ABRAXANE® Approved for Marketing in Japan for Breast Cancer
July 23 2010 - 9:00AM
Business Wire
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated,
global biotechnology company, today announced that Taiho
Pharmaceutical Co., Ltd. has received approval from the Ministry of
Health, Labor and Welfare to market ABRAXANE® IV Infusion 100 mg,
Paclitaxel Injection (Suspension with Albumin), for use in the
treatment of breast cancer. The New Drug Application (J-NDA) for
ABRAXANE was filed with the Ministry of Health, Labor and Welfare
in 2008.
In 2005, Abraxis entered into a license agreement with Taiho
Pharmaceutical, a leading company within the Otsuka Holdings Group,
under which Abraxis granted to Taiho the exclusive rights to market
and sell ABRAXANE in Japan. Abraxis and Taiho are also developing
ABRAXANE in Japan for the treatment of lung and gastric cancer and
other solid tumors.
“The approval to market ABRAXANE in Japan is a major step
forward to providing breast cancer patients with a new treatment
option,” said Patrick Soon-Shiong, M.D., Executive Chairman of
Abraxis BioScience. “Our partner Taiho is working diligently to
make the necessary final arrangements to launch ABRAXANE later this
year. We commend their accomplishments and the tremendous
cooperative efforts of our team and look forward to working closely
with them so that ABRAXANE is widely and readily available to
patients.”
With the approval in Japan, ABRAXANE is now approved in 40
countries. There are approximately 50,000 cases of breast cancer in
Japan.
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 and gastric.
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. For the full
prescribing information for ABRAXANE please visit
http://www.abraxane.com.
About nab®-Driven Chemotherapy
Abraxis BioScience has developed a proprietary nanoparticle
albumin-bound (nab) technology which leverages albumin
nanoparticles for the active and targeted delivery of
chemotherapeutics to the tumor. This nab-driven chemotherapy
provides a new paradigm for penetrating the blood-stroma barrier to
reach the tumor cell. The proposed mechanism of delivery of this
nab-driven chemotherapy is thought to be by targeting a previously
unrecognized tumor-activated, albumin-specific biologic pathway
with a nanoshell of the human blood protein albumin. This
nano-shuttle system is believed to activate an albumin-specific
(Gp60) receptor-mediated transcytosis path through the cell wall of
proliferating tumor cells, using caveolin-1 activated caveolar
transport. Once in the stromal micro-environment, the albumin-bound
drug may be preferentially localized by a second albumin-specific
binding protein, SPARC, a protein secreted into the stroma by tumor
cells. The resulting collapse of stroma surrounding the tumor cell
may thus enhance the delivery of the nab-chemotherapeutic to the
intracellular core of the tumor cell itself.
IMPORTANT SAFETY INFORMATION
The use of ABRAXANE has not been studied in patients with
hepatic or renal dysfunction. In the randomized controlled trial,
patients were excluded for baseline serum bilirubin >1.5 mg/dL
or baseline serum creatinine >2 mg/dL.
ABRAXANE can cause fetal harm when administered to a pregnant
woman. Women of childbearing potential should be advised to avoid
becoming pregnant while receiving treatment with ABRAXANE.
Men should be advised to not father a child while receiving
treatment with ABRAXANE.
It is recommended that nursing be discontinued when receiving
ABRAXANE therapy.
ABRAXANE contains albumin (human), a derivative of human
blood.
Caution should be exercised when administering ABRAXANE
concomitantly with known substrates or inhibitors of CYP2C8 and
CYP3A4.
ABRAXANE therapy should not be administered to patients with
metastatic breast cancer who have baseline neutrophil counts of
less than 1,500 cells/mm3. It is recommended that frequent
peripheral blood cell counts be performed on all patients receiving
ABRAXANE. Patients should not be retreated with subsequent cycles
of ABRAXANE until neutrophils recover to a level >1,500
cells/mm3 and platelets recover to a level >100,000
cells/mm3
In the case of severe neutropenia (
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