China-based Pediatrix Therapeutics announced a licensing agreement with US firm Tris Pharma, Inc., obtaining exclusive commercialization rights to the latter’s entire FDA-approved attention-deficit hyperactivity disorder (ADHD) portfolio, as well as pipeline products. The deal covers the territory of greater China, including mainland China, Hong Kong, Macau, and Taiwan. No financial details were disclosed.
Market Filings and Drug Approvals
Pediatrix and Tris made a joint market filing for methylphenidate hydrochloride oral sustained release dry suspension as a Category 5.1 drug in China in September, currently under review by the Center for Drug Evaluation (CDE). The methylphenidate hydrochloride sustained-release chewable tablets nailed priority review status in China in July. Both drugs, taking effect within 45 minutes, have been approved to treat ADHD abroad.
Tris Pharma Background
Tris is a fully integrated, innovation-driven CNS company that provides a differentiated approach to target unmet medical needs, including the application of novel technologies designed to enhance patient benefits across therapeutic categories. Founded in 2000, Tris’s CNS portfolio includes treatments for pain, addiction, spasticity in multiple sclerosis and cerebral palsy, as well as narcolepsy, and ADHD.-Fineline Info & Tech
