Business
Catalyst Pharmaceuticals Acquires Exclusive North American License For Vamorolone for Duchenne Muscular Dystrophy from Santhera Pharmaceuticals
Vamorolone is a Promising Best-In-Class Dissociative Anti-Inflammatory Steroid Treatment for Duchenne Muscular Dystrophy Synergistic Novel Asset Leverages
About this update from Catalyst Pharmaceuticals, Inc.
[{"type":"text","content":"Vamorolone is a Promising Best-In-Class Dissociative Anti-Inflammatory Steroid Treatment for Duchenne Muscular Dystrophy Synergistic Novel Asset Leverages Catalyst's Expertise and Bolsters Catalyst's Rare Neuroscience Portfolio Granted FDA Fast Track, Orphan Drug Designation, and a PDUFA Action Date of October 26, 2023 Catalyst Expects to Launch Vamorolone in the U.S. Early in Q1 2024, Subject to Regulatory Approval CORAL GABLES, Fla., July 19, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (\"Catalyst\" or \"Company\") (Nasdaq: CPRX), today announced the completion of its acquisition from Santhera Pharmaceuticals Holdings (\"Santhera\") of an exclusive license for North America for vamorolone, a potential treatment for patients suffering with Duchenne Muscular Dystrophy. The license is for exclusive commercial rights in the U.S., Canada, and Mexico, as well as the right of first negotiation in Europe and Japan should Santhera pursue partnership opportunities. Additionally, Catalyst will hold North American rights for any future approved indications of vamorolone. Vamorolone is a promising best-in-class dissociative anti-inflammatory steroid treatment for Duchenne Muscular Dystrophy (\"DMD\"). In clinical studies, vamorolone demonstrated efficacy with a significant reduction of steroid-associated side effects and benefits for bone health, growth, and behavior, offering the potential to address an important unmet medical need in DMD patients. Vamorolone has received FDA Orphan Drug and Fast Track designations and has been granted a PDUFA action date of October 26, 2023. \"With the addition of vamorolone, we have accomplished another important milestone in the execution of our portfolio expansion strategy,\" stated Patrick J. McEnany, Chairman and CEO of Catalyst. \"The license for vamorolone reflects our strategic focus on opportunities where we can not only apply novel technology to address critical unmet patient needs, but where we can leverage Catalyst's existing integrated capabilities and infrastructure to commercialize the drug efficiently. We believe that vamorolone, if approved, has the potential to deliver significant near and long-term value and to be a very meaningful advancement to the current standard of care paradigm for DMD patients.\" Mr. McEnany continued, \"Vamorolone fortifies our neuromuscular portfol...