Press Release

• Presentation underscores potential of several high-impact launches across Oncology and Inflammation & Autoimmunity to drive sustainable long-term growth
• Company announces new positive topline results from Phase 2 trial evaluating ruxolitinib cream (Opzelura^®) in adults with hidradenitis suppurativa (HS)
• Overview of early pipeline, including preliminary results from Phase 1 study of INCB123667 (CDK2i), will also be presented

WILMINGTON, Del.--(BUSINESS WIRE)--Jan. 8, 2024-- Incyte (Nasdaq:INCY) will highlight growth opportunities and provide key updates across its investigational pipeline and commercial portfolio during a presentation today at 7:30 a.m. PT at the 42^nd Annual J.P. Morgan Healthcare Conference in San Francisco.

“As we enter 2024, we see great promise in our portfolio and its potential to drive long-term growth fueled by our strong R&D engine and broad commercial footprint across Oncology and Inflammation & Autoimmunity,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “Today, we provide further clarity into several potential high-impact product launches anticipated by 2030. This includes both indication expansion opportunities and the advancement of novel medicines that could broaden our ability to positively affect patients’ lives.”

Notably, Incyte announces that the primary endpoint was met in its randomized, placebo-controlled, Phase 2 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura^®) in adults with mild/moderate hidradenitis suppurative (HS). At Week 16, patients receiving ruxolitinib cream 1.5% twice daily (BID) had significantly greater decreases from baseline versus placebo in total abscess and inflammatory nodule (AN) count, the primary endpoint of the study. The overall safety profile of ruxolitinib cream is consistent with previous data, and no new safety signals were observed. The Phase 2 data will be submitted for presentation at an upcoming scientific meeting in 2024. A Phase 3 study is currently being evaluated.

Additionally, the Company will highlight progress across its Oncology pipeline and the research it is advancing in areas of high potential, including promising early clinical efficacy data for INCB123667, a potent and selective inhibitor of CDK2, demonstrating its potential use as monotherapy or combination therapy for late-stage cancers. In a Phase 1 study of INCB123667, early clinical activity was observed with several patients with amplified/overexpression of CCNE1, a cell cycle regulator and potential predictive biomarker, achieving partial response (PR). Tumor shrinkage was observed across multiple tumor types, including CCNE+ patients with ovarian cancer. The safety profile of for INCB123667 aligns with the mechanism of action.

In addition, Incyte will provide key updates on:

• Expanding leadership in myeloproliferative neoplasms (MPNs) and graft-versus-host disease (GVHD) with a pipeline including axatilimab, mCALR and V617F that has disease-modifying potential for patients with graft-versus-host disease and the more than 200,000 patients with myelofibrosis, polycythemia vera and essential thrombocythemia.
• Its emerging dermatology franchise, and the intent to maximize the potential of ruxolitinib cream (Opzelura) and expand povorcitinib into multiple indications with high unmet need.

The Company intends to provide additional financial guidance and updates on key clinical programs during its 2023 fourth quarter and year-end earnings conference call.

The J.P. Morgan Healthcare Conference presentation and Q&A session can be accessed at investor.incyte.com. A replay will be archived on the Company’s website for 30 days following the presentation.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, Twitter, Instagram, Facebook, YouTube.

About Opzelura^® (ruxolitinib) Cream 1.5%

Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States and Europe as Opzelura.

Opzelura and the Opzelura logo are registered trademark of Incyte.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: the opportunities for sustainable growth presented by Incyte’s pipeline and products, including multiple programs across oncology and inflammation & autoimmunity, as well as dermatology; expectations regarding Incyte’s R&D and commercial execution; expectations regarding near/mid-term product launches; the potential for sustaining and expanding Incyte’s leadership in MPNs and GVHD and the potential for such innovation to address the needs of more than 200,000 patients; the potential for CDK2i in late stage cancers, including ovarian cancer; opportunities to maximize the potential of Opzelura and Incyte’s expectations for Opzelura in atopic dermatitis, vitiligo and HS; the development of Incyte’s dermatology portfolio beyond Opzelura, including povorcitinib in multiple indications; and expectations regarding clinical trials and results and the timing for same.

These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; the effects of the COVID-19 pandemic and measures to address the pandemic on our clinical trials, supply chain and other third-party providers, sales and marketing efforts, and business, development, and discovery operations, as well as on regulatory agencies such as the FDA; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; our dependence on relationships with and changes in the plans and expenditures of our collaboration partners; the efficacy or safety of our products and the products of our collaboration partners; the acceptance of our products and the products of our collaboration partners in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products and the products of our collaboration partners; sales, marketing, manufacturing, and distribution requirements, including our and our collaboration partners’ ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our quarterly report on Form 10-Q for the quarter ended September 30, 2023. We disclaim any intent or obligation to update these forward-looking statements.

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Source: Incyte