Opthotech achieved a second $50 million enrollment milestone in its 10-month-old agreement granting outside-U.S. licensing and commercialization rights to Novartis for lead product candidate, Fovista®, a Phase III treatment for wet age-related macular degeneration (AMD).
Opthotech said it achieved the latest milestone by reaching the second enrollment goal in its pivotal, multinational Fovista Phase III clinical program.
The Phase III program consists of three pivotal trials designed to test the safety and efficacy of Fovista, Ophthotech’s anti-platelet-derived growth factor (PDGF) compound, in combination with antivascular endothelial growth factor (VEGF) therapy that is currently standard-of-care for treating wet AMD. Opthotech said it expects to enroll a total of 1,866 patients in the three trials in more than 225 centers worldwide.
Initial, top-line data from the Fovista Phase III clinical program is expected to be available in 2016, according to Opthotech.
The $50 million milestone will allow Opthotech to record $40.6 million of revenue in the quarter ending March 31, 2015. The remaining $9.4 million will be deferred and recognized as revenue on a proportional basis through 2017, the company said.
The latest milestone brings Opthotech to $100 million of a possible $130 million in potential enrollment-based milestones under the companies’ agreement, and to a total $300 million in payments from Novartis. The pharma giant paid Opthotech a $200 million upfront fee when the agreement took effect in May 2014, as well as a first enrollment milestone payment of $50 million achieved in September 2014.
Under the companies’ agreement, signed in May 2014, Ophthotech retained sole rights to commercialize Fovista in the U.S. while selling ex-U.S. rights to Novartis. The deal could generate more than $1 billion for Ophthotech in upfront and milestone payments, not including future royalties on ex-US Fovista sales.
In addition to the upfront fee and enrollment-based milestone payments, Ophthotech is eligible for contingent future ex-U.S. marketing approval milestones totaling up to $300 million, and ex-U.S. sales milestones up to $400 million. Ophthotech is also entitled to receive royalties on ex-U.S. Fovista sales.
If approved, Ophthotech said, Fovista is expected to be first to market among anti-PDGF therapies for wet AMD.