Knight Therapeutics Announces Launch of Bijuva® in Canada

Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a Pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of BIJUVA ® (estradiol and progesterone) capsules in Canada. BIJUVA ® is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women with an intact uterus. VMS affects 60% to 80% of women entering menopause 1 and are commonly known as hot flashes or flushes and night sweats. BIJUVA ® is a once-daily combination of bioidentical estradiol and progesterone in a single oral capsule. The two hormones included in BIJUVA ® have the same structure as the hormones produced and circulating in a woman's body.

Dr. Vivien Brown, a renowned family physician recognized for her national and international advocacy efforts in promoting women's health remarked, "Menopause remains undertreated and there is a need to enhance the conversation, especially regarding the most debilitating vasomotor symptoms such as hot flashes and night sweats.  These symptoms can be physically and emotionally challenging, impacting patients' wellbeing and function across several aspects of their daily life. The introduction of Bijuva® in Canada offers an option of hormone therapy (combination of estradiol and progesterone), to add to our toolbox of prescription choices, for the patient in need."

"We are very pleased to offer a new treatment option for menopausal women in Canada. BIJUVA ® offers women the opportunity to address the challenging symptoms of hot flashes and night sweats associated with menopause with a once-daily, single oral capsule," 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 BIJUVA ® . Under the terms of the license agreement related BIJUVA ® in Canada, Knight will pay TherapeuticsMD sales milestone fees and royalties based upon certain aggregate annual sales of BIJUVA ® in Canada.

About BIJUVA ®

BIJUVA® (17β-estradiol (estradiol hemihydrate)/micronized progesterone 1 mg/100 mg and 0.5 mg/100 mg) is a softgel formulation containing solubilized estradiol with micronized progesterone (P4) intended to treat moderate to severe VMS while protecting the endometrium from unopposed estradiol.

BIJUVA® is the first fixed-dose combination of two bioidentical hormones that are most often preferred by women with VMS (estradiol and micronized progesterone). The rationale for the development of BIJUVA was to provide healthcare providers with a well-studied and Health Canada approved treatment option that has demonstrated clinical effectiveness with a favorable benefit/risk profile.

The recommended dose of BIJUVA® is a single capsule, taken orally, each evening with food. BIJUVA® should be used for a duration consistent with treatment goals and the benefits and risks for the individual woman. Postmenopausal women should be periodically re-evaluated as clinically appropriate to determine if treatment is still necessary.

About Menopause

VMS are the hallmark symptom associated with menopause. Up to 80% of women experience VMS or hot flashes during the menopause transition 1,2 , with the majority of women reporting them to be moderate to severe 3 . For many women, VMS can have a significant negative impact on quality of life , sleep quality and mood. The decline in endogenous estrogen levels at the time of menopause plays a role in the onset of VMS and the genitourinary syndrome of menopause (GSM) which is characterized by vulvovaginal atrophy, atrophic vaginitis, or urogenital atrophy 4 - 9 . Furthermore, the menopausal transition represents a critical point in a woman's life that marks an increased risk for cardiovascular disease (CVD) 6,10 , diabetes 11 higher bone turnover and faster bone loss 12 . When left untreated, VMS are associated with significantly higher healthcare utilization costs, work productivity loss, and total costs 13 .

There is robust evidence that estrogen is a highly effective treatment for VMS and GSM 14,15 and when initiated before the age of 60 years (or within 10 years of menopause) it is associated with reduced risk for CVD, osteoporosis, and all-cause mortality 16-22 . Despite the available treatments, VMS is severely undertreated with less than 20% of postmenopausal women who have ever been prescribed estrogen therapy 23 , even when recognized groups such as the North American Menopause Society have stated that hormone therapy remains the most effective treatment for VMS and GSM. 24 . Currently in Canada, bioidentical hormone regimens are only available as separate components and are associated with poor adherence rates due to inconvenient dosing schedules 2 3 . As a result, both safety and efficacy are compromised due to inconsistent hormone bioavailability and bioactivity. It is especially important that the progesterone be provided at sufficient levels to protect the endometrium from estrogenic stimulation and prevent endometrial hyperplasia, which is a precursor of endometrial cancer 25-27 .

