Abraxane to be made available without charge

Monday April 6th 2009

A new breast cancer treatment option can improve survival time and reduce treatment side effects. This new nanoparticle chemotherapy listed on the Pharmaceutical Benefits Scheme shows longer survival in women with metastatic breast cancer.

The new treatment is called Abraxane® (nanoparticle albumin-bound paclitaxel) and it is approved for the treatment of metastatic carcinoma of the breast after the failure of anthracycline therapy (ie, chemotherapy)1.

The published studies on which approval has been based describe Abraxane as "an important advance in the treatment of metastatic breast cancer"2. A study examining survival rates shows that women treated with Abraxane survived 24% longer than women treated with solvent-based (cremophor-EL) paclitaxel, a current global standard of care in the treatment of metastatic breast cancer3. Compared to solvent-based paclitaxel, Abraxane also showed significantly higher patient response rates2.

Abraxane is the first solvent-free taxane available to women with metastatic breast cancer as a treatment option, therefore eliminating solvent induced toxicities such as severe hypersensitivity reactions and fatal anaphylaxis5. It is also the first nanoparticle drug to be approved by the Therapeutic Goods Administration.

Over 80 Australian patients have already been treated with Abraxane free of charge following the launch of a company-sponsored "Abraxane Patient Access Program" (APAP) which began in February 2009.

Australian medical oncologist Associate Professor Fran Boyle from the Mater Hospital in Sydney said that new, more effective options are always welcomed by oncology specialists in Australia.

"Many women have problems tolerating some existing chemotherapies, due to the corticosteroids required to minimise severe hypersensitivity reactions so it is a pleasing addition to the oncologists. drug armamentarium," said Associate Professor Boyle. "However, women who are currently deriving benefit from their existing chemotherapy should not change their therapy. They should discuss this new treatment option with their oncologist".

International oncologist Professor Hope Rugo from the University of California, San Francisco, says the treatment is a welcome addition to the current range of breast cancer treatments available to Australian women.

"The key to better treatment is finding therapies that delay the advance of the tumour, improve patient survival outcomes and, in the case of those chemotherapies that require pre-medication with cortico-steroids, reducing cortico-steroid and solvent-related side effects. The published clinical data and clinical experience in the US suggests Abraxane is going to satisfy those criteria," said Professor Rugo.

About ABRAXANE ®

ABRAXANE is a solvent-free, nanoparticle chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nabTM technology platform, ABRAXANE is a nanoparticle 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. Nanoparticle technology allows ABRAXANE to delivery a 49% higher dose compared to regular 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 and anthracycline pre-treated patients lived significantly longer4.

ABRAXANE is currently under Phase III investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, and metastatic pancreatic.

Abraxane is now approved in over 35 countries including the U.S., Canada, European Union and China, and more than 45,000 cancer patients have received Abraxane therapy in the past three years.

About Specialised Therapeutics, Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to identify and license innovative anti-cancer and other specialised therapies for the Australasian market. Abraxane is the first of such therapies. Based in Melbourne, Australia, the privately held 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 nanoparticle 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. 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.

PBS Indication: Authority Required. Metastatic breast cancer after failure of prior therapy which includes an anthracycline.

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