Viatris Completes Acquisition of Aculys Pharma Including Exclusive Rights to Pitolisant in Japan and to Spydia® in Japan and Certain Other Markets in the Asia-Pacific Region

Core Viewpoint - Viatris Inc. has acquired Aculys Pharma, enhancing its portfolio in the Central Nervous System (CNS) therapy area with exclusive rights to develop and commercialize pitolisant and Spydia in Japan, targeting significant unmet medical needs [1][4][8] Acquisition Details - The acquisition includes exclusive development and commercialization rights for pitolisant in Japan, which is on track for marketing approval by the end of 2025 for treating excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients [2][4] - Viatris also acquired exclusive rights for Spydia Nasal Spray in Japan and certain Asia-Pacific markets, which was approved in June 2025 for treating status epilepticus [3][10] Strategic Alignment - The acquisition leverages Viatris' existing commercial infrastructure and expertise in CNS, aligning with its strategy to target accretive regional business development opportunities [4][8] - Viatris aims to expand its innovative product portfolio in Japan, which includes other products under regulatory review or in pivotal Phase 3 trials [4][14] Financial Terms - The acquisition agreement includes an upfront payment to Aculys Pharma shareholders, with additional payments contingent on achieving specified regulatory and commercial milestones, along with royalties on net sales [5][14] Clinical Trial Results - Recent Phase 3 clinical trial results in Japanese patients for pitolisant showed significant improvement in EDS compared to placebo, with no serious adverse events reported [7][9][14] - The OSAS Phase 3 trial demonstrated statistically significant improvement in EDS for patients receiving pitolisant, consistent with global clinical study results [9][14] Product Information - Pitolisant is a selective/inverse agonist of the histamine H3 receptor, approved in multiple countries for narcolepsy and OSAS, with a strong safety profile [6][14] - Spydia Nasal Spray is the first intranasal anti-seizure medication approved in Japan for status epilepticus, marking a significant advancement in treatment options [10][11]