Healthcare Industry News: zoledronic acid
News Release - December 4, 2013
TherapeuticsMD Appoints Joel S. Krasnow, M.D. as Chief Scientific OfficerBOCA RATON, Fla.--(Healthcare Sales & Marketing Network)--TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company ("TherapeuticsMD" or the "Company"), announced today the appointment of Joel S. Krasnow, M.D., M.B.A., a leading board-certified OB/GYN and reproductive endocrinologist with broad biotech and pharmaceutical experience, as the Company's Chief Scientific Officer and head of its regulatory department.
Dr. Krasnow’s career spans 15 years in the pharmaceutical industry, including several global product registrations in women’s health and related areas. He began his career in academic medicine where he received funding for both basic science and clinical research in women’s health. During his time in academic medicine, Dr. Krasnow served as the Principal Investigator on a number of menopause clinical trials involving investigational hormone therapy (HT) regimens, two of which involved Premarin® and Provera®. He also acted as the Co-Investigator of a study on the endometrial histological effects of Prometrium®. He is widely published, with more than 20 papers in the women’s health field, and has actively participated in trial activities related to numerous grants. His industry experience comprises a broad spectrum of specialties including contraception, HT, reproductive medicine, endocrinology, immunology, urology and gastroenterology. Dr. Krasnow has participated in and directed many IND/NDA/BLA filings, presentations and labeling negotiations resulting in numerous regulatory approvals across therapeutic areas, and has managed clinical and medical marketing programs in women’s health including VagiFem® (vaginal atrophy secondary to menopause) and Activella® (HT).
"We are pleased to welcome Dr. Krasnow to TherapeuticsMD. His hands-on experience with and oversight of the product approval process for both VagiFem and Activella are directly relevant to our strategic path going forward, and will be a real asset as we seek to introduce innovative treatment products in the women’s hormone and health market. With his vast experience in clinical trials design and management, medical affairs, drug safety and pharmacovigilance, and regulatory interactions, especially with the U.S. Food and Drug Administration (FDA), Dr. Krasnow’s contributions will be invaluable as we execute late stage clinical trials for our novel hormone therapy (HT) product candidates including our bioidentical oral E+P combination HT product, our low-dose progesterone candidate for secondary amenorrhea, and estradiol VagiCap for vulvar and vaginal atrophy," said Robert G. Finizio, Co-Founder and Chief Executive Officer of TherapeuticsMD.
Dr. Krasnow joins TherapeuticsMD from Intarcia Therapeutics, where as Chief Safety Officer he was responsible for managing and conducting ongoing safety surveillance on the Intarcia Therapeutics' products, including its lead diabetes product. He also provided scientific input to leverage Intarcia Therapeutics' technology across different clinical applications.
Prior to Intarcia Therapeutics, at Eisai Pharmaceuticals, Dr. Krasnow was promoted to Vice President and Chief Medical Officer of its Frontier Business Unit, where he led clinical development, provided clinical guidance to discovery projects and evaluated in-licensing opportunities. He previously spent over four years in the areas of immunology and metabolism at Hoffman-LaRoche, where as the Clinical Science Leader he led the analysis, reporting and presentation of the clinical data resulting in global product approvals for a monoclonal antibody to the interleukin-6 receptor Actemra® (Tocilizumab), as well as the clinical development and medical marketing of Boniva® (Ibandronate). He also worked at Novartis as the Senior Medical Director in the Arthritis and Bone Division leading to the registration of Reclast® (zoledronic acid) for Paget’s disease and osteoporosis. During his four year tenure as Medical Director of Pfizer’s Global Prescription Business, he managed clinical and medical marketing programs for contraceptive and hormone replacement products. At Organon, he rose to Medical Director, Endocrinology and Women’s Health, and was the Clinical Lead for FDA interactions with Antagon® (Ganirelix) and Mircette®. He also worked at Deloitte Consulting as a Senior Consultant in Pharmaceutical and Managed Care and as a Medical Advisor at Blue Cross of Western Pennsylvania.
Dr. Krasnow received his Doctor of Medicine degree from McGill University School of Medicine in Montreal, Canada, and his Masters of Business Administration from the Katz Graduate School of Business at the University of Pittsburgh. He was a Fellow in the Department of Reproductive Endocrinology at Baylor College of Medicine in Houston, Texas, and spent his residency in the Department of Obstetrics and Gynecology at the University of Chicago.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We are currently developing advanced hormone therapy pharmaceutical products based on novel technologies that enable delivery of bioidentical hormones through a variety of dosage forms and administration routes. We also manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company’s belief that Dr. Krasnow's experience will be directly relevant to the Company's strategic path going forward, that Dr. Krasnow will be a real asset to the Company as it seeks to introduce innovative treatment products in the women's hormone and health market, and that Dr. Krasnow's contributions will be invaluable as the Company executes its late stage clinical trials for its novel HT product candidates are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; risks and uncertainties associated with the Company's business and finances in general; and other risks detailed in the Company's filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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