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Acne was a bust, but excessive sweating scores FDA OK for Dermira — shares climb

After a catastrophic failure in acne that obliterated its stock just months ago, Dermira $DERM had some redeeming news this morning — the FDA has OK’ed its anti-sweating drug glycopyrronium.

Tom Wiggans

The med now goes under the brand name Qbrexza, and it’s a once-daily, topical treatment for people with excessive underarm sweating (also called primary axillary hyperhidrosis). The treatment is applied directly to the skin, blocking sweat gland activation.

“For years, dermatologists have been telling us of the need for new treatment options that address primary axillary hyperhidrosis given the stigma and burden associated with this condition,” said Tom Wiggans, chairman and chief executive officer at Dermira. “From the start, our goal was to develop an approach that went beyond masking a person’s excessive underarm sweating and instead focused on treating the condition in a clinically meaningful way. We partnered with dermatologists and the FDA during the development stage and listened to the people who have been living with this condition to understand how they would define a meaningful benefit. It is our hope that Qbrexza will not only provide the clinical benefit these sufferers have been seeking, but help to reduce the overall burden on their lives.”

Evercore industry analyst Umer Raffat wrote a note this morning about his take on the approval, which was based on results from two Phase III trials.

“I have to admit: I was in the more skeptic camp on unmet need for drug treatments in hyperhidrosis … until I saw a workshop hosted by FDA where I listened to many patient stories about the social stigma/unsuccessful job interviews etc. At present, Dermira estimates 5 (million) hyperhidrosis patients have had a discussion with the doc, but only ~15% treated. Dermira will have to work hard on creating this market.”

Raffat noted that Botox is currently approved in hyperhidrosis, but the drug has seen no sales growth in the indication, holding steady at about $70 million per year. Evercore is modeling $200 million in peak sales, starting in 2019 with about $30 million. Qbrexza is expected to be available nationwide in pharmacies beginning in October 2018.

Dermira’s stock is up 27% on the news. But it’s not yet enough to undo previous damage, as the company’s share price cratered over 65% in March (from $25 per share to $8.59 in a matter of days) following news that its Phase III acne drug failed in trials and would be scrapped. Today in pre-market trading, it’s at $11.04.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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