Viatris Completes Acquisition of Aculys Pharma for Rights to Pitolisant and Spydia® in Japan and Asia-Pacific Markets
Thursday, October 16, 2025
Viatris has completed the acquisition of Aculys Pharma.
The acquisition grants Viatris exclusive rights to develop and commercialise pitolisant and Spydia®, strengthening its Central Nervous System (CNS) portfolio in Japan and selected Asia-Pacific markets.
Pitolisant acts as a selective antagonist and inverse agonist of the histamine H3 receptor, which regulates sleep-wake cycles in the brain. The drug has received approvals from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy and EDS associated with OSAS. By the end of 2023, pitolisant had been approved in 38 countries, including the U.S. and the EU, for narcolepsy, and in 29 EU countries for OSAS.
In June 2025, Spydia® Nasal Spray (5 mg, 7.5 mg, and 10 mg) received approval in Japan for treating status epilepticus in patients aged two years and above. It is the first intranasal anti-seizure treatment in Japan and the first rescue medication approved for out-of-hospital adult use.
Under the agreement, Viatris obtained exclusive development and commercialisation rights in Japan for pitolisant, a selective and inverse agonist of the histamine H3 receptor. Supported by positive Phase 3 trial outcomes in Japanese patients and global clinical data, Viatris plans to seek marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) by the end of 2025. The submission will cover indications for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy, and for EDS associated with obstructive sleep apnoea syndrome (OSAS).
The transaction also includes exclusive rights in Japan and certain Asia-Pacific countries for Spydia® Nasal Spray, which received Japanese regulatory approval in June 2025 for the treatment of status epilepticus.
This acquisition enhances Viatris’ position in the Japanese market, complementing its existing portfolio of innovative therapies, including Effexor (generalised anxiety disorder), selatogrel (acute myocardial infarction), Nefecon (IgA nephropathy), cenerimod (systemic lupus erythematosus), and Tyrvaya (dry eye disease). Several of these candidates are currently in pivotal Phase 3 trials, with a Phase 3 trial for Tyrvaya expected to begin in 2026.
The acquisition reinforces Viatris’ commitment to advancing neurological care and expanding access to innovative CNS therapies across Asia.
Source: prnewswire.com
