Santhera Secures Agreement with Biomedica for the Distribution of AGAMREE® (Vamorolone) in Russia

Core Insights - Santhera Pharmaceuticals has signed an exclusive distribution agreement with Biomedica for AGAMREE® (vamorolone) in Russia, aimed at treating Duchenne muscular dystrophy (DMD) in patients aged four and older [1][2][3] Agreement Details - Under the agreement, Santhera will receive a percentage of net sales, with sales expected to commence in Q1 2026 [2] - The collaboration will facilitate access to AGAMREE for approximately 1,400 DMD patients in Russia through managed access programs [2] Company Statements - Dario Eklund, CEO of Santhera, emphasized the importance of this agreement in increasing access to DMD treatment and noted it as part of a series of global agreements made in 2025 [3] - Oleg Parosin, CEO of Biomedica, highlighted their expertise in neurology and DMD therapies, positioning them as a strong partner for Santhera in Russia [3] Product Information - AGAMREE is a novel drug that modifies the action of glucocorticoids, aiming to dissociate efficacy from safety concerns associated with traditional corticosteroids [4] - In the pivotal VISION-DMD study, AGAMREE demonstrated significant efficacy and a favorable safety profile, with a primary endpoint met at 24 weeks [5] Safety and Efficacy - AGAMREE has shown no growth restrictions or negative effects on bone metabolism, distinguishing it from traditional corticosteroids [6]