Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated
to bringing biotech ingenuity to medical dermatology by delivering
differentiated, new therapies to the millions of people living with
chronic skin conditions, today announced that new post-hoc analyses
from its glycopyrronium tosylate (QBREXZA™ (glycopyrronium) cloth)
clinical program will be presented in poster format at the 77th
Annual Meeting of the American Academy of Dermatology (AAD) being
held in Washington, D.C., March 1-5, 2019.
Poster presentations will highlight post-hoc data analyses from
the Phase 3 clinical trials evaluating glycopyrronium tosylate in
patients 9 years and older with primary axillary hyperhidrosis,
commonly referred to as excessive underarm sweating. Two posters
will feature new analyses from the ARIDO open-label, Phase 3
extension study and will focus on management of treatment-emergent
adverse events, as well as efficacy for patients who were
previously treated with vehicle and transitioned to glycopyrronium
tosylate in ARIDO. A third poster will highlight data from the
ATMOS-1 and ATMOS-2 Phase 3 trials evaluating glycopyrronium
tosylate’s benefit in the treatment of primary axillary
hyperhidrosis across a variety of sub-populations, including
gender, race, and the presence or absence of other sites on the
body affected by hyperhidrosis.
Primary axillary hyperhidrosis is a medical condition that
results in sweating beyond what is needed for normal body
temperature regulation. The condition affects more than 10 million
people in the United States. Glycopyrronium tosylate, now QBREXZA™
(glycopyrronium) cloth, is a topical, once-daily anticholinergic
cloth, designed to block sweat production by inhibiting the
interaction between acetylcholine and the cholinergic receptors
responsible for sweat gland activation. QBREXZA was approved by the
U.S. Food and Drug Administration in June 2018 to treat primary
axillary hyperhidrosis in people 9 years of age and older.
“These data not only underscore glycopyrronium tosylate’s
utility in helping to reduce a person’s excessive underarm sweat,
but also highlight the potential benefit glycopyrronium tosylate
could provide for patients currently living with this chronic skin
condition longer-term,” said Eugene A. Bauer, M.D., chief medical
officer at Dermira. “We are committed to understanding the full
benefit of glycopyrronium tosylate and how it can have a positive
impact on different populations of people living with primary
axillary hyperhidrosis, a chronic medical condition affecting
millions of people in the United States.”
Posters of Interest
Oral Poster Presentation Friday, March 1, 2019 from 11:00-11:05
a.m. ETWalter E. Washington Convention CenterHall H, ePoster
Presentation Center 1Also available as an ePoster throughout the
conference in Hall D
Poster 9906: An Evaluation of Anticholinergic
Adverse Events with Long-Term Use of Topical Glycopyrronium
Tosylate, a Treatment for Primary Axillary Hyperhidrosis
ePoster Presentations Available: Friday, March 1 through Sunday,
March 3, 20199:00 a.m. – 5:00 p.m. ETHall D, Walter E. Washington
Convention Center
Poster 8599: Glycopyrronium Cloth Improves
Axillary Hyperhidrosis Across a Broad Spectrum of Patients: Post
Hoc Analyses of the ATMOS-1 and ATMOS-2 Phase 3 Randomized
Controlled Trials in Patient Subpopulations
Poster 9910: Long-Term Response of Topical
Glycopyrronium Tosylate in Patients with Primary Axillary
Hyperhidrosis According to Double-Blind Treatment Group
All three posters are also available via the AAD mobile
app starting March 1st at 7:00 AM EST.
About HyperhidrosisHyperhidrosis is a condition
of sweating beyond what is physiologically required for normal
thermal regulation and affects an estimated 4.8% of the U.S.
population, or approximately 15 million people.1 Of these, 65
percent, or nearly 10 million people, suffer from sweating
localized to the underarms (axillary disease). Studies have
demonstrated that excessive sweating often impedes normal daily
activities and can also result in occupational, emotional,
psychological, social and physical impairment.1,2
About QBREXZA™ (glycopyrronium) clothQBREXZA
(pronounced kew brex’ zah) is an anticholinergic indicated for
topical treatment of primary axillary hyperhidrosis in adult and
pediatric patients 9 years of age and older. QBREXZA is
applied directly to the skin and is designed to block sweat
production by inhibiting sweat gland activation. For more
information visit www.QBREXZA.com.
Important Safety Information
CONTRAINDICATIONS QBREXZA is contraindicated in patients with
medical conditions that can be exacerbated by the anticholinergic
effect of QBREXZA.
WARNINGS AND PRECAUTIONS Worsening of Urinary Retention: Use
with caution in patients with a history or presence of documented
urinary retention.
Control of Body Temperature: In the presence of high ambient
temperature, heat illness (hyperpyrexia and heat stroke due to
decreased sweating) can occur with the use of anticholinergic drugs
such as QBREXZA.