VMS can appear during pre-menopause, as early as two years prior to the last menstrual period, and usually peaks one year after this final menstrual period 2 8, 2 9 . Fifty percent of women will even experience VMS up to four years after their menopause started and it is estimated that VMS will persist up to 11 to 12 years after the final menstrual period in 12% of women 2 8- 3 0 .

Please see the Full BIJUVA ® 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

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:

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  12. Crandall CJ, Tseng CH, Crawford SL, Thurston RC, Gold EB, Johnston JM, et al. Association of menopausal vasomotor symptoms with increased bone turnover during the menopausal transition. J Bone Miner Res. 2011;26(4):840-9. Epub 2010/09/30. doi: 10.1002/jbmr.259. PubMed PMID: 20878774; PubMed Central PMCID: PMCPMC3179323.
  13. Sarrel P, Portman D, Lefebvre P, Lafeuille MH, Grittner AM, Fortier J, et al. Incremental direct and indirect costs of untreated vasomotor symptoms. Menopause. 2015;22(3):260-6. Epub 2015/02/26. doi: 10.1097/gme.0000000000000320. PubMed PMID: 25714236.
  14. MacLennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev. 2004(4). doi: 10.1002/14651858.CD002978.pub2. PubMed PMID: CD002978.
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  16. Boardman HM, Hartley L, Eisinga A, Main C, Roqué i Figuls M, Bonfill Cosp X, et al. Hormone therapy for preventing cardiovascular disease in post-menopausal women. Cochrane Database Syst Rev. 2015(3):Cd002229. Epub 2015/03/11. doi: 10.1002/14651858.CD002229.pub4. PubMed PMID: 25754617.
  17. Salpeter SR, Buckley NS, Liu H, Salpeter EE. The cost-effectiveness of hormone therapy in younger and older postmenopausal women. Am J Med. 2009;122(1):42-52.e2. Epub 2008/12/31. doi: 10.1016/j.amjmed.2008.07.026. PubMed PMID: 19114171.
  18. Salpeter SR, Walsh JME, Greyber E, Ormiston TM, Salpeter EE. Mortality associated with hormone replacement therapy in younger and older women: a meta-analysis. J Gen Intern Med. 2004;19(7):791-804. doi: 10.1111/j.1525-1497.2004.30281.x. PubMed PMID: 15209595.
  19. Hodis HN, Mack WJ. Hormone replacement therapy and the association with coronary heart disease and overall mortality: clinical application of the timing hypothesis. J Steroid Biochem Mol Biol. 2014;142:68-75. Epub 2013/07/16. doi: 10.1016/j.jsbmb.2013.06.011. PubMed PMID: 23851166.
  20. Manson JE, Aragaki AK, Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, et al. Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials. JAMA. 2017;318(10):927-38. Epub 2017/09/13. doi: 10.1001/jama.2017.11217. PubMed PMID: 28898378; PubMed Central PMCID: PMCPMC5728370.
  21. Mikkola TS, Tuomikoski P, Lyytinen H, Korhonen P, Hoti F, Vattulainen P, et al. Estradiol-based postmenopausal hormone therapy and risk of cardiovascular and all-cause mortality. Menopause. 2015;22(9):976-83. Epub 2015/03/25. doi: 10.1097/gme.0000000000000450. PubMed PMID: 25803671.
  22. Grady D, Rubin SM, Petitti DB, Fox CS, Black D, Ettinger B, et al. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med. 1992;117(12):1016-37. Epub 1992/12/15. doi: 10.7326/0003-4819-117-12-1016. PubMed PMID: 1443971.
  23. Hammond CB. Women's concerns with hormone replacement therapy--compliance issues. Fertil Steril. 1994;62(6 Suppl 2):157s-60s. Epub 1994/12/01. PubMed PMID: 7958011.
  24. Menopause: The Journal of the North American Menopause Society. Vol. 29, No. 7, pp. 767-794. doi: 10.1097/GME.0000000000002028. @2022 by The North American Menopause Society.
  25. Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. JAMA. 1996;275(5):370-5. Epub 1996/02/07. doi: 10.1001/jama.1996.03530290040035. PubMed PMID: 8569016.
  26. Thom MH, Studd JW. Oestrogens and endometrial hyperplasia. Br J Hosp Med. 1980;23(5):506, 8-9, 11-3. Epub 1980/05/01. PubMed PMID: 6992895.
  27. Mack TM, Pike MC, Henderson BE, Pfeffer RI, Gerkins VR, Arthur M, et al. Estrogens and endometrial cancer in a retirement community. N Engl J Med. 1976;294(23):1262-7. Epub 1976/06/03. doi: 10.1056/nejm197606032942304. PubMed PMID: 177870.
  28. Politi MC, Schleinitz MD, Col NF. Revisiting the duration of vasomotor symptoms of menopause: a meta-analysis. J Gen Intern Med. 2008;23(9):1507-13. Epub 2008/06/04. doi: 10.1007/s11606-008-0655-4. PubMed PMID: 18521690; PubMed Central PMCID: PMCPMC2518020.
  29. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018;14(4):199-215. Epub 2018/02/03. doi: 10.1038/nrendo.2017.180. PubMed PMID: 29393299.
  30. Freeman EW, Sammel MD, Lin H, Liu Z, Gracia CR. Duration of menopausal hot flushes and associated risk factors. Obstet Gynecol. 2011;117(5):1095-104. Epub 2011/04/22. doi: 10.1097/AOG.0b013e318214f0de. PubMed PMID: 21508748; PubMed Central PMCID: PMCPMC3085137.

