- FDA informs Sol-Gel that it intends to conduct a pre-approval inspection of the EPSOLAY production site during the week of February 14e, 2022
NESS ZIONA, Israel, December 21, 2021 (GLOBE NEWSWIRE) – Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drugs for the treatment of skin diseases, today announced that the Food and Drug Administration (FDA) has informed the Company of its intention to carry out a pre-approval inspection of the production site of the Company’s drug product, EPSOLAYÂ®, a proprietary topical formulation of Benzoyl Peroxide, 5%, during the week of February 14e, 2022. EPSOLAY is under FDA review for the treatment of inflammatory lesions of rosacea in adults.
“We are delighted that the FDA has informed us of the schedule for its pre-approval inspection of the EPSOLAY production site, which, since April 26, 2021, has been delayed due to travel restrictions linked to COVID-19” , said Alon Seri. Levy, Ph.D., CEO of Sol-Gel. “We believe that EPSOLAY has the potential to change the therapeutic landscape for adult patients with inflammatory lesions of rosacea, a skin disease that affects millions of people in the United States and we hope this development will bring us closer to the planned approval and launch of EPSOLAY in the United States by our partner Galderma.
EPSOLAY is a topical cream containing 5% benzoyl peroxide, under review by the FDA for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY uses proprietary technology to encapsulate benzoyl peroxide in silica-based microcapsules to create a barrier between the drug and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. EPSOLAY is protected by patents granted until 2040.
About the inflammatory lesions of rosacea
The inflammatory lesions of rosacea are a chronic, recurring skin disorder that affects millions of Americans. The condition is especially common in fair-skinned people of Celtic and Northern European descent. Onset usually occurs after the age of 30 and usually begins with a rash and subtle redness on the cheeks, nose, chin, or forehead. If left untreated, rosacea can slowly get worse over time. As the disease progresses, the redness becomes more persistent, blood vessels become visible, and inflammatory lesions often appear. Other symptoms can include burning, stinging, dry skin, plaques, and thickening of the skin.
About Sol-Gel Technologies
Sol-Gel is a dermatology company focused on the identification, development and commercialization of branded and generic topical drugs for the treatment of skin diseases. Sol-Gel has leveraged its proprietary microencapsulation technology platform for TWYNEO, which is approved for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, under investigation for the treatment of inflammatory lesions in rosacea with an NDA filed with the FDA and a PDUFA deadline of April 26, 2021. Both drugs are under exclusive license for marketing in the United States. for Galderma.
The Company’s pipeline also includes early-stage topical drug candidates SGT-210 (topical erlotinib) under investigation for the treatment of palmoplantar keratoderma, SGT-310 (tapinarof cream) and SGT-510 (topical roflumilast). under study for the treatment of plaque psoriasis and other dermatological indications.
For more information, please visit www.sol-gel.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that do not relate to historical facts should be considered as forward-looking statements, including , but not limited to, statements regarding the production site pre-approval inspection schedule for EPSOLAY and FDA approval for EPSOLAY. These forward-looking statements include information about possible or expected future results of our business, our financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by words such as “believe”, “may”, “estimate”, “continue”, “anticipate”, “intend”, “should”, “plan” , “expect,” “predict”, “potential” or the negative of such terms or other similar expressions. Forward-looking statements are based on information available to us at the time these statements are made or on current expectations of our management and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed or suggested by forward-looking statements. Important factors that could cause such differences include, but are not limited to limit, the risk of a further delay in the schedule of the production site pre-approval inspection for EPSOLAY, whether due to COVID-19 travel restrictions or otherwise, a delay in the r receipt of the approval, if any, of the NDA for EPSOLAY, the risk of a delay in the commercial availability of ESPSOLAY, the risk that EPSOLAY will not provide treatment for the expected number of patients, the risks associated with effects of COVID-19 (coronavirus) as well as the following factors: (i) the adequacy of our financial and other resources, in particular in light of our history of recurring losses and the uncertainty as to the adequacy of our liquidity to pursue our comprehensive business goals; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in obtaining such regulatory approvals and the possibility of adverse regulatory or legal action relating to our product candidates even if the regulatory approval is obtained; (v) our ability to market our drug product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face claims from third parties for intellectual property infringement; (xi) the timing and results of any clinical trials that we may conduct or that our competitors and others may conduct with respect to our products or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than us; (xiii) potential product liability claims; (xiv) potentially adverse federal, state and local regulations in the United States, Europe or Israel; and (xv) the loss or retirement of key executives and researchers. These and other important factors discussed in the Company’s annual report on Form 20-F filed with the Securities and Exchange Commission (âSECâ) on March 4, 2021 and our other reports filed with the SEC could make so that actual results differ materially from those indicated by the forward-looking statements contained in this press release. These forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we do not undertake to publicly update any forward-looking statements after the date of this press release to comply with such statements.
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