ABRAXANE Approved for Advanced Breast Cancer Patient Treatment in Quebec

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Mon Jun 29, 2009 8:05am EDT

- Offers New Treatment Option for Metastatic Breast Cancer Patients -
LOS ANGELES & TORONTO--(Business Wire)--
Abraxis BioScience, Inc. (NASDAQ:ABII), an integrated biotechnology company,
today announced the listing of ABRAXANE® for Injectable Suspension (paclitaxel
protein-bound particles for injectable suspension) (albumin-bound) 100 mg in
Quebec for the treatment of metastatic breast cancer with a recommendation from
the Quebec Conseil du Médicament and approval from the Quebec Ministry of
Health. ABRAXANE is approved and commercially available in Canada for the
treatment of metastatic breast cancer, including first-line disease. The listing
of ABRAXANE in Quebec offers an important new treatment option to Quebec women
with advanced breast cancer. 

"Based on clinical study results to date and my first-hand experience, I believe
that ABRAXANE represents a very important and needed new treatment option for
breast cancer," said Dr. André Robidoux, Director of the Breast Cancer Research
Group of the CHUM Research Center. "ABRAXANE is the only taxane that is solvent
free and is approved to treat metastatic breast cancer." 

The Conseil`s approval was based upon comparative clinical trials demonstrating
the tumor response rate of ABRAXANE was nearly double for patients who received
ABRAXANE compared to those who received solvent-based paclitaxel. Patients
treated with ABRAXANE experienced a significant improvement in progression-free
survival and prolonged time to tumor progression compared to patients treated
with solvent-based paclitaxel.i Additionally, a recently published Phase II
study demonstrated that ABRAXANE (administered weekly at 150 mg/m2) nearly
doubled progression-free survival over docetaxel injection (14.6 months versus
7.8 months respectively p=0.012).ii ABRAXANE is indicated in Canada at a dose of
260 mg/m2 every three weeks for the treatment of metastatic breast cancer. 

ABRAXANE uses the natural properties of a human protein, albumin, to deliver the
drug more effectively to tumors. By wrapping the albumin around the active drug,
ABRAXANE can be administered to patients at higher doses without the use of
toxic solvents - often the cause of significant treatment-related side effects
with other taxane chemotherapies. Unlike most taxane chemotherapies, ABRAXANE
eliminates the patient`s need for premedication during treatment to avoid
allergic reactions caused by solvents . Additionally, patients can receive
treatment in as little at 30 minutes compared to more than three hours needed
for solvent-based paclitaxel. 

"With this approval, Quebec doctors and patients now have another effective
treatment option to help women in their fight against advanced breast cancer,"
said Lyndal Walker, Vice President and Managing Director, Abraxis BioScience
Canada. 

According to Canadian Cancer Society statistics, an estimated 5,900 Quebec women
were diagnosed with breast cancer in 2008.iii With an average of 437 women
diagnosed with breast cancer every week, breast cancer is the second leading
cause of cancer mortality among Canadian women.iv

ABRAXANE has now been approved in 36 countries across Europe, North America,
Asia and Australia. Abraxis is continuing to expand its clinical experience with
ABRAXANE and its potential in treating a variety of tumor types at multiple
stages of disease as a single agent and in combination. 

About ABRAXANE®

ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast
cancer which was developed using Abraxis BioScience's proprietary nab®
technology platform. This protein-bound chemotherapy agent combines paclitaxel
with albumin, a naturally-occurring human protein. By wrapping the albumin
around the active drug, ABRAXANE can be administered to patients at higher
doses, delivering higher concentrations of paclitaxel to the tumor site than
solvent-based paclitaxel. ABRAXANE is currently in various stages of
investigation for the treatment of the following cancers: expanded applications
for metastatic breast, non-small cell lung, malignant melanoma, pancreatic,
gastric and head and neck. 

In June 2006 ABRAXANE was approved by Therapeutic Products Directorate of Health
Canada under a Notice of Compliance for the treatment of metastatic breast
cancer in Canada.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. 

About Abraxis BioScience, Inc.

Abraxis BioScience is a fully integrated global biotechnology company dedicated
to the discovery, development and delivery of next-generation therapeutics and
core technologies that offer patients safer and more effective treatments for
cancer and other critical illnesses. The company's portfolio includes the
world's first and only protein-bound nanoparticle chemotherapeutic compound
(ABRAXANE®), which is based on the company's proprietary tumor targeting
technology known as the nab® platform. The first FDA approved product to use
this nab platform, ABRAXANE, was launched in 2005 for the treatment of
metastatic breast cancer and is now approved in 36 countries. The company
continues to expand the nab platform through a robust clinical program and deep
product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol
ABII. For more information about the company and its products, please visit
www.abraxisbio.com. 

i Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle
albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel
in women with breast cancer. J. Clin Oncol. 2005;23(31):7794-803. 

ii Gradishar et al. Significantly Longer Progression-Free Survival With
nab-Paclitaxel Compared With Docetaxel As First-Line Therapy for Metastatic
Breast Cancer. J Clin Oncol. 2009; 0: JCO.2008.18.5397v1. 

iii Canadian Cancer Society. Breast cancer: the facts. October 2008. Available
at:
http://www.cancer.ca/quebec/about%20us/media%20centre/~/media/CCS/Quebec/Qui_sommes_nous/Salle_des_nouvelles/Feuilles_de_faits/Cancer_du_sein_Faits2008_QC-ang.ashx

iv Canadian Cancer Society. Breast Cancer Stats. 16 April 2009. Available at
http://www.cancer.ca/canada-wide/about%20cancer/cancer%20statistics/stats%20at%20a%20glance/breast%20cancer.aspx?sc_lang=.




Abraxis BioScience, Inc.
Maili Bergman
310-883-1300
investorrelations@abraxisbio.com
or
Investors and Media Inquiries
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Carrie Baker
416-644-2264 

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