Benzoyl Peroxide

April 01, 2024 (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, 2%) for Gorlin syndrome, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced that Padagis Israel Pharmaceuticals Ltd (“Padagis”), Sol-Gel’s collaboration partner, submitted a first-to-file Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) for Roflumilast Cream, 0.3%, a drug product generic to Zoryve® Cream (roflumilast cream, 0.3%), indicated for the treatment of plaque psoriasis in patients six years of age and older. On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA. Annual market sales for Zoryve Cream, 0.3% were approximately $95 million in the 12 months ended in January 2024, as measured by IQVIA. Should its ANDA for Roflumilast Cream, 0.3% be approved by the FDA, Padagis believes that its product may be entitled to 180 days of generic market exclusivity. If approved, Sol-Gel and Padagis will share gross profit generated from potential sales of Roflumilast Cream, 0.3% (calculated after the deduction of certain development costs). “According to recent leading analysts’ reports, Zoryve Cream is estimated to generate net revenue exceeding $500 million by the end of 2030. Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis. Though Sol-Gel exited the majority of the partnership in the generic divestment deal announced on November 4, 2021, the Roflumilast Cream, 0.3% project was maintained because of the potential value to both companies,” stated Mr. Mori Arkin, Executive Chairman of the Board of Sol-Gel. Mr. Arkin continued, “Given the market potential of Padagis’s ANDA product, Sol-Gel is exploring all options to maximize the value of this opportunity.” As reported by Arcutis, Q4/2023 net product revenues for Zoryve Cream were $13.5 million, a 357% increase compared to the fourth quarter of 2022 and a 67% increase compared to the third quarter of 2023, driven by sequential improvement in gross-to-net in the mid 60% range, as well as sustained demand growth. 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. Both drugs are exclusively licensed to and commercialized by Galderma in the US, and Searchlight in Canada. 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. The content above comes from the network. if any infringement, please contact us to modify.

BOULDER, CO / ACCESSWIRE / March 27, 2024 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care and dermatological conditions, highlights the safety advantages of its Microcyn technology products in response to concerns related to benzoyl peroxide, a common ingredient in dermatology products. Recently, there have been concerns that popular dermatology products can form benzene, a known carcinogen. A citizen petition by Valisure, LLC, an independent testing laboratory for pharmaceuticals, requested an FDA recall of certain over-the-counter and prescription dermatology products containing benzoyl peroxide. Testing by Valisure showed that benzoyl peroxide in dermatology products from major brands can form benzene, a known human carcinogen, at unacceptably high levels. Previous testing by Valisure has found unacceptably high levels of benzene in common hand sanitizers, as well as in after-sun products. Sonoma's Microcyn products contain hypochlorous acid, a naturally-occurring compound found in the human body. Our patented Microcyn technology is clinically proven to safely remove microorganisms, without drying the skin or harming healthy tissue. Our products also manage pain and itch from minor skin irritations, lacerations, abrasions and minor burns, including sunburns. Unlike many over-the-counter dermatology products, Sonoma's products are regulated by the FDA as 510(k) medical devices. Sonoma has never used benzoyl peroxide in any of its products. "We understand that consumers are seeking safe and effective products, particularly now when there are so many concerns about dangerous ingredients in dermatology and other topical products," said Amy Trombly, CEO of Sonoma Pharmaceuticals. "For over 20 years, we have developed Microcyn technology products that prioritize the health of patients and at-home users, so that consumers do not have to choose between effectiveness and safe ingredients." For more information, or to order any of Sonoma's Microcyn technology products, visit for consumers or for healthcare professionals, or contact our customer service department at 720-452-9690 or customerservice@sonomapharma.com. About Sonoma Pharmaceuticals, Inc. Sonoma Pharmaceuticals is a global healthcare leader for developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care and dermatological conditions. Sonoma's products are clinically proven to reduce itch, pain, scarring, and irritation safely and without damaging healthy tissue. In-vitro and clinical studies of HOCl show it to safely manage skin abrasions, lacerations, minor irritations, cuts, and intact skin. Sonoma's products are sold either directly or via partners in 55 countries worldwide and the company actively seeks new distribution partners. The company's principal office is in Boulder, Colorado, with manufacturing operations in Guadalajara, Mexico. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at . For partnership opportunities, please contact busdev@sonomapharma.com. Forward-Looking Statements Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries (the "company"). These forward-looking statements are identified by the use of words such as "continue," "develop," "anticipate," "expect" and "expand," among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the company's products will not be as large as expected, the company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to meet the company's cash needs, fund further development, as well as uncertainties relative to the COVID-19 pandemic and economic development, varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. The company disclaims any obligation to update these forward-looking statements, except as required by law. Sonoma Pharmaceuticals™ and Microcyn® are trademarks or registered trademarks of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners. SOURCE: Sonoma Pharmaceuticals, Inc. View the original press release on accesswire.com