- A mutual lack of confidence in a successful outcome of a Phase 3 clinical trial, OPH1004, assessing Ophthotech 's (NASDAQ:OPHT) Fovista (pegpleranib) in wet AMD prompts the company and licensee Novartis (NYSE:NVS) to amend their May 2014 licensing and commercialization agreement. Results from the trial are expected in H2.
- Under the terms of the revised deal, Novartis will have a shorter period to terminate the agreement and provides for a process to determine the scope and funding for additional studies that may be required for approval. Ophthotech has permanently waived its right to terminate the agreement in the event that the parties are prevented from materially progressing the development of Fovista as a result of government actions. Under the original agreement, OPHT would have had to pay Novartis a substantial termination fee under such circumstances.
- Novartis will have a royalty-free license to use data from the Lucentis monotherapy arms from OPHT's mid-stage OPH1001 study and late-stage OPH1002 and OPH1003 studies in connection with the development of commercialization of Novartis-controlled anti-VEGF products for at least five years.
- Two previous Phase 3 studies, OPH1002 and OPH1003, failed to demonstrate a Fovista treatment benefit, as did a competitor's Phase 2 study of the combination of a PDGF inhibitor and VEGF inhibitor.
- Previously: Ophthotech to cut as many as 135 employees after Fovista flop; shares off 1% premarket (Dec. 16, 2016)
- Now read: Why Novartis Is A Cornerstone Of Our Portfolio
Original article