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

Abstract:
Approval of Innovative Nanoparticle Chemotherapy Based on Data Demonstrating Significant Superiority in Survival in Women with Metastatic Breast Cancer

ABRAXANE European Launch Planned for Mid-2008

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

LOS ANGELES, CA | Posted on January 22nd, 2008

Abraxis BioScience, Inc. (Abraxis) (NASDAQ:ABII), an integrated biotechnology company, today announced that the European Commission has granted marketing approval for ABRAXANE® 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® 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®

ABRAXANE, the first in a new class of protein-bound nanoparticle drugs utilizing the company's proprietary nanoparticle albumin-bound (nab™) 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, Inc.

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 companys portfolio includes the worlds first and only protein-based nanoparticle chemotherapeutic compound (ABRAXANE®) which is based on the companys 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. 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® is a registered trademark of Bristol-Myers Squibb Company.

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

(260 mg/m2)

    Solvent-based paclitaxel

(175 mg/m2)

    p-value
Response rate (%) [95% CI]
> 1st-line therapy     26.5 [18.98, 34.05] (n = 132)     13.2 [7.54, 18.93] (n = 136)     0.006a
 

(1) Median time to disease progression (weeks) [95% CI]

> 1st-line therapy     20.9 [15.7, 25.9] (n = 131)     16.1 [15.0, 19.3] (n = 135)     0.011b
 

(1) Median Progression Free Survival (weeks) [95% CI])

> 1st-line therapy     20.6 [15.6, 25.9] (n = 131)     16.1 [15.0, 18.3] (n = 135)     0.010b
 

(1) Survival (weeks) [95% CI]

> 1st-line therapy     56.4 [45.1, 76.9] (n = 131)     46.7 [39.0, 55.3] (n = 136)     0.020b

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

a Chi-squared test

b Log-rank test

For more information, please click here

Contacts:
Investors and Media Inquiries:
Abraxis BioScience, Inc.
Daniel Saks
Vice President, Investor Relations and Corporate
Communications
310-405-7417
or
Pondel Wilkinson, Inc.
Rob Whetstone, 310-279-5963

Copyright © Business Wire 2008

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