Sol-Gel Announces Health Canada Approval of EPSOLAY®
Sol-Gel Technologies (NASDAQ: SLGL) has received Health Canada approval for EPSOLAY®, a treatment for inflammatory lesions of rosacea in adults. The approval, granted on August 27, 2025, comes through Sol-Gel's partnership with Searchlight Pharma, their exclusive Canadian licensee.
Under the 2023 licensing agreement, Sol-Gel is eligible to receive up to $11 million in combined milestone payments for TWYNEO and EPSOLAY, plus tiered royalties on net sales. The company expects ex-U.S. territory launches to begin in 2027-2028, with potential EBITDA contribution reaching approximately $10 million annually by 2031.
Sol-Gel is currently conducting a Phase-3 trial of SGT-610 for Gorlin syndrome and a Phase-1b trial of SGT-210 for Darier disease, as the company shifts focus toward dermatological rare diseases.
Sol-Gel Technologies (NASDAQ: SLGL) ha ottenuto l'approvazione da Health Canada per EPSOLAY®, un trattamento per le lesioni infiammatorie della rosacea negli adulti. L'autorizzazione, rilasciata il 27 agosto 2025, è stata concessa tramite la partnership con Searchlight Pharma, licenziataria esclusiva per il Canada.
In base all'accordo di licenza del 2023, Sol-Gel potrà ricevere fino a 11 milioni di dollari in pagamenti milestone combinati per TWYNEO ed EPSOLAY, oltre a royalties graduate sulle vendite nette. L'azienda prevede il lancio fuori dagli Stati Uniti nel periodo 2027-2028, con un potenziale contributo all'EBITDA di circa 10 milioni di dollari annui entro il 2031.
Sol-Gel sta inoltre conducendo uno studio di fase 3 su SGT-610 per la sindrome di Gorlin e uno studio di fase 1b su SGT-210 per la malattia di Darier, mentre l'azienda orienta la propria attenzione verso le dermatologie delle malattie rare.
Sol-Gel Technologies (NASDAQ: SLGL) ha obtenido la aprobación de Health Canada para EPSOLAY®, un tratamiento para las lesiones inflamatorias de la rosácea en adultos. La autorización, concedida el 27 de agosto de 2025, se dio a través de la asociación con Searchlight Pharma, su licenciataria exclusiva en Canadá.
Según el acuerdo de licencia de 2023, Sol-Gel puede recibir hasta 11 millones de dólares en pagos por hitos combinados por TWYNEO y EPSOLAY, además de regalías escalonadas sobre las ventas netas. La compañía espera lanzamientos fuera de EE. UU. entre 2027 y 2028, con una posible contribución al EBITDA de aproximadamente 10 millones de dólares anuales para 2031.
Sol-Gel está llevando a cabo un ensayo de fase 3 de SGT-610 para el síndrome de Gorlin y un ensayo de fase 1b de SGT-210 para la enfermedad de Darier, mientras la compañía se enfoca en enfermedades raras dermatológicas.
Sol-Gel Technologies (NASDAQ: SLGL)가 성인 대상의 염증성 주사(rosacea) 병변 치료제인 EPSOLAY®에 대해 캐나다 보건당국(Health Canada)의 승인을 받았습니다. 이 승인은 2025년 8월 27일에 이루어졌으며, 캐나다 독점 라이선스 파트너인 Searchlight Pharma와의 제휴를 통해 획득한 것입니다.
2023년 체결된 라이선스 계약에 따라 Sol-Gel은 TWYNEO와 EPSOLAY에 대해 최대 미화 1,100만 달러의 마일스톤 지급을 받을 수 있으며, 순매출에 대한 단계별 로열티도 받게 됩니다. 회사는 미국 외 지역 출시를 2027~2028년으로 예상하고 있으며, 2031년까지 연간 약 1,000만 달러의 EBITDA 기여가 가능할 것으로 전망하고 있습니다.
현재 Sol-Gel은 고를린 증후군(Gorlin syndrome) 치료를 위한 SGT-610의 3상 임상과 다리에르병(Darier disease) 치료를 위한 SGT-210의 1b상 임상을 진행 중이며, 희귀 피부질환 분야로 포커스를 전환하고 있습니다.
Sol-Gel Technologies (NASDAQ: SLGL) a obtenu l'autorisation de Santé Canada pour EPSOLAY®, un traitement des lésions inflammatoires de la rosacée chez l'adulte. Cette approbation, délivrée le 27 août 2025, a été obtenue via le partenariat avec Searchlight Pharma, son licencié exclusif au Canada.
Dans le cadre de l'accord de licence de 2023, Sol-Gel peut recevoir jusqu'à 11 millions de dollars de paiements d'étapes combinés pour TWYNEO et EPSOLAY, ainsi que des royalties par paliers sur les ventes nettes. La société prévoit des lancements hors des États‑Unis entre 2027 et 2028, avec une contribution potentielle à l'EBITDA d'environ 10 millions de dollars par an d'ici 2031.
Sol-Gel mène actuellement un essai de phase 3 de SGT-610 pour le syndrome de Gorlin et un essai de phase 1b de SGT-210 pour la maladie de Darier, alors que la société oriente son attention vers les maladies dermatologiques rares.
Sol-Gel Technologies (NASDAQ: SLGL) hat die Zulassung von Health Canada für EPSOLAY® erhalten, eine Behandlung für entzündliche Rosazea-Läsionen bei Erwachsenen. Die Genehmigung wurde am 27. August 2025 erteilt und erfolgte über die Partnerschaft mit Searchlight Pharma, dem exklusiven kanadischen Lizenznehmer.
