Knight and TherapeuticsMD Announce Health Canada Approval of IMVEXXY®
MONTREAL and BOCA RATON, Fla, Aug. 25, 2020 (GLOBE NEWSWIRE) — 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.
“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 IMVEXXYIMVEXXY (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 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: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.