SLGL Sol-Gel Technologies Ltd.

9.47
-0.37  -4%
Previous Close 9.84
Open 9.79
52 Week Low 7.05
52 Week High 16.69
Market Cap $218,093,636
Shares 23,029,951
Float 5,349,816
Enterprise Value $189,339,717
Volume 21,380
Av. Daily Volume 27,509
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
VERED (Epsolay)
Papulopustular rosacea
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
Twyneo
Acne
Approved
Approved
FDA approval announced July 27, 2021.
SGT-510
Phase 2
Phase 2
Phase 2 trial planned.
SGT-210
Palmoplantar keratoderma (PPK)
Phase 1
Phase 1
Phase 1 trial is ongoing.

Latest News

  1. NESS ZIONA, Israel, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ:SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that the Company will participate in H.C. Wainwright's 23rd Global Investment Conference.

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13 – 15, 2021)
    FormatOn demand presentation and 1-on-1 meetings
    Speaker:Gilad Mamlok, Chief Financial Officer
    Date:September 13-15
    Time:Presentation available on demand beginning Monday, September 13th 7 a.m. ET
    To ListenRegister here; a replay will be archived for 90 days at this link (or go to www.sol-gel.com to access within

    NESS ZIONA, Israel, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ:SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that the Company will participate in H.C. Wainwright's 23rd Global Investment Conference.

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13 – 15, 2021)
    FormatOn demand presentation and 1-on-1 meetings
    Speaker:Gilad Mamlok, Chief Financial Officer
    Date:September 13-15
    Time:Presentation available on demand beginning Monday, September 13th 7 a.m. ET
    To ListenRegister here; a replay will be archived for 90 days at this link (or go to www.sol-gel.com to access within the Investors/Events and Presentations section)

    About Sol-Gel Technologies

    Sol-Gel is a 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 TWYNEO, which is FDA 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 of rosacea with an NDA filed with the FDA and a PDUFA goal date that was 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 as a result of COVID-19 travel restrictions. Both product candidates are exclusively licensed for U.S. commercialization with Galderma.

    The Company's pipeline also includes early-stage topical drug candidates SGT-210 (erlotinib gel) under investigation for the treatment of palmoplantar keratoderma, SGT-310 (tapinarof cream, 1%) and SGT-510 (roflumilast) under investigation for the treatment of plaque psoriasis and other dermatologic indications.

    For additional information, please visit www.sol-gel.com.

    Contact:

    Irina Koffler

    Investor relations, LifeSci Advisors

    ikoffler@lifesciadvisors.com

    +1-917-734-7387

    Sol-Gel Technologies

    Gilad Mamlok

    Chief Financial Officer

    gilad.mamlok@sol-gel.com



    Primary Logo

    View Full Article Hide Full Article
    • TWYNEO®, a once-daily cream treatment for acne vulgaris, is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide

    • TWYNEO utilizes Sol-Gel's proprietary microencapsulation technology and is patent protected until 2038
    • Under a previously announced license, Sol-Gel to receive regulatory milestone payment from U.S. commercialization partner, Galderma, in conjunction with this approval and retains the option to regain commercialization rights five years following first commercialization in the U.S.

    NESS ZIONA, Israel, July 27, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ:SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment…

    • TWYNEO®, a once-daily cream treatment for acne vulgaris, is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide



    • TWYNEO utilizes Sol-Gel's proprietary microencapsulation technology and is patent protected until 2038
    • Under a previously announced license, Sol-Gel to receive regulatory milestone payment from U.S. commercialization partner, Galderma, in conjunction with this approval and retains the option to regain commercialization rights five years following first commercialization in the U.S.

    NESS ZIONA, Israel, July 27, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ:SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that the Food and Drug Administration (FDA) has approved its first proprietary drug product, TWYNEO (tretinoin/benzoyl peroxide) cream, 0.1%/3%, indicated for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. TWYNEO uses Sol-Gel's patented technology to entrap tretinoin, a retinoid, and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to slowly release each of the active drug ingredients over time to provide a favorable efficacy and safety profile. TWYNEO is patent protected until 2038. Sol-Gel has partnered with Galderma to commercialize TWYNEO in the U.S. Sol-Gel expects to receive a regulatory milestone payment in conjunction with this approval and retains the option to regain U.S. commercialization rights five years following first commercialization in the U.S.

