Incyte Highlights Growth Opportunities and Provides Business Updates at the 42nd Annual J.P. Morgan Healthcare Conference
09 January 2024 - 12:30AM
Business Wire
- 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
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 42nd 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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