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Biocon Limited and Abraxis Bioscience announce approval 0f Abraxane in India for the treatment of breast cancer
Bangalore, October 18, 2007
Bangalore, India and Los Angeles, Calif (October 18, 2007) – Biocon Limited, India's
leading biotechnology company, and Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated,
global biopharmaceutical company, today announced the approval to market ABRAXANE®
for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)
(albumin-bound) in India for the treatment of breast cancer by the country’s Drug Controller
General. Commercial introduction of ABRAXANE in the Indian market is expected in 2008
following the completion of the appropriate importation certifications.
"The approval of ABRAXANE for the treatment of breast cancer in India is an important step in
providing access to the nab (nanoparticle albumin bound) technology globally,” said Patrick
Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. “In
partnership with Biocon, we are excited to offer physicians in India this important advance in
the treatment of breast cancer.”
Abraxis BioScience will be initiating a worldwide head-to-head Phase III registration trial
comparing weekly ABRAXANE to every three week Taxotere for the treatment of first-line
metastatic breast cancer as well as Phase III trials for the treatment of non-small cell lung
cancer and melanoma. ABRAXANE is currently under active review in Australia, Russia,
China and the European Union by their respective regulatory agencies.
Kiran Mazumdar Shaw, chairman and managing director, Biocon Limited said, “This is a
significant step for Biocon’s innovation led Oncotherapeutics division in our endeavor to bring
new therapeutics for Indian cancer patients. There is a huge need for ABRAXANE in the
treatment of breast cancer in the country and we look forward to attaining market leadership in
this segment.”
ABRAXANE is an important addition 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.
The approval of ABRAXANE in India was based on the clinical trial data that was the basis of
approval in the United States. In that trial, ABRAXANE demonstrated a superior response
rate with an almost doubling of the reconciled target lesion response rate when compared with
Taxol® in a prospectively randomized trial of 460 patients with metastatic breast cancer.
ABRAXANE uses albumin, a human protein, to deliver the active ingredient paclitaxel. Unlike
other chemotherapy treatments, ABRAXANE does not contain chemical solvents which
eliminates the need for pre-medication with steroids or antihistamines often needed to prevent
the toxic side effects associated with solvents. ABRAXANE is administered in 30 minutes (as
compared to three hours for solvent-based paclitaxel).
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.
Forward-Looking Statement
The statements contained in this press release that are not purely historical are forwardlooking
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 its planned clinical trials. 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. These factors include, without
limitation, the fact that results from pre-clinical studies may not be predictive of results to be
obtained in the clinical trial, delays in commencement and completion of the clinical trial,
including slower than anticipated patient enrollment and adverse events occurring during the
clinical trial, 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. Taxol® is a registered trademark of Bristol-Myers Squibb company.
Abraxis BioScience Contact:
Investors and Media: Christine Cassiano, (310) 633-9495
Biocon Limited Contact:
Paula Sengupta/ Gayatri Appaya 20th K.M – Hosur Road, Electronic City P.O., Bangalore 560 100 Tel: +91 80 2808 2808 Fax: +91 80 2852 3423 Email: paula.sengupta@biocon.com gayatri.appaya@biocon.com
Manjulakshmi/Guna Shekar Tel: +91 80 4126 5354 Email : mpanicker@brodeurindia.com vguna@brodeurindia.com
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