BioCentury
ARTICLE | Company News

Ophthotech, Novartis deal

May 26, 2014 7:00 AM UTC

Ophthotech granted Novartis exclusive, ex-U.S. rights to develop and commercialize Fovista, which is in Phase III testing to treat wet age-related macular degeneration (AMD). Ophthotech, which retains sole commercialization rights in the U.S., will receive $200 million in cash up front. The company is also eligible for up to $830 million in milestones, plus mid-30% royalties on Fovista sales. The milestones include $130 million tied to enrollment of an ongoing Phase III trial of Fovista to treat wet AMD in combination with anti-VEGFs; up to $300 million tied to ex-U.S. regulatory milestones; and up to $400 million tied to ex-U.S. sales milestones. Top-line data from the trial are expected in 2016. Fovista is a pegylated aptamer against platelet derived growth factor B ( PDGFB; PDGF2).

Novartis is responsible for other clinical trials and costs for ex-U.S. approvals, including a development program in Asia but excluding regulatory filing fees in the EU. The pharma and Ophthotech also will develop a co-formulation of Fovista with a Novartis anti-VEGF drug in a prefilled syringe. Ophthotech received options to acquire U.S. commercialization rights for the co-formulated product. Ophthotech will be eligible for royalties of "approximately equal value" to the Fovista royalties on sales of a co-formulated product. ...