Healthcare Industry News: CV Therapeutics
News Release - November 23, 2009
Four Senior Executives Join Orexigen(R) Therapeutics Management TeamSeasoned Executives Bring Significant Commercial and Regulatory Experience
SAN DIEGO, Calif., Nov. 23 (Healthcare Sales & Marketing Network) -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX ) today announced that four senior executives have joined the organization, strengthening the management team that is driving the development of its obesity franchise. Additions to the management team include: Dawn Viveash, M.D., Head of Global Regulatory Affairs; Suzanne McDonald, Head of Managed Markets and Government Affairs; Preston Klassen, M.D., Head of Global Contrave Program; and Whedy Wang, Ph.D, MPH, Head of Global Biomedical Information. The new hires will strengthen the Company's efforts with global health authorities, payers and policy makers and tremendously support the filing of the Contrave® New Drug Application (NDA) with the FDA which remains on track for the first half of 2010.
"The strength of the Phase 3 results for Contrave and the Phase 2 results for Empatic(TM) support our belief that these two drug candidates have significant commercial potential," said Mike Narachi, President and CEO of Orexigen. "With these four new additions, we feel we have completed the assembly of one of the industry's most skilled senior teams that will focus exclusively on obesity product development and commercialization. Our team has tremendous depth of experience in clinical research, drug development, regulatory, public affairs, biomedical information, medical affairs and marketing, all of which will help us realize the full commercial potential of our obesity franchise."
Dawn Viveash, M.D., Head of Global Regulatory Affairs
Viveash will oversee the U.S. and international regulatory affairs activities including regulatory filings for Contrave and Empatic. With over 20 years of experience in the biopharmaceutical industry, Viveash has experience with all stages of development and product commercialization. Viveash was most recently at Amylin Pharmaceuticals as Vice President of Regulatory Affairs and Safety, where she managed regulatory affairs and the safety department for a product portfolio that included the company's obesity and diabetes pipeline. Previously, Viveash was Vice President of Regulatory Affairs and Safety at Amgen and Vice President of Regulatory Affairs, Safety and Professional Services at Immunex. Through her leadership roles at Amylin, Amgen and Immunex, Viveash has overseen a number of successful NDA and BLA submissions along with corresponding global regulatory submissions; her experience includes products such as Enbrel®, Aranesp®, Sensipar®, Kepivance® and Byetta®. Viveash has participated in advisory committees and has been involved in regulatory discussions regarding a variety of post marketing safety issues.
Suzanne McDonald, Head of Managed Markets and Government Affairs
McDonald will be responsible for developing managed markets, coordinating reimbursement strategy and steering government affairs. McDonald comes from Takeda Pharmaceuticals where she most recently served as Vice President of Government and External Affairs. In her role there, she was Takeda's liaison with PhRMA serving on key task forces effecting policy and legislation for the industry. Additionally, she built the Government Affairs department and established a corporate presence in Washington D.C., as well as created strategic plans for product reimbursement. Previous roles include Division Vice President and General Manager of Managed Care at Abbott Laboratories.
Preston Klassen, M.D., MHS, Head of Global Contrave Program
Klassen will lead the global development program for Contrave. Formerly the Therapeutic Area Head for Nephrology and Executive Medical Director at Amgen, Klassen most recently led global development efforts for the company's renal franchise. While at Amgen, Klassen oversaw Phase 2-4 clinical activity for products addressing renal, diabetes and other metabolic diseases. His experience includes global regulatory filings, including NDA and sNDA submissions, development and execution of several large cardiovascular outcomes trials, and clinical commercialization activities for marketed products. Starting in 2006, Klassen played a lead role in regulatory interactions related to the benefit/risk profile of erythropoietin stimulating agents for renal indications, including presenting at a 2007 joint meeting of the FDA Cardiovascular and Renal Drugs and the Drug Safety and Risk Management Advisory Committees. Prior to joining Amgen, Klassen was a faculty member in the Division of Nephrology at Duke University Medical Center.
Whedy Wang, Ph.D., MPH, Head of Global Biomedical Information
Wang will direct all aspects of operations related to biomedical information for both the Contrave and Empatic programs. Wang comes to Orexigen from Gilead Sciences Palo Alto (formerly CV Therapeutics), where she was most recently the Vice President of Biometrics. At Gilead, Wang provided strategic input and biometrics oversight to U.S. and EU development and commercial efforts. As a member of the CV Therapeutics executive team, she contributed to the development of corporate strategy and led life cycle management planning. Additionally, Wang was the global project leader for Lexiscan® and Ranexa® and played a key role in the Company's $185 million financing transaction with TPG-Axon. With over 15 years of experience, Wang has directed biometrics efforts in five NDA and sNDA submissions, two advisory committee meetings and two European submissions, all leading to successful approvals.
About Orexigen® Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on developing therapies that offer multiple approaches to treating obesity. The Company's lead investigational product, Contrave®, has completed the COR clinical development program and is on track for a regulatory submission with the FDA in the first half of 2010. The Company's second obesity drug candidate, Empatic(TM) has completed Phase 2 trials. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found at http://www.Orexigen.com.
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the potential for, and timing of, filing an NDA for Contrave. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: additional analyses of data from the Contrave Phase 3 trials and any other clinical trials of Contrave may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted clinical trials; the FDA may not agree with the Company's interpretation of efficacy and safety results; the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDA for Contrave; the third parties on whom Orexigen relies to assist with the development programs for Contrave, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the data or materials generated by such third parties may be of insufficient quality to include in the Company's regulatory submissions; and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. All conclusions and determinations contained herein are subject to the Company's further analysis of the clinical data. The ultimate determination of the safety and efficacy of Contrave will be made by the FDA and other relevant regulatory authorities.
Source: Orexigen Therapeutics
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