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.
Copyright Business Wire 2013