- Novartis and Ophthotech Corp. have suspended big pieces of a licensing agreement for the latter company's lead candidate until the drug can prove its effectiveness in late-stage testing.
- Fovista (pegpleranib) has already failed two pivotal Phase 3 trials testing it in combination with Genentech's Lucentis (ranibizumab) in patients with wet age-related macular degeneration (AMD). Data from a third late-stage trial, OPH1004, evaluating pairings of Fovista with Regeneron's Eylea (aflibercept) or Roche's Avastin (bevacizumab) are expected in the second half of this year.
- In 2014, Ophthotech handed over exclusive manufacturing and commercialization rights to Fovista outside the U.S. to Novartis in exchange for $200 million upfront and potential milestone payments. The development, production and marketing obligations of that agreement are effectively on hold, however, until OPH1004 reads out.
Fovista has reached its do-or-die moment. If the drug doesn't show some sort of clinically meaningful improvement for wet AMD patients in OPH1004, it's likely Novartis will pull the plug on the licensing deal, leaving Ophthotech to develop the candidate solo and stripping the company of its only source of collaboration revenue, which totaled $1.66 million during the first quarter.
Yet even if Fovista can lock down positive results, it may be too late to bring back optimism. Not only has the drug, which functions as a platelet-derived growth factor (PDGF) inhibitor, missed the mark twice when paired with Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, but a similar combination from a rival eye drugmaker also failed last year.
In September, Regeneron disclosed its anti-PDGF agent rinucumab plus Eylea, another anti-VEGF drug, didn't improve visual acuity in a Phase 2 study that enrolled patients with wet AMD.
"The failure of two previously completed Phase 3 clinical trials conducted by Ophthotech ... and the recent failure of a competitor’s Phase 2 trial investigating the combination of a PDGF inhibitor and a VEGF inhibitor, may be indicative of a low likelihood of success for OPH1004," Ophthotech said in a Form 8-K filed with the Securities and Exchange commission on July 10.
Against that backdrop and the new licensing agreement provisions, Ophthotech shares fell more than 3% to $2.67 apiece in Monday morning trading.
A spokesperson for Novartis said the company doesn't expect the new agreement to greatly affect its business, especially because of the recent readouts for RTH258, also called brolucizumab. Last month, the big drugmaker reported positive results from two Phase 3 trials that showed brolucizumab was non-inferior to Eylea at improving best-corrected visual acuity for patients with neovascular AMD.
In addition to the suspended obligations, the new agreement also grants Novartis a shorter notice period in case it chooses to terminate the licensing deal with Ophthotech. What's more, the big drugmaker gets a "fully paid-up, royalty-free license" to Lucentis monotherapy data from aforementioned late-stage trials as well as the Phase 2b OPH1001 study.
The license will last at least five years. Novartis, meanwhile, gets a good chunk of its eye care revenue from another licensing deal that allows it to sell Lucentis in the U.S.
Editor's Note: Novartis responded to BioPharma Dive request for comment after this story's publication. The story has been updated with information from that response.