Ophthotech, a biopharmaceutical company specializing in the development of novel therapeutics to treat diseases of the eye, has entered into an ex-U.S. licensing and commercialization agreement with Novartis Pharmaceuticals focused on the treatment of wet age-related macular degeneration (AMD). Ophthotech grants Novartis exclusive rights to commercialize Ophthotech's lead product candidate, Fovista, in markets outside the U.S. while Ophthotech retains sole rights to commercialize Fovista in the U.S.
Fovista is an anti-PDGF agent in development for the treatment of wet AMD and, if approved, is expected to be first to market in this class of therapies for wet AMD.
Ophthotech could potentially receive over $1 billion in upfront and milestone payments, not including future royalties. Ophthotech will receive immediate payment and near-term milestones totaling up to $330 million, including an upfront fee of $200 million and Fovista phase III enrollment-based milestones of up to $130 million. Ophthotech is eligible to receive contingent future ex-U.S. marketing approval milestones totaling up to $300 million and ex-U.S. sales milestones up to $400 million.
Ophthotech will continue to lead the global Fovista phase III wet AMD pivotal clinical program, which is expected to have initial, topline data available in 2016. Ophthotech will continue its lead role in the potential registration of Fovista in the U.S., while Ophthotech and Novartis will collaborate to seek regulatory approvals outside the U.S.
This collaboration continues the Fovista development strategy to remain agnostic with respect to the choice of the anti-VEGF agent administered in combination with Fovista. Separate injections of the anti-VEGF agent and Fovista would allow physicians to choose their preferred anti-VEGF agent for the combination therapy. The collaboration also provides for the potential development of a fixed combination delivery of a co-formulation of Fovista with a Novartis proprietary anti-VEGF product which would result in additional flexibility for physicians. Novartis also will seek to develop and commercialize alternative innovative delivery technologies such as a Fovista pre-filled syringe as part of this collaboration.