Marinus Pharma Information

Marinus Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to positively impacting the well-being of patients who suffer from epilepsy and neuropsychiatric disorders. The company is in the midst of developing and commercializing ganaxolone which will treat adults and children with epileptic seizures and women with postpartum depression. On June 29, 2017, the Company announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to ganaxolone for the treatment of CDKL5 Disorder. CDKL5 Disorder is a severe, rare genetic disorder that affects children at an early age and causes difficult-to-control seizures and neuro-developmental impairment. Currently, there are no approved therapies for children with CDKL5 Disorder. Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act filing fees. On September 11th, 2017 Marinus announced results from a Phase 2 open-label study of patients with CDKL5 Disorder which support advancing ganaxolone into a definitive late-stage clinical trial. Press release here: http://bit.ly/2gWfOWM