MEXICO CITY - M8 Pharmaceuticals, an Acino company, has entered into an exclusive licensing agreement with Supernus Pharmaceuticals, Inc. (NASDAQ: NASDAQ:SUPN) to seek regulatory approval and commercialize Qelbree® (Viloxazine XR) for the treatment of ADHD in Latin America. Qelbree® is a non-stimulant medication approved in the United States for adults and children over six years old.
The focus of the partnership is to expand access to innovative treatments for ADHD, a prevalent neurobehavioral disorder affecting millions globally. This agreement aligns with Acino's mission to strengthen its position in the central nervous system therapeutic area and provide new treatment options for patients.
Qelbree® has undergone four pivotal trials, leading to its FDA approval for pediatric use in 2021 and for adults in 2022. Further phase 4 clinical trials are underway, including studies on the drug's combination with psychostimulants and its effects on preschool-aged children and co-morbid mood symptoms.
Supernus has selected M8 as its partner for Qelbree®'s regulatory approval and commercialization in key Latin American markets, such as Mexico and Brazil. President and CEO of Supernus, Jack Khattar, expressed confidence in M8's ability to successfully introduce Qelbree® to these new regions, emphasizing the need for innovative solutions in ADHD treatment.
Joel Barlan, Head of Latin America at Acino, welcomed the collaboration, highlighting Supernus' history of CNS innovation and its pipeline of psychiatric and neurological treatments.
Qelbree® represents the first new non-stimulant treatment for adults with ADHD approved in the United States in two decades. Its efficacy and safety have been established in clinical trials, with no evidence of abuse potential.
This partnership is expected to enhance the treatment landscape for ADHD in Latin America, providing a new therapeutic option to address this complex condition. The information is based on a press release statement from M8 Pharmaceuticals.
InvestingPro Insights
As Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) forges a new licensing agreement to expand the reach of its ADHD treatment Qelbree® in Latin America, investors are closely monitoring the company's financial health and market performance. The company's strategic moves are underpinned by solid financial metrics and a positive outlook from analysts. Notably, Supernus holds more cash than debt on its balance sheet, a reassuring sign of financial stability that supports its expansion endeavors. Additionally, the company is trading at a high earnings multiple, with a P/E ratio (Adjusted) for the last twelve months as of Q4 2023 standing at 102.15, reflecting high investor expectations for future earnings growth.
InvestingPro Tips highlight that Supernus is expected to see net income growth this year and has received upward earnings revisions from 2 analysts for the upcoming period. These insights suggest confidence in the company's potential and its ability to capitalize on market opportunities. Moreover, Supernus has been profitable over the last twelve months, which aligns with analysts' predictions that the company will maintain profitability this year.
From a market performance perspective, the company has experienced a large price uptick over the last six months, with a 27.49% price total return, underscoring the market's positive reception to its strategic moves and operational performance. Investors interested in further insights can find additional InvestingPro Tips for Supernus, including an analysis of shareholder yield and valuation multiples, by visiting InvestingPro. Plus, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to a total of 11 InvestingPro Tips for an in-depth understanding of Supernus's investment potential.
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