This Regeneron Drug Just Took Another Step Toward Blockbuster Status


September 13, 2017
By Mark Terry, Breaking News Staff

On Sept. 11, Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced positive data for its Phase III LIBERTY ASTHMA QUEST trial of Dupixent (dupilumab) in asthma. That sounds like great news for the company, and perhaps it is, but investors and analysts don’t seem to agree on whether dupilumab is on its way to being one of the biggest blockbuster drugs in the last two years, or if it’s the most overhyped drug on the market.

Todd Campbell, writing for The Motley Fool, falls into the upcoming blockbuster camp. He notes that the drug, which is already approved for eczema, could potentially enter the $50 billion annual asthma market where, despite other well-known products on the market, there are still about 400,000 asthma-related hospitalizations annually in the U.S. “Clearly,” he writes, “there’s an important need for new treatments that can help patients with asthma and, fortunately, drug developers have stepped up to the challenge by creating new drugs that can better control this condition.”

Competitors include GlaxoSmithKline (GSK) and its Advair Diskus and Nucala, and Teva Pharmaceutical (TEVA) and Cinqair. Both belong to a new class of drugs that target interleukin-5 and in clinical trials were effective at cutting asthma attacks in patients whose disease is well controlled. But so far, their sales are only a small part of overall asthma spending, although they appear to be growing.

Dupixent is also an anti-inflammatory biologic, but it targets interleukin-4 and interleukin-13. In the Phase III trial, adding 300 mg of Dupixent to standard asthma treatments cut severe asthma attacks by 46 percent after 52 weeks. Patients whose test results showed greater IL-4 and IL-13 activity saw reductions of 60 percent and 67 percent, based on 150 or 300 eosinophilic cells/microliter or greater, respectively. The drug also seems to have a good safety profile.

Max Nisen, writing for BloombergGadfly, falls on the skeptical end of the spectrum. As he notes, “The problem with sky-high expectations is that you have to meet them.”

Pointing out that expectations for Dupixent “range from extremely high to ludicrously high,” he says that some analysts expect the drug to hit $4.7 billion in annual sales by 2021, and Geoffrey Porgess, an analyst with Leerink said in June that the drug’s sales could peak at $12 billion in 2026.

Nisen writes, “While the trial data showed Dupixent helps asthma patients, the drug’s effectiveness didn’t live up to earlier results. That may give GlaxoSmithKline PLC (GSK)’s competing drug, Nucala—which already has FDA approval in asthma—and a pipeline joint-venture from AstraZeneca PLCand Amgen Inc. (AMGN) a better chance of keeping or taking market share. It may also sow doubt that further trial disappointments await Dupixent in other diseases.”

And he also suggests that Dupixent’s sales for eczema have been inconsistent and may face competition from AbbVie (ABBV) soon.

But Nisen’s premise appears to be less focused on Dupixent alone, but the company’s expectations overall. Sales of the company’s Eylea for macular degeneration have slowed, and although its Kevzara for arthritis, which was approved this year, is priced lower than competitors, it may have a tough fight in a crowded market. In addition, a drug for pain developed with Teva has had safety problems, and its partnership with Sanofi on cholesterol drug Praluent hasn’t taken off the way the companies hoped, due largely to payers’ reluctant to fork over the money for it when statins are effective and far less expensive. It’s also been battling Amgen over Praluent’s patents.

He writes, “Regeneron deserves credit for a productive run of drug development—the approval of two likely blockbusters in Kevzara and Dupixent in one year is an accomplishment. But it may be time for investors to question whether they’re putting too much emphasis on Regeneron’s potential, while paying too little heed to its limited recent track record of delivering.”



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