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Sol-Gel Announces Health Canada Approval of EPSOLAY®
Globenewswire· 2025-09-04 11:00
Core Insights - Sol-Gel Technologies, Ltd. has received a Notice of Compliance from Health Canada for EPSOLAY, a treatment for inflammatory lesions of rosacea in adults, marking a significant regulatory milestone for the company [1][2][3] Group 1: Product Approvals and Partnerships - The approval of EPSOLAY is a result of Sol-Gel's partnership with Searchlight Pharma, which holds the exclusive license for commercializing EPSOLAY in Canada [2] - Sol-Gel is eligible to receive up to $11 million in potential payments related to TWYNEO and EPSOLAY in Canada, along with tiered royalties on net sales, enhancing the company's financial position [2][3] - The company aims to commercialize EPSOLAY and TWYNEO globally, with launches expected in various territories starting in 2027 and 2028 [3] Group 2: Financial Outlook - Ex-U.S. contributions to the company's EBITDA are projected to gradually increase, potentially reaching approximately $10 million annually by 2031, excluding milestone payments [3] - The non-dilutive revenue from partnerships is expected to support Sol-Gel's growth strategy and strengthen its balance sheet [2][3] Group 3: Product Details - EPSOLAY is a topical cream containing 5% benzoyl peroxide, designed to treat inflammatory lesions of rosacea using a patented technology for sustained release [5] - TWYNEO is a fixed-dose combination cream for acne vulgaris, containing 0.1% tretinoin and 3% benzoyl peroxide, utilizing micro-encapsulation technology to enhance efficacy [4] Group 4: Clinical Trials and Pipeline - Sol-Gel is conducting a Phase-3 clinical trial for SGT-610, a potential treatment for Gorlin syndrome, which could be the first to prevent basal cell carcinomas in affected patients [1][9] - The company is also investigating SGT-210 for the treatment of rare hyperkeratinization disorders, indicating a diverse pipeline in dermatological therapies [9]