Abraxis Receives Approval from EU Commission to Market ABRAXANE for Metastatic Breast Cancer in Europe

22/01/2008 - 13:15

Abraxis BioScience, Inc. (Abraxis) (NASDAQ:ABII), an integrated
biotechnology company, today announced that the European Commission
has granted marketing approval for ABRAXANE(R) powder for suspension
for infusion (an albumin-bound nanoparticle formulation of paclitaxel)
for the treatment of metastatic breast cancer in patients who have
failed first-line treatment for metastatic disease and for whom
standard, anthracycline-containing therapy is not indicated. The Phase
III clinical trial results on which this approval was based
demonstrated that ABRAXANE doubled the response rate and significantly
prolonged progression-free survival and overall survival versus
Taxol(R) in the approved indication.

"ABRAXANE provides a much-needed new treatment option for women
with metastatic breast cancer in Europe," said principal clinical
trial investigator William J. Gradishar, M.D., Professor of Medicine,
Northwestern University, Feinberg School of Medicine, and Division of
Hematology and Medical Oncology and Co-Director, Lynn Sage Breast
Cancer Program at Northwestern Memorial Hospital. "Given the superior
patient outcomes demonstrated in two Phase III clinical trials,
ABRAXANE has become the taxane therapy of choice for oncologists in
the US in this setting."

ABRAXANE is now approved in 33 countries including the U.S. and
Canada. In Europe, there are approximately 300,000 cases of metastatic
breast cancer. The product is currently under active review in
Australia, Russia, Korea and China by their respective regulatory
agencies.

"For the first time, European women with advanced breast cancer
will have access to this novel nanoparticle taxane-based therapy,"
said Martine Piccart-Gebhart, M.D., PhD, Professor in Oncology,
Universite Libre de Bruxelles and Head of the Chemotherapy Department
at the Jules Bordet Institute. "Not only do women with breast cancer
benefit from the efficacy of this new drug, it is also more convenient
to administer and is well tolerated."

"The increased progression-free survival and overall patient
survival in the approved indication constitute a significant advance
that will benefit women with advanced breast cancer," said Professor
Gunter von Minckwitz, Director the German Breast Group, Neu-Isenburg
and Senior Physician at the University Women´s Hospital Frankfurt.

Abraxis BioScience, which is in the process of establishing its
European infrastructure, currently expects to launch ABRAXANE across
Europe in mid-2008. The process of receiving country-specific label
approvals is underway in several European countries. Abraxis expects
the launch of ABRAXANE in Europe to materially contribute to revenues
beginning in 2009. As previously announced, 2008 expenditures to
establish a European infrastructure for ABRAXANE are expected to be
approximately $30 million.

"The approval for ABRAXANE in Europe demonstrates the widespread
confidence in ABRAXANE and its ability to provide physicians and
patients in Europe a new, efficacious alternative in the fight against
cancer. We look forward to expanding our market presence for ABRAXANE
in countries around the world," said Patrick Soon-Shiong, M.D.,
chairman and chief executive officer of Abraxis BioScience.

In the Phase III clinical trial upon which European marketing
approval was based, ABRAXANE demonstrated significant superiority in
the clinical endpoints of response rate, progression free survival and
overall survival when compared with Taxol (paclitaxcel) in patients
for whom the drug is indicated. (See table below.)

Data from the pivotal head-to-head trial results demonstrated that
ABRAXANE nearly doubled the overall target lesion response rate versus
Taxol and achieved a 37 percent improvement in progression-free
survival when compared to Taxol. In addition, time to tumor
progression versus Taxol was significantly prolonged in patients
receiving ABRAXANE. The tolerability with ABRAXANE and Taxol was
comparable, despite the 50% greater dose of paclitaxel administered as
ABRAXANE. Neutropenia was lower with ABRAXANE compared to Taxol.
Although there was an increase in incidence of grade 3 peripheral
neuropathy, time to improvement was improved compared to that reported
for Taxol. No adverse events were reported that were not already known
for paclitaxel.

About ABRAXANE(R)

ABRAXANE, the first in a new class of protein-bound nanoparticle
drugs utilizing the company´s proprietary nanoparticle albumin-bound
(nab(TM)) technology, is currently in various stages of development
for the treatment of the following cancers: first-line metastatic
breast, non-small cell lung, malignant melanoma, pancreatic, gastric,
and head and neck.

