Abraxis BioScience, Inc., a fully integrated, global biotechnology company, announced the launch in Germany of Abraxane, 5 mg/ml powder for suspension for infusion (paclitaxel).
"Abraxane is an ideal treatment for breast cancer patients because of its superior clinical benefits and improved tolerability profile compared to solvent-based paclitaxel," said Prof. Dr. med. Gunter von Minckwitz, managing director, German Breast Group Forschungs GmbH, Neu-Isenburg, Germany. "Additionally, Abraxane does not require premedication and can be administered in 30 minutes versus over 3 hours for solvent-based paclitaxel chemotherapy. Abraxane should therefore be considered as a new and attractive option for oncologists treating metastatic breast cancer in patients who have failed first-line therapy in Germany."
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.
Abraxane is a unique formulation of paclitaxel with a mean particle size of approximately 130 nanometers, that uses the natural properties of a human protein, albumin, to deliver the drug more effectively to tumours. By wrapping the albumin around the active drug, Abraxane can be administered to patients at higher doses, resulting in higher concentrations of the drug at the tumour site and higher efficacy compared to solvent-based paclitaxel. Clinical trials have demonstrated that the tumour response rate was nearly double for patients who received Abraxane compared to those who received solvent-based paclitaxel. Of great significance, patients treated with Abraxane experienced a significant improvement in progression-free survival and prolonged time to tumour progression compared to patients treated with solvent-based paclitaxel (Gradishar 2005).
Toxic solvents, such as Cremophor EL, involved in the delivery of currently approved paclitaxel on the market may be the cause of the significant treatment-related side effects, including anaphylaxis and allergic reactions. Patients receiving Abraxane, a solvent free paclitaxel, do not require premedication before treatment to avoid these reactions related to toxic solvents.
"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," said Patrick Soon-Shiong, M.D., Chairman and chief executive officer of Abraxis BioScience. "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."
"In Europe, we have assembled a solid group of seasoned marketing, regulatory and product support professionals to market this new treatment for women with metastatic breast cancer," said Jean-François Gimonet, M.D., vice president, European Operations of Abraxis BioScience. "The introduction of Abraxane in Germany greatly advances our organization across Europe and further advances Abraxis BioScience towards its goal of becoming an industry leader in the European Union."
Abraxane is available through hospitals in Germany. Following the launches in the United Kingdom 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 United Kingdom, Abraxane is commercially available in the United States and Canada and in India in collaboration with Biocon Limited. In 2009, Abraxane is anticipated to launch in Australia in collaboration with Specialised Therapeutics Australia Pty Ltd; in the United Arab Emirates with partner Neobiocon; and in Korea with partner Green Cross Corporation. 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.
The US Food and Drug Administration (FDA) approved Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in 2005 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 European Medicines Agency (EMEA) approved Abraxane, 5 mg/ml powder for suspension for infusion (paclitaxel), in 2008 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.
Abraxane is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nab® technology platform, Abraxane is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein.
Abraxane is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, melanoma, pancreatic and ovarian.
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.