Abraxis Bioscience Establishes Global Leadership Team.LOS ANGELES Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. -- Abraxis BioScience, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :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([R]), the company's nab(TM) therapy for the treatment of metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. breast cancer, by the European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community . 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 (1) (SAS Institute Inc., Cary, NC, www.sas.com) A software company that specializes in data warehousing and decision support software based on the SAS System. Founded in 1976, SAS is one of the world's largest privately held software companies. See SAS System. for six years, last serving as Global Medico-Marketing Director. Previously, he was Country Manager France-Deputy Chairman, ASTA Medica medica (māˑ·dē·k 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 Universite 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , 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 Zenith Electronics Corporation is an American manufacturer of televisions headquartered in Lincolnshire, Illinois. It was the inventor of the modern remote control, and it introduced HDTV in North America. . He is a graduate of California Coast University Overview California Coast University is nationally accredited by the Distance Education and Training Council (DETC), recognized by the United States Department of Education (U.S. DOE) and the Council for Higher Education Accreditation (CHEA). 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 Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test 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 Noun 1. Bachelor of Science - a bachelor's degree in science BS, SB bachelor's degree, baccalaureate - an academic degree conferred on someone who has successfully completed undergraduate studies degree in Molecular Biology molecular biology, scientific study of the molecular basis of life processes, including cellular respiration, excretion, and reproduction. The term molecular biology was coined in 1938 by Warren Weaver, then director of the natural sciences program at the Rockefeller 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([R])powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); ) 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 Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the 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 approved indication, n 1. reliable signs that a certain remedy should be used. Not synonymous with “authorized.” 2. FDA-approved condition for a drug or other treatment that allows labeling. , and showed comparable tolerability versus Taxol([R]). About ABRAXANE([R]) ABRAXANE, the first in a new class of protein-bound nanometer-sized drugs utilizing the company's proprietary nanoparticle albumin-bound (nab[TM]) 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 Malignant Melanoma Definition Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin. , pancreatic, gastric, and head and neck. The U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 Adjuvant chemotherapy Treatment of the tumor with drugs after surgery to kill as many of the remaining cancer cells as possible. Mentioned in: Neuroblastoma . 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 Antihistamines Definition Antihistamines are drugs that block the action of histamine (a compound released in allergic inflammatory reactions) at the H1 often needed to prevent the toxic side effects Side effects Effects of a proposed project on other parts of the firm. 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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. metastatic breast cancer study for which FDA approval was based included neutropenia Neutropenia Definition Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria. , anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. included anemia, asthenia asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness. neurocirculatory asthenia , diarrhea, ocular/visual disturbances, fluid retention, alopecia alopecia (ăl'əpē`shēə): see baldness. , 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 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([R])), which is based on the company's proprietary tumor targeting technology known as the nab[TM] platform. The first FDA approved product to use this nab platform, ABRAXANE([R]), 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. 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 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([R]) is a registered trademark of Bristol-Myers Squibb Company. |
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