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Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, today 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 tumors. 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 tumor site and higher efficacy compared to solvent-based paclitaxel. Clinical trials have demonstrated that the tumor 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 tumor 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.
ABRAXANE Clinical Trial Results
In the pivotal Phase III clinical trial, ABRAXANE nearly doubled the overall target lesion response rate versus solvent-based paclitaxel (21.5% vs 11.1%, respectively (US PI)). In addition, time to tumor progression versus solvent-based paclitaxel was significantly prolonged in patients receiving ABRAXANE (23.0 vs 16.9 weeks, P=0.006, Gradishar 2005). ABRAXANE was well tolerated compared with solvent-based paclitaxel, despite the 50% greater dose of paclitaxel administered as ABRAXANE. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which the European approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. Neutropenia 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 the full prescribing information for ABRAXANE, including Boxed Warning, please visit www.abraxane.com.
The U.S. 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.
For further information about the approval of ABRAXANE in Europe, please visit www.emea.europa.eu/humandocs/Humans/EPAR/Abraxane/Abraxane.htm.
About Abraxis BioScience, Inc.
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 nab® platform. The first FDA approved product to use this nab® 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.
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.
ABRAXANE is a registered trademark of Abraxis BioScience in the United States, the European Community and various other countries.
nab is a U.S. registered trademark of Abraxis BioScience.
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