Health & Fitness
Health and Fitness
Health and Fitness
Tue, December 16, 2008
Mon, December 15, 2008
Sun, December 14, 2008 Abraxis BioScience Launches Abraxane in European Union
LOS ANGELES & LONDON--([ BUSINESS WIRE ])--Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, today 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 program 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-François 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.
About Abraxane®
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 percent improvement in progression-free survival when compared to solvent-based paclitaxel. In addition, time to tumor 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.
For further information about the approval of Abraxane® in Europe, please visit [ http://www.emea.europa.eu/humandocs/Humans/EPAR/Abraxane/Abraxane.htm ].
About Innovex
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. Innovex operates in multiple geographies and ensures that high quality sales solutions can be provided where the customer needs them – locally, regionally and across multiple countries. For more information, visit [ www.innovex.com ].
About Quintiles
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. With over 21,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit the company's web site at [ www.qtrn.com ].
About Abraxis BioScience
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. The company's portfolio includes the world's first and only protein-bound chemotherapeutic compound (Abraxane®), which is based on the company's proprietary tumor targeting technology known as the nabTM platform. The first FDA approved product to use this nabTM platform, Abraxane®, was launched in 2005 for the treatment of breast cancer after the failure of prior chemotherapy for metastatic disease. Abraxis BioScience trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit [ www.abraxisbio.com ].
FORWARD-LOOKING STATEMENTS
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the launch of Abraxane® in the European Union. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, unexpected safety, efficacy or manufacturing issues with respect to Abraxane®; the need for additional data or clinical studies for Abraxane®; regulatory developments (domestic or foreign) involving the company's manufacturing facilities; the market adoption and demand of Abraxane®, the costs associated with the ongoing launch of Abraxane®; the impact of pharmaceutical industry regulation; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; the ability to successfully manufacture products in a time-sensitive and cost effective manner; the acceptance and demand of new pharmaceutical products; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2007 and in other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis BioScience assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
Taxol® is a registered trademark of Bristol-Myers Squibb Company.
