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Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced the establishment of a global leadership team with newly created positions that strengthen the company's international senior leadership and build a worldwide commercialization platform for growth.
Jean-Francois Gimonet, M.D., will join the company as Vice President, European Operations; Carlo Montagner has been named President, Oncology Pan Asia; Rick Click has been appointed as Global IT/Chief Information Officer; Lisa Guttman has joined as Vice President of Global Clinical Operations; and several additional members of the company's senior team now will have global responsibilities in their respective areas of expertise.
As Vice President, European Operations, Dr. Gimonet will be responsible for building the company's sales and marketing infrastructure in the region. The appointment of Dr. Gimonet follows the recent marketing approval of ABRAXANE®, the company's nabTM therapy for the treatment of metastatic breast cancer, by the European Commission. Preparations are underway to launch ABRAXANE across Europe in mid-2008.
"Jean-Francois comes to Abraxis with 15 years of experience in the field of oncology drug development, sales and marketing," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "He is an enthusiastic and talented executive with the expertise to build a successful organization in Europe dedicated to making ABRAXANE, and other much-needed treatments options we are developing, available to patients in Europe."
Before joining Abraxis, Dr. Gimonet was a senior executive at Baxter SAS for six years, last serving as Global Medico-Marketing Director. Previously, he was Country Manager France-Deputy Chairman, ASTA Medica Oncology, a worldwide producer of oncology products, prior to its acquisition by Baxter. Dr. Gimonet has held several hospital research positions in oncology. He has a distinguished 10-year academic career at the Université Paris - Val-de-Marne (Paris XII), where he earned his Doctor of Medicine degree.
After successfully establishing the marketing organization for ABRAXANE in the United States, Carlo Montagner will become President, Oncology Pan Asia, with responsibility for establishing Abraxis in the Asia-Pacific region. "Since joining the company two years ago with a wealth of experience in heading global oncology businesses for blockbuster chemotherapeutic products, Carlo has done an exceptional job building the Abraxis Oncology team and generating strong sales growth for ABRAXANE in the U.S. We are very pleased that Carlo will now be using his knowledge and experience in Asia-Pacific by focusing on establishing our presence in the region as we build the company's marketing position on a global basis," said Dr. Soon-Shiong.
ABRAXANE is approved for marketing in India, is under active review in Australia, Russia, Korea and China by their respective regulatory agencies, and is under preparation for submission in Japan through a partnership with Taiho Pharmaceutical Co., Ltd.
As Global IT/Chief Information Officer, Mr. Click brings more than 18 years of experience to Abraxis BioScience. He heads the company's international IT department and its related functions, servicing all of the company's offices and operational facilities. Previously, Mr. Click held the position of Chief Information Officer at Molina Healthcare and has held senior positions at eBay's PayPal unit, American Outsourcing Group, Goodman Global Holdings, Honeywell International and Zenith Electronics. He is a graduate of California Coast University and earned a Masters of Business Administration degree and a Professional Masters Degree from Harvard Graduate School of Business.
Ms. Guttman joins Abraxis as Vice President, Global Clinical Operations with more than 18 years of industry experience in a number of therapeutic areas including oncology, cardiovascular disease, and endocrinology. Her extensive knowledge in clinical research operations and industry leadership track record will allow the Abraxis clinical team to expand activity and operations into more than 20 countries and enroll thousands of patients into trials over the next few years to support the growth in the Abraxis pipeline. Prior to joining Abraxis, Ms. Guttman served for more than seven years at Amgen, Inc., most recently as Director, Development Operations. Prior to her position at Amgen, Ms. Guttman worked at Eli Lilly for 10 years in increasingly senior positions in clinical research. Ms. Guttman holds an Honours Bachelor of Science degree in Molecular Biology and a Masters of Business Administration degree from McMaster University in Hamilton, Ontario, Canada.
To further support the company's development into a global enterprise, Abraxis announced that several senior executives have assumed titles that reflect their increased geographic responsibilities. Mitchall G. Clark now serves as Senior Vice President of Global Regulatory Affairs, Jose Iglesias, M.D., is serving as Vice President of Global Clinical Development and Angela Ogden, M.D., is serving as Vice President of Global Medical Affairs.
"These executives will now be contributing to the growth of Abraxis in capacities beyond North America, as we commercialize ABRAXANE globally, expand indications for ABRAXANE and develop our clinical and drug discovery pipeline," said Dr. Soon-Shiong. "They are among the best in their respective fields and bring expertise and passion to their work. I look forward to working closely with this dedicated and highly capable team to realize our collective vision to establish Abraxis as a leading global biotechnology company."
Recently, Abraxis announced that the European Commission has granted marketing approval for ABRAXANE® powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel) 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 Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival in the approved indication, and showed comparable tolerability versus Taxol®.
ABRAXANE, the first in a new class of protein-bound nanometer-sized drugs utilizing the company's proprietary nanoparticle albumin-bound (nab™) technology, is currently in various stages of development for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck.
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. ABRAXANE was approved in Canada in 2006 for the treatment of metastatic breast cancer including first-line disease. The product is currently under active review in Australia, Russia, Korea and China by their respective regulatory agencies. ABRAXANE is the fastest growing taxane in its indication in the U.S. and is used in approximately 5,000 patients with metastatic breast cancer per month in North America.
ABRAXANE uses albumin, a human protein, to deliver the active ingredient paclitaxel. Unlike other chemotherapy treatments, ABRAXANE does not contain chemical solvents, which eliminates the need for pre-medication with steroids or antihistamines often needed to prevent the toxic side effects associated with solvents. ABRAXANE is administered in 30 minutes as compared to three hours for solvent-based paclitaxel.
The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA 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. For the full prescribing information for ABRAXANE, please visit www.abraxane.com.
ABRAXANE is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca Pharmaceuticals LP.
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-based nanoparticle 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 metastatic breast cancer. Abraxis trades on the Nasdaq Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
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 Europe. 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, the market launch of ABRAXANE in Europe, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10 registration statement and other filings with the Securities and Exchange Commission. The information contained in this press release is as of the date of this release. Abraxis 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.
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Abraxis BioScience, Inc.
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