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.
- 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.
-
https://www.thelancet.com/action/showPdf?pii=S2589-5370%2822%2900509-0
-
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
larisa.bernstein@acino.swiss
References:
- Qelbree-Prescribing-Info.pdf (supernus.com)
-
https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-qelbreer-treatment-adhd-adults
- 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.
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