Sol-Gel Technologies Ltd., a dermatology company, focuses on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases.
The company's FDA-approved product, Twyneo, is a novel, once-daily, non-antibiotic topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide, or BPO, and encapsulated tretinoin, developed for the treatment of acne vulgaris, or acne. The company's FDA-approved product, Epsolay, is a novel, o...
Sol-Gel Technologies Ltd., a dermatology company, focuses on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases.
The company's FDA-approved product, Twyneo, is a novel, once-daily, non-antibiotic topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide, or BPO, and encapsulated tretinoin, developed for the treatment of acne vulgaris, or acne. The company's FDA-approved product, Epsolay, is a novel, once-daily topical cream containing encapsulated BPO that it has developed for the treatment of inflammatory lesions of rosacea.
In June 2021, the company entered into two five-year exclusive license agreements with Galderma pursuant to which Galderma has the exclusive right to, and is responsible for, all the U.S. commercial activities for Twyneo, and, Epsolay.
In addition to Twyneo and Epsolay, the company's product candidate pipeline includes topical drug candidate SGT-210 under investigation for the treatment of pachyonychia congenita and other rare skin indications, and the newly acquired SGT-610, topically-applied patidegib, a new chemical entity hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome.
In addition to its product candidates, the company is developing a portfolio of two generic programs related to four generic drug candidates in collaboration with Padagis by assignment from Perrigo UK Finco Limited Partnership, or Perrigo.
Twyneo, is a once-daily, non-antibiotic topical cream, containing a fixed-dose combination of encapsulated benzoyl peroxide, or E-BPO, and encapsulated tretinoin for the treatment of acne. Tretinoin and benzoyl peroxide, the two active components in Twyneo, are both widely-used therapies for the treatment of acne that historically have not been conveniently co-administered due to stability concerns. On December 30, 2019, the company announced top-line results from two pivotal Phase 3 clinical trials evaluating Twyneo for the treatment of acne. Twyneo met all co-primary endpoints in both Phase 3 trials. The Phase 3 program enrolled an aggregate of 858 patients aged nine and older in two multicenter, randomized, double-blind, parallel group, vehicle-controlled trials at 63 sites across the United States. Twyneo was approved for marketing by the U.S. Food and Durg Administration (FDA) in July 2021 in the United States and was licensed to Galderma exclusively in the United States in June 2021.
Epsolay, is a once-daily topical cream containing 5% encapsulated benzoyl peroxide, that the company has developed for the treatment of inflammatory lesions of rosacea in adults. For example, BPO, a common therapy for acne, is not used for the treatment of subtype II rosacea due to side effects. As encapsulated BPO, Epsolay is designed to redefine the standard of care for the treatment of subtype II rosacea. Epsolay, which was approved for marketing by the FDA in April 2022, is the first product containing BPO that is marketed for the treatment of subtype II rosacea. On July 8, 2019, the company announced positive top-line results from its Phase 3 program evaluating Epsolay. The program enrolled 733 patients aged 18 and older in two identical, double-blind, vehicle-controlled Phase 3 clinical trials at 54 sites across the United States. On February 12, 2020, the company announced positive topline results from its open-label, long-term safety study, evaluating Epsolay for a treatment duration up to 52 weeks. Epsolay was approved for marketing by the FDA in April 2022 and was licensed to Galderma exclusively in the United States in June 2021.
