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Kevening Therapeutics Inc. (TSX: GUD) (“Kevening”) and TherapeuticsTM, Inc. (NASDAQ: TXMD) (“TherapeuticsTM”) today announced the approval of BIJUVA® (estradiol and progesterone) pills through Health Canada. In Canada, BIJUVA is indicated for the remedy of moderate to severe menopause-related vasomotor symptoms (LVSVs) in women with an intact uterus. SVM is commonly referred to as hot flashes or hot flashes and night sweats. VM affects 60% to 80% of postmenopausal women. 1
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BIJUVA is a once-daily blend of estradiol and progesterone in an oral singles capsule that will be consumed in two concentrations in Canada. The two hormones included in BIJUVA have the same design as hormones produced and circulating in women’s bodies In the United States, BIJUVA is advertised through TherapeuticsTM and is indicated in women with uterus for the remedy of moderate to severe vasomotor symptoms due to menopause.
“We are pleased to be able to offer a new remedy to postmenopausal women to treat the difficult symptoms of hot flashes and night sweats with BIJUVA,” said Samira Sakhia, Kevening’s president and chief operating officer.
“BIJUVA’s approval through Health Canada is Knight’s life achievement, in addition to the prior approval of IMVEXXY® in August 2020, which provides new remedy features to women in Canada,” said Robert Finizio, CEO of TherapeuticsTM.
Knight and TherapeuticsTM signed a licensing agreement in July 2018 under which TherapeuticsTM granted Knight exclusive marketing rights in Canada for BIJUVA and IMVEXXY (vaginal oestradiol inserts). Under the terms of the BIJUVA-related licensing agreement in Canada, Knight will pay TherapeuticsTM a milestone payment for regulatory approval in Canada for BIJUVA, a sales milestone payment on BIJUVA’s total annual sales in Canada, and royalties on total annual sales. BIJUVA in Canada.
About BIJUVA
BIJUVA has been developed and approved in the United States for moderate to severe menopausal VMS remedy in women with uterus. It is a mixture of 1 mg biodidentic estradiol and one hundred mg of bioidentic progesterone in a comfortable oral capsule. once a day.
In Canada, BIJUVA should be taken in capsules once daily in two concentrations; 1 mg oestradiol / one hundred mg of progesterone and 0. 5 mg of estradiol / one hundred mg of progesterone.
See the full Canadian BIJUVA and IMVEXXY monographs available at https://www. gud-knight. com.
See US full dose data for full dose data. But it’s not the first time For BIJUVA, adding the ENCADRADA WARNING for cardiovascular disorders, breast cancer, endometrial cancer and probable dementia, available https://www. bijuva. com/pi. pdf.
See the full IMVEXXY dosage data in the US. U. S. , Adding THE ENCADRADA WARNING for endometrial cancer, cardiovascular disease, breast cancer and likely dementia, available in www. imvexxy. com/pi. pdf.
About Knight Therapeutics Inc.
Knight Therapeutics Inc. , headquartered in Montreal, Canada, is a specialized pharmaceutical company for the procurement or licensing and marketing of cutting-edge pharmaceutical products for Canada and Latin America. Knight holds a majority stake in Grupo Biotoscana, a pan-American pharmaceutical company specializing in Knight Therapeutics’ stock industry Inc. se located at TSX under the symbol GUD. For more information about Knight Therapeutics Inc. , visit the company’s online page at www. gud-knight. com or www. sedar. com.
Forward-looking statements by Knight Therapeutics Inc.
This document includes forward-forward statements relating to Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve dangers and uncertainties that can also cause actual effects to differ materially from those seen in forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which such forward-looking statements are substantiated to be moderated at the time they were prepared, however, warns the reader that those assumptions related to long-term events, many of which are beyond those of Knight Therapeutics Inc. and its subsidiaries may in the end prove inaccurate. Factors and hazards that can also cause actual effects to differ particularly from existing expectations are addressed in Knight Therapeutics Inc’s annual report. Knight Therapeutics Inc. ‘s annual performance for the year ended December 31, 2019, presented at www. Knight Therapeutics Inc. disclaims any legal objective or liability to update or revise any forward-looking statements as a result of new data or ventilation, unless required by law.
