Healthcare Industry News: Topiramate
News Release - March 27, 2012
VIVUS Announced Expansion of Management TeamMOUNTAIN VIEW, Calif., March 27, 2012 -- (Healthcare Sales & Marketing Network) -- VIVUS, Inc. (Nasdaq:VVUS ), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced the addition of several key employees and expansion of the senior management team in anticipation of the commercialization of Qnexa(R), if approved. New hires in the commercial group include Chris Thompson as national sales director and Alfred Tenuto as senior director of market access. VIVUS has also added Santosh T. Varghese, M.D., as vice president of medical affairs. Barbara Troupin, M.D., MBA, has been promoted to vice president, scientific communication & risk management, and Timothy E. Morris will continue in his role as chief financial officer and will assume responsibility for business development as senior vice president global corporate development and finance. VIVUS has also expanded executive management in its clinical group with the addition of Roman V. Dvorak, M.D., Ph.D, who will serve as senior director, clinical development.
"The addition of experienced professionals in the commercial, medical affairs, and clinical groups will be invaluable as we prepare for the commercialization of Qnexa, if approved. Chris, Alfred and Santosh represent over 70 years of successful pharmaceutical commercial experience and are a welcome addition to our team," commented Leland Wilson, chief executive officer of VIVUS. "Barbara will continue to work with key opinion leaders and will head up the risk management responsibilities for Qnexa, Tim will lead our partnering efforts worldwide, and Roman will assist with the design and implementation of a post-approval Qnexa cardiovascular outcomes study."
Chris Thompson joins VIVUS as the national sales director after a successful 23-year career with Amgen, most recently as the vice president, sales of the Bone Health Business Unit. In this role, Mr. Thompson recruited and managed a team of over 545 employees, including 500 endocrine and primary care sales representatives. During his career at Amgen, Mr. Thompson rose through the ranks from a field sales representative to executive management positions. In addition, he has sales and sales management experience with Baxter International and Johnson & Johnson.
Alfred Tenuto joins VIVUS as the senior director of market access after a successful 13-year career with Eli Lilly & Company, most recently as director of trade. In this role, Mr. Tenuto was responsible for the distribution network and relationships with wholesalers and specialty pharmacies. At VIVUS, he will manage the Qnexa distribution network and be responsible for Federal and State public policy and reimbursement with private third party payors. In addition, he has pharmaceutical market access, pharmacy and national accounts experience with ALZA.
Dr. Varghese joins VIVUS as vice president medical affairs. Dr. Varghese comes from Elan Corporation, where he was responsible for the global and U.S. medical affairs bio-neurology therapeutic group for Tysabri. Prior to Elan, he built and led medical affairs teams responsible for large brands, such as Allegra and Nasacort at Aventis/Sanofi-Aventis; Clarinex/Claritin, Nasonex, Integrilin, Zetia, Vytorin, and other compounds within Schering-Plough/Merck. At VIVUS, he will establish the medical affairs group for Qnexa and will provide scientific and medical brand strategy to the commercial team. In addition, he will supervise and provide direction to field based teams and assume responsibility for safety and interaction with the FDA.
Roman V. Dvorak M.D., PhD will serve as the senior director, clinical development. Dr. Dvorak brings to VIVUS more than 15 years of clinical research experience, both in academia and the industry. He has worked in various clinical development and medical affairs positions with Johnson & Johnson, Pfizer, Tercica and Leptos Biomedical. His research as well as drug development work has focused on the area of metabolic diseases, particularly obesity and diabetes. He has designed and implemented clinical studies from Phase 1 to Phase 4, including large international registration trials.
