Novartis' Lucentis combo flop gives Regeneron a shot at the wet AMD lead

Regeneron
A Novartis-Ophthotech team and Regeneron have each now failed an anti-PDGF combo study.

Ophthotech and Novartis may not have been so happy when their wet AMD combo came up short in a pair of late-stage studies Monday. But one drugmaker cheered the news: Regeneron.

The pair had combined Lucentis with Ophthotech candidate Fovista, a drug in the new anti-PDGF class, hoping the combo would beat solo Lucentis in wet AMD patients. It didn't. That failure meant an evening of the score for the Regeneron med, which failed an anti-PDGF combo study in September.

While analysts differ in how shocking they found the Ophthotech/Novartis flop—Leerink Partners’ Geoffrey Porges, for one, wrote to clients that “we are not surprised by the results but equally did not necessarily predict this complete failure”—Regeneron wasn’t surprised at the outcome.

“Regeneron had been outspoken in recent weeks in dismissing the outlook for Fovista, and this disclosure amounts to a significant vindication of their insights and expertise,” Porges wrote.

As he figures, a Fovista launch would have thrown 12% to 15% of Eylea’s blockbuster sales into jeopardy, and the new med might have quickly drawn away 4% to 6% of that haul.

And the Lucentis-Fovista combo wouldn't have been the only threat. As Barclays analyst Geoff Meacham pointed out in his own research note, “while Eylea has proven to be modestly better than Lucentis, the added benefit of Fovista to anti-VEGF therapy could have driven share” toward a pairing of Fovista and Roche’s Avastin, a med that’s frequently used off-label in wet AMD.

Now, with the Fovista flub representing the second failure for the anti-PDGF class—after Regeneron’s rinucumab-Eylea combo actually fell short of Eylea alone—Porges sees “more or less the end of the competitive risk to Regeneron’s Eylea franchise posed by this technology.”

Meanwhile, Ophthotech and Novartis’ pain also spells an opportunity for Regeneron to surge ahead with a different combo that weds Eylea and anti-ANG2 prospect nesvacumab. The coformulation therapy already has the FDA’s fast-track designation in wet AMD, diabetic macular edema and diabetic retinopathy, and a successful phase 2 study “would place Regeneron ahead of the competition for wet AMD and DME therapy,” Canaccord Genuity’s John Newman wrote in an investor note.

It may be awhile before that happens, though. That combo “remains behind in development,” Meacham wrote, with phase 2 results anticipated in the second half of next year.