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 the launch of “Life
Unfolds,” a new direct-to-consumer creative campaign designed to
generate awareness of QBREXZA™ (glycopyrronium) cloth as a
potential treatment option for people living with primary axillary
hyperhidrosis, commonly known as excessive underarm sweating.
QBREXZA, the first and only, once-daily, topical prescription
anticholinergic, is approved by the U.S. Food and Drug
Administration (FDA) to treat adult and pediatric patients 9 years
of age and older living with this chronic, medical skin condition.
The multichannel campaign will launch with a direct-to-consumer
television advertisement featuring QBREXZA patients and highlight
uncomfortable situations that people living with the condition
routinely experience. Additionally, the campaign will launch in
national consumer print media outlets, across digital and social
media platforms and in dermatologists’ offices across the United
States. Visit www.Qbrexza.com to learn more about the treatment,
including appropriate use and important safety
information.
“The Life Unfolds campaign was contemplated, designed and
developed based on feedback from people living with primary
axillary hyperhidrosis who provided us with important insights on
what it means to live with this condition and their expectations
for potential treatment options,” said Lori Lyons-Williams, chief
commercial officer at Dermira. “The goal of this multichannel
creative campaign is to show real people who are currently managing
their excessive underarm sweating with QBREXZA therapy and
encourage others who might be suffering to consider seeing a
dermatologist to learn what impact the treatment may have on their
lives.”
The campaign supports Dermira’s commitment to educate patients
about its therapies in a transparent and patient-focused
manner.
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.
About DermiraConnectTo support, convenient and
affordable access to our medicines, DermiraConnect is designed to
offer financial assistance and other customized support services
for eligible patients and healthcare professionals. For more
information about DermiraConnect, visit www.dermiraconnect.com or
call 1-877-DERMIRA.
Important Safety
InformationContraindications: QBREXZA is
contraindicated in patients with medical conditions that can be
exacerbated by the anticholinergic effect of QBREXZA (e.g.,
glaucoma, paralytic ileus, unstable cardiovascular status in acute
hemorrhage, severe ulcerative colitis, toxic megacolon complicating
ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
WARNINGS AND PRECAUTIONS
Worsening of Urinary Retention: QBREXZA should
be used with caution in patients with a history or presence of
documented urinary retention. Prescribers and patients should be
alert for signs and symptoms of urinary retention (e.g., difficulty
passing urine, distended bladder), especially in patients with
prostatic hypertrophy or bladder-neck obstruction. Instruct
patients to discontinue use immediately and consult a physician
should any of these signs or symptoms develop. Patients with a
history of urinary retention were not included in the clinical
studies.
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. Advise patients using
QBREXZA to watch for generalized lack of sweating when in hot or
very warm environmental temperatures and to avoid use if not
sweating under these conditions.
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, including erythema (17.0%), burning/stinging
(14.1%) and pruritus (8.1%) were also common.
DRUG INTERACTIONS
Anticholinergics: Coadministration of QBREXZA
with anticholinergic medications may result in additive interaction
leading to an increase in anticholinergic adverse effects. Avoid
coadministration of QBREXZA with other anticholinergic-containing
drugs.
INSTRUCTIONS FOR ADMINISTERING QBREXZA
Instruct patients to use one cloth to apply QBREXZA to both
axillae by wiping the cloth across one underarm, ONE TIME. Using
the same cloth, apply the medication to the other underarm, ONE
TIME. Inform patients that QBREXZA can cause temporary dilation of
the pupils and blurred vision if it comes in contact with the
eyes.
Instruct patients to wash their hands with soap and water
immediately after discarding the used cloth.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data on
QBREXZA use in pregnant women to inform a drug-associated risk for
adverse developmental outcomes.
Lactation: There are no data on the presence of
glycopyrrolate or its metabolites in human milk, the effects on the
breastfed infant, or the effects on milk production. The
developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for QBREXZA and
any potential adverse effects on the breastfed infant from QBREXZA
or from the underlying maternal condition.
Renal Impairment: The elimination of
glycopyrronium is severely impaired in patients with renal
failure.
Please see Full Prescribing Information
About Dermira Dermira 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). Please see the QBREXZA prescribing
information. Dermira is also evaluating lebrikizumab for the
treatment of moderate-to-severe atopic dermatitis (a severe form of
eczema) and plans to initiate a Phase 3 clinical development
program by the end of 2019; and has early-stage research and
development 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 Statements The
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; Dermira’s plans and
strategies relating to its direct-to-consumer campaign, including
goals to generate awareness of QBREXZA™ (glycopyrronium) cloth as a
potential treatment option for people living with primary axillary
hyperhidrosis and to and encourage others who might be suffering
from primary axillary hyperhidrosis to consider seeing a
dermatologist to learn what impact the treatment may have on their
lives; and the intended benefits of DermiraConnect of providing
financial assistance and other customized support services for
eligible patients and healthcare professionals. 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 market acceptance of Dermira’s potential 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 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
Relations650-422-7753investor@dermira.com
References
- 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.
A video accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/ca672c1e-ab7c-4cd0-acf4-9636e75ee698
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/d0ade989-d66d-4a3f-ae75-186d9ff5a6b8
Journey Medical (NASDAQ:DERM)
Historical Stock Chart
From Jun 2024 to Jul 2024
Journey Medical (NASDAQ:DERM)
Historical Stock Chart
From Jul 2023 to Jul 2024