Abraxis BioScience Announces Licensing Agreement with Biocon Limited for the Commercialization of ABRAXANE in India
August 08 2007 - 10:35PM
Business Wire
Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global
biopharmaceutical company, today announced a licensing agreement
with Biocon Limited, India�s leading biotechnology company, for the
commercialization of ABRAXANE� (paclitaxel protein-bound particles
for injectable suspension) (albumin-bound) in India. Under the
terms of the agreement, Biocon will also have the right to market
ABRAXANE in Pakistan, Bangladesh, Sri Lanka, the United Arab
Emirates, Saudi Arabia, Kuwait and certain other South Asian and
Persian Gulf countries. As part of this agreement, Abraxis will
receive royalties from Biocon based on net sales of ABRAXANE in
these countries. �This agreement is an important step in the
development of a global commercialization framework that
incorporates unique country-by-country needs,� said Bruce Wendel,
executive vice president, Corporate Development for Abraxis
BioScience. �Importantly, we are pleased that this partnership with
Biocon affords us the opportunity to bring ABRAXANE, an important
advance in chemotherapy, to these countries while broadening our
existing relationship with Biocon, one of the leading biotechnology
companies in India.� In July�2007, Abraxis submitted to India�s
Ministry of Health�and Family Welfare an application to market
ABRAXANE in India for the treatment of breast cancer. About
ABRAXANE� The U.S. Food and Drug Administration approved ABRAXANE�
for Injectable Suspension (paclitaxel protein-bound particles for
injectable suspension) (albumin-bound) in January 2005 for the
treatment of breast cancer after failure of combination
chemotherapy for metastatic disease or relapse within six months of
adjuvant chemotherapy. Prior therapy should have included an
anthracycline unless clinically contraindicated. 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�, please visit www.abraxane.com. ABRAXANE
was developed by Abraxis BioScience, Inc. ABRAXANE is marketed in
the United States under a co-promotion agreement between Abraxis
and AstraZeneca Pharmaceuticals LP. 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.
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