Healthcare Industry News:  Bristol-Myers Squibb 

Biopharmaceuticals Oncology Regulatory

 News Release - July 14, 2008

Abraxis BioScience Announces Approval to Market ABRAXANE for Metastatic Breast Cancer in China

Approval of ABRAXANE Based on Pivotal Phase III Randomized Trials in the U.S. and China

Company Developing Infrastructure and Alliances in Asia-Pacific Region


LOS ANGELES--(HSMN NewsFeed)--Abraxis BioScience, Inc. (NASDAQ:ABII ), a fully integrated biotechnology company, today announced it has received approval from the China State Food and Drug Administration to market ABRAXANE® Paclitaxel for Injection (Albumin Bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The Phase III clinical trials in the U.S. and China on which this approval was based demonstrated that ABRAXANE doubled the response rate, significantly prolonged time to tumor progression, and in the U.S. trial, significantly improved overall survival versus Taxol® in the approved indication.

Data from the U.S. pivotal head-to-head trial demonstrated that ABRAXANE nearly doubled the overall response rate versus Taxol (33% vs. 19%; P = .001) and achieved a 25% percent improvement in time to tumor progression when compared to Taxol. Furthermore, patients receiving ABRAXANE in the second-line setting had a significantly prolonged survival by an additional 27% compared to solvent-based Taxol. The tolerability with ABRAXANE and Taxol was comparable, despite the 50% greater dose of paclitaxel administered as ABRAXANE.

A second head-to-head trial in Chinese patients with metastatic breast cancer further demonstrated the improved efficacy of ABRAXANE compared to solvent-based Paclitaxel Injection. ABRAXANE significantly improved overall response rate versus solvent-based Paclitaxel Injection (54% vs. 29%; P = <.001) and achieved a 26% percent improvement in progression free survival when compared to solvent-based Paclitaxel Injection (7.6 months vs. 6.2 months; P = 0.118). Both therapies had similar toxicity profiles.

ABRAXANE is now approved for marketing in 35 countries. Abraxis has three issued Chinese patents covering ABRAXANE, as well as five additional pending patent applications in China.

In the Asia-Pacific region, ABRAXANE was approved in India in November 2007 and in Korea in April 2008. ABRAXANE is under regulatory review by the Therapeutic Goods Administration (TGA) in Australia and by the Federal Authority for Healthcare and Social Development Regulation in Russia for the treatment of breast cancer. In March 2008, the Japanese licensee of Abraxis, Taiho Pharmaceutical Co., filed a New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare to market ABRAXANE for the treatment of breast cancer in Japan.

“The approval for ABRAXANE in China provides the most populated country in the world with an important new treatment option for women with metastatic breast cancer,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “With cancer rates on the rise in China, the introduction of a new taxane therapy such as ABRAXANE is particularly important.”

From 2000 to 2005, the incidence of breast cancer in China has increased 25% to 25 out of every 100,000 women. There are approximately 400,000 women with breast cancer in China, with approximately 168,000 new cases of breast cancer reported in China each year. In the commercial center of Shanghai, in 2007, 55 out of every 100,000 women had breast cancer, a 31 percent increase since 1997, and about 45 out of every 100,000 women in Beijing had the disease, representing a 23 percent increase during the past 10 years. According to IMS market data, there were approximately 1.5 million vials of paclitaxel injection (30 mg/vial) sold in China in 2007, representing total market value of $83 million. This represents a 30% increase over 2006, when the total market value of paclitaxel injection was approximately $64 million. The total taxane market in China was approximately $167 million in 2007.

About ABRAXANE®

ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nabTM technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminates the need for solvents in the administration process. Because solvents are not used for administration, ABRAXANE allows for the delivery of a 49% higher dose compared to solvent-based paclitaxel (Taxol®) without compromising safety and tolerability. In a previous randomized Phase III study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumor response rate compared to solvent-based paclitaxel.

ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, and gastric. 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, including Boxed Warning, please visit www.abraxane.com.

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

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-bound chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nabTM platform. The first FDA approved product to use this nabTM 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 approval and launch of ABRAXANE in China. 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, 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; 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, 2007 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.

Taxol® is a registered trademark of Bristol-Myers Squibb Company.


Source: Abraxis BioScience

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