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
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
CONTACT INFORMATION:
Knight Therapeutics Inc.Samira SakhiaPresident and Chief
Operating OfficerT: 514-514.484.4483F:
514-481-4116info@gudknight.comwww.gudknight.comArvind UtchanahChief
Financial OfficerT. 514.484.4483 F.
514.481.4116Email: info@gudknight.comWebsite: www.gud-knight.com
TherapeuticsMDNichol OchsnerVice President, Investor
Relations561-961-1900, ext. 2088Nochsner@TherapeuticsMD.com
TherapeuticsMD (NASDAQ:TXMD)
Historical Stock Chart
From Aug 2024 to Sep 2024
TherapeuticsMD (NASDAQ:TXMD)
Historical Stock Chart
From Sep 2023 to Sep 2024