Novartis has acquired from Ophthotech exclusive rights to market the eye drug candidate Fovista® outside the U.S., while retaining U.S. marketing rights, under a licensing and commercialization agreement that could net Opthotech more than $1 billion.
Novartis agreed to pay Ophthotech $200 million upfront, and $130 million in payments tied to Phase III patient enrollment milestones. In addition, Ophthotech is eligible to receive up to $300 million contingent on winning future marketing approval milestones outside the U.S., and up to $400 million tied to sales milestones outside the U.S. million. Additionally, Ophthotech is entitled to royalties on ex-US sales of Fovista.
“As one of the largest ex-US partnering deals ever in the biotechnology industry, this collaboration with Novartis is potentially transformational for Ophthotech,” David R. Guyer, M.D., Ophthotech’s CEO and chairman, said in a statement. “This agreement represents an important achievement for the Company as we continue to execute on a strategy to deliver science-driven retinal products and offer physicians multiple treatment options to improve patient outcome.
Fovista is an anti-PDGF aptamer now under study in combination with anti-VEGF agents for patients suffering from wet age-related macular degeneration (wet AMD). Fovista offers a new mechanism of action designed to further improve visual acuity and potentially slow disease progression.
“Fovista in combination with currently available anti-VEGF treatments could further improve outcomes of patients suffering from avoidable vision loss,” added David Epstein, division head, Novartis Pharmaceuticals.
Ophthotech said it will continue to lead the global Fovista Phase III wet AMD pivotal clinical program, which is expected to enroll up to 1,866 patients in three trials in more than 225 centers worldwide, and release initial, topline data in 2016. Ophthotech will continue to lead the effort to win U.S. registration of Fovista, while joining with Novartis on pursuing regulatory approvals outside the U.S.
Novartis hopes to commercialize Fovista both as a standalone drug and with an undisclosed anti-VEGF treatment, in hopes of staking a claim in the increasingly lucrative wet AMD market. For example, Eylea® (aflibercept) last year generated $1.409 billion in U.S. sales for Regeneron and a combined $472 million outside the U.S. for Regeneron and co-marketing partner Bayer HealthCare.
As part of the agreement, Novartis will seek to develop and commercialize alternative delivery technologies for Fovista, such as a prefilled syringe, and will also develop a co-formulation of Fovista with one of its undisclosed anti-VEGF compounds.
The agreement comes more than a year after Ophthotech reported promising Phase II results showing that the combination therapy of Fovista and Lucentis® (ranibizumab) met the primary endpoint of mean vision gain in wet AMD patients, who saw a mean 10.6 letters on the ETDRS standardized chart after 24 weeks of treatment, vs. 6.5 letters for patients taking Lucentis alone. No new safety signals were observed with Fovista / Lucentis adjunctive therapy as compared to Lucentis monotherapy.
