Core Insights - Santhera Pharmaceuticals has signed an exclusive agreement with Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. for the distribution and promotion of AGAMREE® (vamorolone) in Turkey for treating Duchenne muscular dystrophy (DMD) in patients aged four and older [1][2] - The supply and sales by GEN are expected to commence in the first half of 2026, starting with named patient sales followed by commercial sales [1] - Santhera will receive a small upfront payment and an ongoing percentage of net sales as per previous agreements [1] Company Overview - Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on developing innovative medicines for rare neuromuscular diseases with high unmet medical needs [7] - AGAMREE® (vamorolone) is a dissociative steroid with a novel mode of action, approved in multiple regions including the U.S., EU, UK, China, and Hong Kong for the treatment of DMD [7][9] - The company has out-licensed rights to AGAMREE for North America and certain Southeast Asian countries [9] Product Information - AGAMREE is designed to bind to the same receptor as glucocorticoids but modifies its downstream activity, potentially dissociating efficacy from steroid safety concerns [3] - In the pivotal VISION-DMD study, AGAMREE met the primary endpoint of Time to Stand (TTSTAND) velocity versus placebo with a p-value of 0.002 at 24 weeks, demonstrating a good safety and tolerability profile [4] - Unlike corticosteroids, AGAMREE shows no restriction of growth and has no negative effects on bone metabolism [5] Partner Company Overview - Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. is Turkey's leading specialty pharmaceutical company, focusing on innovative therapies for neurological and neuromuscular disorders since 1998 [10] - GEN has a GMP-certified facility and invests in original drug development through dedicated R&D centers [10]