Knight Therapeutics Announces Launch of JORNAY PM(TM) in Canada

Executive Summary

• Knight Therapeutics announced the Canadian launch of JORNAY PM™ (extended‑release methylphenidate capsules) for children ages 6‑12 with ADHD.
• The product is the first and only evening‑dosed methylphenidate formulation available in Canada, offering symptom control from waking through early evening.
• Knight holds exclusive distribution rights in Canada and Latin America under an agreement with Ironshore Pharmaceuticals (now part of Collegium Pharmaceutical).

Key Details

• Product: JORNAY PM™ – methylphenidate HCl extended‑release capsules using delayed‑release/extended‑release microbead technology.
• Indication: Treatment of Attention‑Deficit Hyperactivity Disorder (ADHD) in children 6‑12 years old.
• Regulatory Status: Health Canada approval received November 2024.
• Commercial Rights: Exclusive rights for Canada and Latin America secured via May 2024 agreement with Ironshore Pharmaceuticals & Development, Inc. (now under Collegium Pharmaceutical).
• Market Opportunity: Canadian ADHD market ≈ $1.25 billion in 2024; methylphenidates > $500 million, growing > 14% CAGR over four years (IQVIA).
• Clinical Evidence: Two multicenter, randomized, double‑blind, placebo‑controlled Phase 3 trials met primary and key secondary endpoints, showing statistically significant improvement in ADHD symptoms from morning through evening. Most frequent adverse events: insomnia, affect lability, headache, decreased appetite, increased diastolic BP, upper respiratory infection.
• Quotes:
• Dr. Doron Almagor (MD, FRCPC): Emphasized smooth onset at waking and sustained benefit into early evening.
• Samira Sakhia, President & CEO: Highlighted the launch as a commitment to addressing diverse ADHD needs in Canada.

Notable Quotes

• “Effective ADHD management begins with helping children transition smoothly into their day… This first and only evening‑dosed methylphenidate treatment offers a new option for managing ADHD symptoms in children.” – Dr. Doron Almagor
• “We are thrilled to introduce JORNAY PM™ to the Canadian market, offering a new and innovative treatment option for ADHD patients and their families.” – Samira Sakhia, President & CEO, Knight Therapeutics

Materiality Assessment: Material – Positive (significant commercial launch of a novel, FDA‑approved product in a large, growing market).