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Find Clinical Drug Pipeline Developments & Deals by Sol-Gel Technologies
Beimei purchases and licenses rights to exclusively commercialize Twyneo (tretinoin). It is an approved product indicated for acne vulgaris in adults and pediatric patients 9 years of age and older.
Zoryve-Generic (roflumilast), PDE4 Inhibitor, small molecule. It is a topical cream indicated for the treatment of plaque psoriasis in patients six years of age and older.
SGT-610 (patidegib) is a topical gel formulated, small molecule, Hedgehog signaling pathway Inhibitor drug, which is being investigated for the treatment of Gorlin syndrome.
Under the agreement, Searchlight Pharma will be responsible for obtaining and maintaining any regulatory approvals required to market and sell Twyneo (tretinoin), used for acne vulgaris and Epsolay (benzoyl peroxide), used for inflammatory lesions of rosacea, in Canada.
The Company intends to use the net proceeds from the Offerings to fund the acquisition of SGT-610, the topically-applied patidegib, a new chemical entity hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome.
SGT-610 (patidegib), an Orphan Drug candidate, broadens Sol-Gel’s pipeline with the potential to be the first therapy for preventing new basal cell carcinomas in Gorlin syndrome, if approved by the FDA.
Approval of EPSOLAY (benzoyl peroxide) is supported by data from Phase 3 trial, which demonstrated reduction in inflammatory lesions of rosacea by nearly 70% by end of both 12-week trials vs. 38-46% with vehicle.
TWYNEO is a topical cream containing a fixed‑dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older.
Under the new Agreement, Sol-Gel has retained collaboration rights to two generic programs acyclovir cream and ivermectin cream related to four generic drug candidates that it believes to have the most value-generating potential.
The NDA filing is based on two positive, identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of Epsolay compared to vehicle in patients with papulopustular rosacea.