Ionis Enters License Agreement with Recordati for Zilganersen
Ionis Pharmaceuticals announced that it has entered into a license agreement with Recordati, under which Recordati obtained exclusive rights to develop and commercialize zilganersen, an investigational RNA-targeted medicine for Alexander disease, 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. Ionis plans to independently launch zilganersen in the U.S, which is currently under FDA review with a Prescription Drug User Fee Act action date of September 22. As the potential first and only disease modifying treatment for AxD, zilganersen would also mark Ionis' first independent commercial launch in neurology.
