Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve Cream

Patent challenge initiated by Arcutis Biotherapeutics

NESS ZIONA, Israel, April 01, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company pioneering treatments for patients with severe skin conditions, conducting a Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, and with two approved large-category dermatology products, TWYNEO and EPSOLAY, today announced that Padagis Israel Pharmaceuticals Ltd (“Padagis”), Sol-Gel’s collaboration partner, submitted a first-to-file Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) for Roflumilast Cream, 0.3%, a drug product generic to Zoryve Cream (roflumilast cream, 0.3%), indicated for the treatment of plaque psoriasis in patients six years of age and older. On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.

Annual market sales for Zoryve Cream, 0.3% were approximately $95 million in the 12 months ended in January 2024, as measured by IQVIA. Should its ANDA for Roflumilast Cream, 0.3% be approved by the FDA, Padagis believes that its product may be entitled to 180 days of generic market exclusivity. If approved, Sol-Gel and Padagis will share gross profit generated from potential sales of Roflumilast Cream, 0.3% (calculated after the deduction of certain development costs).

“According to recent leading analysts’ reports, Zoryve Cream is estimated to generate net revenue exceeding $500 million by the end of 2030. Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis. Though Sol-Gel exited the majority of the partnership in the generic divestment deal announced on November 4, 2021, the Roflumilast Cream, 0.3% project was maintained because of the potential value to both companies,” stated Mr. Mori Arkin, Executive Chairman of the Board of Sol-Gel.

Mr. Arkin continued, “Given the market potential of Padagis’s ANDA product, Sol-Gel is exploring all options to maximize the value of this opportunity.”

As reported by Arcutis, Q4/2023 net product revenues for Zoryve Cream were $13.5 million, a 357% increase compared to the fourth quarter of 2022 and a 67% increase compared to the third quarter of 2023, driven by sequential improvement in gross-to-net in the mid 60% range, as well as sustained demand growth.