Ophthotech Corporation, a biopharmaceutical company, announced that Genentech, a Roche wholly-owned subsidiary, has elected to exercise its option to participate in the financial arrangements relating to Novartis' rights under the Ophthotech/Novartis ex-US agreement for Fovista (pegpleranib) to treat wet age-related macular degeneration (AMD).
Roche's option originates from a pre-existing agreement between Roche and Novartis. Ophthotech's agreement with Novartis and its financial terms remain unchanged including potential payments to Ophthotech of over $1 billion in upfront and milestone payments, and future royalties on ex-US Fovista sales. Ophthotech continues to retain sole rights to Fovista 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," stated David R. Guyer, M.D., chief executive officer and chairman of the Board 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, and also highlights the industry's acknowledgement of the large commercial opportunity resulting from the significant unmet need in the large and expanding market for wet AMD. Our Fovista ex-US agreement with Novartis remains unchanged. We continue to be very impressed with the extensive resources and tremendous commitment that Novartis is putting into the Fovista programme. Additionally, we are excited about the recent completion of patient recruitment in two of the phase 3 trials of Fovista."
In October 2015, Ophthotech announced the completion of patient recruitment for its second phase 3 trial of Fovista in combination with Lucentis (ranibizumab) for the treatment of wet AMD. The company expects to announce initial, topline data from both Phase 3 trials of Fovista in combination with Lucentis in the fourth quarter of 2016. A third phase 3 trial, which is investigating Fovista in combination with other anti-VEGF agents, continues to enroll patients with recruitment on track.
The company believes that Fovista is the most advanced 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 novel therapies for wet AMD.
The Ophthotech/Novartis ex-US licensing and commercialisation agreement went into effect on May 19, 2014, and remains unchanged. Previously announced terms of the agreement include: Ophthotech granted Novartis exclusive rights to commercialise Ophthotech's lead product candidate, Fovista, in markets outside the United States while Ophthotech retains sole rights to commercialise Fovista in the United States.
Ophthotech continues to lead the global Fovista phase 3 wet AMD pivotal clinical programme. Ophthotech continues its lead role in the potential registration of Fovista in the United States, while Ophthotech and Novartis will collaborate to seek regulatory approvals outside the United States.
This collaboration continues Ophthotech's 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 is seeking to develop and commercialize alternative innovative delivery technologies such as a Fovista pre-filled syringe as part of this collaboration.
Previously announced financial terms of the agreement remain unchanged and include: Ophthotech to potentially receive over $1 billion in upfront and milestone payments during the course of the collaboration, not including future royalties.
Ophthotech received a total of $300 million in upfront fees and enrollment milestone payments. These fees received from Novartis consisted of a $200 million upfront fee upon the execution of the agreement in May of 2014 and a $50 million enrollment-based milestone fee achieved in September 2014 and a second $50 million enrollment-based milestone fee achieved in March 2015. An additional $30 million in potential enrollment-based milestone payments remain available under the agreement.
Ophthotech is eligible to receive contingent future ex-US marketing approval milestones totaling up to $300 million and ex-US sales milestones up to $400 million.
Ophthotech is entitled to receive royalties on ex-US Fovista sales.