    "The FDA approval of TWYNEO underscores our ability to deliver innovative, proprietary drugs to the market," stated Dr. Alon Seri-Levy, Co-Founder and Chief Executive Officer of Sol-Gel. "Based on the clinical data observed, we believe that TWYNEO has the potential to change the treatment landscape for the tens of millions of patients suffering from acne vulgaris. With market leader, Galderma, handling the product launch of TWYNEO, we are excited that TWYNEO will soon be available to patients in the U.S.," continued Dr. Seri-Levy. "We remain focused on obtaining FDA approval of EPSOLAY® (benzoyl peroxide), our other Galderma-partnered product – the approval of which has been delayed due to FDA's COVID-19-related restrictions. We are also making progress on our innovative earlier stage programs for erlotinib, roflumilast and tapinarof with the intent of advancing them into the clinic," he concluded.

    "Galderma was founded forty years ago around a commitment to serve the dermatological needs of healthcare professionals and their patients," said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. "Our heritage in acne dates back to our founding and we are excited to partner with Sol-Gel to bring yet another acne innovation to market for a condition that impacts up to 50 million Americans annually.1"

    "TWYNEO combines, for the first time, two of the most commonly used topical agents available for the treatment of acne into a single application. Due to stability issues, these products don't play well together, and we were never able to recommend even consecutive co-application of the two agents. Sol-Gel's technology has solved this problem," said Hilary Baldwin, M.D., Clinical Associate Professor of Dermatology, Rutgers Robert Wood Johnson School of Medicine, Medical Director, The Acne Treatment and Research Center and Past President of the American Acne and Rosacea Society. "The approval of TWYNEO offers patients efficacy with these two products in a single convenient application. I believe physicians will look forward to adding TWYNEO to their acne treatments toolbox."

    The New Drug Application (NDA) for TWYNEO was approved by the FDA on July 26, 2021. The NDA was supported by positive results from two Phase 3, randomized, double-blind, vehicle-controlled, multi-center studies (NCT03761784, and NCT03761810), in which TWYNEO demonstrated efficacy and a favorable tolerability profile in subjects nine years of age and older with facial acne vulgaris. TWYNEO is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide. For more information, visit www.sol-gel.com.

    About Acne Vulgaris

    Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects up to 50 million people in the U.S. The disease occurs most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults. Acne vulgaris patients suffer from the appearance of lesions on areas of the body with a large concentration of oil glands, such as the face, chest, neck and back. These lesions can be inflamed (papules, pustules, nodules) or non-inflamed (comedones). Acne vulgaris can have a profound effect on the quality of life of those suffering from the disease. In addition to carrying a substantial risk of permanent facial scarring, the appearance of lesions may cause psychological strain, social withdrawal and lowered self-esteem.

    About TWYNEO

    TWYNEO is a topical cream containing a fixed‑dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. TWYNEO is the first acne treatment that contains a fixed‑dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The formulation of TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream.

    Indications and Usage

    TWYNEO is a combination of tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.



    IMPORTANT SAFETY INFORMATION


    CONTRAINDICATIONS: History of serious hypersensitivity reaction to benzoyl peroxide or any component of TWYNEO.



    WARNINGS AND PRECAUTIONS

    • Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with use of benzoyl peroxide products.
    • Skin Irritation: Pain, dryness, exfoliation, erythema, and irritation may occur with use of TWYNEO. Avoid application of TWYNEO to cuts, abrasions, eczematous or sunburned skin.
    • Photosensitivity: Minimize unprotected exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided.

    ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 1%) are pain, dryness, exfoliation, erythema, dermatitis, pruritus and irritation (all at the application site).

    Please see full Prescribing Information here.

    About EPSOLAY

    EPSOLAY is an investigational topical cream containing benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea, also known as papulopustular rosacea, in adults. If approved, EPSOLAY has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product. The benzoyl peroxide in EPSOLAY is in a solid form that is incorporated into silica-based microcapsules. EPSOLAY is not approved by the FDA and the safety and efficacy have not been established.

    About Sol-Gel Technologies

    Sol-Gel is a 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 TWYNEO, which is approved for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older; and EPSOLAY, under investigation for the treatment of inflammatory lesions of rosacea with an NDA filed with the FDA and a PDUFA goal date that was 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 as a result of COVID‑19 travel restrictions. Both product candidates are exclusively licensed for U.S. commercialization with Galderma.

