Brickell Biotech Announces Approval of Sofpironium Bromide Gel, 5% in Japan for Treatment of Primary Axillary Hyperhidrosis Received by its Development Partner, Kaken Pharmaceutical
Japan is the first country to approve sofpironium bromide with commercial launch expected later this year
Brickell is on track to initiate its U.S. pivotal Phase 3 program for sofpironium bromide in Q4 2020
BOULDER, Colo., Sept. 25, 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, 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.
“We are thrilled with the Japanese approval of sofpironium bromide, which is the first topical prescription product to be approved in Japan for the treatment of primary axillary hyperhidrosis,” commented Robert Brown, Chief Executive Officer of Brickell. “This is a significant milestone for Brickell and Kaken, as Kaken can now focus its efforts on the commercial launch of sofpironium bromide gel in Japan, which is expected to occur later this year. Most importantly, this novel, first-in-class therapy will soon be available to help improve the quality of life for Japanese patients suffering from this debilitating condition.”
This regulatory approval is based on the results of the Japanese Phase 3 pivotal registration study of sofpironium bromide gel, 5% in 281 patients with primary axillary hyperhidrosis, in which all primary and secondary efficacy endpoints demonstrated statistically significant differences between sofpironium bromide gel and vehicle (placebo). In addition, sofpironium bromide gel was deemed to be safe and generally well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study in Japan.
Under the sublicense agreement with Kaken, Brickell is entitled to receive sales-based milestone payments, as well as tiered royalties based on a percentage of net sales of sofpironium bromide gel in Japan. Importantly, Kaken has rights to develop and commercialize sofpironium bromide in Korea, China and certain other Asian countries, and will now turn its attention to these markets.
Sofpironium bromide is currently being developed by Brickell in the U.S. for the treatment of primary axillary hyperhidrosis. Brickell is on track to initiate its pivotal Phase 3 program in the U.S. for sofpironium bromide gel, 15% during the fourth quarter of 2020, which will ultimately be comprised of two pivotal Phase 3 trials to evaluate sofpironium bromide gel compared to vehicle in approximately 350 subjects (per trial) with primary axillary hyperhidrosis.