Botanix` excessive sweat treatment Sofdra gains FDA approval
BERWYN, Pa. – Troutman Pepper client Botanix Pharmaceuticals Limited (ASX: BOT), a clinical dermatology company, has announced the acquisition of Sofpironium Bromide gel, 15%, from Brickell Biotech Inc. (Nasdaq: BBI), a clinical-stage pharmaceutical company. The gel was developed to treat primary axillary hyperhidrosis, a medical condition that results in excessive underarm sweating. Read a company press release about the acquisition.
BOULDER, Colo., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that the final patient has completed the Phase 3 pivotal Cardigan II study, which is evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis. The Company expects to announce topline results for the U.S. Phase 3 pivotal Cardigan I and Cardigan II studies concurrently in the fourth quarter of 2021. Pending the outcome of these studies, the Company expects to submit a New Drug Application (NDA) for sofpironium bromide gel, 15% to the U.S. FDA in mid-2022.
BOULDER, Colo., June 29, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that the final patient has completed the Phase 3 pivotal Cardigan I study, and that all planned patients have been enrolled in the Phase 3 pivotal Cardigan II study. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.
BOULDER, Colo., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that its Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”) plans to launch sofpironium bromide gel, 5% under the brand name ECCLOCK® in Japan for the once daily treatment of primary axillary (underarm) hyperhidrosis on November 26, 2020. In addition, ECCLOCK® has been placed today on Japan’s National Health Insurance (NHI) drug reimbursement price list. The NHI listed drug price for ECCLOCK® in Japan is ¥243.70 per gram, which is ¥4,874.00 (USD $46.47) for a 20 gram bottle or approximately a two-week supply.
BOULDER, Colo., Sept. 25, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (BBI-OLD) (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, announced today that its Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”), received approval to manufacture and market sofpironium bromide gel, 5% under the brand name ECCLOCK® in Japan for the treatment of primary axillary (underarm) hyperhidrosis.
Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, announced today that Brickell and its Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”), were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide, a retrometabolically designed new chemical entity, currently under development in the United States and Japan as a potential best-in-class treatment for primary axillary hyperhidrosis. This patent is expected to provide additional protection in Japan through 2040 for these newly developed and distinct characterized crystalline forms of sofpironium bromide. Patent protection for these crystalline forms of sofpironium bromide currently is being pursued worldwide, including in the United States.
Presentation based on positive Phase 3 pivotal study results of Sofpironium Bromide in Japanese Patients with Primary Axillary Hyperhidrosis
Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that positive results from its Phase 2b study with sofpironium bromide in patients with primary axillary hyperhidrosis were published in the peer-reviewed Journal of the American Academy of Dermatology (JAAD).
Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that its development partner, Kaken Pharmaceutical Co. Ltd. (“Kaken”) submitted a new drug application for approval of manufacturing and marketing for sofpironium bromide in Japan for primary axillary hyperhidrosis. The application for sofpironium bromide in Japan involves data from the Phase 3 study in Japan, targeting patients with primary axillary hyperhidrosis, in which positive results were obtained.