Knight Therapeutics Announces Health Canada Approval for JORNAY PM to Treat Attention-Deficit Hyperactivity Disorder

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved JORNAY PM ™, an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children.

JORNAY PM ™ is the first and only evening-dosed methylphenidate product commercially available in Canada to treat ADHD in patients from 6 to 12 years of age. JORNAY PM ™ consists of microbeads with a delayed-release layer and an extended-release layer. The first layer delays the release of the active ingredient until morning while the extended-release layer controls the release of the active ingredient starting in the morning and continuing throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until the evening.

"As a psychiatrist who treats ADHD, I find the introduction of JORNAY PM ™ particularly exciting because its distinct mechanism of delivery addresses one of the most difficult aspects of ADHD management—early morning functioning. JORNAY PM ™ offers an effective treatment that assists in better morning routines. This new treatment is a welcome addition to the growing options available for ADHD management in Canada", said Dr. Doron Almagor (MD, FRCPC) Child, Adolescent, and Adult Psychiatrist.

JORNAY PM ™ was studied in two multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trials ^1,2 . Both studies met their primary and key secondary endpoints demonstrating a statistically significant and clinically meaningful improvement in ADHD symptom control upon awakening, through the afternoon, and into the early evening .

"I am proud to announce the approval of JORNAY PM ™ in Canada. This exciting new launch, expected in the second half of 2025, represents a significant advancement for our Canadian business as we continue to expand our offerings for ADHD treatment," said Samira Sakhia, President and CEO of Knight. "Following this approval, we are building a well-rounded ADHD portfolio with a range of complementary therapies that address diverse patient needs and offer greater support for their families."

In May 2024, Knight entered into an agreement with Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Ironshore Therapeutics, Inc. (now part of Collegium Pharmaceutical, Inc.; Nasdaq: COLL), for the exclusive rights to distribute JORNAY PM ™ in Canada and Latin America.

According to IQVIA Canada, the total Canadian market of extended-release methylphenidate products was $469 million in 2023, with an 8.1% increase in prescriptions compared to 2022 and a 16% compound annual growth rate (CAGR) over the past four years.

About ADHD ³

ADHD is a chronic, often lifelong neurodevelopmental disorder that affects both children and adults. The estimated prevalence of ADHD is 5-9% in children and adolescents and 3-5% in adults. ³ The disorder is characterized by symptoms of inattention, hyperactivity, and impulsivity that can significantly impact an individual's ability to function in daily life. Although patients' symptoms of ADHD can change over time, they will generally require continued monitoring and treatment over their lifetime. Current first-line pharmacotherapies for ADHD include long-acting methylphenidate or amphetamine-based psychostimulants and non-stimulants. Individual products for both differ in their delivery systems and release profiles to provide distinct durations of effect. However, not all patients derive adequate symptom coverage with currently available therapies. As a result, there remains a significant medical need for additional treatment options for patients with ADHD.

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.ca .

Forward-Looking Statements for Knight

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, 2023, as filed on www.sedarplus.ca . 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.

References:

1. Childress, A. C., Cutler, A. J., Marraffino, A., McDonnell, M. A., Turnbow, J. M., Brams, M., DeSousa, N. J., Incledon, B., Sallee, F. R., & Wigal, S. B. (2020). A randomized, double-blind, placebo-controlled study of HLD200, a delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder: An evaluation of safety and efficacy throughout the day and across settings. Journal of Child and Adolescent Psychopharmacology, 30(1), 2–14. https://doi.org/10.1089/cap.2019.0070
2. Pliszka, S. R., Wilens, T. E., Bostrom, S., Arnold, V. K., Marraffino, A., Cutler, A. J., López, F. A., DeSousa, N. J., Sallee, F. R., Incledon, B., & Newcorn, J. H. (2017). Efficacy and safety of HLD200, delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 27(6), 474–482. https://doi.org/10.1089/cap.2017.0084
3. CADDRA - Canadian ADHD Resource Alliance. (2020). Canadian ADHD Practice Guidelines, 4.1 Edition. https://adhdlearn.caddra.ca/wp-content/uploads/2022/08/Canadian-ADHD-Practice-Guidelines-4.1-January-6-2021.pdf
   
   

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