Novartis, Spark Therapeutics in Gene-Therapy PactBy
Novartis and Spark Therapeutics, a Philadelphia, Pennsylvania-headquartered biopharmaceutical company, have signed a license pact to develop and commercialize investigational voretigene neparvovec, a vision-loss drug, outside the US while Spark Therapeutics exclusively commercializes Luxturna (voretigene neparvovec-ryzl), Spark Therapeutic’s gene therapy for treating patients with an inherited form of vision loss that may result in blindness, in the US.
Under the agreement, Spark Therapeutics will retain regulatory responsibility for obtaining European Medicines Agency (EMA) approval for investigational voretigene neparvovec. Spark Therapeutics also signed a separate agreement to manufacture and supply investigational voretigene neparvovec to Novartis. No other programs in Spark Therapeutics’ pipeline are part of this agreement.
Under the licensing agreement, Novartis will pay Spark Therapeutics $105 million in cash as an upfront fee. Spark Therapeutics is eligible to receive up to an additional $65 million in cash milestone payments based on near-term EMA regulatory approval and initial sales outside the US in certain markets. Spark Therapeutics is also entitled to receive royalty payments on net sales of investigational voretigene neparvovec outside the US.
Source: Spark Therapeutics