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.
Copyright Business Wire 2013