Knight Therapeutics Announces Product Launch for IMVEXXY® in Canada

MONTREAL, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of IMVEXXY^® in Canada. IMVEXXY^® (estradiol vaginal inserts) is approved 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 areas^1-4. IMVEXXY^® is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose of 17β estradiol; the 4 mcg represents the lowest effective Health Canada-approved dose of vaginal estradiol.

Dr. Vivien Brown, a family physician known to advocate on a national and international scale on women’s health issues, preventative healthcare, and healthy aging commented “There is a need to raise awareness amongst patients about the challenges of menopause, in particular the most bothersome symptoms such as painful intercourse. The launch of IMVEXXY^® provides a safe, simple, easy to use and effective treatment to add to our armamentarium.

“We are very excited about the launch of IMVEXXY^®, a new treatment option for postmenopausal women in Canada. IMVEXXY^® offers women a simple, effective alternative that is reimbursed across Canada and will address the very bothersome and painful VVA symptoms that significantly impacts quality of life,” said Samira Sakhia, President and Chief Executive Officer of Knight.

Knight and TherapeuticsMD signed a license agreement in July 2018 pursuant to which TherapeuticsMD granted Knight the exclusive Canadian commercialization rights to IMVEXXY^® (estradiol vaginal inserts). Under the terms of the license agreement related to IMVEXXY^® in Canada, Knight will pay TherapeuticsMD sales milestone fees and royalties based upon certain aggregate annual sales of IMVEXXY^® in Canada.

About IMVEXXY^®

IMVEXXY^® (estradiol vaginal inserts) was developed for the treatment of postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA).

IMVEXXY^® is a small, light pink, tear-shaped, softgel vaginal insert that is digitally inserted into the vagina. IMVEXXY^® inserts contain 4 mcg or 10mcg of estradiol and is administered initially intravaginally once daily at approximately the same time for two weeks, followed by one insert twice weekly, every three to four days.

IMVEXXY^® was designed for easy insertion at any time of day and with no need for an applicator. The goal of IMVEXXY^® is to provide an early onset of efficacy, with low systemic estrogen levels and improved administration to enhance treatment compliance and patient satisfaction.

About VVA

VVA is a chronic and progressive medical condition that can have a deleterious effect on quality of life (QOL), significantly increase risk for depression and anxiety⁵, interfere with sexual function and lead to loss of intimacy with partners⁶. Up to 84% of postmenopausal women report symptoms associated with VVA and approximately half of women report their symptoms to be moderate or severe^7-14. However, VVA is severely undertreated with only 7% of women who receive a prescription treatment¹⁵.

Common symptoms of VVA include dyspareunia, vaginal dryness, irritation, burning sensation, dysuria, and vaginal discharge^1,2,16. Dyspareunia and vaginal dryness are closely linked and are the most commonly reported symptoms by women with VVA due to menopause, and can either occur early during the menopause transition or after several years of reduced estrogen levels¹⁷. Unlike vasomotor symptoms (VMS) associated with menopause, VVA symptoms are progressive and do not subside or resolve with time².

Results of multiple surveys show that VVA symptoms can have a negative impact on sex life, marriage/relationship, self-esteem, and social life^6,9,10,15. For most women, pain during intercourse can be a factor in loss of libido and arousal and can affect their relationship with their partner ²⁰. VVA symptoms can have a psychological impact on sexual activities, with 52% to 80% of women (nationally and internationally) believing that vaginal discomfort would have a negative impact on their QOL and 40% to 68% believing that VVA would decrease satisfaction, frequency, and spontaneity of sex^10,15,16.

For the treatment of VVA, most women (55%) chose the treatment that was recommended by their HCP, 25% chose a method based on how it was administered, and only 5% chose it based on recommendation of a friend or family member. A small percentage of women (7%) were using prescribed VVA therapies, 25% were using OTC therapies, 18% were past users of a prescribed therapy, and 50% had never used a treatment. Before talking to an HCP, only about one-third of the women were extremely or very familiar with VVA treatment options (oral hormone therapies (HT), vaginal ET, OTC products, and lifestyle changes)⁷.

Please see the Full IMVEXXY^® Canadian Product Monograph available at https://knighttx.com/CA/products/.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. 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.knighttx.com or www.sedarplus.com.

Forward-Looking Statements for Knight Therapeutics Inc.

This document may contain 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, 2022 as filed on www.sedarplus.com. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information or future events, except as required by law.

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.
5. Moyneur E, Dea K, Derogatis LR, Vekeman F, Dury AY, Labrie F. Prevalence of depression and anxiety in women newly diagnosed with vulvovaginal atrophy and dyspareunia. Menopause. 2020;27(2):134-142.
6. Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10(7):1790-1799.
7. Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S. The Women's EMPOWER Survey: Identifying Women's Perceptions on Vulvar and Vaginal Atrophy and Its Treatment. J Sex Med. 2017;14(3):413-424.
8. Krychman M, Kingsberg S. REVEAL: Revealing Vaginal Effects at Mid-Life: surveys of postmenopausal women and health care professionals who treat postmenopausal women. Wyeth; 2009.
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12. Palma F, Volpe A, Villa P, Cagnacci A. Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. Maturitas. 2016;83:40-44.
13. Santoro N, Komi J. Prevalence and impact of vaginal symptoms among postmenopausal women. J Sex Med. 2009;6(8):2133-2142.
14. Simon JA, Kokot-Kierepa M, Goldstein J, Nappi RE. Vaginal health in the United States: results from the Vaginal Health: Insights, Views & Attitudes survey. Menopause. 2013;20(10):1043-1048.
15. Krychman M, Graham S, Bernick B, Mirkin S, Kingsberg SA. The Women's EMPOWER Survey: Women's Knowledge and Awareness of Treatment Options for Vulvar and Vaginal Atrophy Remains Inadequate. J Sex Med. 2017;14(3):425-433.
16. Parish SJ, Nappi RE, Krychman ML, et al. Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy. Int J Womens Health. 2013;5:437-447.
17. NAMS. Changes in the Vagina and Vulva. 2017; http://www.menopause.org/for-women/sexual-health-menopause-online/changes-at-midlife/changes-in-the-vagina-and-vulva. Accessed April 3, 2017.
    
    

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