The company maintains exclusive, worldwide commercial rights, including the United States for its investigational product candidates, which consist of:
SGT-610 that the company is developing for a treatment of Gorlin Syndrome, a rare disease with no therapies approved by the U.S. Food and Drug Administration (FDA) or the European Commission (EC). SGT-610 is aimed to prevent new basal cell carcinomas (BCCs) in adults with Gorlin syndrome without systemic adverse events and is expected to be the first drug approved for the treatment of Gorlin syndrome patients. SGT-610 has been granted Orphan Drug Designation by the FDA and the EC, as well as Breakthrough Designation by the FDA. Both FDA and the European Medicines Agency (EMA) have agreed that a single pivotal Phase 3 study is required for the approval of this investigatioal drug, to be followed by a long-term safety study. SGT-610 phase 3 clinical study will include essential modifications to a former Phase 3 study conducted by patidegib's seller, PellePharm Inc. (PellePharm). In PellePharm's study the SGT-610 arm was found to be as tolerable as the vehicle and the significant adverse events of oral hedgehog inhibitors were not observed. The company's Phase 3 study is planned to be powered at 90%, with about 100 participating subjects. The company expects to begin its Phase 3 study in the second of half of 2023, and expects results by the end of 2025.
SGT-210 (erlotinib) is a topical drug candidate for the treatment of pachyonychia congenita and other hyperkeratosis indications. Erlotinib is a tyrosine kinase receptor inhibitor which acts on the epidermal growth factor receptor, a protein expressed on the surface of cells, whose job is to help cells grow and divide. Sol-Gel's scientists have managed to overcome erlotinib formulation limitations and developed a topical product with a significantly higher concentration of erlotinib than that which was reported to be inefficient. SGT-210 is expected to treat pachyonychia congenita without the adverse events caused by oral erlotinib. The company's Phase-1 study was initiated in December 2022.
The company is also developing a portfolio of two generic programs related to four generic drug candidates in collaboration with Padagis, by assignment from Perrigo.
On January 30, 2023, the company purchased the topically-applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome pursuant to an asset purchase agreement with PellePharm, dated January 23, 2023. The company broadened its pipeline with this new chemical entity, designated as investigational compound SGT-610, which, if approved by the FDA, has the potential to be the first-ever treatment for Gorlin syndrome. SGT-610 has been granted Orphan Drug Designation by the FDA and the EC, as well as Breakthrough Designation by the FDA. Each of the FDA and EMA has agreed that approval may be supported by a single pivotal Phase 3 study. The company plans to conduct a Phase 3 trial, with the objective of providing Gorlin syndrome patients with the first drug that could prevent new basal cell carcinomas, or BCCs.
In June 2021, the company entered into two exclusive license agreements with Galderma, pursuant to which Galderma has the exclusive right to, and is responsible for, all U.S. commercial activities for Twyneo and Epsolay, including promotion and distribution, and the company was responsible for obtaining all regulatory approvals of the products in the United States, which it completed in July 2021 and April 2022, respectively. Each of the license agreements has a term of five years from the date of Galderma's first commercial sale of the applicable product in the United States. The license agreements provide that Galderma is responsible for all filings and communications with regulatory authorities in the U.S. until expiration of the applicable license agreement. In connection with the licenses, the company and Galderma have entered into a three-party supply agreement with Douglas Manufacturing Limited, which will supply Galderma Holding SA (Galderma) the Twyneo product, and Galderma entered into a supply agreement with a third party for the supply of the Epsolay product.
Approved Product and Investigational Product Candidates
Twyneo for Acne
Using its proprietary, silica-based microencapsulation technology platform, the company developed Twyneo to become a preferred treatment for acne by dermatologists and their patients.
Twyneo is a novel, once-daily, non-antibiotic topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin that the company developed for the treatment of acne. On December 30, 2019, the company announced top-line results from two pivotal Phase 3 clinical trials evaluating Twyneo for the treatment of acne. Twyneo met all co-primary endpoints in both Phase 3 trials. The Phase 3 program enrolled an aggregate of 858 patients aged nine and older in two multicenter, randomized, double-blind, parallel group, vehicle-controlled trials at 63 sites across the United States. Twyneo was approved for marketing by the FDA in July 2021.
Epsolay for Subtype II Rosacea
Epsolay is a once-daily investigational topical cream containing 5% encapsulated benzoyl peroxide that the company has developed for the treatment of papulopustular (subtype II) rosacea. Epsolay is the first product to contain encapsulated benzoyl peroxide for the treatment of subtype II rosacea and has the potential to redefine the standard of care for the treatment of inflammatory lesions associated with subtype II rosacea.
