Knight Therapeutics Inc, a Pan American specialty pharmaceutical company, announced today that it has entered into a exclusive license with Supernus Pharmaceuticals, Inc, ("Supernus"), a biopharmaceutical company focused on the development and commercialization of products for the treatment of the central nervous system (CNS), which grants Knight the rights to seek approval regulatory and commercialize Qelbree ® in Canada. Qelbree ® is an extended-release formulation of the multimodal serotonergic and norepinephrine modulating agent (SNMA) viloxazine, a non-stimulant medication for the treatment of attention-deficit/hyperactivity disorder (ADHD). Financial terms of the deal have not been disclosed.
Qelbree ® (viloxazine extended-release capsules) is commercially available in the United States as a prescription medication to treat ADHD in patients 6 years of age and older. Based on the results of four pivotal studies, 1-4 the United States Food and Drug Administration approved Qelbree ® 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 IV clinical trials 5 , the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive primary results presented in September 2023 6 ). A second Phase IV clinical trial 7 in preschool children with ADHD is planned to begin in January 2024. A third Phase 4 clinical trial 9 is studying the impact of Qelbree ® on prevalent comorbid mood symptoms in patients with ADHD.
“This partnership represents the progressive implementation of our strategy to expand our presence in SNC and enter one of the most important segments that still has relevant unmet medical needs,” said Samira Sakhia, President and CEO of Knight. "We are delighted to apply for regulatory approval and be able to provide a novel non-stimulant medication to improve the treatment of patients living with ADHD."
"Supernus was able to identify in Knight the commercial expertise and capabilities necessary to achieve the successful approval and launch of Qelbree ® in Canada," stated Jack Khattar , President and CEO of Supernus Pharmaceuticals. "Supernus is proud of its support of other regions and patients who need innovative solutions to overcome the challenges of treating a complex disorder like ADHD."
About ADHD 8
ADHD is a neurodevelopmental disorder that affects both children and adults. The prevalence of ADHD is estimated to be 5-9% in children and 3-5% in adults. This disorder is characterized by symptoms of inattention, hyperactivity, and impulsivity that can have a significant impact on the ability to lead a functional daily life. Although ADHD patients' symptoms may change over time, they will generally require lifelong monitoring and treatment. Current pharmacological therapies for ADHD include amphetamine- or methylphenidate-based psychostimulants, as well as long-acting non-psychostimulant options. However, not all patients respond to existing therapies. Therefore, there continues to be a significant medical need for additional treatment options for patients with ADHD.
Acerca de Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal , Canada, is a specialty pharmaceutical company focused on acquiring or 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. shares trade on the TSX under the symbol GUD.
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