Brickell Biotech, Inc. Signs Exclusive License and Development Agreement for BBI-4000 with Kaken Pharmaceutical Co., Ltd.

New Molecular Entity Holds Promise for Transforming Treatment of Hyperhidrosis (Excessive Sweating), a Significant Global Unmet Medical Need

MIAMI, FL – April 1, 2015 – Brickell Biotech, Inc. (“Brickell”), a clinical-stage pharmaceutical company focused on the development of differentiated, innovative therapeutics to satisfy current unmet medical needs in the global dermatology markets, today announced the signing of an exclusive license and development agreement for BBI-4000 with Kaken Pharmaceutical Co., Ltd. (“Kaken”), a top-tier specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel dermatological drugs.

Under the terms of the license and development agreement, Kaken will have exclusive rights to develop and commercialize BBI-4000 in Japan, the second largest dermatology market in the world, and certain other Asian countries. Brickell will receive an upfront payment from Kaken as well as milestone payments based on the achievement of certain objectives. Tiered royalties that will be adjusted based on sales are expected to be paid to Brickell following the launch of BBI- 4000 in those markets. Kaken will also assume responsibility for certain global R&D activities. Terms of the deal were not disclosed.

BBI-4000 is a novel, topical soft-anticholinergic currently undergoing testing in a randomized, double-blind, vehicle-controlled Phase 2b clinical trial in 180 patients with primary axillary (underarm) hyperhidrosis in the U.S. An estimated eight million people in the U.S. (3% of the population suffer from hyperhidrosis, or excessive sweating.)

"We are very pleased that Kaken, one of Japan’s premier specialty pharmaceutical companies, has recognized BBI-4000 as the most attractive novel therapeutic in development for hyperhidrosis. Kaken’s agreement to commit significant resources for clinical development and commercialization activities will accelerate moving BBI-4000 through the regulatory approval process and toward commercialization so that individuals with hyperhidrosis in Japan and other Asian countries will have a meaningful new treatment option," said Charles Stiefel, Chairman of Brickell.

Triad Healthcare Partners, a division of Triad Securities Corp., served as financial adviser to Brickell Biotech on this transaction.

About BBI-4000

BBI-4000 is a new molecular entity that belongs to a class of drugs called ‘anticholinergics,’ which exert their effect by blocking the action of acetylcholine, a molecule that transmits signals within the nervous system that are responsible for a range of bodily functions, including the activation of sweat glands. Soft-anticholinergics such as BBI-4000 exert their action topically and are rapidly metabolized into a considerably less active metabolite when they reach the blood system; this may allow effective doses to be used without the limiting systemic side effects associated with other drugs in this class.

About Brickell Biotech

Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of skin diseases.

Founded by a team of experienced pharmaceutical executives, Brickell’s development strategy includes: rapidly and cost effectively developing product candidates; executing strategic partnerships; maintaining a diversified product portfolio that addresses unmet medical needs; and leveraging professional relationships with thought leaders and contract research organizations in the pharmaceutical industry. For more information, visit www.brickellbio.com.

About Kaken Pharmaceutical Co., Ltd.

Kaken (Tokyo Stock Exchange: 4521) is a Japanese specialty pharmaceutical company with a strong presence in the market of dermatology (antifungals) and orthopedics. The company’s primary areas of R&D focus include inflammation, immunology (dermatitis, rheumatoid arthritis and osteoarthritis), pain and antifungals.

Media Contact:
Anne Granfield 646-805-2033
anne.granfield@finsbury.com

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