Leo Pharma Targets Topical JAK Market Amid Opzelura Launch Slowdown

Leo Pharma is set to challenge Incyte with its new JAK inhibitor cream, delgocitinib, aiming to make a significant impact in the topical atopic dermatitis market. Currently, Incyte's Opzelura cream holds a strong position in this market.

Leo Pharma is optimistic about delgocitinib's potential, supported by multiple positive studies, including a recent phase 3 trial comparing it to the existing standard-of-care treatments. The company is now investing more resources to expedite the treatment's launch, as highlighted in its first-quarter earnings report.

Presently, delgocitinib is under regulatory review in Europe. Leo Pharma is also exploring ways to commercialize the product in other markets, including the United States. The cream has already been available in Japan, marketed by Japan Tobacco for the past four years.

The clinical evidence backing delgocitinib includes two phase 3 studies against a placebo cream and an open-label extension study, all demonstrating its effectiveness in treating moderate-to-severe chronic hand eczema. Notably, delgocitinib recently outperformed the standard-of-care treatment, alitretinoin capsules, which is currently the only approved treatment for chronic hand eczema patients unresponsive to topical corticosteroids.

In the DELTA FORCE study, involving 513 patients, delgocitinib showed a significant reduction in the Hand Eczema Severity Index scores at both week 12 and week 24, surpassing the results of alitretinoin. Additionally, the cream excelled in secondary measures related to treatment success and quality of life.

Kreesten Meldgaard Madsen, Leo Pharma’s chief development officer, expressed confidence in delgocitinib's potential role in expanding treatment options for chronic hand eczema, a challenging condition to manage.

Should delgocitinib receive approval, it would compete directly with Incyte’s Opzelura, the only other marketed topical JAK inhibitor. Opzelura is a cream version of Incyte's successful JAK inhibitor, Jakafi, and is approved not only for atopic dermatitis but also for vitiligo.

Incyte is working to extend Opzelura's applications to include pediatric atopic dermatitis, with plans to submit a request for this indication within the year. This expansion could potentially add two to three million new eligible patients, according to the company's projections.

Opzelura and Jakafi significantly contributed to Incyte's impressive fourth-quarter sales last year, a period that Barry Flannelly, Incyte's North America general manager, described as one of the best recent launches in dermatology following Opzelura’s approval in 2021. However, sales figures for both drugs declined in the first quarter of this year, missing analysts' expectations.

While Jakafi's decline was attributed to higher inventory drawdown and Opzelura's drop to a cyberattack on Change Healthcare, analysts from William Blair cautioned that these factors do not necessarily indicate a positive outlook for future estimates. Opzelura's first-quarter revenues fell to $86 million, a 21.5% decrease from the previous quarter.

In summary, Leo Pharma’s delgocitinib is gearing up to enter and possibly disrupt the topical atopic dermatitis market with promising clinical trial results and strategic investments aimed at accelerating its launch. Meanwhile, Incyte's Opzelura faces challenges in maintaining its market lead amidst these developments.