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SOL - GEL Sol - Gel Technologies and Galderma Announce Exclusive Licenses for the Commercialization of EPSOLAYⓇ and TWYNEO® in the United States June 28 , 2021 - Upfront and approval payments of up to $ 15 million - Tiered royalties ranging from mid- to high - teen percentage of net sales - Sol - Gel option to regain commercialization rights 5 years following first commercialization NESS ZIONA , Israel & LAUSANNE , Switzerland -- ( BUSINESS WIRE ) -- Jun . 28 , 2021-- Sol - Gel Technologies , Ltd. ( NASDAQ : SLGL ) , a clinical - stage dermatology company , and Galderma , the world's largest independent dermatology company , today announced they have signed two exclusive 5 - year license agreements for the commercialization of EPSOLAYⓇ and TWYNEOⓇ in the United States . Under these agreements , Galderma has an exclusive license to commercialize Sol - Gel's most advanced investigational drug products using Sol - Gel's proprietary micro - encapsulation technology , in each case provided the product is approved by the FDA : • EPSOLAY ( benzoyl peroxide , 5 % , cream ) is under investigation for the treatment of inflammatory lesions of rosacea in adults , with a Prescription Drug User Fee Act ( PDUFA ) goal date originally set for April 26 , 2021. Action on the NDA for EPSOLAY has not yet been taken due to the inability of the FDA to conduct a pre - approval inspection of the production site of EPSOLAY due to COVID - 19 travel restrictions . • TWYNEO ( benzoyl peroxide , 3 % , and tretinoin , 0.1 % , cream ) is under investigation for the treatment of acne vulgaris with a PDUFA goal date set for August 1 , 2021 . Sol - Gel is entitled to up to $ 15 million in upfront payments and regulatory approval milestone payments assuming 2021 approval of both products . Sol - Gel is also eligible to receive tiered double - digit royalties ranging from mid - teen to high - teen percentage of net sales as well as up to $ 9 million in sales milestone payments . " Galderma already owns the current market leading brands for rosacea and acne , and I am therefore delighted that Galderma views EPSOLAY and TWYNEO as innovative and with the potential to become key market brands , " stated Dr. Alon Seri - Levy , Chief Executive Officer of Sol - Gel . " Our partnerships with Galderma represent an important development for rosacea and acne patients while also strengthening our balance sheet by providing non - dilutive capital without compromising our desire to establish Sol - Gel as a leading dermatology company . We intend to remain focused on developing our promising pipeline and we are appreciative of the flexibility that these agreements provide through Sol - Gel retaining commercial rights after the initial five - year term , " commented Dr. Seri - Levy . " Innovation is at the heart of our commitment to advancing dermatology , " said Baldo Scassellati Sforzolini , Global Head of Research & Development at Galderma . " The potential to deliver two innovative products featuring Sol - Gel's proprietary micro - encapsulation technology represents an important milestone for acne and rosacea patients and underscores Galderma's position as the partner of choice in dermatology . " About EPSOLAY EPSOLAY is an investigational topical cream containing encapsulated benzoyl peroxide , 5 % , for the treatment of inflammatory lesions of rosacea , also known as papulopustular rosacea , in adults . EPSOLAY utilizes a patented technology process to encapsulate benzoyl peroxide within silica - based microcapsules to create a barrier between the medication and the skin . The silica - based shell is designed to release benzoyl peroxide slowly over time to provide a favorable efficacy and safety profile . If approved , EPSOLAY has the potential to be the first FDA - approved single - active benzoyl peroxide prescription drug product . EPSOLAY is not approved by the FDA and the safety and efficacy have not been established . About Papulopustular Rosacea Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans . Rosacea condition is common , especially in fair - skinned people of Celtic and northern European heritage . Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks , nose , chin , or forehead . If left untreated , rosacea can slowly worsen over time . As the condition progresses the redness becomes more persistent , blood vessels become visible and inflammatory lesions ( papules and pustules ) often appear . Other symptoms may include burning , stinging , dry skin , plaques and skin thickening . About TWYNEO TWYNEO is an investigational , fixed - dose combination of encapsulated benzoyl peroxide , 3 % , and encapsulated tretinoin , 0.1 % , cream for the treatment of acne vulgaris . If approved , TWYNEO will be the first acne treatment that contains a fixed - dose combination of benzoyl peroxide and tretinoin , which are separately encapsulated in silica using Sol - Gel's proprietary micro - encapsulation technology . Tretinoin and benzoyl peroxide are widely prescribed separately as a combination treatment for acne ; however , benzoyl peroxide causes degradation of the tretinoin molecule , thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation . The silica - based microcapsule is designed to protect tretinoin from oxidative decomposition by benzoyl peroxide , thereby enhancing the stability of the active drug ingredients . The silica - based shell is also designed to release the ingredients slowly over time to provide a favorable efficacy and safety profile . TWYNEO is not approved by the FDA and the safety and efficacy have not been established . About Acne Vulgaris Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects approximately 40 to 50 million people in the United States . The disease occurs most frequently during childhood and adolescence ( affecting 80 % to 85 % of all adolescents ) but it may also appear in adults . Acne 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 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 .