Abraxis BioScience, Inc., a fully integrated, global biotechnology company, announced the launch in the European Union of Abraxane paclitaxel 5 mg/ml powder for suspension for infusion.
Abraxane is an albumin-bound nanoparticle formulation of paclitaxel. 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 launch of Abraxane in the EU, initially in the UK, is a significant milestone in our programme to provide patients across the European continent 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. "Abraxis BioScience has made significant progress in 2008 in expanding the market reach of Abraxane in India, China and the Asia-Pacific region. Our EU launch marks an important entry point in building a truly global presence for Abraxis BioScience as we seek approvals for new indications for Abraxane and continue to develop additional advanced medications in our pipeline."
"In a key phase III clinical study, Abraxane demonstrated statistically significant superiority over solvent-based paclitaxel injection in the clinical endpoints of response rate, progression free survival and overall patient survival in patients treated according to the approved indication, with comparable tolerability," said Robert Coleman, MBBS, M.D., FRCP, Professor and Honorary Consultant Medical Oncologist at the Cancer Research Centre, Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield. "Given the clinical benefits compared with paclitaxel injection, Abraxane should become the paclitaxel therapy of choice for oncologists throughout Europe for the second-line treatment of patients with metastatic breast cancer."
"Use of Abraxane requires no pre-medication as it is not formulated with toxic solvents and is more convenient to administer than solvent-based paclitaxel," said Prof. Dr. med. Gunter von Minckwitz, managing director, German Breast Group Forschungs GmbH, Neu-Isenburg, Germany.
The Department of Health approved a price of 246 pounds per 100 mg vial of Abraxane. Following the current launch in the UK, Abraxane will be launched in Germany in the first quarter of 2009, followed by additional nations in Europe on a country by country basis.
"We have assembled a solid group of seasoned marketing, regulatory and product support professionals to market this new treatment for women in Europe with metastatic breast cancer," said Jean-Francois Gimonet, M.D., vice president, European Operations of Abraxis BioScience. "This launch lays the foundation for building our organization across Europe and for establishing Abraxis BioScience as an industry leader in the European Union."
Sales force and commercial services for Abraxis BioScience in the EU will be provided by Innovex, a unit of Quintiles Transnational Corp., which is the leading global commercial solutions provider to the pharmaceutical, biotech and medical device industries.
To date, Abraxane has been approved for marketing in 36 countries. In addition to Europe, Abraxane recently was launched in Australia in collaboration with Specialised Therapeutics Australia Pty Ltd; in the United Arab Emirates with partner Neobiocon; and, in India with Biocon Limited. The Korean FDA has granted marketing approval for Abraxane and the launch in that country is expected in 2009 with Abraxis' partner Green Cross Corporation. Additionally, approval has been received in China, with an anticipated launch in 2009. Abraxane is currently under active review in Japan and Russia.
The phase III clinical trial upon which European marketing approval was based demonstrated that Abraxane nearly doubled the overall target lesion response rate versus solvent-based paclitaxel and achieved a 28 per cent improvement in progression-free survival when compared to solvent-based paclitaxel. In addition, time to tumour progression versus solvent-based paclitaxel was significantly prolonged in patients receiving Abraxane. The tolerability with Abraxane and solvent-based paclitaxel was comparable, despite the 50% greater dose of paclitaxel administered as Abraxane. Neutropaenia was lower with Abraxane compared to solvent-based paclitaxel. Although there was an increase in incidence of grade 3 peripheral neuropathy, time to improvement was improved compared to that reported for solvent-based paclitaxel. No adverse events were reported that were not already known for paclitaxel.
Innovex is the sales and marketing unit of Quintiles Transnational Corp. Innovex is a leading commercial solutions provider that offers sales and marketing services designed to accelerate the success of pharmaceutical, biotechnology and medical device products.
Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, financial partnering and commerzialisation for the biotechnology and healthcare industries.
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.