Brickell Biotech Inc. (NASDAQ:BBI) has announced that Kaken Pharmaceutical Co Ltd, its Japanese development partner, will launch ECCLOCK® (sofpironium bromide gel) 5% as a once-daily primary axillary hyperhidrosis treatment in Japan.
Kaken to launch ECCLOCK® in Japan Following NHI’s price listing
Most importantly, the Japanese National health insurance has placed ECCLOCK® on its drug reimbursement price. According to NHI, ECCLOCK® will cost 243.7 Japanese Yen, which is roughly $46.47 per 20-gram bottle or around two weeks supply.
Robert Brown, the company’s CEO, said that they are delighted to announce a planned commercial launch and reimbursement of ECCLOCK® in Japan. He said that this would be the first topic prescription to receive approval and be marketed in Japan to treat primary axillary hyperhidrosis. Brown explained the vital step to Kaken’s move with the planned ECCLOCK® commercial launch in Japan was the receipt of the NHI’s reimbursement price listing. He said that Kaken is better positioned to launch ECCLOCK® as a proprietary first-in-class therapy in Japan for patients with devastating medical conditions.
The Japanese Pharmaceutical and Medical Devices Agency gave Kaken Approval on September 25, 2020, for the manufacture and marketing of ECCLOCK® as a once-daily primary axillary hyperhidrosis treatment. According to the Kaken sublicense agreement, Brickell is eligible for sales-based milestones and tiered royalties depending on the percentage of ECCLOCK® net sales in Japan. On the other hand, Kaken has development and commercialization rights for ECCLOCK® in China, Korea, and other Asian countries.
Brickell conducting studies to evaluate the safety and efficacy of ECCLOCK®
Brickell is currently developing sofpironium bromide for primary axillary hyperhidrosis treatment. Recently the company commenced its pivotal third phase clinical program in the US comprising of two vital Phase 3 clinical studies (Cardigan I and II). The studies seek to evaluate efficacy to the safety of sofpironium bromide gel 15% versus placebo ion 350 subjects aged above nine years with primary axillary hyperhidrosis. The company will report top-line results of Cardigan I and II studies in Q4 2021.