Regeneron, Sanofi take another big step toward quick dupilumab OK

Interleukin 4

Regeneron ($REGN) and Sanofi ($SNY) have added another big piece to the late-stage data puzzle for dupilumab, which could be approved and launched in early 2017.

Just two months after reporting the first two rounds of stellar Phase III data for the drug in treating atopic dermatitis, the biopharma collaborators added their third set of promising results.

The highlights: The drug combined with topical corticosteroids--the standard of care--beat SoC alone handily at 16 and 52 weeks. Four out of 10 patients on the drug demonstrated a complete or near complete clearing of skin lesions, with 64% achieving a 75% elimination of eczema.

For this pair of well-financed players with an outstanding record on R&D in recent years, the data help reassure analysts that the drug is pointed to a near-term approval especially with a breakthrough drug designation in place to speed things along at the regulatory front.

“Since dupilumab received breakthrough therapy designation from the FDA, we expect a fast review process, with potential approval and subsequent launch in early 2017,” noted Leerink’s Geoffrey Porges.

"This is the first long-term Phase 3 data that demonstrated dupilumab with topical corticosteroids was superior to topical corticosteroids alone, and provided sustained efficacy, significantly improving measures of overall disease severity, skin clearing, itching, and quality of life through one year of treatment," said Dr. George Yancopoulos, the CSO at Regeneron. "Although topical corticosteroids are standard therapies for atopic dermatitis, they are non-specific anti-inflammatory agents, while dupilumab is a targeted therapy that specifically blocks the IL-4/IL-13 signaling pathway. Our collective clinical data demonstrate that this pathway is a root cause in atopic dermatitis, asthma and nasal polyposis and we continue to evaluate the potential of this pathway in these atopic and allergic diseases."

If the data hold up under regulatory review, Regeneron and Sanofi will likely kindle renewed expectations of blockbuster peak sales that could exceed $2.5 billion a year. Some optimistic buy-siders have pushed their peak estimates to $4 billion or $5 billion.

- here's the release

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