    The Company's pipeline also includes early-stage topical drug candidates SGT-210 (erlotinib gel) under investigation for the treatment of palmoplantar keratoderma, SGT-310 (tapinarof cream, 1%) and SGT-510 (roflumilast) under investigation for the treatment of plaque psoriasis and other dermatologic indications.

    For additional information, please visit 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, statements regarding FDA approval of EPSOLAY and statements regarding the progress on our innovative earlier stage programs. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. 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 expectation 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 of a further delay in receipt of approval, if any, of the NDA for EPSOLAY, the risk that we don't progress on our innovative earlier stage programs, the risk of a delay in the commercial availability of ESPSOLAY and/or TWYNEO, the risk that EPSOLAY and TWYNEO will not provide treatment to the number of patients anticipated, risks relating to the effects of COVID-19 (coronavirus) 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 ability to commercialize our pharmaceutical 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 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, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on March 4, 2021 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. Any such forward-looking statements represent management's estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.

    For further information, please contact:

    Sol-Gel Technologies

    Gilad Mamlok

    Chief Financial Officer

    gilad.mamlok@sol-gel.com

    Irina Koffler

    Investor relations, LifeSci Advisors

    ikoffler@lifesciadvisors.com

    +1 917 734 7387

    Galderma

    Shannon Iwaniuk

    Global Communications, US

    shannon.iwaniuk@galderma.com

    Christian Marcoux, M.Sc.

    Chief Communications Officer

    christian.marcoux@galderma.com 

    +41 21 642 71 99

    1Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E et al. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. Journal of the American Academy of Dermatology 2006;55:490-500.



    Primary Logo

    View Full Article Hide Full Article
  2. NESS ZIONA, Israel, July 20, 2021 (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, will report second quarter 2021 financial results on Wednesday, August 4, 2021 at 7:05 AM ET.

    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 with an NDA filed with…

    NESS ZIONA, Israel, July 20, 2021 (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, will report second quarter 2021 financial results on Wednesday, August 4, 2021 at 7:05 AM ET.

    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 with an NDA filed with the FDA and a PDUFA goal date set for August 1, 2021; and EPSOLAY®, under investigation for the treatment of inflammatory lesions of rosacea with an NDA filed with the FDA and a PDUFA goal date set for April 26, 2021. Both product candidates are exclusively licensed for U.S. commercialization with Galderma Holding SA.    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 as a result of COVID-19 travel restrictions. 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.

    Contact:

    Irina Koffler

    Investor relations, LifeSci Advisors

    ikoffler@lifesciadvisors.com

    +1 917 734 7387

    Sol-Gel Technologies

    Gilad Mamlok

    Chief Financial Officer

    gilad.mamlok@sol-gel.com



    Primary Logo

    View Full Article Hide Full Article
    • Sol-Gel investigational SGT-510 was found to be more effective than roflumilast cream, 0.3%, in a human xenograft psoriasis animal model

    • Sol-Gel is developing tapinarof cream, 1%, aiming to offer product formulation innovations and increased affordability for patients compared to the brand expected to be launched

    • Our proof-of-concept study for SGT-210 (erlotinib gel) in palmoplantar keratoderma patients has been completed and indicated a possible modest improvement

    • Sol-Gel to host Conference Call today at 8:00 am U.S. EDT to discuss the data and provide a corporate update

    NESS ZIONA, Israel, June 28, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ:SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing…

    • Sol-Gel investigational SGT-510 was found to be more effective than roflumilast cream, 0.3%, in a human xenograft psoriasis animal model



    • Sol-Gel is developing tapinarof cream, 1%, aiming to offer product formulation innovations and increased affordability for patients compared to the brand expected to be launched



    • Our proof-of-concept study for SGT-210 (erlotinib gel) in palmoplantar keratoderma patients has been completed and indicated a possible modest improvement



    • Sol-Gel to host Conference Call today at 8:00 am U.S. EDT to discuss the data and provide a corporate update

    NESS ZIONA, Israel, June 28, 2021 (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 positive pre-clinical data for SGT-510, its investigational topical roflumilast drug candidate and provided a corporate update.

