M8 Pharmaceuticals and Supernus Sign Licensing Deal for Qelbree® in Latin America

MEXICO CITY, May 7, 2024 – M8 Pharmaceuticals, a subsidiary of Acino, has announced an exclusive licensing partnership with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN). This collaboration aims for regulatory approval and commercialization of Qelbree® (Viloxazine XR) in Latin America under M8's trademark.

Qelbree® (viloxazine extended-release capsule) is an approved treatment in the United States for attention deficit hyperactivity disorder (ADHD) in adults and children aged six and older. Differing from many ADHD medications on the market, Qelbree® offers a non-stimulant option. The medication, which is a selective norepinephrine reuptake inhibitor, received US Food and Drug Administration (FDA) approval in 2021 for children and adolescents, and in 2022 for adults.

The approval was based on positive outcomes from four pivotal trials demonstrating its efficacy and safety. Currently, Qelbree® is undergoing several phase 4 clinical trials, including studies combining it with psychostimulants for children and adolescents, and trials focusing on preschool-age children with ADHD. Another trial is investigating its effect on co-morbid mood symptoms in ADHD patients.

This strategic partnership aligns with Acino's mission to provide innovative treatments to Latin American patients, specifically enhancing their offerings in the central nervous system (CNS) therapeutic area. The collaboration will introduce a new treatment option for ADHD, potentially transforming the care paradigm for millions of patients in the region.

Jack Khattar, President and CEO of Supernus Pharmaceuticals, expressed confidence in M8 as the right partner to advance Qelbree® in Latin America, focusing on regulatory approval and commercial success in Mexico and Brazil. Joel Barlan, Head of Latin America at Acino, also welcomed the collaboration, highlighting Supernus's strong track record in CNS innovation.

ADHD is a widespread neurobehavioral disorder marked by inattention, hyperactivity, and impulsivity, affecting both children and adults. Globally, the prevalence is approximately 7.2% in children and 2.5% in adults. If untreated, ADHD can lead to various adverse outcomes, including emotional issues, substance misuse, educational challenges, and difficulties with employment and relationships. Adults with ADHD face a significantly higher risk of premature death, especially if they have additional psychiatric conditions.

Viloxazine extended-release tablets offer a non-stimulant, once-daily treatment option with demonstrated efficacy and safety. Clinical trials have shown symptom improvement as early as one to two weeks, with notable reductions in ADHD symptom scores in both children and adults. In the United States, Qelbree® was approved by the FDA in 2021 as the first new non-stimulant treatment for adult ADHD in two decades. The pivotal Phase III study showed significant symptom reduction compared to placebo, as well as improvements in various subscales and secondary efficacy endpoints.

M8 Pharmaceuticals focuses on licensing, marketing, and distributing innovative therapeutics in Latin America, aiming to become the preferred partner for high-value therapies across several therapeutic areas, including CNS, respiratory, cardiometabolic, immunology, gastroenterology, onco-hematology, and rare diseases. Acino, headquartered in Zurich and part of Abu Dhabi-based ADQ, delivers quality pharmaceuticals to promote affordable healthcare in select markets, leveraging its manufacturing capabilities and network for supply and out-licensing.

Supernus Pharmaceuticals, based in the United States, specializes in developing and commercializing CNS treatments, with a diverse portfolio that includes approved therapies for epilepsy, migraine, ADHD, and Parkinson's disease. Their ongoing development efforts cover a range of CNS conditions, such as depression, seizure disorders, and narcolepsy.