Abraxis BioScience and Biocon Limited Announce Licensing Agreement for G-CSF in North America and the European Union
July 19 2007 - 3:05PM
Business Wire
Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global
biopharmaceutical company, and Biocon Limited, India�s leading
biotechnology 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. �We are very
excited to enter into this collaboration with Biocon. We believe
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. 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. �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." �We believe that this collaboration will
facilitate affordable access of high-quality supportive care
therapy and proprietary products to cancer patients across the
world," said Dr. Subir Basak, general manager, Business Development
& 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 Biocon�s 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.
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