Spark hands over Luxturna rights outside US to Novartis for $170m

pharmafile | January 25, 2018 | News story | Sales and Marketing Luxturna, Novartis, Spark Therapeutics, pharma 

Novartis has confirmed a deal worth a potential $170 million with Spark Therapeutics to develop and commercialise its gene therapy Luxturna (voretigene neparvovec) in markets outside the US, where it is already approved by the FDA for confirmed biallelic RPE65 mutation-associated retinal dystrophy – an inherited eye condition which can lead to complete blindness in some patients.

While the drug broke ground by becoming the first approved treatment for a congenital condition, it has also stirred up some controversy over its price – at $850,000 per treatment, or $425,000 per eye, it is the most expensive therapy in US history.

As part of the deal, Novartis will pay £105 million to spark upfront, and will be eligible for a further $65 million in milestone payments upon near-term approval of the drug in Europe, where it is currently being reviewed, as well as other select markets. Luxturna will retain exclusive rights to the drug in the US, and is entitled to royalties on its net sales outside of the country.  In a separate agreement, Spark will also manufacture and supply the gene therapy to Novartis.

“This collaboration builds on our commitment to ophthalmology,” commented Shreeram Aradhye, Global Head of Medical Affairs and Chief Medical Officer at Novartis, adding, “We look forward to leveraging our global presence to ensure that patients outside the US have access to this potentially life-changing treatment.”

Matt Fellows

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