02:55:26 EDT Thu 02 May 2024
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Knight Therapeutics Inc
Symbol GUD
Shares Issued 104,186,536
Close 2024-01-04 C$ 5.36
Market Cap C$ 558,439,833
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Knight Therapeutics rolls out IMVEXXY in Canada

2024-01-04 10:31 ET - News Release

Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES PRODUCT LAUNCH FOR IMVEXXY IN CANADA

Knight Therapeutics Inc. has launched 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. IMVEXXY is the only product in its therapeutic class to offer a four-microgram (mcg) and 10 mcg dose of 17-beta estradiol: The four 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, preventive health care 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 licence agreement in July, 2018, pursuant to which TherapeuticsMD granted Knight the exclusive Canadian commercialization rights to IMVEXXY. Under the terms of the licence 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.

IMVEXXY is a small, light pink, tear-shaped, softgel vaginal insert that is digitally inserted into the vagina. IMVEXXY inserts contain four mcg or 10 mcg of estradiol and are 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 anxiety, interfere with sexual function, and lead to loss of intimacy with partners. Up to 84 per cent of postmenopausal women report symptoms associated with VVA and approximately half of women report their symptoms to be moderate or severe. However, VVA is severely undertreated, with only 7 per cent of women receiving a prescription treatment.

Common symptoms of VVA include dyspareunia, vaginal dryness, irritation, burning sensation, dysuria and vaginal discharge. 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 levels. Unlike vasomotor symptoms (VMS) associated with menopause, VVA symptoms are progressive and do not subside or resolve with time.

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

For the treatment of VVA, most women (55 per cent) chose the treatment that was recommended by their HCP (health care professional), 25 per cent chose a method based on how it was administered and only 5 per cent chose it based on recommendation of a friend or family member. A small percentage of women (7 per cent) were using prescribed VVA therapies, 25 per cent were using OTC (over-the-counter) therapies, 18 per cent were past users of a prescribed therapy and 50 per cent 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).

Please see the full IMVEXXY Canadian product monograph available at the company's website.

About Knight Therapeutics Inc.

Knight Therapeutics, 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.

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