Healthcare Industry News: Helsinn Healthcare
News Release - June 26, 2006
Exelixis Appoints Experienced Biotechnology Executive as Chief Medical OfficerSOUTH SAN FRANCISCO, Calif., June 26 (HSMN NewsFeed) -- Exelixis, Inc. (Nasdaq: EXEL ) today announced the appointment of Gisela M. Schwab, M.D., as senior vice president and chief medical officer. In this position, Dr. Schwab will leverage more than 13 years of biopharmaceutical industry experience to direct the global clinical development strategies and to design and implement clinical trials to evaluate the company's pipeline of novel cancer therapeutic agents. She also will be responsible for building and leading a top-tier clinical development and translational medicine organization. Dr. Schwab will report to Jeffrey R. Latts, M.D., executive vice president of development at Exelixis.
Dr. Schwab has extensive expertise in building and managing functional teams leading to worldwide product registration. Most recently, she was senior vice president and chief medical officer at Abgenix, Inc., a human antibody- based drug development company that was acquired by Amgen, Inc. in April 2006. In this position, she led worldwide product development activities, including preclinical development; pharmacokinetics and toxicology; regulatory affairs and clinical development in diverse therapeutic areas, including hematology and oncology. Previously she served as vice president, clinical development, at Abgenix from 1999 to 2001. From 1992 to 1999 she held various roles of increasing responsibility at Amgen Inc., most recently as therapeutic area leader for the clinical development of Amgen's hematology and oncology pipeline. Dr. Schwab received her Doctor of Medicine degree from the University of Heidelberg, trained at the National Cancer Institute and is board certified in internal medicine and hematology and oncology.
"As a company with eight compounds in clinical development and an expectation of advancing multiple compounds into the clinic each year for the foreseeable future, a significant amount of our resources are committed to clinical development activities," said George Scangos, Ph.D., president and chief executive officer of Exelixis. "Dr. Schwab's expertise in managing both early and late stage clinical development activities will be a key strategic asset for us. In addition, her skills as a leader and manager will play an essential role in our plans to develop and build an industry-leading development organization to support our growing number of clinical programs. We are excited about her joining the Exelixis team and look forward to the positive impact that she will have on the development of our portfolio."
Dr. Schwab, will report to Jeffrey Latts, M.D., executive vice president of development at Exelixis. Dr. Latts will have overall responsibility for the company's development activities, including chemistry, manufacturing and control, non-clinical development, clinical development, translational medicine and regulatory affairs. Dr. Latts commented, "Dr. Schwab has a proven track record of success in developing novel compounds at all stages of development. Her broad experience in the field of oncology will be a significant asset to Exelixis as we continue to grow our portfolio."
Dr. Schwab commented, "I am very excited to join an organization with one of the most promising pipelines in our industry. I also look forward to being a part of the Exelixis team that shares my passion for improving the treatment options for patients with cancer and other serious diseases."
Exelixis currently has two programs in Phase II clinical trials (XL999, XL784) and expects to initiate Phase II programs for two additional compounds this summer. In addition to the eight compounds currently in clinical development, the company expects to file additional investigational new drug (IND) applications for three compounds currently in preclinical development by the end of 2006.
Exelixis, Inc. is a biotechnology company dedicated to the discovery and development of novel therapeutics that will potentially enhance the care and lives of patients with cancer and other serious diseases. The company is leveraging its fully integrated gene-to-drug platform to fuel the growth of its proprietary drug pipeline. Exelixis' development pipeline covers cancer and metabolism and is comprised of the following compounds: XL119 (becatecarin), for which a multinational Phase III clinical trial in bile duct tumor is ongoing and which has been exclusively licensed to Helsinn Healthcare S.A.; XL784, which is being advanced in a Phase II trial as a treatment for renal disease; XL999, an anticancer compound currently in a Phase II program for a variety of solid tumors and hematologic malignancies; XL647, XL880, XL820, XL844 and XL184, anticancer compounds currently in Phase I clinical trials; and multiple compounds in preclinical development for diseases including cancer and various metabolic and cardiovascular disorders. Exelixis has established broad corporate alliances with major pharmaceutical and biotechnology companies including GlaxoSmithKline (GSK) and Bristol-Myers Squibb Company. Pursuant to a product development and commercialization agreement between Exelixis and GSK, GSK has the option, after completion of clinical proof-of-concept by Exelixis, to elect to develop up to three compounds in Exelixis' product pipeline, which may include XL784 and the cancer compounds identified in this press release (other than XL119), thus potentially triggering milestone payments and royalties from GSK and co- promotion rights by Exelixis. For more information, please visit the company's web site at www.exelixis.com.
This press release contains forward-looking statements, including without limitation statements related to advancing multiple compounds into the clinic each year for the foreseeable future. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis' current expectations. Forward-looking statements involve risks and uncertainties. Exelixis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the potential failure of product candidates to demonstrate safety and efficacy in clinical testing; the ability of Helsinn Healthcare S.A. to conduct the Phase III clinical trial of XL119 sufficient to achieve FDA approval; the ability to complete and initiate trials at the referenced times; the ability to conduct clinical trials sufficient to achieve a positive completion; the ability to file INDs at the referenced times; the ability of Exelixis to advance additional preclinical compounds into clinical development; the uncertainty of the FDA approval process; and the therapeutic and commercial value of the company's compounds. These and other risk factors are discussed under "Risk Factors" and elsewhere in our quarterly report on Form 10-Q for the quarter ended March 31, 2006 and other filings with the Securities and Exchange Commission. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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