ISRAEL – The Food and Drug Administration (FDA) has approved Sol-Gel Technologies’ (a dermatology company) drug Twyneo indicated for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older.
Sol-Gel has partnered with Galderma to commercialize Twyneo in the U.S and expects to receive a regulatory milestone payment in conjunction with this approval and retains the option to regain U.S. commercialization rights five years following first commercialization in the U.S.
The New Drug Application (NDA) was supported by positive results from two Phase 3, randomized, double-blind, vehicle-controlled, multi-center studies, in which Twyneo demonstrated efficacy and a favorable tolerability profile in subjects nine years of age and older with facial acne vulgaris.
Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects up to 50 million people in the U.S.
The disease occurs most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults.
Acne vulgaris patients suffer from the appearance of lesions on areas of the body with a large concentration of oil glands, such as the face, chest, neck and back.
These lesions can be inflamed (papules, pustules, nodules) or non-inflamed (comedones). Acne vulgaris can have a profound effect on the quality of life of those suffering from the disease.
In addition to carrying a substantial risk of permanent facial scarring, the appearance of lesions may cause psychological strain, social withdrawal and lowered self-esteem.
Dermatology drug market size
According to Research and Markets, the global dermatology drugs market is expected to grow from US$37.57 billion in 2020 to US$40.49 billion in 2021 at a compound annual growth rate (CAGR) of 7.8%.
The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges.
Novartis has been dominant in this market with various skin related therapy in its portfolio as they expect a few others within the pipeline to be added in.
Sol-Gel is focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases.
The Company’s pipeline also includes early-stage topical drug candidates SGT-210 under investigation for the treatment of palmoplantar keratoderma, SGT-310 and SGT-510 under investigation for the treatment of plaque psoriasis and other dermatologic indications.
