TherapeuticsMD & Theramex Announce the Approval of BIJUVE® Capsules Indicated for Hormone Replacement Therapy in the United ...
April 08 2021 - 4:05PM
Business Wire
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading
women’s healthcare company, and Theramex, a dedicated women’s
health company, announced that BIJUVE® has received approval from
the Medicines and Healthcare products Regulatory Agency (MHRA) for
use in the United Kingdom and, from the Federal Agency for
Medicines and Health Products (FAMHP) for use in Belgium under
BIJUVA®.
A “decentralized procedure” (DCP) for the regulatory approval of
BIJUVA® in several European countries was completed in February.
Following this each country undertakes a national process which
includes approvals for labeling and other country specific
requirements. Theramex expects approvals from other major EU
countries shortly.
“The approval of BIJUVE in the UK and BIJUVA in Belgium marks a
significant accomplishment by Theramex that offers a new treatment
option to post-menopausal women,” said Robert Finizio, Chief
Executive Officer of TherapeuticsMD.
“We are excited to bring this first and only combination of
micronized progesterone and estradiol to the UK and Belgium through
our license agreement with TherapeuticsMD,” said Robert Stewart,
Chief Executive Officer of Theramex.
BIJUVA is the first and only oral combined HRT with
bio-identical hormones*, made available to patients across Europe
through the license agreement that TherapeuticsMD and Theramex
signed in June 2019 granting Theramex the exclusive license and
supply agreement to commercialize BIJUVA outside the United States,
Canada, and Israel. Under the terms of the license agreement
related to BIJUVA, Theramex will pay TherapeuticsMD a milestone fee
for the regulatory approval in certain specified European markets
of BIJUVA, sales milestone fees based upon certain aggregate annual
net sales of BIJUVA, and royalties based on aggregate annual net
sales of BIJUVA in licensed territories.
In the U.S., BIJUVA is marketed by TherapeuticsMD and is
indicated in a woman with a uterus for the treatment of moderate to
severe vasomotor symptoms (VMS) due to menopause.
*Bio-identical hormones are hormones that are
structurally identical to the hormones your body produces
naturally. It is not known if there is a difference in risks
between synthetic hormones and bio-identical hormones.
About BIJUVA
BIJUVA was developed and approved in the U.S. for the treatment
of moderate to severe VMS due to menopause in women with a uterus.
It is a combination of 1 mg bio-identical estradiol and 100 mg
bio-identical progesterone in a once-daily oral softgel
capsule.
Please see U.S. Important Safety Information for BIJUVA,
including BOXED WARNING for cardiovascular disorders, breast
cancer, endometrial cancer and probable dementia, available at
https://www.bijuva.com/pi.pdf.
About Theramex
Theramex is a leading, global specialty pharmaceutical company
dedicated to women and their health. With a broad portfolio of
innovative and established brands covering contraception,
fertility, menopause and osteoporosis, Theramex supports women at
every stage of their lives. Theramex’s commitment is to understand
its patients, serve their needs, and offer healthcare solutions to
help improve their lives. Theramex’s vision is to be a lifetime
partner for women and the healthcare professionals who treat them
by providing innovative, effective solutions that care for and
support women as they advance through each stage of their lives. To
learn more about Theramex, please visit www.theramex.com.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading healthcare
company, focused on developing and commercializing novel products
exclusively for women. Our products are designed to address the
unique changes and challenges women experience through the various
stages of their lives with a therapeutic focus in family planning,
reproductive health, and menopause management. The company is
committed to advancing the health of women and championing
awareness of their healthcare issues. To learn more about
TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on
Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
Forward-Looking Statements for TherapeuticsMD Inc.
This press release by TherapeuticsMD, Inc. may contain
forward-looking statements. Forward-looking statements may include,
but are not limited to, statements relating to TherapeuticsMD’s
objectives, plans and strategies as well as statements, other than
historical facts, that address activities, events or developments
that the company intends, expects, projects, believes or
anticipates will or may occur in the future. These statements are
often characterized by terminology such as "believes," "hopes,"
"may," "anticipates," "should," "intends," "plans," "will,"
"expects," "estimates," "projects," "positioned," "strategy" and
similar expressions and are based on assumptions and assessments
made in light of management’s experience and perception of
historical trends, current conditions, expected future developments
and other factors believed to be appropriate. Forward-looking
statements in this press release are made as of the date of this
press release, and the company undertakes no duty to update or
revise any such statements, whether as a result of new information,
future events or otherwise. Forward-looking statements are not
guarantees of future performance and are subject to risks and
uncertainties, many of which are outside of the company’s control.
Important factors that could cause actual results, developments and
business decisions to differ materially from forward-looking
statements are described in the sections titled "Risk Factors" in
the company’s filings with the Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q, as well as reports on Form 8-K, and include
the following: the effects of the COVID-19 pandemic; the company’s
ability to maintain or increase sales of its products; the
company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®,
and BIJUVA® and obtain additional financing necessary therefor;
whether the company will be able to comply with the covenants and
conditions under its term loan facility; whether the company will
be able to successfully divest its vitaCare business and the
proceeds that may be generated by such divestiture; the potential
of adverse side effects or other safety risks that could adversely
affect the commercialization of the company’s current or future
approved products or preclude the approval of the company’s future
drug candidates; whether the FDA will approve the lower dose of
BIJUVA; the company’s ability to protect its intellectual property,
including with respect to the Paragraph IV notice letters the
company received regarding IMVEXXY and BIJUVA; the length, cost and
uncertain results of future clinical trials; the company’s reliance
on third parties to conduct its manufacturing, research and
development and clinical trials; the ability of the company’s
licensees to commercialize and distribute the company’s products;
the ability of the company’s marketing contractors to market
ANNOVERA; the availability of reimbursement from government
authorities and health insurance companies for the company’s
products; the impact of product liability lawsuits; the influence
of extensive and costly government regulation; the volatility of
the trading price of the company’s common stock and the
concentration of power in its stock ownership.
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version on businesswire.com: https://www.businesswire.com/news/home/20210408005726/en/
TherapeuticsMD Nichol Ochsner Vice
President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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