About TherapeuticsTM, Inc.
TherapeuticsTM, Inc. es a leading, cutting-edge warething care company aimed at the progression and commercialization of new women-only products. Our products are designed to respond to exclusive settings and demanding situations where women delight in the other stages of their lives. with a healing concentrate in the circle of family planning, reproductive fitness and menopause management. The company is committed to promoting women’s fitness and selling awareness of their fitness problems. For more information about TherapeuticsTM, www. healingsmd. com or join us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsTM.
Forward-looking statements through Therapeutics Inc.
This press release from TherapeuticsMD, Inc. may include forward-looking statements. Forward-looking statements would possibly come with, but are not limited to, statements regarding TherapeuticsMD’s goals, plans, and methods, as well as statements, other than ancient facts, that relate to activities, occasions, or extensions that the company is contemplating. , expects, projects, believes or anticipates or possibly happens in the long term. These statements are characterized by terms such as “believes”, “expects”, “possibly”, “anticipates”, “should”, “intends”, “plans”, “will”, “expects” Array “Estimates”, plans , “positions”, “strategy” and similar expressions, and are based on assumptions and tests performed in gentle control, delight and belief in old trends, existing situations, expected long-term expansions and other points considered appropriate. Forward-looking statements included in this press release are made as of the date of this press release, and the company assumes no legal responsibility to update or revise such statements, whether as a result of new information, long-term occasions, or else. Forward-looking statements are not promises of long-term functionality and are subject to dangers and doubts, many of which are beyond the control of the company. Important points that may also cause actual effects, extensions and business decisions that differ materially from the forward-looking statements are described in the sections entitled “Risk Factors” in the documents filed through the Company with the Securities and Exchange Commission, adding your most recent annual report. Report on Form 10-K and quarterly reports on Form 10-Q, as well as reports on Form 8-K, and come up with 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 expand and market, accept IMVEXXY®, ANNOVERA®, and BIJUVA®, and download the additional financing required for this purpose; If the company will be able to comply with the agreements and situations of its term credit line; the potential for unwanted side effects or other protective hazards that may also have negative effects on the market or placement of the Company’s existing or long-term approved products or prevent you from approving the Company’s long-term candidate drugs ; whether the FDA will approve the efficacy supplement for the reduced dose of BIJUVA; the ability of the company to protect its intellectual property, adding with respect to paragraph IV the notification letters that the company has earned in relation to IMVEXXY and BIJUVA; the duration, burden, and questionable effects of long-term clinical trials; the use of third parties by the company to carry out its manufacturing, studies and expansion, and clinical trials; the ability of the company’s licensees to market, accept, place and distribute the company’s products; the Company’s market ability to place traders in the market to place ANNOVERA; the possibility of obtaining reimbursements from the government, government and fitness insurance companies for corporate products; have an effect on product liskill judgments; the influence of extensive and costly government regulation; the volatility of the company’s non-unusual inventory value and the concentration of strength in its shareholding. PDF copies of the company’s old press releases and monetary tables can be viewed and downloaded on its website: https://ir. therapeuticsmd. com/press-releases.
References:
Freeman EW, Sherif K. Prevalence of hot flashes and sweats worldwide: a systematic review. Climate 2007; 10: 197-214
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contacts
Knight Therapeutics Inc. Samira Sakhia President and Chief Operating Officer T: 514-484-4483F: 514-481-4116info@gudknight. com www. gudknight. com
Arvind Utchanah CFO T: 514-484-4483F: 514-481-4116 Email: info@gudknight. com Website: www. gud-knight. com
TherapeuticsTM Nichol OchsnerVicePresident, Investor Relations 561-961-1900, ext. 2088 Nochsner@TherapeuticsMD. com