Healthcare Industry News: Elan
News Release - September 13, 2010
AVEO Pharmaceuticals, Inc. Appoints Michael P. Bailey to the Newly Created Position of Chief Commercial OfficerCompany Enhances Leadership Team and Prepares for Forward Integration
CAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)--AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO ), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the appointment of Michael P. Bailey to the newly created role of chief commercial officer, as well as the addition of Donna M. Radzik, Ph.D., in the newly created role of vice president, technical operations. Both of these positions will report to Elan Ezickson, executive vice president and chief business officer of AVEO.
“We are very pleased to welcome Michael and Donna to our organization,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “These strategic appointments and additions to our team come as we prepare for the upcoming regulatory and commercial planning activities associated with our triple VEGF receptor inhibitor, tivozanib, now that we have completed enrollment in our global Phase 3 clinical trial, TIVO-1, in patients with renal cell carcinoma.”
“Michael’s experiences in building commercial organizations and leading the global launch of Erbitux® across multiple oncology indications, as well as Donna’s experience with CMC and supply chain matters, will be important as AVEO prepares for commercialization of tivozanib in renal cell cancer and other future potential indications,” said Mr. Ezickson. “These appointments represent continued strategic growth for AVEO and will provide us with the added depth and breadth we believe are appropriate for a rapidly advancing oncology company.”
Mr. Bailey brings more than 18 years of experience in the pharmaceutical industry to AVEO and joins the company from Synta Pharmaceuticals, where he served as senior vice president, business development and chief commercial officer since 2008. Prior to joining Synta, Mr. Bailey led ImClone's Worldwide Commercial Organization, where he was responsible for commercial aspects for the planning and launch of Erbitux across multiple indications. In addition, Mr. Bailey was a key member of the strategic leadership committees for ImClone and its North American and worldwide partnerships. Prior to his role at ImClone, Mr. Bailey managed the cardiovascular development portfolio at Genentech, Inc. and was a key member of their global commercial partnership teams. Mr. Bailey received a B.S. in psychology from St. Lawrence University and an M.B.A. in international marketing from the University of Notre Dame Graduate School of Business.
Dr. Radzik has more than 25 years of experience in the biopharmaceutical industry where she has contributed to the development, approval and commercial technical support of both small and large molecule therapies. Prior to joining AVEO, Dr. Radzik most recently served as vice president, technical operations at Sanofi Pasteur Biologics (formerly Acambis) where she was responsible for bulk and drug product production of live viral vaccines. Prior to this role, Dr. Radzik served as senior vice president of U.S. technical operations for UCB, where she was a site director and accountable for the supply chain of numerous products. Prior to joining UCB by acquisition, she held various senior positions at Celltech and Celltech’s predecessor, Medeva Inc., including head of technical operations and development and global quality assurance. She has also held leadership roles at Hoechst-Roussel, Marion Merrell Dow and Lederle Laboratories/Medical Research Division of American Cyanamid. Dr. Radzik received a B.S. in chemistry from Grand Valley State University and a Ph.D. in analytical chemistry from Purdue University.
Tivozanib, an investigational new drug, is a highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, exhibiting picomolar inhibitory activity against all three receptors. Due to its potency and specificity, AVEO believes tivozanib may enable optimal inhibition of the VEGF pathway, while minimizing side effects associated with off-target activity. Such a profile may enable tivozanib to be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility. The European Medicines Agency has granted AVEO orphan medicinal product designation for tivozanib for the treatment of renal cell carcinoma (RCC).
AVEO recently completed patient enrollment ahead of schedule in TIVO-1, a global, randomized (1:1), controlled Phase 3 clinical trial evaluating tivozanib compared to sorafenib (Nexavar®) in patients with RCC. The primary endpoint of the trial is to compare the progression-free survival (PFS) of tivozanib vs. sorafenib. In addition to TIVO-1, the company has initiated a series of clinical trials evaluating tivozanib in combination with other agents in multiple solid tumor settings, including an ongoing Phase 1b trial in combination with temsirolimus (Torisel®), an approved mTOR inhibitor, in patients with metastatic renal cell carcinoma; a Phase 1b trial in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers; and a Phase 1b trial in combination with paclitaxel (Taxol®) in patients with metastatic breast cancer. A Phase 1b trial evaluating tivozanib as monotherapy in patients with non-small cell lung cancer is also being conducted.
AVEO is also utilizing its Human Response Platform™ in its efforts to help identify rational drug combinations and patient populations most likely to be responsive to these combination therapies.
AVEO Pharmaceuticals (NASDAQ: AVEO ) integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The company’s lead product, tivozanib, is an oral, triple VEGF receptor inhibitor with a highly differentiated profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEO’s proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development and has provided a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR. For more information, please visit the company's website at www.aveopharma.com.
Any statements in this press release about our future expectations, plans and prospects, including statements about the preparation of upcoming regulatory and commercial activities related to tivozanib, the appropriateness of the added depth and breadth the new employees referred to in this press release bring to AVEO, tivozanib’s potential for combinability with other therapeutic agents, tivozanib’s ability to enable optimal inhibition of the VEGF pathway while minimizing side effects associated with off-target activity, AVEO’s cancer biology platform offering AVEO a unique advantage in oncology drug development and AVEO’s promising pipeline of antibodies, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for tivozanib and our other product candidates; the possibility that positive results in our Phase 2 clinical trial of tivozanib may not be predictive of the results in our Phase 3 clinical trial; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses and our inability to raise substantial additional funds to achieve our goals; general economic and industry conditions; and other factors discussed in the "Risk Factors" section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Source: AVEO Pharmaceuticals
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