Arcutis Expands Patent Portfolio with Roflumilast Pharmacokinetics Patent
September 28 2021 - 4:05PM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing meaningful
innovations in immuno-dermatology to address the urgent needs of
patients living with immune-mediated dermatological diseases and
conditions, today announced a new patent issued by the United
States Patent and Trademark Office covering its invention for
improving delivery and extending half-life of both the cream and
foam formulations of topical roflumilast.
Arcutis is developing topical cream and foam formulations of
roflumilast, a highly potent and selective phosphodiesterase type 4
inhibitor (PDE4), to treat psoriasis, atopic dermatitis, and
seborrheic dermatitis. Clinical trial data has shown that Arcutis’
topical roflumilast formulations are uniquely suited to address
unmet patient needs without difficult trade-offs between efficacy,
safety, and tolerability.
“We believe this new patent represents important additional
protection for our unique, proprietary topical roflumilast
treatment, and is separate and distinct from our formulation
patents. While we believe our issued and pending formulation
patents provide substantial protection for topical roflumilast,
having this additional patent covering the unique pharmacokinetic
characteristics of our treatment is meaningful additional
protection,” said Frank Watanabe, Arcutis’ President and Chief
Executive Officer. “This new patent also further validates Arcutis’
dermatological development platform that builds on our deep
dermatological expertise, which includes one of the foremost
topical formulators and five dermatology clinicians on staff. With
eight issued patents and additional pending patents, we expect
patent protection at least into 2037.”
About ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is a medical dermatology company that champions
meaningful innovation to address the urgent needs of patients
living with immune-mediated dermatological diseases and conditions.
With a commitment to solving the most persistent patient challenges
in dermatology, Arcutis harnesses our unique dermatology
development platform coupled with our dermatology expertise to
build differentiated therapies against biologically validated
targets. Arcutis’ dermatology development platform includes a
robust pipeline with seven clinical programs for a range of
inflammatory dermatological conditions, with our first NDA
submission late in the third quarter or early in the fourth quarter
of 2021, and three more Phase 3 clinical data readouts anticipated
by the end of 2022. The company’s lead product candidate, topical
roflumilast, has the potential to advance the standard of care for
plaque psoriasis, atopic dermatitis, scalp psoriasis, and
seborrheic dermatitis. For more information,
visit www.arcutis.com or follow Arcutis on LinkedIn and
Twitter.
Forward-Looking StatementsThis press release
contains "forward-looking" statements, including, among others,
statements regarding the potential for roflumilast to revolutionize
the standard of care in plaque psoriasis and other inflammatory
dermatological conditions. These statements involve substantial
known and unknown risks, uncertainties and other factors that may
cause our actual results, levels of activity, performance, or
achievements to be materially different from the information
expressed or implied by these forward-looking statements and you
should not place undue reliance on our forward-looking statements.
Risks and uncertainties that may cause our actual results to differ
include risks inherent in the clinical development process and
regulatory approval process, the timing of regulatory filings, and
our ability to defend our intellectual property. For a further
description of the risks and uncertainties applicable to our
business, see the "Risk Factors" section of our Form 10-K filed
with U.S. Securities and Exchange Commission (SEC) on February 16,
2021, as well as any subsequent filings with the SEC. We undertake
no obligation to revise or update information herein to reflect
events or circumstances in the future, even if new information
becomes available.
Contacts:MediaAmanda Sheldon,
Head of Corporate
Communications805-418-5006asheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor
Relations805-418-5006emcintyre@arcutis.com
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