Knight Therapeutics Enters into Exclusive Supply and Distribution Agreement with Ironshore Pharmaceuticals & Development, Inc. for JORNAY PM® for Canada and Latin America

MONTREAL, May 09, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has entered into an exclusive supply and distribution agreement with Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Ironshore Therapeutics, Inc. (“Ironshore”), granting Knight the rights to seek regulatory approval and commercialize JORNAY PM^® in Canada and Latin America. Currently approved in the US, JORNAY PM^®, is an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Financial terms of the agreement were not disclosed.

JORNAY PM^® is the first and only evening-dosed methylphenidate product commercially available in the United States to treat ADHD in patients 6 years of age and older. 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 from the early morning and throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until they go to bed. JORNAY PM^® was studied in two 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 symptoms upon awakening, through the afternoon, and into the evening. JORNAY PM^® was submitted for approval in Canada in November 2023.

“With this transaction, Knight is bringing a highly innovative and differentiated ADHD stimulant medication and are continuing to build a very promising pipeline in ADHD in Canada and LATAM” said Samira Sakhia, President and CEO of Knight. “We are excited to provide treatment options to patients across their treatment journey and execute our strategy of expanding our presence in CNS. ”

“We are excited to partner with Knight, a company with demonstrated capabilities and a commitment to patients with ADHD. Ironshore is confident in Knight’s commercial experience to successfully launch JORNAY PM^® in Canada and Latin America," said Stephanie Read, Ironshore’s President and CEO. "Ironshore is proud to expand the availability of JORNAY PM^® outside the United States and provide patients with ADHD and their caregivers innovative alternatives in ADHD intervention."

About ADHD³

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. 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. Both classes of psychostimulants have comparable efficacy and tolerability at the population level, but 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.

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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