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

2024-04-01

研发

上市批准专利侵权

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.

About Sol-Gel Technologies

Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and Epsolay, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. Both drugs are exclusively licensed to and commercialized by Galderma in the US, and Searchlight in Canada.

The Company’s pipeline also includes Phase 3 clinical trial of Orphan and breakthrough drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyperkeratinization disorders.

The content above comes from the network. if any infringement, please contact us to modify.

机构

Padagis Israel Pharmaceuticals Ltd.