Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and
TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced
today the approval of IMVEXXY® by Health Canada. In Canada, IMVEXXY
is for the treatment of postmenopausal moderate to severe
dyspareunia, a symptom of vulvar and vaginal atrophy (VVA). VVA is
a prevalent, chronic, and progressive condition associated with
menopause. Common symptoms of VVA include dryness, discomfort, and
pain in the vaginal and vulvar areas1-4. IMVEXXY is an
applicator-free, estradiol softgel vaginal capsule indicated for
postmenopausal women who experience pain before, during or after
sex. IMVEXXY (estradiol vaginal inserts) is marketed by
TherapeuticsMD in the U.S. for the treatment of moderate to severe
dyspareunia, a symptom of VVA, due to menopause.
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“IMVEXXY offers a new option for postmenopausal women to address
their unmet medical needs and helps manage the suffering associated
with a very bothersome and painful VVA symptom that significantly
impacts quality of life,” said Samira Sakhia, President and Chief
Operating Officer of Knight Therapeutics.
“The approval of IMVEXXY by Health Canada marks a significant
new milestone for Knight and we could not be more pleased as they
bring this new treatment option to women in Canada,” said Robert
Finizio, Chief Executive Officer of TherapeuticsMD.
Knight and TherapeuticsMD signed a licensing agreement in July
2018 pursuant to which TherapeuticsMD granted Knight the exclusive
Canadian commercialization rights to IMVEXXY and BIJUVA® (estradiol
and progesterone) capsules. Under the terms of the licensing
agreement related to IMVEXXY in Canada, Knight will pay
TherapeuticsMD a milestone fee for the regulatory approval in
Canada of IMVEXXY, sales milestone fees based upon certain
aggregate annual sales of IMVEXXY in Canada, and royalties based on
aggregate annual sales of IMVEXXY in Canada.
About IMVEXXY
IMVEXXY (estradiol vaginal inserts) was developed and approved
in the U.S. for the treatment of moderate to severe dyspareunia, a
symptom of vulvar and vaginal atrophy, due to menopause.
IMVEXXY is the only product in its therapeutic class to offer a
4 mcg and 10 mcg dose; the 4 mcg represents the lowest U.S. Food
and Drug Administration-approved dose of vaginal estradiol.
Please see the Full IMVEXXY® Canadian Product Monograph
available at https://www.gud-knight.com.
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.
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.
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 therefore;
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: 1. Mac Bride MB, Rhodes DJ, Shuster LT.
Vulvovaginal atrophy. Mayo Clin Proc. 2010;85(1):87-94. 2. The
North American Menopause Society. Management of symptomatic
vulvovaginal atrophy: 2013 position statement of The North American
Menopause Society. Menopause. 2013;20(9):888-902. 3. Wysocki S,
Kingsberg S, Krychman M. Management of vaginal atrophy:
implications from the REVIVE survey. Clin MedInsights Reprod
Health. 2014;8:23-30. 4. Chen L, Ng M, van der Vlugt TH, Price PH,
Orencia A. Statistical considerations for the efficacy assessment
of clinical studies of vulvar and vaginal atrophy. Ther Innov Regul
Sci. 2010;44(5):581-588.
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Knight Therapeutics Inc. Samira
Sakhia President and Chief Operating Officer T: 514-678-8930 F:
514-481-4116 info@gudknight.com www.gudknight.com
Arvind Utchanah Chief Financial Officer T. 514.484.4483 ext. 115
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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