Brickell Bio’s Development Partner, Kaken Pharmaceutical, Submits New Drug Application for Sofpironium Bromide in Japan for...
January 10 2020 - 4:05PM
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.
About Sofpironium Bromide
Sofpironium bromide, is a proprietary new
molecular entity that belongs to a class of medications called
anticholinergics. Anticholinergics block the action of
acetylcholine, a chemical that transmits signals within the nervous
system that are responsible for a range of bodily functions,
including activation of the sweat glands. Sofpironium bromide was
retrometabolically designed. Retrometabolic drugs are designed to
exert their action topically and are potentially rapidly
metabolized into a considerably less active metabolite once
absorbed into the blood. This proposed mechanism of action may
allow for highly effective doses to be used while limiting systemic
side effects. Sofpironium bromide was discovered at Bodor
Laboratories, Inc. by Dr. Nicholas Bodor.
About Hyperhidrosis
Hyperhidrosis is a life-altering medical
condition where a person sweats more than the body requires to
regulate its temperature. More than 15 million people, or 4.8% of
the population of the United States, are believed to suffer from
hyperhidrosis. Axillary (underarm) hyperhidrosis is the targeted
first indication for sofpironium bromide and is the most common
occurrence of hyperhidrosis, affecting an estimated 65% of patients
in the United States or 10 million individuals. Doolittle et al.
Arch Dermatol Res (2016).
About Brickell
Brickell Biotech, Inc. is a clinical-stage
pharmaceutical company focused on developing innovative and
differentiated prescription therapeutics for the treatment of
debilitating skin diseases. Brickell’s pipeline consists of
potential novel therapeutics for hyperhidrosis, cutaneous T-cell
lymphoma, psoriasis, and other prevalent dermatological conditions.
Brickell’s executive management team and board of directors bring
extensive experience in product development and global
commercialization, having served in leadership roles at large
global pharmaceutical companies and biotechs that have developed
and/or launched successful products, including several that were
first-in-class and/or achieved iconic status, such as Cialis®,
Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell’s
strategy is to leverage this experience to in-license, acquire,
develop and commercialize innovative products that Brickell
believes can be successful in the currently underserved dermatology
global marketplace. For more information, visit
www.brickellbio.com.
Cautionary Note Regarding
Forward-Looking Statements
Any statements made in this press release
relating to future financial, business and/or research and clinical
performance, conditions, plans, prospects, trends, or strategies
and other such matters, including without limitation, the
anticipated timing, scope, design and/or results of future clinical
trials and prospects for commercializing any of Brickell’s product
candidates are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. In addition, when
or if used in this press release, the words “may,” “could,”
“should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,”
“plan,” “predict” and similar expressions and their variants, as
they relate to Brickell, may identify forward-looking statements.
Brickell cautions that these forward-looking statements are subject
to numerous assumptions, risks, and uncertainties, which change
over time, often quickly and in unanticipated ways. Important
factors that may cause actual results to differ materially from the
results discussed in the forward-looking statements or historical
experience include risks and uncertainties, including without
limitation, whether Brickell prevails in arbitration and/or
litigation relating to its license agreement with Bodor, the costs
associated with, and the management time associated with
arbitration and/or litigation, potential delays in product
development, regulatory or law changes, unanticipated demands on
cash resources, risks associated with developing, and obtaining
regulatory approval for and commercializing novel therapeutics.
Further information on the factors and risks
that could cause actual results to differ from any forward-looking
statements are contained in Brickell’s filings with the United
States Securities and Exchange Commission (SEC), which are
available at www.sec.gov (or at www.brickellbio.com). The
forward-looking statements represent the estimates of Brickell as
of the date hereof only, and Brickell specifically disclaims any
duty or obligation to update forward-looking statements.
Brickell Investor Contact:Patti
BankManaging Director, WestwickeIR@brickellbio.com
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