UPDATED: Can Sanofi, Regeneron steer a $3B-plus dupilumab launch through today's tough waters?

Add another stack of data to Sanofi and Regeneron’s stash on blockbuster-to-be dupilumab. The experimental treatment for atopic dermatitis, aka eczema, aced a pair of late-stage studies, presented at the European Academy of Dermatology and Venereology meeting in Vienna over the weekend.

Just last week, the drug won priority review from the FDA, putting it on course for a potential launch in March, under the brand name Dupixent. As a first-in-class med for patients who are suffering despite other treatments, dupilumab could continue that course right to blockbuster territory.

The new drug handily beat placebo on all measures in the latest trials, including an itch-assessment score that could be helpful in winning patients to the new med. "Efficacy was solid across the co-primary endpoints as well as quality of life scores," Bernstein analyst Tim Anderson wrote in a Saturday note. And those secondary data--on itching, anxiety and more--suggest that, "for many patients with severe atopic dermatitis, dupilumab will be life transforming," Leerink Partners analyst Geoffrey Porges wrote to investors Monday.

Normally, such data would suggest "spectacular commercial potential" in a market like atopic dermatitis, Porges said. That’s certainly what Sanofi and Regeneron want, of course, but as the analyst pointed out, some recent big-time launches in chronic diseases haven't gone as well as expected. And that includes the two companies' own PCSK9 launch, Praluent, which has run up against payer obstacles.

On a call Saturday after the data was published, though, company executives sketched out some ideas for making it happen. Sketched, rather than drew; they didn’t offer much detail. No hint about pricing, for instance, likely to be a key decision. And they wouldn’t say how many sales reps will be out detailing the med.

On Saturday's call, Sanofi and Regeneron did say that 1.6 million patients are estimated to qualify for Dupixent treatment under the indication that’s up for FDA approval, a much smaller target than the broad eczema population, which could make payer negotiations somewhat less onerous, the companies suggested during the call.

As for marketing to doctors, the partners say they’ll target physicians with experience treating psoriasis--and many of those doctors participated in clinical trials, so that shouldn’t be too tough, executives said.

But analysts, even those with big sales forecasts, worry that Dupixent will face pushback from payers, and they're looking for more information on how Sanofi and Regeneron plan to roll out the med. The two partners need "to explain how they plan to price and promote dupi, at a manageable expense investment, to avoid the formidable roadblocks that have stalled the recent launches of other chronic use specialty therapeutics" that have blockbuster sales expectations, Porges said.

The data will help, of course; the two newly released dupilumab trials are “the first large pivotal studies where a systemic investigational therapy has demonstrated significant reduction in the signs and symptoms of atopic dermatitis, and showed improvement in studied quality of life measures," Dr. Eric Simpson, lead author of The New England Journal of Medicine paper published simultaneously with the data release.

"Additionally," Simpson said, "the reduction of itch intensity is important because itching is one of the most burdensome symptoms for patients and can impact other aspects of their lives, such as sleep."

Current options for eczema patients include immunosuppressants such as cyclosporine--which can increase the risk of dangerous infections and cancer--and topical steroids, whose own set of potential side effects includes skin-thinning. The adverse events that commonly popped up in dupilumab research include conjunctivitis and dry eye. There were two cases of hypersensitivity reactions.

Consensus sales forecasts for Dupixent in 2021 stand at €2.9 billion ($3.26 billion). Bernstein’s estimate, quoted in Anderson’s weekend note, is €2.6 billion. Leerink's is much higher, at $5 billion-plus.

In June, the companies rolled out Phase III data showing that a dupilumab/corticosteroid combo topped steroids alone. Four out of 10 patients on the new med demonstrated a complete or near-complete clearing of skin lesions, with 64% achieving a 75% elimination of eczema. And these latest two studies add to that.

In the two newly released trials, SOLO 1 and SOLO 2, dupilumab topped placebo at clearing up the itchy skin lesions that characterize the disorder. In the first trial, 37% of dupilimab patients on a weekly dose saw their skin clear or nearly clear up, as measured by a standard assessment scale that was the study’s primary endpoint. That compared with 10% of patients on placebo. Among patients on a biweekly dose of dupilumab, the success rate was 38%.

In SOLO 2, the spread was similar, with 36% clearance for patients on either of the two dupilumab dosing regimens, and 8% for placebo patients. Half or almost half of dupilumab patients also saw 75% improvement on another scale that served as a secondary endpoint in the U.S. and co-primary in the E.U.

And in one quality-of-life measure, dupilumab patients found their skin didn’t itch as much. On a 10-point scale, itching severity dropped by at least 4 points in 36% to 40% of dupilumab patients in the two different dosing arms of both studies. Among placebo patients in the two studies, 8% and 10% saw similar improvements.

Next up: Data for other potential dupilumab uses, including asthma. A pivotal study, dubbed QUEST, is now fully enrolled, but results won’t be available for a year.

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