Roche and Novartis are working hard on next-generation drugs for wet age-related macular degeneration, and they're hoping to steal significant market share away from entrenched drugs. But analysts aren't convinced the new candidates can do the job.
The Swiss pharma giants each rolled out data over the weekend backing their candidates—faricimab from Roche and brolucizumab from Novartis—as they work to establish the up-and-comers as upgrades to Roche and Novartis’ shared stalwart Lucentis and Regeneron’s Eylea.
Roche, for its part, said that in a phase 2 study, patients dosed with faricimab either every 16 weeks or every 12 weeks showed lasting vision benefits comparable to those patients achieved with every-four-week dosing of Lucentis.
The new data “show the potential of faricimab to allow fewer injections while achieving and sustaining the same visual gains seen with a current standard of care,” Roche Chief Medical Officer Sandra Horning, M.D., said in a statement, calling the injections “burdensome.”
As Jefferies analyst Biren Amin pointed out in a note to clients, though, those dosing schedules aren’t “significantly better” than those of brolucizumab, the Novartis prospect, or Eylea, which won FDA approval for a 12-week regimen in August. Plus, Lucentis dosing “could go to 6 months” using a new delivery system that Roche is trialing, Amin noted. So all things considered, “faricimab's utility in wAMD looks substantially reduced.”
Meanwhile, brolucizumab showed once again that it could hang with Eylea: In a phase 3 study, it topped the Regeneron blockbuster at reducing retinal fluid and central subfield thickness, a key measure of abnormal fluid accumulation and edema that can result in vision loss. But as one eye expert and opinion leader told Amin, “retinal dryness and slightly reduced injection burden were incremental advances but not game-changers in his view, and would still consider cost as a major driver of his decision to prescribe.”
Amin isn’t the only analyst that hasn’t been blown away by the new Roche and Novartis challengers. In February, after results on both experimental drugs rolled out at the Bascom Palmer Angiogenesis Meeting, Leerink Partners’ Geoffrey Porges wrote that “the confusing and somewhat lackluster data presented over the weekend for Eylea’s theoretical competitors should lift some of the overhang” on Regeneron’s stock.
“We walked away from the meeting with questions about the reliability, reproducibility, and readiness of the data for brolucizumab and RG7716, and believe the value erosion in Regeneron’s stock due to competitive Eylea threats is vastly overstated,” he added at the time.
That doesn’t mean Eylea and Lucentis won’t get a run for their money in the marketplace; biosimilar nemeses are readying cheaper copies of the products that could whittle away the big guns’ market share.
Regeneron is racing to expand Eylea’s reach before that happens. In August, executives said they would put more money behind direct-to-consumer advertising and widen the company’s discount program for doctors. The New York biotech is also vying for an approval for its prefilled syringe in diabetic eye disease, though the FDA shot down that application last week because of manufacturing troubles.