Spark licenses blindness gene therapy rights outside U.S. to Novartis

(Reuters) - Spark Therapeutics Inc , whose breakthrough gene therapy to treat a rare form of blindness was approved by U. S. regulators in December, has licensed rights to the drug in markets outside the United States to Switzerland-based Novartis AG

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Philadelphia-based Spark said it will keep U. S. rights to Luxturna, or voretigene neparvovec, which is the first approved gene therapy for an inherited disease. It plans to launch the one-time treatment in March, charging an unprecedented $850,000.

Spark will receive $105 million from Novartis and up to $65 million in milestone payments based on near-term European regulatory approval and initial sales in certain markets. Spark is also entitled to future royalties on net sales outside the United States.

In a statement, Spark said the deal leverages Novartis' "large, existing commercial and medical infrastructure in ophthalmology, as well as its commitment to commercializing genetic-based medicines."

Novartis last year won U. S. approval for Kymriah, the first of a new type of potent gene-modifying immunotherapy for leukemia.

Luxturna treats inherited retinal disease caused by defects in a gene known as RPE65, which affects between 1,000 and 2,000 people in the United States. It works by delivering by an eye injection viral vector particles containing a correct copy of the gene to retinal cells, restoring their ability to make a needed enzyme.

(Reporting By Deena Beasley; Editing by Susan Thomas)

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