MONTREAL and BOCA RATON, Fla., Nov. 26, 2019 — 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 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. Bijuva is licensed by Knight from TherapeuticsMD.
“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 JoyestaTM (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.
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 probable 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 web site at www.gud-knight.com or www.sedar.com.
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.
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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