The U.S. Food and Drug Administration (FDA) approved ABRAXANE for
Injectable Suspension (paclitaxel protein-bound particles for
injectable suspension) (albumin-bound) in 2005 for the treatment of
breast cancer after failure of combination chemotherapy for metastatic
disease or relapse within six months of adjuvant chemotherapy.
ABRAXANE was approved in Canada in 2006 for the treatment of
metastatic breast cancer including first-line disease. The product is
currently under active review in Australia, Russia, Korea and China by
their respective regulatory agencies. ABRAXANE is the fastest growing
taxane in its indication in the U.S. and is used in approximately
5,000 patients with metastatic breast cancer per month in North
America.

ABRAXANE uses albumin, a human protein, to deliver the active
ingredient paclitaxel. Unlike other chemotherapy treatments, ABRAXANE
does not contain chemical solvents, which eliminates the need for
pre-medication with steroids or antihistamines often needed to prevent
the toxic side effects associated with solvents. ABRAXANE is
administered in 30 minutes as compared to three hours for
solvent-based paclitaxel.

Prior therapy should have included an anthracycline unless
clinically contraindicated. The most serious adverse events associated
with ABRAXANE in the randomized metastatic breast cancer study for
which FDA approval was based included neutropenia, anemia, infections,
sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other
common adverse reactions included anemia, asthenia, diarrhea,
ocular/visual disturbances, fluid retention, alopecia, hepatic
dysfunction, mucositis and renal dysfunction. For the full prescribing
information for ABRAXANE, please visit www.abraxane.com.

ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE is
marketed in the United States under a co-promotion agreement between
Abraxis and AstraZeneca Pharmaceuticals LP.

About Abraxis BioScience

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-based nanoparticle chemotherapeutic compound (ABRAXANE(R))
which is based on the company´s proprietary tumor targeting technology
known as the nab(TM) platform. The first FDA approved product to use
this nab platform, ABRAXANE(R), was launched in 2005 for the treatment
of metastatic breast cancer. 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.

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 launch
of ABRAXANE in Europe. 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 market launch of ABRAXANE in Europe, the impact of pharmaceutical
industry regulation, the impact of competitive products and pricing,
the acceptance and demand of new pharmaceutical products, the impact
of patents and other proprietary rights held by competitors and other
third parties. Additional relevant information concerning risks can be
found in Abraxis BioScience´s Form 10 registration statement and other
filings 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.

Taxol(R) is a registered trademark of Bristol-Myers Squibb
Company.

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*T
Table 1: Results for overall response rate, median time to disease
progression, progression-free survival, and overall survival as
assessed by the investigator
----------------------------------------------------------------------
Efficacy variable Abraxane Solvent-based p-value
(260 mg/m2) paclitaxel
(175 mg/m2)
----------------------------------------------------------------------
Response rate (%) (95% CI)
----------------------------------------------------------------------
> 1st-line therapy 26.5 (18.98, 13.2 (7.54, 18.93) 0.006(a)
34.05) (n = 132) (n = 136)
----------------------------------------------------------------------

(1) Median time to disease progression (weeks) (95% CI)
----------------------------------------------------------------------
> 1st-line therapy 20.9 (15.7, 25.9) 16.1 (15.0, 19.3) 0.011(b)
(n = 131) (n = 135)
----------------------------------------------------------------------

(1) Median Progression Free Survival (weeks) (95% CI))
----------------------------------------------------------------------
> 1st-line therapy 20.6 (15.6, 25.9) 16.1 (15.0, 18.3) 0.010(b)
(n = 131) (n = 135)
----------------------------------------------------------------------

(1) Survival (weeks) (95% CI)
----------------------------------------------------------------------
> 1st-line therapy 56.4 (45.1, 76.9) 46.7 (39.0, 55.3) 0.020(b)
(n = 131) (n = 136)
----------------------------------------------------------------------
*T

(1) This data is based on Clinical Study Report: CA012-) Addendum
dated Final (23 March-2005)

(a) Chi-squared test

(b) Log-rank test