Viatris Expands CNS Portfolio in Japan with Acquisition of Aculys Pharma, Gaining Exclusive Rights to Pitolisant and Spydia®
Viatris Inc. (Nasdaq: VTRS), a leading global healthcare company, today announced the successful acquisition of Aculys Pharma, Inc., a clinical-stage biopharmaceutical company dedicated to the development and commercialization of innovative therapies for neurological conditions. Through this strategic transaction, Viatris has obtained exclusive rights to develop and commercialize two key assets in the Central Nervous System (CNS) therapeutic area—pitolisant and Spydia®—strengthening its portfolio of innovative treatments in Japan and select Asia-Pacific markets.
Pitolisant is a selective/inverse agonist of the histamine H3 receptor and represents a promising treatment option for patients with sleep disorders. Viatris now holds exclusive development and commercialization rights for pitolisant in Japan. The drug has demonstrated encouraging results in recent Phase 3 clinical trials conducted in Japanese patients, with a positive benefit-risk profile established across global studies. Leveraging these findings, Viatris is advancing toward filing for marketing approval with the Ministry of Health, Labour and Welfare (MHLW) in Japan. The regulatory submission is expected by the end of 2025, targeting treatment indications for excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. Additionally, pitolisant is being considered for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome (OSAS), further broadening its potential therapeutic impact.
Alongside pitolisant, the acquisition includes exclusive rights for Spydia Nasal Spray in Japan and certain other Asia-Pacific markets. Spydia received approval in Japan in June 2025 for the treatment of status epilepticus, an acute and life-threatening condition requiring rapid medical intervention. This approval positions Viatris to provide an important therapeutic option to patients experiencing prolonged seizures and underscores the company’s commitment to addressing critical unmet medical needs in neurological disorders.
Corinne Le Goff, Chief Commercial Officer of Viatris, emphasized the strategic significance of the acquisition: “The acquisition of Aculys Pharma leverages our deep commercial infrastructure in Japan and longstanding expertise in CNS, positioning us to bring these innovative treatments to more patients in need. The addition of pitolisant and Spydia to our portfolio is strategically aligned with our commitment to grow in areas where we can make the greatest impact and exemplifies our business development strategy designed to complement our core strengths in key markets around the world.”
The acquisition of Aculys Pharma is a key component of Viatris’ broader strategy to expand its portfolio of innovative products in Japan. The company currently has several other high-priority assets under development or regulatory review in the Japanese market. These include Effexor for the treatment of generalized anxiety disorder (GAD), which is currently under regulatory review; selatogrel for the management of acute myocardial infarction (AMI); Nefecon for IgA nephropathy; and cenerimod for systemic lupus erythematosus (SLE), all of which are progressing through pivotal Phase 3 clinical trials. Additionally, Tyrvaya, for the treatment of dry eye disease, is expected to enter Phase 3 trials in 2026. The addition of pitolisant and Spydia complements these assets, further enhancing Viatris’ ability to address complex and high-impact therapeutic areas.
Under the terms of the acquisition agreement, Viatris provided an upfront payment to Aculys Pharma shareholders as consideration for the transaction. Additional payments are structured to be contingent upon the achievement of specified regulatory and commercial milestones, along with royalties on net sales, aligning incentives between the two organizations to maximize the successful development and commercialization of these CNS therapies.
Viatris’ acquisition of Aculys Pharma reflects the company’s commitment to growth through strategic business development, targeted portfolio expansion, and leveraging its global infrastructure to bring innovative therapies to patients worldwide. By gaining exclusive rights to pitolisant and Spydia in Japan and select Asia-Pacific markets, Viatris not only strengthens its CNS pipeline but also reinforces its ability to deliver therapies that address unmet medical needs, improve patient outcomes, and expand access to advanced treatments for neurological conditions.
The integration of these assets into Viatris’ commercial operations in Japan is expected to accelerate patient access to novel therapeutic options. The company’s deep expertise in CNS and established market presence provides a strong foundation for successful launch and distribution of both pitolisant and Spydia. With this acquisition, Viatris is well-positioned to expand its footprint in the Japanese biopharmaceutical market and continue delivering innovative therapies to patients with serious and complex conditions.
Through this strategic move, Viatris underscores its ongoing commitment to innovation, patient-centric care, and leadership in the CNS therapeutic area, while creating new growth opportunities in Japan and the broader Asia-Pacific region. The acquisition demonstrates Viatris’ dedication to advancing treatments that make a meaningful difference in the lives of patients while enhancing its global portfolio of high-value therapies.
