Ophthotech Announces that Genentech, a Roche Wholly-Owned Subsidiary, Elects to Exercise Its Right to Opt-in to the Novartis Portion of the Ophthotech / Novartis Ex-US Agreement for Fovista®to Treat Wet Age-Related Macular Degeneration
“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”
“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® program. 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.
Background of the Fovista® Ex-US Agreement
The Ophthotech / Novartis ex-US licensing and commercialization agreement went into effect on May 19, 2014, and remains unchanged. Previously announced terms of the agreement include:
- Ophthotech granted Novartis exclusive rights to commercialize Ophthotech’s lead product candidate, Fovista®, in markets outside the United States while Ophthotech retains sole rights to commercialize Fovista® in the United States.
- Ophthotech continues to lead the global Fovista® Phase 3 wet AMD pivotal clinical program. 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……….
- Read more: http://www.businesswire.com/news/home/20151117005654/en/Ophthotech-Announces-Genentech-Roche-Wholly-Owned-Subsidiary-Elects Source: Business Wire