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Novartis, Spark enter licensing agreement for Luxturna outside US
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Novartis and Spark Therapeutics have entered a licensing agreement, with Novartis obtaining the rights to develop, register and commercialize Luxturna outside of the United States, according to a press release.
Luxturna (voretigene neparvovec-rzyl) is the first gene therapy approved to restore vision in patients with biallelic mutations of the RPE65 gene.
Novartis will make an upfront cash payment of $105 million to Spark, as well as milestone payments up to $65 million, according to a press release from Spark. Spark will remain responsible for obtaining approval from the European Medicines Agency.
A market authorization application for Luxturna was filed with the EMA on July 31, 2017. Upon approval, commercialization rights will be transferred to Novartis, which will have exclusive rights to pursue development, registration and commercialization in all countries outside of the United States, the release said.
Spark will retain exclusive rights for Luxturna in the United States.