BASEL (dpa-AFX) - Novartis (NVS) announced a licensing agreement with Spark Therapeutics covering development, registration and commercialization rights to voretigene neparvovec in markets outside the US. Novartis will make an upfront payment as well as pay milestones and royalties to Spark Therapeutics. The market authorization application with the European Medicines Agency was filed on July 31, 2017. Commercialization rights will be transferred to Novartis upon successful completion of registration and issuance of market authorization.
Voretigene neparvovec, known as LUXTURNA in the US, received FDA approval on December 19, 2017 as a one-time gene therapy to restore functional vision in children and adult patients with biallelic mutations of the RPE65 (retinal pigment epithelial 65 kDa protein) gene. Spark Therapeutics retains exclusive rights for LUXTURNA in the US.
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