NOV 26, 2015
Ophthotech announced that Genentech will join Novartis and split rights to pegpleranib (Fovista) for the treatment of wet AMD.
Under a pre-existing agreement, Genentech will exercise its option to participate in rights for the drug outside the United States. Opthotech had already entered into an exclusive ex-U.S. licensing deal with Novartis in 2014.
The anti-platelet-derived growth factor (anti-PDGF) drug is in its second phase 3 trial in combination with ranibizumab (Lucentis) for the treatment of wet AMD. Phase 2b results showed patients receiving a combination of pegpleranib and ranibizumab achieved better vision compared with ranibizumab monotherapy (10.6 letters vs. 6.5 letters). Ophthotech continues to retain sole rights to pegpleranib in the United States.
"We are indeed pleased by what is potentially an unprecedented arrangement between two of the leading pharmaceutical companies for a single product in the ex-US territory, while the US rights are retained by the innovator biotech company," said David R. Guyer, M.D., chief executive officer of Ophthotech. "We believe that this arrangement further validates Fovista's novel technology, reflects the industry's need for the next-generation therapeutic option for wet AMD. Our Fovista ex-US agreement with Novartis remains unchanged. Additionally, we are excited about the recent completion of patient recruitment in two of the phase 3 trials of Fovista."
A third Phase 3 trial, which is investigating pegpleranib in combination with other anti-VEGF agents, is currently enrolling. Ophthotech expects to announce topline data from pegpleranib in combination with ranibizumab Phase 3 trials in late 2016.