Operating Machinery or an Automobile: Transient blurred vision
may occur with use of QBREXZA. If blurred vision occurs, the
patient should discontinue use until symptoms resolve. Patients
should be warned not to engage in activities that require clear
vision such as operating a motor vehicle or other machinery, or
performing hazardous work until the symptoms have resolved.
ADVERSE REACTIONS The most common adverse reactions seen in ≥2%
of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis
(6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary
hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry
throat (2.6%), dry eye (2.4%), dry skin (2.2%) and constipation
(2.0%). Local skin reactions of erythema (17.0%), burning/stinging
(14.1%) and pruritus (8.1%) were also common.
It is important for patients to understand how to correctly
apply QBREXZA (see Patient Product Information). Instruct patients
to wash their hands with soap and water immediately after
discarding the used cloth.
Please see Full Prescribing Information.
About DermiraDermira is a
biopharmaceutical company dedicated to bringing biotech ingenuity
to medical dermatology by delivering differentiated, new therapies
to the millions of patients living with chronic skin
conditions. Dermira is committed to understanding the
needs of both patients and physicians and using its insight to
identify, develop and commercialize leading-edge medical
dermatology products. The company’s approved treatment, QBREXZA™
(glycopyrronium) cloth, is indicated for pediatric and adult
patients (ages 9 and older) with primary axillary hyperhidrosis
(excessive underarm sweating). Dermira is also evaluating
lebrikizumab in a Phase 2b clinical trial for the treatment of
moderate-to-severe atopic dermatitis (a severe form of eczema) and
has early-stage research programs in other areas of dermatology.
Dermira is headquartered in Menlo Park, Calif. For
more information, please visit http://www.dermira.com.
Follow Dermira
on Twitter, LinkedIn and Instagram.
In addition to filings with the Securities and Exchange
Commission (SEC), press releases, public conference calls and
webcasts, Dermira uses its website (www.dermira.com),
LinkedIn page (https://www.linkedin.com/company/dermira-inc-),
corporate Instagram account
(https://www.instagram.com/dermira_inc/) and corporate Twitter
account (@DermiraInc) as channels of distribution of information
about its company, product candidates, planned financial and other
announcements, attendance at upcoming investor and industry
conferences and other matters. Such information may be deemed
material information and Dermira may use these channels
to comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor Dermira’s website, LinkedIn
page, Instagram and Twitter accounts in addition to following
its SEC filings, news releases, public conference calls
and webcasts.
Forward-looking statementsThe information in
this news release contains forward-looking statements and
information within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, which are subject to the “safe harbor” created
by those sections. This news release contains forward-looking
statements that involve substantial risks and uncertainties,
including statements with respect to: Dermira’s goal of bringing
biotech ingenuity to medical dermatology by delivering
differentiated, new therapies to the millions of patients living
with chronic skin conditions; and the potential longer-term benefit
glycopyrronium tosylate could provide for patients currently living
with primary axillary hyperhidrosis. These statements deal with
future events and involve known and unknown risks, uncertainties
and other factors that may cause actual results, performance or
achievements to be materially different from the information
expressed or implied by these forward-looking statements. Factors
that could cause actual results to differ materially include risks
and uncertainties such as those relating to Dermira’s dependence on
third-party clinical research organizations, manufacturers,
suppliers and distributors; Dermira’s ability to attract and retain
key employees; Dermira’s ability to obtain necessary additional
capital; market acceptance of Dermira’s current and future
products; the impact of competitive products and therapies;
Dermira’s ability to manage the growth and complexity of its
organization; Dermira’s ability to maintain, protect and enhance
its intellectual property; and Dermira’s ability to continue to
stay in compliance with its material contractual obligations,
applicable laws and regulations. You should refer to the section
entitled “Risk Factors” set forth in Dermira’s Annual Report on
Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other
filings Dermira makes with the SEC from time to time
for a discussion of important factors that may cause actual results
to differ materially from those expressed or implied by Dermira’s
forward-looking statements. Furthermore, such forward-looking
statements speak only as of the date of this news
release. Dermira undertakes no obligation to publicly
update any forward-looking statements or reasons why actual results
might differ, whether as a result of new information, future events
or otherwise, except as required by law.
Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650.421.7216erica.jefferson@dermira.com
Erin MurphyDirector, Corporate
Communications650.422.7746erin.murphy@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650.422.7753ian.clements@dermira.com
- Doolittle et. al., Hyperhidrosis: An Update on Prevalence and
Severity in the United States. Arch Dermatol Res.
308:743-749, 2016.
- Kamudoni, et al., The impact of hyperhidrosis on patients’
daily life and quality of life: a qualitative investigation. Health
and Quality of Life Outcomes, 15(1). 2017.
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