Taipei, Taiwan, 8 May, 2025 —Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a leading global pharmaceutical company, announces today that it has entered into an exclusive license agreement with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) ("Supernus"), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, granting Lotus the rights to seek regulatory approval and commercialize Qelbree® in South Korea, Taiwan, Hong Kong SAR, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Qelbree® is an extended-release formulation of viloxazine, a novel nonstimulant medication for the treatment of attention-deficit hyperactivity disorder (ADHD). Financial terms of the agreement were not disclosed.
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 4 pivotal trials, Qelbree® was approved by the US Food and Drug Administration in 2021 for the treatment of patients between 6 and 17 years of age with ADHD, and subsequently in 2022 it was extended to also include adults with ADHD. Qelbree® is currently being studied in one clinical trial in children 4-5 years of age with ADHD, which was initiated in March 2024. A clinical trial studying the impact of Qelbree® on adults with ADHD and co-morbid mood symptoms recently completed, and the results will be presented at scientific meetings.
Petar Vazharov, CEO of Lotus, added, “This agreement marks an important step in our commitment to expanding access to innovative CNS therapies across key Asia-Pacific markets, including South Korea, Taiwan, Hong Kong SAR, and Southeast Asia. We look forward to working with Supernus and leveraging our expertise to bring Qelbree® to patients who need it most.”
“Supernus is proud to help expand Qelbree®’s availability into other regions outside the U.S. for patients in need of innovative solutions to overcome the challenges of treating a complex disease such as ADHD,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Lotus’ commitment to providing innovative therapies makes them the right partner for expanding Qelbree® into additional global markets.”
About Lotus
Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in nearly every global market including the U.S., Europe, Japan, China, and Brazil. Lotus runs over 100 strategically selected pharmaceutical projects in development and registrations across Asia and the US, with over 250 commercial products. The Company invests in diversified best portfolio consisting of high-barrier oncology, complex generics as well as 505(b)2 and NCE via internal R&D investment and licensing-in partnership, and also strengthens its portfolio competitiveness by adding biosimilar products with support from strategic partners. Its industry-leading infrastructure certified by most of the advanced regulatory authorities around the world, including US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.
Media Inquiries:
Jeffrey Tsang, Head of IR and corporate communications
Yu-ying Yang, Associate Director, Corporate communications
+886 2 2700 5908
investor@lotuspharm.com
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for epilepsy, depression, and other CNS disorders.
Investor Contact:
Peter Vozzo
ICR Healthcare
Office: (443) 213-0505
peter.vozzo@icrhealthcare.com