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.
Abraxis will market Abraxane in Australia through a strategic relationship with Specialised Therapeutics Australia. 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.
Green Cross, Abraxis’s partner in Korea, expects to launch Abraxane in that country in the first half of 2009. Abraxane is expected to be launched in China in the first half of 2009. In the US, Abraxane is co-marketed in collaboration with AstraZeneca Pharmaceuticals. In addition to the review by Ministry of Health, Labour and Welfare in Japan, Abraxane is currently under active review in Russia.
Patrick Soon-Shiong, chairman and CEO of Abraxis, said: “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. 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.”