- Through a deal announced Wednesday, a German-based biotechnology company has agreed to help Regeneron develop a gene therapy for an inherited retinal disease.
- The company, ViGeneron, claims to have an improved method for engineering the viral vehicles often used to shuttle genetic medicine into the proper cells. So far, ViGeneron's research has focused on diseases of the eye, with projects dedicated to illnesses like retinitis pigmentosa and age-related macular degeneration, or AMD.
- ViGeneron, which is already working with Biogen on gene therapies for inherited eye diseases, now has another large partner in Regeneron. Per deal terms, the companies plan to research, develop and validate a gene therapy for an undisclosed inherited retinal disease target. ViGeneron hasn't revealed specific financial details, but said the deal includes an upfront payment and research funding from its new collaborator.
Excluding its coronavirus antibody drug, Regeneron has long counted Eylea as its top-selling product. Last year, net sales of the eye therapy totaled $5.8 billion in the U.S. and $3.6 billion across the rest of the world, where Regeneron's partner Bayer is in charge of commercialization.
First approved in 2011 for a certain kind of AMD, Eylea's market dominance has persisted for roughly a decade, outselling rival treatments like Roche's Lucentis. But challenges are mounting. The Food and Drug Administration last fall approved Susvimo, a refillable implant that continuously administers a formulation of Lucentis and that could be seen, at least by some patients, as a more convenient option than Eylea, which is administered every month or two as an injection into the eye. More recently, Roche received FDA approval for a new AMD drug called Vabysmo that can be given as infrequently as once every four months.
Key patents protecting Eylea are also set to expire over the next few years, opening the door to copycat competition. Already, several biosimilar versions of Eylea developed by Viatris, Novartis' generics unit Sandoz, and partners Biogen and Samsung Bioepis have advanced to late-stage testing.
Additionally, the FDA in September cleared for market Biogen and Samsung's biosimilar to Lucentis. The drug is expected to launch this year, and may offer patients with AMD and certain other eye diseases a lower-cost treatment option.
Against these headwinds, Regeneron has been working to reinforce Eylea's position in the market. It's testing, for example, a higher dose of the drug with the hope of extending the time between dosing.
With the ViGeneron deal, Regeneron may be further hedging its bets by investing in gene therapy's potential to treat eye conditions. It's not alone, either. Biogen linked up with ViGeneron in early 2021, while AbbVie and Novartis have recently either partnered with or bought small biotechs developing genetic medicines for the eye.