    The study was conducted at the Skin Research Laboratory, Rappaport Faculty of Medicine, Technion Institute of Technology, Haifa, Israel, under the supervision of Professor Amos Gilhar, M.D. Professor Gilhar has pioneered a human psoriasis xenograft mouse model, consisting of immunodeficient mice transplanted with healthy human skin, and used it to validate a number of approved topical and systemic dermatology products, including those sold by large pharmaceutical companies. For the study, the human xenograft animal model was induced with psoriasis by injection of activated allogeneic IL2-enriched peripheral blood mononuclear cells isolated from psoriatic patients. The mice were then treated with several topical agents and assessed for recovery after each intervention.

    "Our model has been proven to predict efficacy for novel approaches in the treatment of psoriasis, providing very valuable information to the companies leveraging this assay," commented Professor Gilhar.

    All tested articles were applied for 14 days either once or twice daily:

    • Nine (9) out of 10 animals fully recovered following a twice-daily application of dexamethasone (the positive control);
    • None (0) out of 10 recovered following a once-daily application of vehicle cream (the negative control);
    • Three (3) out of 10 animals recovered following a once-daily application of roflumilast cream, 0.3% that was formulated by Sol-Gel according to conventional methods of cream formulation;
    • Six (6) out of 10 animals fully recovered following once-daily application of SGT-510.

    Based on these results, Sol-Gel filed a provisional patent application for its novel and non-obvious formulation of SGT-510. By the end of 2022, the Company expects to have head-to-head data against a formulation of roflumilast cream, 0.3% and expects to initiate Phase 2 work thereafter.

    Mr. Mori Arkin, Executive Chairman of the Board of Sol-Gel, commented, "While this small study does not represent a formal statistical analysis, we are very pleased that these early-stage results, demonstrating 60% recovery after a once-daily application of SGT-510 in the human psoriasis xenograft mouse model, supported our predefined hypothesis and confirmed our expectations about formulation superiority using our approach. Given our expertise in formulation science and topical drug delivery, we believe that we have an advantage due to the patentability of SGT-510. It is our belief that if these results are corroborated by clinical studies, a patent, if granted, will provide us not only freedom to operate, but more importantly, intellectual property protection against generic entrants until expiry of our patent in 2040."

    Mr. Arkin continued, "Due to the safety-limiting features of steroids, the prospect of an effective alternative to steroid medicine for the treatment of psoriasis, such as SGT-510, is significant and would fill a critical unmet need for these patients. Sol-Gel intends to develop SGT-510 in accordance with the 505(b)(2) regulatory pathway by only referencing the oral roflumilast brand DALIRESP®. The rationale for this carefully planned regulatory strategy is to create a clear path to market, with no litigation requirement. We expect that all Orange Book-listed DALIRESP® patents will have expired by the time of its New Drug Application (NDA) submission, and that no Paragraph IV certification with a consequent 30-month stay would be required. As we plan to develop more than one roflumilast product, including potential combination products, we may also utilize alternative regulatory strategies. Our deep involvement in topical generics along with the supportive view of independent intellectual property experts guides us to believe that there is a significant risk that present patents and patent applications for roflumilast 0.3% cream may be unable to prevent early genericization of the roflumilast products currently under development. Should this be the case, our innovative formulations of roflumilast, if approved by the FDA, would give us the opportunity to become a leading player in the multi-billion-dollar psoriasis and atopic dermatitis markets in the second half of the decade."

    Mr. Arkin added, "Separately, we have made progress towards the development of our proprietary formulation of tapinarof cream, 1%, SGT-310. We plan to pursue a de-novo NDA via the 505(b)(1) regulatory pathway, with the goal of creating a second alternative to an investigational tapinarof cream, 1%, for which an NDA was already submitted to the FDA. According to this strategy, we plan to launch our tapinarof drug product worldwide no later than five years following the U.S. approval of the first tapinarof cream, aiming to increase affordability for patients compared to the brand expected to be launched. In addition, we intend to differentiate ourselves by offering tapinarof product formulation innovations for new indications. We have already been refining our strategy in line with best regulatory practices, and our drug product will be developed via our active pharmaceutical ingredient (API) manufacturing collaboration with Wavelength Pharmaceuticals, previously known as Perrigo API, a company with an impressive track record of FDA GMP compliance."

    Mr. Arkin further added: "Our proof-of-concept (POC) study for SGT-210 (erlotinib gel) in six (6) palmoplantar keratoderma (PPK) patients has been completed and indicated modest improvement and a favorable safety profile. In this study, we used a very low concentration of erlotinib. We are now planning to test erlotinib at much higher concentrations in an animal model in the second half of 2021 and if successful, will conduct a second POC study on PPK patients in 2022. We remain optimistic about this program."

