By Fineline Cube 
Viatris Inc. (NASDAQ: VTRS) today announced the completion of its acquisition of Aculys Pharma, gaining exclusive development and commercialization rights to two central nervous system (CNS) assets—Pitolisant (Wakix) and Spydia (diazepam nasal spray). The deal expands Viatris’ innovative portfolio in Japan and positions the company to capture a growing market for narcolepsy, obstructive sleep apnea, and status epilepticus therapies.
Deal Highlights
| Element | Detail |
|---|---|
| Acquisition Structure | Upfront payment to Aculys shareholders; milestone‑based additional consideration; royalty on net sales |
| Assets | 1. Pitolisant – selective H3 receptor inverse agonist (Wakix) for narcolepsy & OSAS |
| 2. Spydia (diazepam nasal spray) – first intranasal anti‑seizure rescue in Japan | |
| Geographic Scope | Exclusive development/commercialization in Japan and selected APAC markets |
Pitolisant – A Breakthrough Narcolepsy Treatment
- Regulatory Status – Orphan Drug (EMA & FDA) and FDA Breakthrough Therapy designation.
- Commercial Track Record – Approved in 38 countries (incl. U.S. & EU) for narcolepsy; 29 EU countries for OSAS.
- Strategic Value – Aculys’ partnership with Bioprojet granted Viatris exclusive Japanese rights, enabling rapid market entry and revenue generation.
Spydia – First Intranasal Rescue for Status Epilepticus
- Product Profile – 5 mg, 7.5 mg, and 10 mg diazepam nasal spray for patients ≥ 2 years.
- Regulatory Milestone – First intranasal anti‑seizure drug approved in Japan (June 2025).
- Market Opportunity – First out‑of‑hospital rescue medication for adults, addressing a critical unmet need in acute seizure management.
Strategic Implications for Viatris
- Portfolio Diversification – Adds two high‑barrier, high‑margin CNS products to Viatris’ global lineup.
- Market Expansion – Leverages Aculys’ established APAC presence to accelerate commercialization in Japan and beyond.
- Revenue Upside – Milestone and royalty structures align long‑term upside with commercial success.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech