Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and
TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced
today that Knight's New Drug Submission (NDS) for BIJUVA® has been
accepted for review by Health Canada. BIJUVA, estradiol and
progesterone capsules, is licensed by Knight from TherapeuticsMD.
BIJUVA is a bio-identical* hormone therapy combination of estradiol
and progesterone in a single, daily oral capsule intended for the
treatment of moderate-to-severe vasomotor symptoms associated with
menopause in women with intact uteri.
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“With our submission, we are excited about BIJUVA moving closer
to commercialization in Canada,” said Jonathan Ross Goodman, Chief
Executive Officer of Knight. “BIJUVA offers a combination of
bio-identical hormones to reduce moderate-to-severe vasomotor
symptoms in menopausal patients.”
“We are pleased with Knight’s regulatory filing for BIJUVA in
Canada,” said Robert Finizio, Chief Executive Officer of
TherapeuticsMD, “and look forward to their commercialization of
BIJUVA in Canada.”
Knight and TherapeuticsMD signed an agreement in July 2018
granting Knight the exclusive Canadian commercialization rights to
BIJUVA and Joyesta™ (an applicator-free estradiol softgel vaginal
capsule for the treatment of postmenopausal symptoms of vulvar and
vaginal atrophy due to estrogen deficiency, commercialized by
TherapeuticsMD in the U.S. under the name IMVEXXY®).
*Bio-identical refers to estradiol and progesterone that are
molecularly identical to the hormones circulating naturally in the
woman’s body. There is no evidence that bio-identical hormones are
safer or more effective than synthetic hormones.
About BIJUVA
BIJUVA is a novel combination of bio-identical estradiol and
bio-identical progesterone in a once-daily oral softgel capsule. It
is approved in the U.S. for the treatment of moderate to severe
vasomotor symptoms due to menopause in women with a uterus.
Please see U.S. Full Prescribing Information for IMVEXXY,
including BOXED WARNING for endometrial cancer, cardiovascular
disorders, breast cancer, and probably dementia, are available at
www.imvexxy.com/pi.pdf.
Copies of the U.S. Full Prescribing Information for BIJUVA,
including BOXED WARNING for cardiovascular disorders, breast
cancer, endometrial cancer and probable dementia, are 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 the Canadian and select international markets. Knight
Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For
more information about Knight Therapeutics Inc., please visit the
company's website 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, 2018. 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 U.S. 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 company’s ability to maintain or
increase sales of its products; the company’s ability to develop
and commercialize IMVEXXY®, ANNOVERA™, BIJUVA® and its hormone
therapy drug candidates and obtain additional financing necessary
therefor; whether the company will be able to comply with the
covenants and conditions under its term loan facility, including
the conditions to draw additional tranches thereunder; 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; 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 and gain foreign regulatory
approvals necessary therefor; 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:
www.therapeuticsmd.com/pressreleases.aspx.
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version on businesswire.com: https://www.businesswire.com/news/home/20191126005263/en/
Knight Therapeutics Inc. Samira
Sakhia President and Chief Financial Officer T: 514-678-8930 F:
514-481-4116 info@gudknight.com www.gudknight.com
TherapeuticsMD Nichol Ochsner Vice
President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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