Sol-Gel Technologies Collaboration Partner Filed First-to-File Paragraph IV Certification for Duobrii

• Patent challenge initiated by Bausch Health Companies
  

NESS ZIONA, Israel, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that Bausch Health Companies, Inc. (NYSE:BHC) initiated patent infringement action in the U.S. District Court for the District of New Jersey on August 31, 2020 with regards to Perrigo Company plc (“Perrigo”) (NYSE; TASE: PRGO) Abbreviated New Drug Application (“ANDA”) for a generic version of Duobrii (halobetasol propionate and tazarotene) lotion, for the treatment of plaque psoriasis in adults¹.

On July 23, 2020, Sol-Gel’s partner Perrigo filed a Notice of first-to-file Paragraph IV Certification asserting that certain U.S. patents, each of which is listed in the FDA's Orange Book for Duobrii (halobetasol propionate and tazarotene) lotion, are either invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of Perrigo’s generic lotion.

Development of halobetasol propionate and tazarotene lotion is covered under a previous collaboration between Sol-Gel and Perrigo. Consistent with Sol-Gel’s prior agreements with Perrigo, Perrigo will seek regulatory approval with the U.S. Food and Drug Administration (“FDA”) for the generic product candidate. If approved by the FDA, Perrigo will lead the commercialization efforts for the generic product candidate in the United States. Sol-Gel and Perrigo will share the development costs and any gross profits generated from potential sales of the generic product candidate.

Annual market sales of Duobrii for the last 12 months ended July 2020 amounted to $88.4 million².

About Sol-Gel Technologies

Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for the development of Twyneo, under investigation for the treatment of acne vulgaris, and Epsolay, under investigation for the treatment of papulopustular rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment of palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.