In the EU, Abraxane is indicated for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated, the company said.
Abraxane is available through hospitals in Germany. Following the launches in the UK and Germany, Abraxane will be launched in additional nations in Europe on a country by country basis in 2009.
Abraxane has now been approved for marketing in 36 countries across Europe, North America, Asia and Australia. In addition to Germany and the UK, Abraxane is commercially available in the US and Canada and in India in collaboration with Biocon.
In 2009, Abraxane is anticipated to launch in Australia in collaboration with Specialised Therapeutics Australia; in the UAE with partner Neobiocon; and in Korea with partner Green Cross.
Additionally, marketing approval for Abraxane has been received in China with an anticipated launch in 2009. Abraxane is currently under active review in Japan and Russia.
Patrick Soon-Shiong, chairman and CEO of Abraxis BioScience, said: The launch of Abraxane in Germany is a significant step in our goal to provide patients across Europe with a new option for the treatment of metastatic breast cancer. This marks an important milestone in building a truly global presence for Abraxis BioScience as we continue to seek approvals for new indications for Abraxane and continue to develop advanced medicines in our pipeline.