesh Bamzai, president (marketing), Biocon.

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.

ABOUT BIOCON LTD

Biocon Limited is India's pioneer biotechnology enterprise established in 1978. It is also Asia's largest biotechnology company and the only Asian company to feature amongst the top 20 global biotechnology companies in a report released by Med Ad News. 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 Biocon's 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.