Company: Regeneron Pharmaceuticals, Bayer
2020 sales: $8.36 billion
Diseases: wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema
Regeneron entered 2020 scrambling to defend its best-seller Eylea against Novartis’ freshly-minted rival Beovu, but a safety flag for its competitor and pandemic resilience on Eylea’s part have kept the anti-VEGF med at the top of its game.
Despite pandemic blows to total scripts and new patient starts on Eylea in late March and early April, the drug fared better than most for the year. In the second quarter, Eylea sales were down 4%, but still managed to beat expectations, and came nowhere near the 25% decline that Novartis and Roche posted for their rival eye drug Lucentis. By Q4, Eylea sales were up 10%, and full-year sales had grown 7% over 2019.
Eylea booked $8.36 billion in 2020 sales, split between $4.95 billion for Regeneron in the U.S., and $2.82 billion for Bayer, which markets the macular degeneration drug outside the U.S.
Regeneron has Eylea's flexible dosing regimen to thank for that stability. The drug is approved for an eight-week dosing schedule, but that timeline can be stretched to 12 weeks in wet age-related macular degeneration (AMD)—a much-needed perk for patients limiting in-person doctor visits amid the pandemic.
Meanwhile, Novartis’ Beovu seemed poised to sweep the floor with Eylea at the top of the year, and Regeneron was pulling out all the stops to make sure that didn’t happen. The New York-based drugmaker’s threefold strategy centered on a recently-launched prefilled syringe, longer dosing intervals and, potentially, preventive use.
Then, the American Society of Retina Specialists last February alerted doctors that Beovu could be associated with occlusive retinal vasculitis, a condition that could potentially cause vision loss. The news granted Eylea some breathing room and gave Regeneron and Bayer a chance to trumpet their drug’s safety.
Looking over clinical data on Eylea, which comprised eight phase 3 trials involving “tens of thousands of injections,” the partners Regeneron and Bayer found no similar reports, Regeneron’s top scientist, George Yancopoulos, said on a call with investors last May. And according to post-marketing data, which covered more than 32 million Eylea doses, “the rate of any possibly related safety event was less than 1 out of every 6 million Eylea doses sold,” he said.
Beovu’s safety flag notwithstanding, Eylea has been mounting a solid defense. In February 2020, Regeneron rolled out phase 3 data showing that after two years, injectable Eylea cut the risk of vision-threatening complications by 75% versus placebo in patients with non-proliferative diabetic retinopathy (DR). Fifty-eight percent of patients in the control arm developed diabetic macular edema or compromised vision at the two-year mark, solidifying the case for Eylea in the preventive setting, Regeneron said.
In April, Regeneron published data from a separate, National Institutes of Health-run diabetic retinopathy study, which found that Eylea slashed the risk of progression to vision-threatening complications by 68%. Investigators confirmed Eylea’s effectiveness at a 16-week dosing interval, with Regeneron saying it planned to take both the NIH study and its original phase 3, dubbed Panorama, to the FDA to discuss extended dosing.
Meanwhile, Regeneron and Novartis' ophthalmology feud boiled over into an all-out patent war last summer, when Novartis filed a complaint to the U.S. International Trade Commission, alleging Regeneron's prefilled syringe tech, which the drugmaker introduced in late 2019, infringed upon its patent.
Regeneron riposted with petitions to the U.S. Patent and Trademark Office that challenged Novartis' patent. It also sued Novartis and Vetter Pharma—the exclusive filler for the Lucentis prefilled syringe and Regeneron’s collaborator on Eylea—for antitrust violations.