The company expects that Epsolay will compete directly with Soolantra. The company utilized the FDA's 505(b)(2) regulatory pathway in seeking approval of Epsolay in the United States. On July 8, 2019, the company announced positive top-line results from its Phase 3 program evaluating Epsolay. Epsolay was approved by the FDA in April 2022.
SGT-610 for Gorlin Syndrome
SGT-610 is a topical product intended to prevent new BCC formation in adults with Gorlin syndrome without the risk of accompanying systemic adverse events observed with oral BCC therapies.
SGT-210 for Keratodermas
The company is developing SGT-210 for the treatment of keratoderma, such as PC and PPK, a group of skin conditions characterized by thickening of the skin. SGT-210 is designed to be used alone or in combination for the treatment of hyperproliferation and hyperkeratinization disorders, including PPK. On January 2, 2020, the company announced the initiation of a Phase 1 clinical study of SGT-210 in patients with palmoplantar keratoderma. The Phase 1 concept study SGT-84-01 is a single-center, single-blinded, vehicle-controlled study designed to evaluate the bioavailability, safety and tolerability of SGT-210, as well as inform on potential efficacy. During the third quarter of 2021, the company reported that the study with respect to six (6) palmoplantar keratoderma (PPK) patients has been completed and indicated modest improvement and a favorable safety profile. Two concentrations of topical erlotinib Phase-1 study on healthy volunteers was initiated in December 2022.
SGT-210, for Pachyonychia Congenita and Other Rare Skin Indications
The company is conducting pre-clinical testing to explore the possible activity of SGT-210 in various new pharmaceutical indications.
Generic Drug Product Candidates
In addition to its investigational product candidates, the company is developing a portfolio of two generic topical dermatological programs related to four generic drug candidates in collaboration with Padagis Israel Pharmaceuticals Ltd (Padagis) by assignment from Perrigo. Padagis has significant experience in the development of generic drugs.
In November 2021, the company announced that it had signed an agreement with Padagis, pursuant to which it sold its rights related to 10 generic collaborative agreements between the parties.
The company has two collaboration agreements with Padagis for the development, manufacturing and commercialization of two generic product candidates. Under such agreements, Padagis will conduct the regulatory (if relevant), scientific, clinical and technical activities necessary to develop the generic product candidates and seek regulatory approval with the FDA for the generic product candidates. If approved by the FDA, Padagis has agreed to commercialize the generic product candidates in the United States.
Intellectual Property
The company's intellectual property and proprietary technology are directed to the development, manufacture and sale of Twyneo, Epsolay and its investigational product candidates.
The company's patent portfolio that is directed to Twyneo, Epsolay and its investigational product candidates includes 199 patents and patent applications and claims processes for manufacture (including silica microencapsulation platform and other technologies), formulations, composition of matter, and methods of use. Of these 199 patents and patent applications, 104 are granted patents (21 in the United States and 83 in other countries) and 95 are pending applications (42 in the United States and 53 in other countries).
For Twyneo, the company has obtained patent protection for the composition of matter in the United States, Canada, Japan, Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom) and Mexico (with a term until 2028). There are four patent families protecting the process for the encapsulation of the active agents of the company's Twyneo product (one patent family has patents granted in Canada, India, Mexico, Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom) and Japan (with a term until 2028) and applications pending in the United States; the second patent family has patents granted in Mexico, Canada and the United States (with a term until 2029) and an application pending in the United States; the third patent family has patents granted in Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom), China, India, Japan, Canada, Mexico and the United States (with a term until 2030) and an application pending in the United States); and the fourth patent family has patents granted in Canada, China, Israel, India, Mexico and the United States). The company owns a pending patent for the formulation of its Twyneo product in the United States (with a term until 2032), and patents granted in China, Japan, Canada, Mexico and Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland, the United Kingdom) (with a term until 2032). The company has pending patent applications in the United States for the composition of its Twyneo product and patents granted in the United States and Canada for the method of treatment of Twyneo (with a term until 2038). The company has five trademarks registered for its Twyneo product in Israel, Europe, the United States and Canada.
