Novartis licenses ophthalmology gene therapy from Spark Therapeutics

Novartis has agreed an exclusive licensing deal for an innovative ophthalmology gene therapy from Spark Therapeutics.

The deal covers development, registration and commercialisation rights to voretigene neparvovec – which is sold in the US under the brand name Luxturna – for all markets outside the US.

Luxturna was approved by the US Food and Drug Administration last month as a one-time gene therapy to restore functional vision in children and adult patients with biallelic mutations of the RPE65 gene, while the European Medicines Agency is also reviewing the drug.

This new therapy works by providing patients with a working copy of the RPE65 gene, making it possible to treat progressive vision loss that would otherwise typically lead to blindness.

Novartis will pay an upfront fee in addition to milestone-based payments and royalties to Spark Therapeutics, which will retain exclusive rights for Luxturna in the US, as well as maintaining responsibility for obtaining EU approval.

Shreeram Aradhye, global head of medical affairs and chief medical officer at Novartis Pharmaceuticals, said: "This collaboration builds on our commitment to ophthalmology. We look forward to leveraging our global presence to ensure that patients outside the US have access to this potentially life-changing treatment."

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