Ionis announces license agreement with Recordati for zilganersen in Alexander disease (AxD) in all countries outside the U.S.
- Recordati brings deep rare disease expertise and proven capabilities in commercialization, access and country-specific regulatory environments -
- Ionis to independently commercialize zilganersen in the U.S. assuming FDA approval -
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that it has entered into a license agreement with Recordati (“Recordati”), under which Recordati obtained exclusive rights to develop and commercialize zilganersen, an investigational RNA-targeted medicine for Alexander disease (AxD), in all countries outside the U.S. Ionis will maintain sole commercial responsibility for zilganersen in the U.S. and will continue to lead development globally. Recordati will be responsible for regulatory filings and commercialization outside the U.S., including country-specific support for early access pathways based on local regulations and access dynamics.
"Recordati combines proven rare disease and global commercialization expertise with deep experience navigating regional and local regulatory environments and the infrastructure needed to reach patients outside the United States, making them the right partner to deliver zilganersen to patients with urgency. They recognize, as we do, the high unmet need for this rare, serious and often fatal neurodegenerative disease,” said Brett P. Monia, Ph.D., chief executive officer, Ionis. "Together, we are committed to working closely to help bring zilganersen to people living with Alexander disease outside the United States and enable broader access to this important treatment.”