    Management to Host Conference Call Today

    Sol-Gel will host an investor conference call today at 8 AM U.S. EDT to discuss today's announcement, herein, and the strategy of the company following today's partnership news, announced separately.  

    To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

    Domestic:  1-877-407-0784 

    International: 1-201-689-8560

    Passcode: 13720829

    The live conference call and replay can also be accessed by audio webcast here and also on the Investor Relations section of the Company's website, located at https://ir.sol-gel.com/investor-relations.

    About Roflumilast

    Roflumilast is a selective, long-acting inhibitor of Phosphodiesterase-4 (PDE4). It is the active ingredient in the Food and Drug Administration (FDA) approved medication, DALIRESP®, which is as an oral treatment indicated in the U.S. as a therapy to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.  

    A roflumilast cream 0.3% formulation is under investigation as a once-daily treatment of plaque psoriasis and positive Phase 3 results were recently reported.

    About Tapinarof

    Tapinarof is a novel, first-in-class, small-molecule topical therapeutic aryl hydrocarbon receptor (AhR)–modulating agent. It is in clinical development for the treatment of psoriasis and atopic dermatitis. The efficacy of tapinarof in psoriasis is attributed to its specific binding and activation of AhR, a ligand-dependent transcription factor, leading to the downregulation of proinflammatory cytokines, including interleukin 17, and regulation of skin barrier protein expression to promote skin barrier normalization.

    About Erlotinib        

    Erlotinib is a tyrosine kinase receptor inhibitor which acts on the Epidermal Growth Factor Receptor (EGFR). It is the active pharmaceutical ingredient (API) in Tarceva® which is used to orally treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Currently, there are no topical products of erlotinib, and erlotinib is not approved for plaque psoriasis.

            

    About Wavelength Pharmaceuticals

    Wavelength is a customer-focused backward-integrated world-class developer and manufacturer of Active Pharmaceutical Ingredients (APIs). It is the independent company of choice for pharmaceutical industry leaders that require advanced API solutions and reliable supply to gain sustainable competitive advantage. The company is on the same wavelength as its customers – a partner in tune with the results required to best support their needs. Founded in Israel in 1987, with more than 280 customers in 50 countries, Wavelength produces more than 630 metric tons of commercial products every year, across a wide range of technologies including injectables, inhalables, highly potent, cytotoxic and controlled substances. Its cGMP-compliant facility is a first-class operation recognized for excellence in safety and environmental stewardship. Wavelength has achieved an exceptional track record for more than 30 years with all leading global regulatory authorities, including USFDA, EU-EMA, PMDA, TGA, KFDA, ANVISA and COFEPRIS. The company includes experts in complex chemistry, process development and scale-up, enzymatic reactions, crystalline forms and particle design, spray drying and other bioavailability-enhancing solutions. Wavelength offers end-to-end customized solutions to meet individual customer requirements, including full-spectrum API CDMO services from pre-clinical grams to multi-ton commercial scale – always with uncompromising consistent quality, regulatory compliance and exceptional customer service.

    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 with an NDA filed with the FDA and a PDUFA goal date set for August 1, 2021; and EPSOLAY®, under investigation for the treatment of inflammatory lesions of rosacea with an NDA filed with the FDA and a PDUFA goal date set for April 26, 2021. Both product candidates are exclusively licensed for U.S. commercialization with Galderma Holding SA.    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 as a result of COVID-19 travel restrictions. 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.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning Securities of the Private 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. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. 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, including statements regarding the timing for the initiation of a Phase I study for SGT-510, the intellectual property protection that would be provided by a patent for SGT-210, the anticipated status of patents at the time of an NDA submission for SGT-210, the timing of the launch of our tapinarof drug product and the timing of a test of erlotinib with a much higher concentrations in an animal model and a second POC study on PPK patients. Forward-looking statements are based on information we have when those statements are made or our management's current expectation 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 of a delay in receipt of approval, if any, of the NDA for TWNYEO, the risk of a further delay in receipt of approval, if any, of the NDA for EPSOLAY, the risk of a delay in the initiation of a Phase I study for SGT-510, the risk that a patent for SGT-210 will not provide the anticipated intellectual property protection, the risk that all Orange Book-listed DALIRESP® patents will not have expired by the time of our NDA application for SGT-21 and that a consequent 30-month stay will required, the risk of a delay in the launch of our tapinarof drug product, the risk of a delay the timing of a test of erlotinib with a much higher concentrations in an animal model and the risk of a delay in a second POC study on PPK patients, risks relating to the effects of COVID-19 (coronavirus) 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 ability to commercialize our pharmaceutical 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 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, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on March 4, 2021 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. Any such forward-looking statements represent management's estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.

