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Novartis negotiates ex-US rights to Spark gene therapy

Strikes $170m deal for Luxturna

Novartis

Novartis has agreed to develop Spark Therapeutics’ recently-approved gene therapy Luxturna outside the US, in a deal valued at $170m.

The Swiss pharma group is paying $105m for ex-US rights to Luxturna (voretigene neparvovec-rzyl), which is currently filed for approval in the EU for the treatment of patients with vision loss due to Leber congenital amaurosis or retinitis pigmentosa caused by confirmed biallelic RPE65 mutations. Another $65m is on offer based on EU approval and initial sales performance plus royalties.

Luxturna is the first gene therapy to be approved in the US where it has a similar indication - biallelic RPE65-mediated inherited retinal disease (IRD) - and is being launched at a price of $850,000 if a patient has the one-off treatment on both eyes.

The deal fulfils one of the pledges of Novartis’ new chief executive Vas Narasimhan, who wants to turn the company into a force in the emerging category of cell- and gene-based diseases. The firm has also made strides forward in the former category with the recent approval of its CAR-T cancer immunotherapy Kymriah (tisagenlecleucel).

RPE65-mediated IRD affects somewhere between 1,000 and 2,000 people in the US and a similar number in the EU, and occurs when both parents pass on the RPE65 mutation to a child. Luxturna provides patients with a working copy of the RPE65 gene to treat otherwise progressive vision loss that typically leads to blindness.

Spark still has responsibility to secure approval for the gene therapy in Europe but will transfer commercial rights to Novartis if that comes through, and has also agreed a separate deal for the manufacture and supply of Luxturna. Novartis is an established global player in ophthalmology with its Alcon division and this could help Luxturna’s roll-out in the EU if approved by the EMA.

"This collaboration builds on our commitment to ophthalmology,” commented Shreeram Aradhye, chief medical officer at Novartis Pharma, adding that there is currently no therapy for RPE65-related disease outside the US.

"No otherwise healthy child should have to go blind due to this devastating disease,” he said. “Gene therapy is a promising new avenue to potentially address this unmet need.”

The deal with Spark was announced shortly after Novartis reported its fourth quarter results, with sales up 5% to $12.9bn - ahead of analyst expectations.

The gains were driven by strong performances from new immunotherapy Cosentyx (secukinumab), which breached the $2bn sales threshold for the year, as well as heart failure therapy Entresto (sacubitril and valsartan) which is gathering momentum after a slow start in the market and according to the company could become a $4bn-$5bn brand.

Article by
Phil Taylor

25th January 2018

From: Sales

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