Healthcare Industry News: SUSTIVA
News Release - May 3, 2011
Optimer Pharmaceuticals Expands Senior Management TeamSAN DIEGO, May 3, 2011 -- (Healthcare Sales & Marketing Network) -- Optimer Pharmaceuticals, Inc. (NASDAQ:OPTR ) today announced the appointment of Nancy Ruiz, M.D., as Senior Vice President of Research and Development, Cynthia Schwalm as Senior Vice President of International and Kasia Petchel, M.D., as Senior Vice President of Pharmacovigilance. These newly created positions will strengthen the senior management team as the Company prepares for the potential launch of its lead product candidate, DIFICID™, while seeking to build its hospital specialty products capability and pipeline.
"With the recent FDA Advisory Committee's unanimous vote in favor of market approval of DIFICID for the treatment of Clostridium difficile infection, we are taking additional steps to build a powerful team that will contribute to a successful product launch and long term company growth," said Pedro Lichtinger, Optimer's President and CEO. "These additions to our senior management team will support the safety and risk management of DIFICID, maximize our international business, and improve our capability to build our product pipeline."
Dr. Ruiz joins Optimer with more than 20 years of Phase 1 through Phase 4 clinical research experience in infectious diseases and immunology, which includes more than 15 years in the pharmaceutical industry. She joins Optimer from Merck Research Laboratories (formerly Schering-Plough Research Institute) where she served as Vice President, Project and Pipeline Management for Infectious Diseases. During that tenure she fulfilled several leadership and strategic roles, including Senior Project Leader of early and late development teams responsible for the C. difficile monoclonal antibody program, as well as the antifungal, antibacterial, vaccines, HIV and hepatitis C teams (including the development and recent filing of boceprevir). Previously, Dr. Ruiz held several leadership roles at Bristol-Myers Squibb, where she gained global early and late clinical development and medical affairs experience in infectious diseases (HIV- SUSTIVA®, Reyataz®; hepatitis B-Baraclude®) and immunology (rheumatoid arthritis- Orencia® and transplant- belatacept). Prior to initiating her career as a clinician and clinical investigator, Dr. Ruiz received her B.A. at Temple University in Philadelphia and her M.D. at the Ponce School of Medicine in Puerto Rico. She is a Diplomat of the American Board of Internal Medicine and the American Board of Infectious Diseases and a Fellow of the American College of Physicians and Fellow of the Infectious Diseases Society of America.
Ms. Schwalm brings a strong track record of growth and development in hospital and specialty markets during her 30 years of experience in the fields of pharmaceuticals, biotechnology, medical devices and health care delivery. She joins Optimer from Eisai Pharmaceuticals, Inc., the U.S. commercial arm of Tokyo-based Eisai Co., LTD, where she served as President. Ms. Schwalm had full operating responsibilities for Eisai Pharmaceuticals where she led commercial, medical and manufacturing functions. Her team built independent commercial capabilities for Eisai and drove double digit top line and bottom line P&L growth during her tenure. She came to Eisai in 2008 from Amgen Inc. where, over the course of her five-year tenure, she rose to Vice President and General Manager of the U.S. oncology business. Under her leadership, the unit's annual revenues tripled to over $5 billion, as she directed approximately 500 people in all areas of oncology strategy and commercialization. Prior to Amgen, she spent 18 years at Johnson & Johnson holding positions of increasing responsibility, culminating in her appointment as the managing director of Ortho-Biotech UK & Ireland. At Johnson & Johnson Ms. Schwalm also led worldwide franchise development for two franchises in the pharmaceuticals division. Ms. Schwalm is a member of Harvard JFK School of Public Policy Women's Leadership Board and the International Women's Forum, a merit-based organization of the highest ranking women in business. In April 2009, she was recognized as one of New Jersey's Top 50 Women in Business by NJ Biz. Ms. Schwalm also serves on the boards of the Sarah Cannon Research Institute, The Children's Aid and Family Services Organization of Bergen County, NJ and Beth Abrahams Family Services, NYC. She holds a B.S. degree in nursing from the University of Delaware and an M.B.A. from the Wharton School of Business.
Dr. Petchel joins Optimer with more than 20 years of pharmaceutical industry experience in safety science, pharmacovigilance and risk management. Prior to joining Optimer, Dr. Petchel was the Vice President, Global Head Drug Safety Risk Management at Roche. There she led the company's Global Safety organization and initiated significant changes to advance into proactive benefit risk management. During this time, Dr. Petchel also chaired Roche's Drug Safety Committee (DSC), the highest corporate body for all assessments of product safety. Prior to that, she served as an executive at Pfizer, Inc. from 1996 to 2006, most recently as the Vice President and Global Head Safety Surveillance Reporting, where she oversaw more than 500 staff in four global locations, focusing on long-term strategic planning for safety. Prior to her career at Pfizer, she worked at various positions in the pharmaceutical industry including late Phase 3 development activities, global medical affairs and drug safety, spanning companies such as Ciba-Geigy, Sanofi and Zeneca, with assignment locations in North America, Switzerland, Singapore and South East Asia. Dr. Petchel is a board-certified physician epidemiologist and received her M.D. at the University of Zagreb, Croatia and her postgraduate training at Harvard University. Dr. Petchel is also a founding board member and a past Vice President and President of the American Academy of Pharmaceutical Physicians.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has two anti-infective product candidates in development, DIFICID™ (fidaxomicin) and Pruvel™ (prulifloxacin). DIFICID is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company's request for six-month Priority Review of Optimer's NDA for DIFICID, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a MAA with the European Medicines Agency (EMA) for DIFICID. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.
Forward Looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the potential approval and commercial launch of DIFICID, Optimer's establishment of a commercial organization, the potential growth of Optimer's product pipeline and the future roles and contributions of Dr. Petchel, Ms. Schwalm, and Dr. Ruiz at Optimer. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product development efforts, the receipt of regulatory approvals, Optimer's ability to recruit and retain a commercial sales force, Optimer's ability to identify and develop additional product candidates and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
Source: Optimer Pharmaceuticals
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