    For further information, please contact:

    Sol-Gel Technologies



    Gilad Mamlok

    Chief Financial Officer

    +972-8-9313433



    Investor relations

    Irina Koffler

    LifeSci Advisors

    +1-917-734-7387

    ikoffler@lifesciadvisors.com



     



    Primary Logo

    View Full Article Hide Full Article
  3. - 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 commercialization rights 5 years following first commercialization

    Sol-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.

    Under 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…

    - 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 commercialization rights 5 years following first commercialization

    Sol-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.

    Under 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:

    • EPSOLAY (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.
    • TWYNEO (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.

    Sol-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.

    "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 appreciative of the flexibility that these agreements provide through Sol-Gel retaining commercial rights after the initial five-year term," commented Dr. Seri-Levy.

    "Innovation is at the heart of our commitment to advancing dermatology," said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. "The potential to deliver two innovative products featuring Sol-Gel's proprietary micro-encapsulation technology represents an important milestone for acne and rosacea patients and underscores Galderma's position as the partner of choice in dermatology."

    About EPSOLAY

    EPSOLAY is an investigational topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea, also known as papulopustular rosacea, in adults. EPSOLAY utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to release benzoyl peroxide slowly over time to provide a favorable efficacy and safety profile. If approved, EPSOLAY has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product. EPSOLAY is not approved by the FDA and the safety and efficacy have not been established.

    About Papulopustular Rosacea

    Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. Rosacea condition is common, especially in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin, or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and inflammatory lesions (papules and pustules) often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.

    About TWYNEO

    TWYNEO is an investigational, fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. If approved, TWYNEO will be the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin, which are separately encapsulated in silica using Sol-Gel's proprietary micro-encapsulation technology. Tretinoin and benzoyl peroxide are widely prescribed separately as a combination treatment for acne; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The silica-based microcapsule is designed to protect tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability of the active drug ingredients. The silica-based shell is also designed to release the ingredients slowly over time to provide a favorable efficacy and safety profile. TWYNEO is not approved by the FDA and the safety and efficacy have not been established.

    About Acne Vulgaris

    Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects approximately 40 to 50 million people in the United States. The disease occurs most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults. Acne patients suffer from the appearance of lesions on areas of the body with a large concentration of oil glands, such as the face, chest, neck and back. These lesions can be inflamed (papules, pustules, nodules) or non-inflamed (comedones). Acne can have a profound effect on the quality of life of those suffering from the disease. In addition to carrying a substantial risk of permanent facial scarring, the appearance of lesions may cause psychological strain, social withdrawal and lowered self-esteem.

    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 micro-encapsulation 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.

    About Galderma

    Galderma is the world's largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we're in shapes our life stories, we are advancing dermatology for every skin story. For more information: www.galderma.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, statements regarding FDA approval of EPSOLAY AND TWYNEO and statements regarding the timing and potential commercialization of EPSOLAY and TWYNEO. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. 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, including statements regarding the financial benefits of the agreements with Galderma, the benefits of EPSOLAY and TWYNEO to patients, and the timing of the commercial availability of EPSOLAY and TWYNEO. Forward-looking statements are based on information we have when those statements are made or our management's current expectation 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 of a delay in receipt of approval, if any, of the NDA for TWNYEO, the risk of a further delay in receipt of approval, if any, of the NDA for EPSOLAY, the risk that Sol-Gel will not receive all the financial benefits under the agreements with Galderma, the risk of a delay in the commercial availability of ESPSOLAY and/or TWYNEO, the risk that EPSOLAY and TWYNEO will not provide treatment to the number of patients anticipated, risks relating to the effects of COVID-19 (coronavirus) 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 ability to commercialize our pharmaceutical 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 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, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on March 4, 2021 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. Any such forward-looking statements represent management's estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.

    View Full Article Hide Full Article
View All Sol-Gel Technologies Ltd. News