Healthcare Industry News: Herceptin
News Release - June 3, 2008
Sunesis Pharmaceuticals Expands Development Leadership Team to Focus on Late-Stage Development of Voreloxin (Formerly SNS-595)SOUTH SAN FRANCISCO, Calif., June 3 (HSMN NewsFeed) -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS ) today announced the expansion of its late-stage development leadership team with the appointment of industry veterans Steven B. Ketchum, Ph.D., as Senior Vice President, Research and Development and Mary G. Bolton, M.D., Ph.D., as Vice President, Clinical Development. In addition, Judith A. Fox, Ph.D., has been promoted to Vice President, Product and Preclinical Development and Glenn C. Michelson, M.D., has been promoted to Vice President, Clinical Strategy.
"As our lead anti-cancer product candidate, voreloxin, continues to demonstrate promising clinical activity and a consistent safety profile in both acute myeloid leukemia and ovarian cancer, we are excited to welcome Drs. Steve Ketchum and Mary Bolton to Sunesis," said Daniel Swisher, Sunesis' Chief Executive Officer. "We are also pleased to announce the promotions of Drs. Judy Fox and Glenn Michelson. Judy and Glenn have made tremendous contributions to our voreloxin development program. Collectively, the extensive product development and regulatory expertise of this expanded leadership team will be a tremendous asset as we prepare for the expected initiation of late-stage trials for voreloxin next year."
"With the promising clinical activity and safety profile seen to date for voreloxin, I am excited by the opportunity to lead Sunesis' talented development organization as we advance this first-in-class product candidate into its next phase of development," said Dr. Ketchum.
Dr. Ketchum brings more than fifteen years experience in late-stage product development and clinical regulatory strategy, having led the filings of multiple successful New Drug Applications (NDAs) and supplemental NDAs (sNDAs). He joins Sunesis from Reliant Pharmaceuticals, Inc., where he served as Senior Vice President, Research & Development and Medical Affairs. In this role, he was responsible for the strategic direction and day-to-day operations, as well as the organizational growth, of Reliant's clinical R&D and product development capabilities. Previously, Dr. Ketchum served as Senior Vice President, Operations and Regulatory Affairs for IntraBiotics Pharmaceuticals, Inc. from 2002 to 2005, where he was responsible for regulatory affairs, project management, quality assurance, and supply chain management in support of late-stage clinical research. Dr. Ketchum also held positions of increasing responsibility in regulatory affairs during his nearly eight-year tenure at ALZA Corporation from 1994 to 2002, most recently as Senior Director, Regulatory Affairs. He earned a Ph.D. in Pharmacology from University College London (funded by the Sandoz Institute for Medical Research) and a B.S. in Biological Sciences from Stanford University.
Over the past year, Dr. Bolton has served as a consultant to Sunesis on the development of voreloxin. As a medical oncologist, she brings more than a decade of industry experience in the clinical development of oncology therapeutics to her new post as Vice President, Clinical Development. From 2004 to 2005, Dr. Bolton was Vice President, Clinical Development for Sonus Pharmaceuticals, Inc. responsible for Phase 1-3 clinical development of the company's lead molecule. Before that, she served as Medical Director with ZymoGenetics, Inc. and as Medical Director for Cell Therapeutics, Inc., leading each company's clinical development programs and providing input on regulatory strategy. From 1999 to 2001, Dr. Bolton led the Herceptin® post-marketing team at Genentech, Inc., where she served as a Clinical Scientist. Prior to her industry experience, Dr. Bolton spent several years as a practicing oncologist, most recently as Assistant Professor of Medical Oncology at the Lombardi Cancer Center, Georgetown University Medical Center. She received her Ph.D. from the Department of Physiology at Johns Hopkins University School of Medicine, her M.D. from the Medical College of Pennsylvania and a B.A. from Boston University.
