Some analysts are predicting Regeneron ($REGN) and Sanofi's ($SNY) candidate eczema treatment, dupilumab, could wind up capturing annual sales of more than $5 billion. And Friday, the pair took a step toward making those projections a reality.
Sanofi R&D head Elias Zerhouni
Dupilumab came up big in two Phase III trials of patients with moderate-to-severe atopic dermatitis, the companies said, significantly clearing skin, reducing itching, and upping quality of life and mental health over placebo. Now, the drugmakers will put those results into a regulatory package they plan to submit in the third quarter of this year.
If approved, dupilumab--which already bears the FDA's "breakthrough" tag--would be the first in its class of immunotherapies to hit the market, and as Sanofi R&D chief Elias Zerhouni pointed out in a statement, right now there are "no approved systemic therapies in the U.S." for this patient pool, "underscoring the clear unmet medical need."
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.
And right now, most atopic dermatitis patients are flying under the radar, Sanofi said; the condition affects about 7 million to 8 million adults in the U.S., and the company estimates only 1.6 million of them are currently diagnosed and treated.
All things considered, analysts see dupilumab racking up more than $2.5 billion a year--with some among them forecasting an annual haul of up to $4 billion or $5 billion.
"These results may bring new hope to AD patients, many of whom have suffered for years," Zerhouni said. Sanofi and Regeneron will "work to bring this innovative therapy to patients as quickly as possible."
The Sanofi/Regeneron team isn't stopping there on dupilumab. Earlier this year, Regeneron Chief Scientific Officer George Yancopoulos called the med an "incredible growth opportunity, both within indications and among additional indications"--such as asthma, for which dupilumab is already being tested. "We think that this could really be an important drug for very different assortments of allergic-related diseases," Yancopoulos told investors.
- read the release
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