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Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Australia Pty Ltd, today announced that approval has been received from the Therapeutic Goods Administration (TGA) in Australia to market ABRAXANE® (nanoparticle albumin-bound paclitaxel) 100 mg powder for injection (suspension) for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. 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. With this approval, ABRAXANE is now cleared for marketing in 36 countries.
"Along with recent approvals in China and South Korea in the Asia-Pacific region, this approval provides an important treatment option for women in Australia with metastatic breast cancer," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "In the US, ABRAXANE has rapidly grown to become the taxane treatment of choice in its approved indication. We are pleased to make ABRAXANE available in the Australian market."
Abraxis will market ABRAXANE in Australia through a strategic relationship with Specialised Therapeutics Australia, Pty Ltd. Based in Melbourne, Specialised Therapeutics Australia plans to launch ABRAXANE in the fourth quarter of 2008. A reimbursement application to the national Pharmaceutical Benefits Scheme has been submitted.
Breast cancer is the most common cancer experienced by women in Australia. Each year, over 13,000 Australian women are diagnosed with breast cancer. By 2011, it is estimated that nearly 14,800 Australian women will be diagnosed with breast cancer each year.
Abraxis has made significant progress in 2008 in expanding the market reach of ABRAXANE in the Asia-Pacific region. In March 2008, Abraxis' partner, Taiho Pharmaceutical Co., Ltd., filed a New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare in Japan to market ABRAXANE for the treatment of breast cancer. The Korean FDA (KFDA) granted marketing approval in April 2008 for ABRAXANE for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease. Green Cross Corporation, the company's partner in Korea, expects to launch ABRAXANE in that country in the first half of 2009. In June Abraxis received approval in China from the China State Food and Drug Administration to market ABRAXANE for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. ABRAXANE is expected to be launched in China in the first half of 2009. In July Biocon Limited and Abraxis launched ABRAXANE in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
ABRAXANE was approved in the European Union in January 2008 for the treatment of metastatic breast cancer after failure of first-line treatment for metastatic disease and in Canada in 2006 for the treatment of metastatic breast cancer including first-line disease.
In 2005, the U.S. Food and Drug Administration (FDA) approved ABRAXANE 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. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study on which 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.
In the U.S., ABRAXANE is co-marketed in collaboration with AstraZeneca Pharmaceuticals LP.
In addition to the review by Ministry of Health, Labour and Welfare in Japan, ABRAXANE is currently under active review in Russia.
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 eliminate the need for solvents in the administration process. Because solvents are eliminated, 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.i
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, gastric, and head and neck.
About Specialised Therapeutics, Pty Ltd
Specialised Therapeutics Australia Pty Ltd (STA) was established to identify and license innovative anti-cancer therapies which may benefit Australians and New Zealanders suffering from this disease. Abraxane is the first of such anti-cancer therapies. Based in Melbourne, Australia, the company is currently negotiating the rights to several more important therapeutic agents for distribution in Australia and New Zealand.
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 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.
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 Australia. 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.
i Abraxane [package insert]. Los Angeles, Calif: Abraxis BioScience, Inc., August 2007.
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