Arcutis Expands Patent Portfolio with Roflumilast Pharmacokinetics Patent

WESTLAKE VILLAGE, Calif., Sept. 28, 2021 (GLOBE NEWSWIRE) --  (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 Arcutis

Arcutis 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  or follow Arcutis on and .

Forward-Looking Statements

This 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:

Media

Amanda Sheldon, Head of Corporate Communications

805-418-5006

Investors

Eric McIntyre, Head of Investor Relations

805-418-5006