US biotech firm Spark Therapeutics (Nasdaq: ONCE) has entered into a licensing agreement with Swiss pharma giant Novartis (NOVN: VX) to develop and commercialize investigational voretigene neparvovec outside the USA, while Spark will continue to exclusively commercialize Luxturna (voretigene neparvovec-ryzl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness, in the USA.
Under the agreement, Spark will retain regulatory responsibility for obtaining European Medicines Agency approval for investigational voretigene neparvovec. Spark also entered into a separate agreement to manufacture and supply investigational voretigene neparvovec to Novartis. No other programs in Spark’s pipeline are part of this agreement.
Under the terms of the accord, Novartis will pay Spark Therapeutics $105 million in cash as an upfront fee. Spark is eligible to receive up to an additional $65 million in cash milestone payments based on near-term European Medicines Agency (EMA) regulatory approval and initial sales outside the USA in certain markets. Spark is also entitled to receive royalty payments on net sales of investigational voretigene neparvovec outside the USA.
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