Leo Pharma prepares to come for the topical JAK market as Incyte's Opzelura cream launch cools off

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来源: FiercePharma

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Watch out, Incyte. Leo Pharma and its JAK inhibitorJAK inhibitor cream delgocitinib are coming to disrupt the topical atopic dermatitis market, currently inhibited by Incyte’s approved Opzelura.

With several positive studies in hand, including a recent phase 3 trial pitting the candidate against the current standard-of-care, Leo says its delgocitinib has growth driver potential.

Now, the drugmaker will be “investing additional resources in accelerating the launch of this potential treatment to patients,” Leo said in its first quarter earnings release.

The cream is currently under regulatory review in Europe. As for other markets including the U.S., Leo is “assessing ways” to bring the potential treatment to commercialization, it said.

Delgocitinib has been marked in Japan by Japan Tobacco for four years now.

Leo's evidence supporting the drug includes two phase 3 studies against a placebo cream and an open-label extension study proving its success in treating patients with moderate-to-severe chronic hand eczema.

Most recently, delgocitinib went up against standard-of-care alitretinoin capsules, the only currently approved treatment for chronic hand eczema patients who do not respond to topical corticosteroids.

In the DELTA FORCE study of 513 patients, Leo’s candidate proved a superior reduction in scoring on the Hand Eczema Severity Index at week 12 and week 24. It also trumped alitretinoin in two other secondary measures assessing treatment success and quality of life.

“We are confident that with the DELTA FORCE study, delgocitinib cream may play a crucial role in expanding the options available for patients in this hard-to-treat condition,” chief development officer Kreesten Meldgaard Madsen said at the time.

If the drug scores approval, it would compete with the only other marketed topical JAK inhibitorJAK inhibitor, Incyte’s Opzelura.

That med is a cream version of the company’s popular JAK inhibitorJAK inhibitor Jakafi. Other than atopic dermatitis, Opzelura is also approved to treat vitiligo.

Incyte is now moving to expand the Jakafi counterpart into pediatric atopic dermatitis use and expects to submit its bid for the indication this year along with “multiple data readouts,” head of R&D Pablo Cagnoni said on the company’s first-quarter earnings call. A pediatric nod would add some two million to three million eligible patients to the med’s reach, the company said.

Opzelura and Jakafi brought Incyte to blockbuster fourth-quarter sales last year, reflecting what the company’s North America general manager Barry Flannelly called “one of the best recent dermatology launches” on Opzelura’s part following its 2021 approval.

More recently over this year’s first quarter, sales for both Opzelura and Jakafi sank on a quarterly basis, missing analyst’s consensus.

While Jakafi was impacted by higher inventory drawdown and Opzelura by Change Helathcare’s cyberattack, the explanations “still will not provide investors with data point to suggest there is upside to estimates in the near term,” analysts at William Blair wrote in a note to clients.

Opzelura pulled first-quarter revenues of $86 million, dipping 21.5% from the fourth quarter.

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