CONTACT INFORMATION:

Knight Therapeutics Inc.
Samira Sakhia Arvind Utchanah
President & Chief Executive Officer Chief Financial Officer
T: 514.484.4483 T. +598.2626.2344
F: 514.481.4116
Email: IR@knighttx.com Email: IR@knighttx.com
Website: www.knighttx.com Website: www.knighttx.com

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  • Accelerates Solventum's business transformation and sharpens focus on strategic areas for growth to deliver long-term shareholder value

  • Strengthens balance sheet with proceeds to be used primarily for debt paydown

Solventum (NYSE: SOLV) today announced it has entered into a definitive agreement to sell its Purification & Filtration 1 business to Thermo Fisher Scientific Inc. (NYSE: TMO) (" Thermo Fisher ") for $4.1 billion . Solventum expects the transaction to be neutral to 2025 EPS and expects an estimated $3.4 billion in net proceeds, which it intends to use primarily to pay down debt. The transaction is expected to be completed by the end of 2025, subject to regulatory approval and customary closing conditions.

Solventum Logo (PRNewsfoto/3M Healthcare US Opco LLC)

"The sale of the Purification & Filtration business is part of phase three of our transformation plan and follows a thorough analysis of the value and strategic alignment of our businesses," said Bryan Hanson , Solventum CEO. "This transaction will enhance our strategic focus and key metrics while reducing leverage and significantly strengthening our balance sheet. It also enables us to invest in the innovation, programs and talent we need to execute our mission and deliver shareholder value."

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Solventum will discuss the transaction on its upcoming fourth quarter and full-year 2024 earnings call scheduled for February 27, 2025 . With this significant change in the Company's portfolio and the other major actions taken since becoming an independent publicly traded company on April 1, 2024 , Solventum has scheduled an Investor Day on March 20, 2025 , to provide investors with an update on the progress made, its go-forward positioning and long-range plan. The Investor Day will be held in New York City , and the Company will share additional logistical details in due course.

