Bangalore India/LOS ANGELES, July 19, 2007
Biocon Limited, India's leading biotechnology company and Abraxis BioScience,Inc.(NASDAQ ABBI), an integrated, global biopharmaceutical company, today announced an agreement wherein Abraxis will license the right to develop a biosimilar version of G-CSF (Granulocyte-Colony Stimulating Factor) in North America and the European Union. Under the terms of the agreement, Biocon will receive an upfront licensing fee and, following approval in the licensed territories, royalties from Abraxis BioScience. Detailed financial terms of the agreement were not disclosed.
Abraxis Bioscience is an ideal partner for Biocon as we increase our focus on oncology. We are confident that both partners will realize success in attaining market leadership for G-CSF in their respective markets, said Kiran Mazumdar-Shaw, chairman and managing director of Biocon Limited.
The present licensing arrangements will certainly pave the way to other opportunities in the foreseeable future. G-CSF is an haematopoietic growth factor that works by encouraging the bone marrow to produce more white blood cells. Therapeutic G-CSF is primarily used for the treatment of neutropenia, the lowering of the white blood cells that fight infections.
Biocon has received regulatory approval from the Indian DCGI for the treatment of neutropenia in cancer patients and intends to launch the product in India through its Oncotherapeutics division. We are very excited to enter into this collaboration with Biocon. We believe that this partnership allows us to participate in the emerging biosimilars market and build a new platform for growth. said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience.
We believe that this collaboration will facilitate affordable access of high-quality supportive care therapy to cancer patients across the world, said Dr. Subir Basak, general manager, Business Development and Oncotherapeutics SBU Head, Biocon Limited.
The biological activity of Biocon's G-CSF used in clinical trials was evaluated by NIBSC National Institute of Biological Standards and Control, UK, which provides independent testing of biological medicines.
The NIBSC found that the potency of Biocons drug met the necessary requirements of a biosimilar G-CSF.
About Biocon Limited
Established in 1978, Biocon Limited is one of India's premier biotechnology companies. Biocon and its two subsidiary companies, Syngene International Ltd and Clinigene International Ltd form a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research, clinical research and enzymes. With successful initiatives in clinical development, bio-processing and global marketing, Biocon delivers products and solutions to partners and customers across the globe. Many of these products have USFDA and EMEA acceptance.
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-EGFRTM. Visit us at www.biocon.com
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq Global Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.
FORWARD LOOKING STATEMENT
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 development of the licensed intellectual property portfolio. 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. The development of the licensed intellectual property portfolio could be affected by a number of factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing 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 Abraxis BioScience's Form 10-K for the year ended December 31, 2006 and 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.