Dr. Troupin has been promoted to the newly created position of vice president of scientific communication and risk management. Dr. Troupin has been vice president of scientific communication and risk management since February 2012. Prior to that, she held senior director roles in medical affairs and in clinical development at VIVUS, initially joining the company in April 2006. Before joining VIVUS, Dr. Troupin was the medical director for Profil Institute for Clinical Research in San Diego, a niche Phase 1 site focused on complex clinical trials in diabetes and obesity. Prior to that she was the medical director for Radiant Research in San Diego for five years and was the principal investigator on more than 150 cardiovascular and metabolic clinical studies. In her new role, Dr. Troupin will supervise development of publications and presentations, advise in the development of Scientific Symposia and Advisory Boards, and establish and support communications with medical and scientific key opinion leaders and advocates. In addition, she will take responsibility for the implementation of the Risk Evaluation and Mitigation Strategies (REMS) for Qnexa.
In addition to his current role as senior vice president finance and chief financial officer, Mr. Morris assumes responsibility for global corporate development, including partnering efforts for Qnexa and avanafil.
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed Phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by U.S. and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. In January 2012, we received the 180-day LOI from the CHMP. In order to perform additional analyses to allow further insights into the data as previously presented, we requested and have received an extension to respond and we plan to submit in the second quarter of 2012.
Qnexa is also in Phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. For more information about the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," "intend," "likely," "may," "plan," "potential," "predict," "opportunity" and "should," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the response from the United States Food and Drug Administration, or FDA, to our resubmission of the New Drug Application, or NDA, for Qnexa for the treatment of obesity, including weight loss and maintenance of weight loss, recommended for obese patients (BMI >=30 kg/m2), or overweight patients (BMI >=27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity), with a contraindication that excludes the use of Qnexa by women who are pregnant; the timing and final results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to Topiramate during pregnancy, or FORTRESS; the reliability of the electronic medical claims healthcare databases used in FORTRESS; the FDA's interpretation of and agreement with the information VIVUS submitted relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study (OB-305) and Sleep Apnea study (OB-204); that we may be required to provide further analysis of clinical trial data; our response to questions and requests for additional information including additional pre-clinical or clinical studies from the European Medicines Agency, or EMA, and the CHMP of the Marketing Authorization Application, or MAA, for Qnexa; the results of external studies to assess the teratogenic risk of Topiramate; results of the upcoming advisory meeting on cardiovascular assessment for obesity drugs; whether or not the FDA chooses to follow the recommendation of the second advisory committee in its vote in favor of approval of Qnexa; the impact, if any, of the agreement and initiation by one of our competitors with an obesity compound to conduct or complete a cardiovascular outcomes study pre-approval; impact on future sales based on specific indication and contraindications contained in the label and extent of the Risk Evaluation and Mitigation Strategy, or REMS and distribution system for Qnexa, if approved; the FDA's response to the NDA filed for avanafil; our ability to successfully commercialize or establish a marketing partnership for avanafil or our partner's ability to obtain and maintain regulatory approval to manufacture and adequately supply avanafil for commercial use; our history of losses and variable quarterly results; substantial competition; risks related to the failure to protect our intellectual property and litigation in which we may become involved; uncertainties of government or third party payer reimbursement; our reliance on sole source suppliers; our limited sales and marketing efforts and our reliance on third parties; failure to continue to develop innovative investigational drug candidates and drugs; risks related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; our ability to demonstrate through clinical testing the safety and effectiveness of our investigational drug candidates; our dependence on the performance of our collaborative partners; the timing of initiation and completion of clinical trials and submissions to the FDA or foreign authorities; the volatility and liquidity of the financial markets; our liquidity and capital resources; our expected future revenues, operations and expenditures; and our ability to successfully create a commercial infrastructure in the United States to launch Qnexa, if approved, on our own. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and commercialization of new products. There are no guarantees that our response to the FDA's CRL or CHMP's 180-day list of outstanding issues, the FDA's requests stemming from the end-of-review meeting or the results of FORTRESS and subsequent meetings and communications will be sufficient to satisfy the FDA or CHMP's safety concerns, that the FDA or foreign authorities will not require us to conduct any additional prospective studies or retrospective observational studies, that we will be able to agree with the FDA on the details of the REMS, the cardiovascular outcomes study or the label for Qnexa, or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ending December 31, 2011, and periodic reports filed with the Securities and Exchange Commission.
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