- Offers New Treatment Option for Metastatic Breast Cancer Patients -
LOS ANGELES and TORONTO, June 29 /CNW/ - Abraxis BioScience, Inc.
(NASDAQ: ABII), an integrated biotechnology company, today announced the
listing of ABRAXANE(R) 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
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/m(2)) 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/m(2) 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.
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic
breast cancer which was developed using Abraxis BioScience's proprietary
nab(R) 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(R)), which is based on the company's
proprietary tumor targeting technology known as the nab(R) 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
(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:
(iii) Canadian Cancer Society. Breast cancer: the facts. October 2008.
Available at: http://www.cancer.ca/quebec/about%20us/media%
(iv) Canadian Cancer Society. Breast Cancer Stats. 16 April 2009.
Available at http://www.cancer.ca/canada-wide/about%
For further information:
For further information: Abraxis BioScience, Inc., Maili Bergman, (310)
883-1300, firstname.lastname@example.org; Investors and Media Inquiries:
High Road Communications, Nathalie Bergeron, (514) 908-0110 ext. 308