TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced today the appointment of Sebastian Mirkin, M.D., a prominent women’s health product development executive with extensive experience in the pharmaceutical industry and clinical research, as Chief Medical Officer, effective November 25th, 2013. Dr. Brian Bernick, TherapeuticsMD’s current Chief Medical Officer, will then serve as Chief Clinical Officer. Dr. Mirkin joins TherapeuticsMD from Pfizer, Inc. where he served as the Global Lead of Women’s Health Clinical Research and Development. Most recently, he oversaw the development and successful marketing authorization of Duavee™ (conjugated estrogens/bazedoxifene), a menopausal combination product approved by the U.S. Food and Drug Administration (FDA) earlier this month. Dr. Mirkin supervised and directed early- and late-stage clinical programs for Pfizer’s small molecule and biologic product candidates to address menopausal symptoms, osteoporosis, contraception, uterine fibroids and endometriosis. He successfully executed large phase 3 clinical trials for numerous other development programs and oversaw the filing of New Drug Applications and regulatory submissions worldwide for products addressing vasomotor symptoms associated with menopause, vulvar and vaginal atrophy, osteoporosis, and contraception, leading to marketing authorizations in the U.S., Europe and Japan. “We are very pleased to welcome Dr. Mirkin to TherapeuticsMD. His strong and highly relevant experience overseeing successful clinical trial programs is the precise expertise we need for advancing the development of our bio-identical hormone franchise as we seek to introduce FDA-approved products that match the molecular structure of the estradiol and/or progesterone produced in a woman’s body. More specifically, we believe his work on the first new combination hormone product to come to market in more than nine years could increase the likelihood of a positive outcome for our portfolio of products,” said Robert G. Finizio, Co-Founder and Chief Executive Officer of TherapeuticsMD. “We view his decision to join the company at this time to be a significant validation of our scientific and clinical platform, as well as the leadership role TherapeuticsMD is playing in advancing innovative treatments in the women’s hormone and health market,” concluded Finizio.
Prior to joining Pfizer, Dr. Mirkin spent three years at Wyeth Research at the Department of Women’s Health and Bone Repair, Clinical Development. Previously, he was the Global Lead for Medical Services Female Health Care, Global Marketing Department, at Akzo Nobel/Organon International.“Dr. Mirkin has extensive experience in the pharmaceutical industry and has been successful in obtaining regulatory approval for several products in Women’s Health. His joining TherapeuticsMD signals the company’s commitment to develop novel hormonal replacement therapy for women,” said David F. Archer, M.D., Director of Intramural Clinical Research Center Force, CONRAD, Director of Clinical Research Center, Jones Institute for Reproductive Medicine, and an investigator in TherapeuticsMD’s REPLENISH trial. Dr. Mirkin began his post-doctoral career with a four-year Reproductive Endocrinology Fellowship in the Contraceptive Research and Development Program (CONRAD) at the Jones Institute for Reproductive Medicine at Eastern Virginia Medical School’s Department of Obstetrics and Gynecology under the mentorship of Dr. Archer. Dr. Mirkin did research on angiogenesis and endometrial gene expression during the window of implantation. “I look forward to serving as TherapeuticsMD’s CMO and helping the company fulfill its goal of offering important hormone therapies that represent real innovation and fill critical voids in women’s health at every major life stage,” added Dr. Mirkin. Dr. Mirkin received his Doctor of Medicine degree from the National University of Rosario School of Medicine (Argentina), where he also was a resident and then Chief of Residents in the Department of Obstetrics and Gynecology. He is widely published and has actively participated in clinical trial activities related to numerous grants, including National Institutes of Health (NIH) grants and a Serono unrestricted grant. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD ® and BocaGreenMD™ brands. We are developing advanced hormone therapy pharmaceutical products that fill the critical and long-ignored need for better treatments in the hormone and women’s health market. Our advanced hormone therapies are based on a novel technology that enables delivery of bio-identical hormones through a variety of dosage forms and administration routes. These bio-identical hormone therapies match the molecular structure of the estradiol and/or progesterone produced in the body. Current programs include the REPLENISH Trial, a Phase 3 clinical study evaluating the safety and efficacy of our TX 12-001-HR 17ß-estradiol and progesterone combination product candidate in reducing the symptoms of menopause. We are also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure. More information is available at the following websites: www.therapeuticsmd.com, www.ReplenishTrial.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com. vitaMedMD ® and TherapeuticsMD ® are registered trademarks and BocaGreenMD™ is a trademark of TherapeuticsMD, Inc. Duavee™ is a trademark of Pfizer, Inc.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Dr. Mirkin’s appointment as the company’s Chief Medical Officer, the opinions of Dr. Mirkin, Mr. Finizio, and Dr. Archer with respect to what Dr. Mirkin’s experience and expertise will signal or achieve for the company, its portfolio of products, its platform, its role in the women’s hormone and health market, and its commitment to the development of novel hormone replacement therapy for women, the company’s intention to introduce FDA-approved products that match the molecular structure of the estradiol and/or progesterone hormones produced in a women’s body, the company’s focus, the company’s commitment to the development of advanced hormone therapy pharmaceutical products that fill a critical and long-ignored need in the hormone and women’s health market, the anticipated achievements, attributes, and benefits of TX 12-001-HR, what the REPLENISH clinical trial is designed to evaluate, and statements regarding other hormone technology that the company is currently evaluating 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, 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.