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 .
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 (<500 cells/mm3 for 7
days or more) during a course of ABRAXANE therapy, a dose reduction for
subsequent courses is recommended.
Sensory neuropathy occurs frequently with ABRAXANE.
If grade 3 sensory neuropathy develops, treatment should be withheld
until resolution to grade 1 or 2 followed by a dose reduction for all
subsequent courses of ABRAXANE.
Severe cardiovascular events possibly related to single-agent ABRAXANE
occurred in approximately 3% of patients in the randomized trial. These
events included chest pain, cardiac arrest, supraventricular
tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary
embolism, and hypertension.
In the randomized metastatic breast cancer study, the most important
adverse events included alopecia (90%), neutropenia (all cases 80%;
severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia
(any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia
(all 33%; severe 1%), infections (24%), nausea (any 30%; severe 3%),
vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), and
mucositis (any 7%; severe <1%).
Other adverse reactions have included ocular/visual disturbances (any
13%; severe 1%), fluid retention (any 10%; severe 0%), hepatic
dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST
[SGOT] 39%), renal dysfunction (any 11%; severe 1%), thrombocytopenia
(any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%),
cardiovascular reactions (severe 3%), and injection site reactions
(<1%). During postmarketing surveillance, rare occurrences of severe
hypersensitivity reactions have been reported with ABRAXANE.
About Specialised Therapeutics, Pty Ltd
Specialised Therapeutics Australia Pty Ltd (STA) was established to
identify, develop and commercialise innovative anti-cancer and other
specialised therapies for the Australasian market. Currently STA markets
two world leading cancer therapies, ABRAXANE and ALOXI (palonosetron).
Based in Melbourne, Australia, the privately held company is currently
developing several more important therapeutic agents for release in
Australia and New Zealand.
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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 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 41 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 .
FORWARD-LOOKING STATEMENTS
The statements contained in this press release that are not purely
historical are forward-looking 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 the clinical development
plan, and the timing and scope of clinical studies and trials, for
ABRAXANE and the global commercialization of ABRAXANE. 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 other pre-clinical
studies or future clinical trials; delays in commencement and completion
of clinical studies or trials, including slower than anticipated patient
enrollment and adverse events occurring during the clinical trials;
decisions by regulatory authorities regarding whether and when to
approve ABRAXANE for various indications as well as their decisions
regarding labeling and other matters that could affect the availability
or commercial potential of ABRAXANE; unexpected safety, efficacy or
manufacturing issues with respect to ABRAXANE; the need for additional
data or clinical studies for ABRAXANE; regulatory developments (domestic
or foreign) involving the company's manufacturing facilities; the market
adoption and demand of ABRAXANE, the costs associated with the ongoing
launch of ABRAXANE; research and development associated with the nab®
technology platform; the impact of pharmaceutical industry
regulation; the impact of competitive products and pricing; the
availability and pricing of ingredients used in the manufacture of
pharmaceutical products; the ability to successfully manufacture
products in a time-sensitive and cost effective manner; the acceptance
and demand of new pharmaceutical products; 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 the
company's Annual Report on Form 10-K for the year ended December 31,
2009 and in 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.