For Epsolay, the company has obtained patents in China, Canada, Japan, Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom), Mexico and the United States (with a term until 2032) covering the composition for topical treatment of rosacea. The company has further pending applications for this composition in the United States. There are two patent families directed to the process for encapsulation of the active agents of Epsolay (one patent family has granted patents in Canada, India, Mexico, Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom) and Japan (with a term until 2028) and pending applications in the United States; and the second patent family has patents granted in Canada, China, Israel, India, Mexico and the United States). The company also has 4 granted patents and one allowed application in the United States (with a term until 2040) and 11 patent applications pending covering the methods of use of Epsolay for the treatment of rosacea (four in Canada and seven in the United States).The company has one not yet published international application and one U.S. application with a term until 2042.
The company has pending applications in Australia, Brazil, Chile, Colombia, Korea, Malaysia, New Zealand, the Philippines, Thailand, Vietnam and South Africa, and three pending applications in the United States covering the compositions of Epsolay and Twyneo, the processes for the encapsulation of the active agents of its Epsolay and Twyneo, and the methods of use.
The company has four registered trademarks in Europe, Canada, the United States and Israel. These registrations cover potential brand names for its Epsolay in Israel, Europe, Canada and the United States.
For SGT-210, the company has 21 pending applications in China, Canada, Japan, Korea, Europe, Mexico and the United States, and one allowed application in the United States that refer to methods and compositions of use in the treatment of psoriasis.
For SGT-610, the company has one pending application in the United States that refers to a method of treatment with SGT-610, and the company purchased from PellePharm Inc. (PellePharm) 3 granted patents in the U.S. (with a term until 2036), 2 granted patents in South Africa, and granted patents in Israel, Japan, Mexico and Australia and pending applications in Brazil, Canada, Chile, Europe and New Zealand. The company also licensed from Royalty Security LLC. (as part of the asset purchase from PellePharm) 26 granted patents in the U.S. (with terms 2025-2031), 4 granted patents in Canada (with terms 2025-2030), 78 granted patents in Europe (EPO members, such as Norway, France, Germany, Ireland, Switzerland, the United Kingdom, Spain, Italy, etc.) 50 Granted patents in the rest of the world (such as Argentina, Australia, Brazil, Chile, China, Israel, India, Jordan, Japan, Korea, Lebanon, Mexico, New Zealand, Pakistan, Russia, Singapore, Thailand, Taiwan, Ukraine, South Africa, and pending applications in Europe (Norway), Brazil, Pakistan and the United Arab Emirates.
Marketing, Sales and Distribution
The company has limited sales, marketing and distribution capabilities. In June 2021, the company entered into two five-year exclusive license agreements with Galderma pursuant to which Galderma has the exclusive right to, and is responsible for, all the U.S. commercial activities for Twyneo and Epsolay. The company also expects to collaborate with third parties that have sales and marketing experience in order to commercialize Twyneo and Epsolay outside of the United States, and its other investigational product candidates, if approved by the FDA for commercial sale, in lieu of the company's own sales force and distribution systems. In other markets, the company also expects to selectively pursue strategic collaborations with third parties in order to maximize the commercial potential of its product candidates.
Environmental, Health and Safety Matters
The company's activities require permits from various governmental authorities, including local municipal authorities, the Ministry of Environmental Protection and the Ministry of Health. The Ministry of Environmental Protection and the Ministry of Health, local authorities and the municipal water and sewage company conduct periodic inspections in order to review and ensure the company's compliance with the various regulations. The company's business permit is in effect until December 31, 2026.
Research and Development
The company's research and development expenses were $12.7 million for the year ended December 31, 2022.
History
Sol-Gel Technologies Ltd. was founded in 1997. The company was incorporated under the laws of the state of Israel in 1997.
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