Knight Therapeutics Enters into Exclusive License Agreement with Supernus Pharmaceuticals for Qelbree® (viloxazine) in Canada

MONTREAL, Dec. 19, 2023 (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 license agreement with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) ("Supernus"), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, granting Knight the rights to seek regulatory approval and commercialize Qelbree^® in Canada. Qelbree^® is an extended-release formulation of viloxazine, a multimodal serotonergic and norepinephrine modulating agent (SNMA), a nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Financial terms of the agreement were not disclosed.

Qelbree^® (viloxazine extended-release capsules) is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older. Based on the results of 4 pivotal trials,^1-4 Qelbree^® was approved by the US Food and Drug Administration in 2021 for the treatment of children 6-17 years of age and in 2022 for the treatment of adults. Qelbree^® is also currently being studied in several phase 4 clinical trials⁵, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 2023⁶). A second phase 4 clinical trial⁷ in preschool age children with ADHD is planned to commence in January 2024. A third phase 4 clinical trial⁹ is studying the impact of Qelbree^® on co-morbid mood symptoms prevalent in patients with ADHD.

“This partnership represents the continued execution of our strategy of expanding our presence in CNS and entering in one of the most important segments still presenting relevant unmet medical needs,” said Samira Sakhia, President and CEO of Knight. “We are excited to pursue regulatory approval and bring a novel nonstimulant medication to enhance treatment of patients living with ADHD.”

Supernus was able to identify in Knight the right commercial experience and capabilities to get Qelbree^® approved and successfully launch it in Canada," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Supernus is proud to support other regions and patients in need of innovative solutions to overcome the challenges of treating a complex disease such as ADHD."

About ADHD⁸

ADHD is a neurodevelopmental disorder that affects both children and adults. The estimated prevalence of ADHD is 5-9% in children 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 pharmacotherapies for ADHD include amphetamine or methylphenidate-based psychostimulants as well as long-acting non-psychostimulant options. However, not all patients respond to existing 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, 2022, 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. Nasser A et al. (2020). A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children. Clinical Therapeutics, 42(8), 1452-1466. DOI: https://doi.org/10.1016/j.clinthera.2020.05.021
2. Nasser A et al. (2021). Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial. Clinical Therapeutics, 43(4), 684-700. DOI: https://doi.org/10.1016/j.clinthera.2021.01.027
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4. Nasser A et al. (2022). A Phase III, Randomized, Double‑Blind, Placebo‑Controlled Trial Assessing the Efcacy and Safety of Viloxazine Extended‑Release Capsules in Adults with Attention‑Defcit/Hyperactivity Disorder. CNS Drugs, 36(8), 897-915. DOI: https://doi.org/10.1007/s40263-022-00938-w
5. US National Library of Medicine. (2021, March 8 - ). Open-label study of SPN-812 administered with psychostimulants in children and adolescents with ADHD (ADHD). Identifier NCT04786990. https://clinicaltrials.gov/study/NCT04786990
6. Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms. (2023, September 10). Retrieved from https://ir.supernus.com/node/13856/pdf
7. US National Library of Medicine. (2021, March 4 - ). Evaluation of SPN-812 (viloxazine extended-release capsule) in preschool-age children with ADHD. Identifier NCT04781140. https://clinicaltrials.gov/study/NCT04781140
8. 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
9. Presented during Supernus Pharmaceuticals R&D Day; October 18, 2023