Abraxis BioScience and Specialised Therapeutics Announce Approval to Market ABRAXANE for Metastatic Breast Cancer in New Zealand
July 29 2010 - 5:00AM
Business Wire
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated,
global biotechnology company, and Specialised Therapeutics Ltd.
today announced that MEDSAFE, the New Zealand Medicines and Medical
Devices Safety Authority, has approved for marketing ABRAXANE®
(nanoparticle albumin-bound paclitaxel) for the treatment of
metastatic breast cancer after failure of anthracycline
therapy.
Abraxis BioScience granted exclusive marketing rights to
Specialised Therapeutics for ABRAXANE in New Zealand. Specialised
Therapeutics will commence distribution upon receiving
reimbursement approval of ABRAXANE from the New Zealand
pharmaceutical reimbursement authority, Pharmac. ABRAXANE is
currently fully reimbursed for “Metastatic breast cancer after
failure of prior therapy” in Australia under the Pharmaceutical
Benefits Scheme.
“In the U.S. and Australia ABRAXANE has rapidly become the
taxane treatment of choice in its approved indication,” said
Patrick Soon-Shiong, M.D., Executive Chairman of Abraxis
BioScience. “We are pleased to provide this new treatment option
for women in New Zealand with metastatic breast cancer.”
“ABRAXANE offers a safer and more efficacious taxane therapy for
New Zealand women with metastatic breast cancer,” said Carlo
Montagner, Chief Executive Officer of Specialised Therapeutics.
“Discussions with Pharmac will commence shortly and we hope to make
ABRAXANE available as soon as an agreement with Pharmac is
reached.”
With the approval in New Zealand, ABRAXANE is now approved in 41
countries.
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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