Business
Sol-Gel Technologies and Galderma Announce Exclusive Licenses for the Commercialization of EPSOLAY® and TWYNEO® in the United States
- 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
About this update from Sol-gel Technologies Ltd.
[{"type":"text","content":"\n- Upfront and approval payments of up to $15 million\n- Tiered royalties ranging from mid- to high-teen percentage of net sales\n- Sol-Gel option to regain commercialization rights 5 years following first commercialization\n\n NESS ZIONA, Israel & LAUSANNE, Switzerland--(BUSINESS WIRE)--\nSol-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.\n\nUnder 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:\n\n\nEPSOLAY (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.\n\n\nTWYNEO (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.\n\n\nSol-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.\n\n“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 appr...