M8 Pharmaceuticals, an Acino company, signs an exclusive licensing agreement with Supernus for Qelbree® (Viloxazine XR) in Latin America

MEXICO CITY, May 7, 2024 /PRNewswire/ -- M8 Pharmaceuticals, an Acino company ('M8') announces that the company has signed an exclusive licensing agreement with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) ('Supernus'), a biopharmaceutical company focused on the development and commercialization of products for the treatment of diseases of the central nervous system (CNS), to seek regulatory approval and commercialize Qelbree® (Viloxazine XR) under M8's trademark in Latin America.

Qelbree® (viloxazine extended-release capsule) which is approved in the United States is an extended-release formulation of viloxazine, a selective norepinephrine reuptake inhibitor to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. Unlike most ADHD medications on the market, this medication is a non-stimulant option.

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 four pivotal trials,1-4 Qelbree® was approved by the US Food and Drug Administration (FDA) 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 trials, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 2023). A second phase 4 clinical trial in preschool age children with ADHD is planned to commence in January 2024. A third phase 4 clinical trial is studying the impact of Qelbree® on co-morbid mood symptoms prevalent in patients with ADHD.

This strategic partnership is aligned with Acino's mission to provide Latin American patients access to innovative medicines and strengthen its leadership position in the central nervous system therapeutic space. The collaboration will provide prescribers with a new option to improve the ADHD treatment paradigm for millions of patients.

"Supernus ran an extensive process to find the right partner Qelbree® to seek regulatory approval and successful commercialization in Mexico and Brazil" 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."

"We are delighted to announce this collaboration with Supernus, a company with a fantastic track record of innovation in the CNS space and a robust pipeline of novel medicines to treat psychiatric and neurological disorders" said Joel Barlan, Head of Latin America at Acino.                                                           

About ADHD:

Attention deficit hyperactivity disorder (ADHD) is a common neurobehavioral disorder that affects millions of children and adults.  Characterized by ongoing patterns of inattention, hyperactivity, and impulsivity, ADHD can significantly interfere with an individual's functioning and development.(1) Typically first diagnosed in childhood, up to 90% of patients have symptoms  persisting into adulthood.  The worldwide population prevalence is 7.2% in children and 2.5% in adults.1 When untreated, individuals with ADHD are prone to a wide range of poor outcomes such as, emotional problems, self-harm, substance misuse, educational under-achievement, difficulties with employment and relationships, and criminality (2).  Adults with ADHD often have 4x higher risk of premature death, which can be even higher if they have additional psychiatric comorbidities such as substance use disorder.

1. Wolraich ML, Hagan JF, Allan C, et al. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics 2019; 144: 20192528.
2. https://www.thelancet.com/action/showPdf?pii=S2589-5370%2822%2900509-0 
3. https://applications.emro.who.int/docs/EMRPUB_leaflet_2019_mnh_214_en.pdf 

About Viloxazine Extended-Release:

Viloxazine extended-release tablets is an innovative non-stimulant formulation, to be taken once daily.

In 6-8 week clinical trials, efficacy and improvement in symptoms were observed as early as 1 to 2 weeks. It has a proven safety and tolerability profile, with no evidence of abuse potential in clinical studies.

• In a study of children 6 to 11 years of age, ADHD symptom score reductions were statistically significant for doses of 100 mg and 200 mg, starting at week 1. (2)
• In the study of adolescents 12 to 17 years of age, reductions in ADHD symptom score were statistically significant for 400mg starting at week 2. (2)
• In the flexible dose study of adults 18 to 65 years of age, reductions in ADHD symptom score were statistically significant in Qelbree patients , starting in week 2. (2)

In the United States, Qelbree® represents the first approval of a new non-stimulant treatment for adults in 20 years. It was approved by the USFDA in 2021, based on positive results from a randomized, double-blind, placebo-controlled Phase III study of Qelbree® in adults with ADHD.

The Phase III study met the primary endpoint, showing that the reduction in change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at the end of the study was statistically higher in adults treated with Qelbree® versus placebo (p=0.0040). Significant improvement in the AISRS subscale scores for inattention and hyperactivity/impulsivity symptoms were also observed in the study1. Additionally, the study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in change from baseline in the Clinical Global Impression Scale – Illness Severity (CGI-S) at week 6. The active dose was well tolerated. (3)

About M8 Pharmaceuticals, an Acino company

M8 is a specialty biopharmaceutical company focused on licensing, marketing, and distributing innovative and established therapeutics in Latin America. We aim to become the preferred pharmaceutical partner for licensing high-value, innovative and proven therapies across our main therapeutic areas: CNS, respiratory, cardiometabolic, immunology, gastroenterology, onco-hematology, and rare diseases. Our mission is to provide the people of Latin America with access to the innovative and proven medicines they need to transform their lives.

About Acino 

Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. Acino is part of ADQ, an Abu Dhabi-based investment and holding company. We deliver quality pharmaceuticals to promote affordable healthcare in these markets. We leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing. For more information, visit www.acino.swiss.  

About Supernus Pharmaceuticals, Inc.

Supernus is a US-based pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our extensive expertise in product development and commercialization has been built over the past 30 years.

Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD and Parkinson's disease (PD). We are developing a broad range of new CNS product candidates that include depression, seizure disorders, narcolepsy and other CNS disease states,

For more information, visit www.supernus.com.

For media inquiries:
Larisa Bernstein, Global Head of Communications, Acino
[email protected]

References:

1. Qelbree-Prescribing-Info.pdf (supernus.com)
2. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-qelbreer-treatment-adhd-adults 
3. Nasser A, Hull JT, Chaturvedi SA, Liranso T, Odebo O, Kosheleff AR, Fry N, Cutler AJ, Rubin J, Schwabe S, Childress A. A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2022 Aug;36(8):897-915. doi: 10.1007/s40263-022-00938-w. Epub 2022 Jul 27. PMID: 35896943; PMCID: PMC9328182.

SOURCE M8 Pharmaceuticals