Results

With Novartis and Roche gunning to carve up Eylea franchise, Regeneron has another PhIII success story to tell

Working furiously to stay ahead of two powerhouse rivals in Novartis and Roche, Regeneron today is running out a promising set of fresh top-line data for its franchise drug Eylea. And one prominent analyst quickly rewarded them with a projection of $700 million in added sales in 5 years.

Researchers led by chief scientific officer George Yancopoulos say they hit the primary endpoint in their Phase III study for severe non-proliferative diabetic retinopathy, setting up a supplemental application at the FDA.

The blockbuster drug had little problem overcoming a placebo in the Panorama study, with 58% in the drug arms scoring at least a two-step improvement in the diabetic retinopathy severity scale compared to only 6% for the sham.

Regeneron shares bumped up 2% in mid-morning trading on Monday.

Analysts focused on Regeneron $REGN have been looking to the Panorama data to give them a fresh set of numbers they can use to compare Eylea with two experimental meds moving up the pipeline: Novartis’ $NVS brolucizumab (RTH258) and Roche’s $RHHBY RG7716.

As expected, Leerink’s Geoffrey Porges led the cheering section for Regeneron, where he’s been an unabashed supporter.

(T)his result opens up a significant new market for Eylea, which could expand the addressable pool of patients in the broader diabetic eye disease indication by 30-40% compared to the current DME-only indication. We anticipate US approval and launch for this indication for Eylea in 2019E, and already include US sales estimates for Regeneron of $200mm in 2019E, growing to $700mm by 2023E. Overall, our US Eylea sales estimate in 2019E of $4,397mm is 6% higher than recent consensus, and our 2023E estimate of $4,992mm is 19% higher than recent consensus, which suggests that consensus is not valuing this incremental indication.

Regeneron is fielding a full slate of new trials in a drive to stay out front, including a study of its own quarterly dosing regimen. Late last year, though, Regeneron and Bayer were forced to halt work on a next-gen combo to succeed Eylea after it couldn’t beat the standard bearer in a mid-stage study.

Novartis has been particularly aggressive with its blockbuster forecast for brolucizumab, which it expects will hit the market next year with an easier dosing schedule after posting positive data compared to Eylea. And Roche, no slouch in the competition game, is moving through the clinic with its own blockbuster slayer.

Diabetic retinopathy often starts as NPDR, a condition that affects more than a half million people in the US, according to Regeneron. As the ailment progresses into diabetic retinopathy — a condition that afflicts millions — leaky blood vessels distort vision.

It’s hard to overestimate the importance of this drug to Regeneron. Even as the big biotech brings on new drugs with Sanofi, worldwide sales of Eylea hit close to $6 billion last year, dwarfing any income it earned from the rest of its portfolio combined.

“This is the first time a therapy has demonstrated it can reverse disease progression in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema, in a trial specifically designed to study this population,” said Yancopoulos. “Patients in the trial continue to be evaluated to determine if Eylea can prevent progression to neovascular vision-threatening complications or diabetic macular edema. We look forward to sharing one-year results later this year.”


George Yancopoulos, Regeneron R&D chief.


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RAPS Convergence 2018

Director/Sr Director, Oncology/Immuno-Oncology
Aro Biotherapeutics Company Denver, CO
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Aro BioTx Philadelphia, PA
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