Viatris Expands Neurology Portfolio in Japan through Acquisition of Aculys Pharma

Viatris has acquired Tokyo-based Aculys Pharma to expand its neurology portfolio in Japan, according to a BioSpace press release. The deal grants Viatris the rights to develop and commercialize pitolisant and Spydia, two assets in the Central Nervous System segment. Viatris plans to file for marketing approval in Japan by the end of 2025 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The acquisition strengthens Viatris' CNS portfolio and commercial presence in Japan and the broader Asia-Pacific region.

Viatris Inc. (Nasdaq: VTRS) has expanded its neurology portfolio in Japan through the acquisition of Tokyo-based Aculys Pharma Inc. The deal, announced on October 15, 2025, grants Viatris exclusive rights to develop and commercialize pitolisant and Spydia, two innovative assets in the Central Nervous System (CNS) therapy area. This strategic move aims to strengthen Viatris' presence in Japan and the broader Asia-Pacific region, particularly in areas with significant unmet medical needs.

Pitolisant, a selective/inverse agonist of the histamine H3 receptor, has shown promising results in recent Phase 3 clinical trials in Japan. The drug was approved in 2016 by the European Medicines Agency (EMA) for the treatment of narcolepsy with or without cataplexy, and in 2021 for excessive daytime sleepiness associated with Obstructive Sleep Apnea Syndrome (OSAS). Viatris plans to file for marketing approval in Japan by the end of 2025 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Spydia Nasal Spray, developed by Neurelis Inc., is the first intranasal anti-seizure medication approved in Japan for the treatment of status epilepticus. The drug was approved in Japan in June 2025 and will be marketed by Viatris in Japan and certain other markets in the Asia-Pacific region.

The acquisition aligns with Viatris' strategy to grow in areas where it can make the greatest impact and complement its core strengths in markets across the world. It also leverages Viatris' deep commercial infrastructure in Japan and longstanding expertise in the CNS therapy area. The deal further expands Viatris' portfolio of innovative products in Japan, which includes Effexor, selatogrel, Nefecon, cenerimod, and Tyrvaya, all of which are in various stages of clinical trials.

Under the terms of the acquisition agreement, Viatris made an upfront payment to Aculys Pharma shareholders, with additional consideration contingent upon the achievement of specified regulatory and commercial milestones, and royalties on net sales.