Morgan Stanley & Co. LLC, Perella Weinberg Partners and J.P. Morgan Securities LLC served as financial advisors to Solventum, and Cleary Gottlieb Steen & Hamilton served as legal advisor to Solventum.

1 Other than for its operations in Belgium , France and Ireland , for which Thermo Fisher granted a binding offer to Solventum

About Solventum  
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better — while empowering healthcare professionals to perform at their best. See how at Solventum.com .

Forward-Looking Statements
This news release contains forward-looking information about Solventum's financial results, estimates, and business prospects that involve substantial risks and uncertainties. In particular, statements regarding the future performance of Solventum, including guidance for 2024, are forward-looking statements. You can identify these statements by the use of words such as "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "projects," "seeks," "sees," "should," "targets," "will," "would," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or business plans or prospects. Among the factors that could cause actual results to differ materially are the following: (1) the effects of, and changes in, worldwide economic, political, regulatory, international, trade and geopolitical conditions, natural disasters, war, public health crises, and other events beyond Solventum's control; (2) operational execution risks; (3) damage to our reputation or our brands; (4) risks from acquisitions, strategic alliances, divestitures and other strategic events; (5) Solventum's business dealings involving third-party partners in various markets; (6) Solventum's ability to access the capital and credit markets and changes in Solventum's credit ratings; (7) exposure to interest rate and currency risks; (8) the highly competitive environment in which Solventum operates and consolidation in the healthcare industry; (9) reduction in customers' research budgets or government funding; (10) the timing and market acceptance of Solventum's new product and service offerings; (11) ongoing working relationships with certain key healthcare professionals; (12) changes in reimbursement practices of governments or private payers or other cost containment measures; (13) Solventum's ability to obtain components or raw materials supplied by third parties and other manufacturing and related supply chain difficulties, interruptions, and disruptive factors; (14) legal and regulatory proceedings and legal compliance risks (including third-party risks) with regards to antitrust, Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws, environmental laws, anti-kickback and false claims laws, privacy laws, tax laws, and other laws and regulations in the United States and other countries in which Solventum operates; (15) potential liabilities related to a broad group of perfluoroalkyl and polyfluoroalkyl substances, collectively known as "PFAS"; (16) risks related to the highly regulated environment in which Solventum operates; (17) risks associated with product liability claims; (18) climate change and measures to address climate change; (19) security breaches and other disruptions to information technology infrastructure; (20) Solventum's failure to obtain, maintain, protect, or effectively enforce its intellectual property ("IP") rights; (21) pension and postretirement obligation liabilities; (22) any failure by the 3M Company (" 3M ") to perform any of its obligations under the various separation agreements in connection with the separation from 3M (the "Spin-Off"); (23) any failure to realize the expected benefits of the Spin-Off, and/or that the Spin-Off will not be completed within the expected time frame, on the expected terms or at all; (24) a determination by the IRS or other tax authorities that the distribution or certain related transactions should be treated as taxable transactions; (25) expected financing transactions undertaken in connection with the separation and risks associated with additional indebtedness; (26) the risk that incremental costs of operating on a standalone basis (including the loss of synergies), costs of restructuring transactions and other costs incurred in connection with the separation will exceed Solventum's estimates; and (27) the impact of the Spin-Off on its businesses and the risk that the Spin-Off may be more difficult, time-consuming or costly than expected, including the impact on its resources, systems, procedures and controls, diversion of management's attention and the impact on relationships with customers, suppliers, employees and other business counterparties.

Changes in such assumptions or factors could produce significantly different results. A further description of these factors is located under "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" in Solventum's periodic reports on file with the U.S. Securities & Exchange Commission. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information or future events or developments.

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/solventum-announces-sale-of-its-purification--filtration-business-to-thermo-fisher-scientific-inc-for-4-1b-302384734.html

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