Abraxis Bioscience (MM) (NASDAQ:ABBI)
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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.