Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and
TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced
today the approval of BIJUVA® (estradiol and progesterone) capsules
by Health Canada. In Canada, BIJUVA is indicated for the treatment
of moderate to severe vasomotor symptoms (VMS) associated with
menopause in women with an intact uterus. VMS are commonly known as
hot flashes or flushes and night sweats. VMS affect 60% to 80% of
women entering menopause.1
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BIJUVA is a once-daily combination of estradiol and progesterone
in a single oral capsule that will be available in two strengths in
Canada. The two hormones included in BIJUVA have the same structure
as the hormones produced and circulating in the woman’s body. 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 due to menopause.
“We are pleased to be able to offer a new treatment for
postmenopausal women to address challenging symptoms of hot flashes
and night sweats with BIJUVA,” said Samira Sakhia, President and
Chief Operating Officer of Knight.
“The approval of BIJUVA by Health Canada is a significant
accomplishment by Knight, adding to the earlier approval of
IMVEXXY® in August 2020, that offers new treatment options to women
in Canada,” said Robert Finizio, Chief Executive Officer of
TherapeuticsMD.
Knight and TherapeuticsMD signed a license agreement in July
2018 pursuant to which TherapeuticsMD granted Knight the exclusive
Canadian commercialization rights to BIJUVA and IMVEXXY (estradiol
vaginal inserts). Under the terms of the license agreement related
to BIJUVA in Canada, Knight will pay TherapeuticsMD a milestone fee
for the regulatory approval in Canada of BIJUVA, sales milestone
fees based upon certain aggregate annual sales of BIJUVA in Canada,
and royalties based on aggregate annual sales of BIJUVA in
Canada.
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.
In Canada, BIJUVA is available as a once-daily capsule in two
strengths; 1 mg estradiol/100 mg progesterone and 0.5 mg
estradiol/100 mg progesterone.
Please see the Full BIJUVA and IMVEXXY Canadian Product
Monographs available at https://www.gud-knight.com.
Please see U.S. Full Prescribing Information for BIJUVA,
including BOXED WARNING for cardiovascular disorders, breast
cancer, endometrial cancer and probable dementia, available at
https://www.bijuva.com/pi.pdf.
Please see U.S. Full Prescribing Information for IMVEXXY,
including BOXED WARNING for endometrial cancer, cardiovascular
disorders, breast cancer, and probable dementia, available at
www.imvexxy.com/pi.pdf.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is
a specialty pharmaceutical company focused on acquiring or
in-licensing and commercializing innovative pharmaceutical products
for Canada and Latin America. Knight owns a controlling stake in
Grupo Biotoscana, a pan-Latin American specialty pharmaceutical
company. Knight Therapeutics Inc.'s shares trade on TSX under the
symbol GUD. For more information about Knight Therapeutics Inc.,
please visit the company's web site at www.gud-knight.com or
www.sedar.com.
Forward-Looking Statements for Knight Therapeutics
Inc.
This document contains forward-looking statements for Knight
Therapeutics Inc. and its subsidiaries. These forward-looking
statements, by their nature, necessarily involve risks and
uncertainties that could cause actual results to differ materially
from those contemplated by the forward-looking statements. Knight
Therapeutics Inc. considers the assumptions on which these
forward-looking statements are based to be reasonable at the time
they were prepared but cautions the reader that these assumptions
regarding future events, many of which are beyond the control of
Knight Therapeutics Inc. and its subsidiaries, may ultimately prove
to be incorrect. Factors and risks, which could cause actual
results to differ materially from current expectations are
discussed in Knight Therapeutics Inc.'s Annual Report and in Knight
Therapeutics Inc.'s Annual Information Form for the year ended
December 31, 2019 as filed on www.sedar.com. Knight Therapeutics
Inc. disclaims any intention or obligation to update or revise any
forward-looking statements whether as a result of new information
or future events, except as required by law.
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; 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 efficacy supplement
for 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. PDF copies of
the company’s historical press releases and financial tables can be
viewed and downloaded at its website:
https://ir.therapeuticsmd.com/press-releases.
References:
- Freeman EW, Sherif K. Prevalence of hot flushes and night
sweats around the world: a systematic review. Climacteric
2007;10:197–214
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200921005824/en/
Knight Therapeutics Inc. Samira
Sakhia President and Chief Operating Officer T: 514-484-4483 F:
514-481-4116 info@gudknight.com www.gudknight.com
Arvind Utchanah Chief Financial Officer T: 514-484-4483 F:
514-481-4116 Email: info@gudknight.com Website:
www.gud-knight.com
TherapeuticsMD Nichol Ochsner Vice
President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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