Dr. Fox joined Sunesis in 2006 as Senior Director, Program Leader and will now have an expanded role as Vice President, Product and Preclinical Development. Previously, she served as Senior Director in the Translational Sciences Department for Chiron Corporation (now Novartis AG) from 2005 to 2006, where she led the clinical pharmacology and preclinical pharmokinetics (PK)/drug metabolism group, supporting the development of the company's novel oncology compounds. From 2002 to 2005, Dr. Fox was Senior Director/Senior Staff Scientist for Genencor International, where she started the Pharmacological Sciences Department. Dr. Fox's industry career began in the PK/Metabolism Department for Genentech, where she ultimately led the group responsible for all oncology projects from late-stage research through clinical development. This was preceded by leadership of the immunology focus area within the PK/Metabolism Department. During her ten years at Genentech, she contributed to the development of products such as Herceptin®, Xolair®, Raptiva® and Avastin®. Dr. Fox received her Ph.D. in Biological Chemistry from the Massachusetts Institute of Technology and an A.B. in Chemistry from Bryn Mawr College. She conducted postdoctoral research at The Rockefeller University.
Dr. Michelson joined Sunesis in 2006 as Senior Director and Head of Clinical Science, Oncology, bringing more than a decade of experience as a medical oncologist and in drug development in both industry and academic settings. Newly promoted to the position of Vice President, Clinical Strategy, he will oversee the clinical development of Sunesis' novel cancer therapeutics, with an emphasis on the planning and execution of late-stage clinical studies focused on regulatory approval. From 2004 to 2006, Dr. Michelson served as Director in the Clinical Oncology Therapeutic Unit at Chiron (now Novartis AG), where he served as Medical Director and as lead clinician for the company's kinase programs. Previously, he was Medical Director, Clinical Development for Cell Therapeutics, where he was responsible for Phase 3 studies of Xyotax®. Dr. Michelson began his pharmaceutical industry career at Pfizer Global Research and Development (formerly Agouron), from 1998 to 2003, where he led Phase 1 through Phase 3 clinical development programs in oncology. Dr. Michelson has held faculty positions at the University of California, San Diego, and at the University of Louisville, and has been a Principal Investigator for a number of clinical trials. He received both his M.D. and B.A. in Chemistry from the University of Louisville.
Option Award Disclosure
The Compensation Committee of the company's Board of Directors approved an employment commencement grant to Dr. Ketchum of a non-qualified stock option to purchase 150,000 shares of Sunesis common stock, effective June 30, 2008. Options covering 140,000 of these shares were granted without shareholder approval pursuant to Nasdaq Marketplace Rule 4350 (i)(1)(A)(iv) and with the following material terms: (a) an exercise price equal to the fair market value of the company's common stock on June 30, 2008, (b) a term of ten years, and (c) a vesting schedule providing that the option is exercisable as to one-quarter of the total grant on the first anniversary of Dr. Ketchum's date of hire, and one-forty-eighth of the total grant each month thereafter until the grant is fully vested.
About Sunesis Pharmaceuticals
Sunesis is a clinical-stage biopharmaceutical company focused on the development of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.
Safe Harbor Statement
This press release contains forward-looking statements including without limitation statements related to the future development and timing of late-stage trials of voreloxin (formerly SNS-595) and potential safety and efficacy and commercial potential of voreloxin. Words such as "promising," "advance," "look forward," "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' 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 risk that Sunesis' drug development activities or those of its partners, including enrollment and reporting of results, could be halted significantly or delayed for various reasons; the risk that Sunesis' clinical trials for voreloxin or its other programs may not demonstrate safety or efficacy or lead to regulatory approval; the risk that preliminary data and trends may not be predictive of future data or results; the risk that Sunesis' preclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies; risks related to the conduct of Sunesis' clinical trials and manufacturing; and risks related to Sunesis' need for additional funding. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-K for the year ended December 31, 2007, Sunesis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 and other filings with the Securities and Exchange Commission. Sunesis 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.
Source: Sunesis Pharmaceuticals
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