Viatris Inc., a global healthcare company, has announced the acquisition of Aculys Pharma, Inc., a clinical-stage biopharmaceutical firm focused on innovative neurological treatments. This acquisition grants Viatris exclusive development and commercialization rights in Japan for two key assets: pitolisant and Spydia, expanding its Central Nervous System (CNS) therapy portfolio in the region.
Pitolisant, a selective/inverse agonist of the histamine H3 receptor, has shown promising results in recent Phase 3 trials involving Japanese patients. Based on these data and its established global benefit-risk profile, Viatris plans to file for marketing approval with Japan’s Ministry of Health, Labour and Welfare (MHLW) by the end of 2025. The drug targets excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, as well as EDS associated with obstructive sleep apnea syndrome (OSAS).
The deal also includes rights to Spydia Nasal Spray, approved in Japan in June 2025 for treating status epilepticus, as well as rights in select Asia-Pacific markets.
“The acquisition leverages our strong commercial infrastructure and CNS expertise in Japan, enabling us to deliver these innovative treatments to more patients,” said Corinne Le Goff, Chief Commercial Officer of Viatris. “Pitolisant and Spydia complement our strategic focus on impactful therapies and strengthen our presence in this key market.”
This move builds on Viatris’ expanding Japanese portfolio, which includes several products in advanced clinical stages such as Effexor for generalized anxiety disorder, selatogrel for acute myocardial infarction, Nefecon for IgA nephropathy, and cenerimod for systemic lupus erythematosus. Additionally, the company anticipates starting a Phase 3 trial for Tyrvaya in dry eye disease in 2026.
The acquisition underscores Viatris’ commitment to advancing innovative CNS therapies and growing its footprint in the Asia-Pacific region.