Viatris announced that it has acquired Aculys Pharma, which in 2022 had acquired development and commercialization rights to Neurelis’s NRL-1 (Valtoco) intranasal diazepam for the treatment of epilepsy in Japan, Australia, and other Asia-Pacific countries. In addition to Spydia, Aculys’s pipeline included pitolisant, which is in development for excessive sleepiness in narcolepsy and sleep apnea.
In October 2023, Aculys announced that it would file an NDA in Japan, and the MHLW approved 5 mg, 7.5 mg, and 10 mg doses of the nasal spray, which will be marketed as “Spydia,” in June 2025. In the US, Valtoco was approved for use in patients 6 years old and older in January 2020, and the FDA approved it use in children aged 2-5 earlier this year.
Viatris Chief Commercial Officer Corinne Le Goff commented, “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 of innovative products is strategically aligned with our commitment to grow in areas where we can make the greatest impact and is a great example of our business development strategy designed to complement our core strengths in markets across the world.”
Read the Viatris press release