Gemäß der Lizenzvereinbarung von 2023 kann Sol-Gel bis zu 11 Millionen US-Dollar an kombinierten Meilensteinzahlungen für TWYNEO und EPSOLAY erhalten sowie gestaffelte Tantiemen auf den Nettoumsatz. Das Unternehmen rechnet mit Markteinführungen außerhalb der USA für 2027–2028 und einem möglichen EBITDA-Beitrag von rund 10 Millionen US-Dollar jährlich bis 2031.
Sol-Gel führt derzeit eine Phase-3-Studie mit SGT-610 für das Gorlin-Syndrom sowie eine Phase-1b-Studie mit SGT-210 für die Darier-Krankheit durch, während sich das Unternehmen stärker auf seltene dermatologische Erkrankungen fokussiert.
- Health Canada approval expands market reach for EPSOLAY
- Potential for up to $11 million in milestone payments plus tiered royalties
- Expected ex-U.S. EBITDA contribution of $10 million annually by 2031
- Strategic partnerships already in place across multiple global territories
- Extended timeline for global market launches (2027-2028)
- Company plans to seek strategic alternatives for acne and rosacea business
- Dependency on partners for commercialization success
Insights
Health Canada's approval of EPSOLAY strengthens Sol-Gel's global commercialization strategy and diversifies revenue streams while supporting its strategic pivot toward rare dermatological diseases.
The Health Canada approval for EPSOLAY represents a significant regulatory milestone in Sol-Gel's commercialization strategy. This approval unlocks the Canadian market through the company's partnership with Searchlight Pharma established in 2023. The deal structure includes
This approval fits into Sol-Gel's broader global strategy, which now has commercialization partnerships across multiple international territories. According to management projections, these ex-U.S. partnerships could contribute approximately
What's particularly noteworthy is Sol-Gel's strategic evolution. The company is deliberately pivoting from acne and rosacea treatments toward rare dermatological diseases, as evidenced by their ongoing Phase-3 trial for SGT-610 for Gorlin syndrome and Phase-1b trial of SGT-210 for Darier disease. This approval and the associated non-dilutive revenue strengthen their financial position to execute this strategic shift.
Management's comment about potentially seeking "strategic alternatives" for the TWYNEO and EPSOLAY business suggests a possible future divestiture of these assets once their ex-U.S. commercial value is more firmly established. This would allow Sol-Gel to focus entirely on their rare disease pipeline while potentially generating significant capital from selling these approved products.
The recent U.S. transaction with Mayne Pharma (mentioned but not detailed in this release) further demonstrates Sol-Gel's active portfolio management approach, monetizing approved assets while reinvesting in specialized pipeline candidates with potentially higher margins and less competitive pressure than the broader acne/rosacea markets.
NESS ZIONA, Israel, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with severe skin conditions, conducting a Phase-3 clinical trial of SGT-610 (patidegib gel,
This approval comes as a result of Sol-Gel’s partnership with Searchlight Pharma, Sol-Gel’s exclusive licensee for commercializing EPSOLAY in the Canadian market. Under the exclusive license agreement signed in 2023, Searchlight was responsible for obtaining Canadian regulatory approval for EPSOLAY, and with this milestone achieved, Searchlight is preparing to launch EPSOLAY for rosacea patients in Canada. As part of the agreement, Sol-Gel is eligible to receive up to
Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: "We are delighted that Health Canada has approved EPSOLAY, enabling us to bring this innovative treatment to rosacea patients in Canada. The recently announced U.S. transaction with Mayne Pharma and agreements executed during the past year, underscore our ability to unlock value from our assets while strengthening our financial position. We look forward to supporting Searchlight Pharma in the Canadian launch of EPSOLAY and to advancing our pipeline of novel dermatological therapies."
Mr. Arkin further commented: "Health Canada's approval of EPSOLAY brings the company a step closer towards achieving its strategy to commercialize EPSOLAY and TWYNEO throughout the world, across ex-U.S. territories, including Europe, Asia, Africa, Latin America, and Australia, where most partnership agreements are already in place. Based on current plans, launches in many of these territories are expected to begin in 2027 and 2028, and partners forecasts indicate that ex-U.S. contribution to the EBITDA of the company are expected to gradually increase and potentially reach approximately
Lastly, Mr. Arkin added: "As acne and rosacea are no longer a core business for the company, we expect that at the right time when the commercial potential of our ex-U.S. TWYNEO and EPSOLAY will become more visible, we will look to seek strategic alternatives for this business."
About TWYNEO and EPSOLAY
TWYNEO is a topical cream containing a fixed-dose combination of tretinoin,
EPSOLAY is a topical cream containing benzoyl peroxide (BPO),
About Gorlin Syndrome and SGT-610
SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors.
About Sol-Gel Technologies
Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults.
The Company’s pipeline also includes Phase 3 clinical trial of Orphan and breakthrough drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyperkeratinization disorders.
For additional information, please visit our new website: www.sol-gel.com
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to the amounts expected to be received under our current and future licensing agreements and other collaborations, the timing of the launch of TWYNEO and EPSOLAY in various countries and future strategic alternatives for the company’s businesses. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk that the amounts received from our current and future licensing agreements and other collaborations will not be as anticipated, the risk of delay of the launch of TWYNEO and EPSOLAY in various countries, the risk of any change in the Company’s strategic view of the acne and rosacea business, our ability to enter into further collaborations a delay in the timing of our clinical trials, top-line results and regulatory filings, a delay in receipt of payments from Mayne Pharma and others, the success of our clinical trials, and an increase in our anticipated costs and expenses, as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (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 receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ 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 third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our 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 we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on April 29, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release.
Sol-Gel Contact:
Eyal Ben-Or
Chief Financial Officer
info@sol-gel.com
+972-8-9313429
Source: Sol-Gel Technologies Ltd.
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