January 24, 2018 5:30pm
Novartis (NVS) will commercialize investigational voretigene neparvovec when and if approved in the EU and all other markets outside the U.S. ONCE will also be eligible to receive up to $65 million in milestone payments, as well as receive a royalty on net sales outside the U.S. ONCE is up +$1.39 or + 2.51% in the aftermarket
ONCE has entered into a licensing agreement with Novartis Pharmaceuticals to develop and commercialize investigational voretigene neparvovec outside the U.S., while ONCE will continue to exclusively commercialize LUXTURNA(TM) (voretigene neparvovec-ryzl) in the U.S.
- Under the agreement ONCE will retain regulatory responsibility for obtaining European Medicines Agency approval for investigational voretigene neparvovec.
- ONCE also entered into a separate agreement to manufacture and supply investigational voretigene neparvovec to Novartis.
- No other programs in ONCE`s pipeline are part of this agreement.
The bucks: Under the terms of the licensing agreement, NVS will pay ONCE $105 million in cash as an upfront fee. ONCE is eligible to receive up to an additional $65 million in cash milestone payments based on near-term European Regulatory Agency (EMA) regulatory approval and initial sales outside the U.S. in certain markets.
ONCE is also entitled to receive royalty payments on net sales of investigational voretigene neparvovec outside the U.S.