Incyte's Opzelura Gains Momentum as Jakafi Faces Patent Cliff

Incyte Corporation's topical JAK inhibitor Opzelura is showing significant growth and expansion potential as the company's blockbuster drug Jakafi approaches its patent expiration in 2028. The pharmaceutical giant is making strategic moves to diversify its portfolio and maintain its strong market position in the coming years.

Opzelura's Rising Sales and Expansion Plans

Opzelura, approved in 2021 for atopic dermatitis and vitiligo, has demonstrated robust growth with sales reaching $508 million in 2024, a 50% increase from the previous year. The drug's fourth-quarter revenue of $162 million included $24 million from international sales, signaling positive momentum in its European launch.

Incyte is actively pursuing several expansion opportunities for Opzelura:

1. An expected approval for pediatric atopic dermatitis in the second half of 2025, potentially adding 2-3 million patients to its market.
2. Ongoing phase 3 trials in prurigo nodularis, with data expected in the first half of 2025.
3. Studies in mild to moderate hidradenitis suppurativa.

The company has provided its first revenue guidance for Opzelura, projecting 2025 sales between $630 million and $670 million. This forecast is based on anticipated demand growth in its approved indications and the potential pediatric atopic dermatitis launch.

Jakafi's Extended-Release Formulation and Market Position

While Opzelura gains traction, Jakafi remains Incyte's primary revenue driver, generating $773 million in the fourth quarter of 2024. The company is working to extend Jakafi's lifecycle through a once-daily extended-release formulation. After addressing previous FDA concerns, Incyte plans to submit a new application by the end of 2025, aiming for a 2026 launch.

CEO Hervé Hoppenot noted that polycythemia vera patients currently comprise 35% of all Jakafi users, underscoring the drug's continued importance in Incyte's portfolio.

Incyte's Broader Pipeline and 2025 Outlook

Beyond its JAK inhibitor franchise, Incyte has a busy year ahead with 18 key milestones expected, including:

• Four new product launches
• Three phase 3 study initiations
• Four pivotal readouts
• Seven proof-of-concept readouts

Notable developments include the launch of Niktimvo for chronic graft-versus-host disease and potential expansions for lymphoma drug Monjuvi and PD-1 inhibitor Zynyz. Additionally, Incyte anticipates a crucial readout for its phase 3 povorcitinib trial in hidradenitis suppurativa during the first half of 2025, with the company claiming "best-in-class efficacy" for this asset.

As Incyte navigates the approaching patent cliff for Jakafi, the company's focus on Opzelura's growth and its diverse pipeline demonstrates a proactive approach to maintaining its market position in the evolving pharmaceutical landscape.