Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage
pharmaceutical company, today announced the completion of its
merger with Vical Incorporated (“Vical”), following approval by
Vical’s stockholders. Brickell is expected to commence trading
today on The Nasdaq Capital Market under the ticker symbol “BBI.”
“This merger is a significant milestone for
Brickell. We are on track to initiate the Phase 3 program of
our lead asset, sofpironium bromide, for patients with axillary
hyperhidrosis this year,” said Robert Brown, Brickell’s Chief
Executive Officer. “With over 10 million individuals in the
United States suffering from this debilitating condition, we are
excited to advance the development of sofpironium bromide as a
potential best-in-class therapy.”
Vical contributes approximately $35 million to
the combined company in addition to an R&D financing
arrangement with NovaQuest Capital Management (“NovaQuest”) that
provides $25 million in funding.
Following the completion of the merger, the
combined company has approximately 7.8 million shares of common
stock outstanding. Brickell’s stockholders received common stock,
representing approximately 56% of the outstanding shares and
Vical’s stockholders retained approximately 44% based on certain
assumptions regarding the calculation of the fully diluted
shares.
The combined company will continue to operate
under the leadership of Robert Brown as Chief Executive Officer.
Rob joined Brickell in January 2019 from Eli Lilly where, for the
prior ten years, he was the Chief Marketing Officer overseeing
global product launches and commercial operations of the
company.
About Sofpironium Bromide
Sofpironium bromide is a new molecular entity
and “soft” drug 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 the activation of sweat glands. Soft drugs, such as
sofpironium bromide, are designed to exert their action topically
and be rapidly metabolized once absorbed into the blood. This
mechanism of action may allow for highly effective doses to be used
while limiting systemic side effects associated with drugs in this
class.
Based upon the positive Phase 2 clinical trial
results and the recently completed pivotal Phase 3 clinical trial
results from Brickell’s Japanese partner, Kaken, as well as
Brickell’s ongoing Phase 3 long-term safety study, Brickell intends
to initiate two pivotal Phase 3 clinical trials in patients with
primary axillary hyperhidrosis in the United States in the fourth
quarter of 2019.
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 or when
Brickell will achieve any of the milestones in the funding
agreement with NovaQuest, 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 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:
Adam LevyChief Business OfficerIR@brickellbio.com
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