Brickell Biotech Announces Launch Date for Sofpironium Bromide Gel, 5% (ECCLOCK) in Japan by its Development Partner, Kaken Pharmaceutical
Kaken plans to launch ECCLOCK for the treatment of primary axillary hyperhidrosis in Japan on November 26, 2020
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ECCLOCK placed on Japan’s National Health Insurance (NHI) drug reimbursement price list
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.
“We are excited to announce the reimbursement and planned commercial launch of ECCLOCK in Japan, which is the first topical prescription product to be approved and marketed there for the treatment of primary axillary hyperhidrosis,” said Robert Brown, Chief Executive Officer of Brickell. “A key step to Kaken’s moving forward with the planned commercial launch of ECCLOCK in Japan was their receipt of the reimbursement price listing by the NHI. Kaken is now well-positioned to launch ECCLOCK in Japan on November 26 as an important novel, first-in-class therapy for the millions of Japanese patients suffering with this debilitating medical condition.”
On September 25, 2020, Kaken received approval from the Japanese Pharmaceuticals and Medical Devices Agency to manufacture and market ECCLOCK for the once-daily treatment of primary axillary hyperhidrosis.
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 ECCLOCK in Japan. Furthermore, Kaken has rights to develop and commercialize sofpironium bromide in Korea, China and certain other Asian countries.
Sofpironium bromide is currently being developed by Brickell in the U.S. for the treatment of primary axillary hyperhidrosis. Brickell recently initiated its pivotal Phase 3 clinical program in the U.S., which is comprised of two pivotal Phase 3 clinical trials (Cardigan I and II) to evaluate the safety and efficacy of sofpironium bromide gel, 15% compared to vehicle (placebo) in approximately 350 subjects (per trial) aged nine years and older with primary axillary hyperhidrosis. Brickell expects to report topline data from both the Cardigan I and II studies in the fourth quarter of 2021.