- While Novartis forecasts a strong launch of its eye treatment Beovu, Wall Street remains skeptical that the drug's newly minted label will allow it to compete with a market-leading product from Regeneron.
- The Food and Drug Administration approved Beovu to treat a vision-loss disease known as wet AMD. The agency's decision rested on two late-stage clinical trials that found Beovu was non-inferior to Regeneron's Eylea, as measured by how patients' distance vision changed over the course of a year. Novartis set the list price of Beovu at $1,850 per vial, matching the per-dose price for Eylea.
- Yet unlike Eylea, Beovu doesn't have a four-week dosing regimen, which Piper Jaffray analyst Christopher Raymond claims could limit uptake among patients who need more frequent injections. The drug's label included data that showed worse rates of inflammation and immunogenicity than Eylea, while also excluding secondary endpoint results that showed Beovu outperforming Eylea on several measures of eye health.
Raymond doesn't see Eylea (aflibercept) as having an infallible market position. He noted how doctors who treat diseases such as wet AMD appear to be "quick adopters of any advance," which could put Eylea in danger if a drug comes along that has more convenient dosing along with similar or better efficacy and safety.
He argues Beovu (brolucizumab) is not that drug, however.
"We’ve long detected a very aggressive pre-launch market prep and education campaign on the part of Novartis, to the point where many physicians we’ve spoken with expressed a belief that brolu may represent a meaningful improvement on the efficacy front," Raymond wrote in an Oct. 8 investor note on Regeneron.
"While we tip our hat to [Novartis] for the effort, we think this label renders Beovu as little more than an also-ran."
That hypothesis hinges on a few parts of the drug's label. Intraocular inflammation — which, according to SVB Leerink analyst Geoffrey Porges, is a "major concern for retinal specialists and a key factor in the treatment selection" — was higher for patients treated with Beovu as opposed to Eylea, at 4% and 1%, respectively. Porges wrote in a note to clients that this inflammation rate had not been previously disclosed.
Additionally, a much higher percentage of Beovu-treated patients tested positive at least once for antibodies that attack the drug, compared to clinical data collected for Eylea or Roche's Lucentis (ranibizumab).
Beovu gained approval at eight-week and 12-week dosing regimens, while Eylea is approved at four-, eight- and 12-week regimens.
Porges, who covers Regeneron, expects the company to harp on these differences as Beovu enters the market. Though Novartis and its new drug are "strong competitors," Porges foresees Eylea continuing to grow over the next couple years. SVB Leerink models U.S. Eylea sales of $4.89 billion in 2021 and $4.99 billion in 2023, when the drug is expected to lose patent protection, whereas consensus estimates are $4.38 billion in 2021 and $4.1 billion in 2023.
Leading up to Beovu's approval, there were some who anticipated the drug to significantly affect the market. For instance, OptumRx, a payer, listed Beovu as one of the five pipeline drugs that could have the biggest impact in the third quarter.
Back in late 2017, when positive data from those two late-stage studies of Beovu were still trickling out, Cowen & Co. forecasted sales of $250 million for the drug in 2020 and $1.25 billion in 2024. The investment bank noted, though, that its ultimate forecast would rely on further labeling, dosing and pricing clarity.
Shares of both Novartis and Regeneron were down a little more than 1% late Tuesday morning.