Abraxis BioScience, Inc., 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.