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, announced today that QBREXZA™
(glycopyrronium) cloth is now available for prescribing to treat
primary axillary hyperhidrosis, commonly known as excessive
underarm sweating. The new therapy is available in retail and
community pharmacies nationwide. In June 2018, QBREXZA, a
once-daily, prescription anticholinergic, was 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.
“People living with primary axillary hyperhidrosis often report
feelings of isolation, and struggle in silence for years before
finally speaking to a healthcare professional. In most instances,
people are often too embarrassed to seek treatment, and when they
do, they may not find solutions that effectively control their
excessive underarm sweating,” said Lisa J. Pieretti, Executive
Director for the International Hyperhidrosis Society and a patient
advocate for more than 15 years. “The availability of QBREXZA
represents an FDA-approved, topical medicine for the millions of
adults and children who may be looking for a new way to treat their
excessive underarm sweating. It is my hope that many of these
sufferers will finally get the sweat help they have been seeking
much of their lives.”
To provide seamless and affordable access to QBREXZA, Dermira
recently announced the launch of DermiraConnect. The program is
designed to offer financial assistance and other customized support
services to eligible patients and healthcare professionals seeking
to access QBREXZA.
To date, Dermira has secured coverage for approximately 53% of
the total U.S. commercial lives, exceeding the Company’s goal of
securing more than 30% coverage by October 1, 2018 and 50% coverage
by January 1, 2019.* In addition to Express Scripts, Inc. and
OptumRx, several other payers have also agreed to provide access to
QBREXZA through their national formularies beginning today.
“We are thrilled that QBREXZA is now available to dermatologists
and patients as a new treatment option for primary axillary
hyperhidrosis,” said Tom Wiggans, chairman and chief executive
officer at Dermira. “This condition can have a significant impact
on the way people with this condition feel and the choices they
make in their lives. We hope that patients treated with QBREXZA not
only experience a reduction in sweat, but also a renewed
confidence. No one, adult or child, should feel isolated or suffer
in silence because of a treatable medical condition like primary
axillary hyperhidrosis.”
*Percentage calculated based on Dermira data on file.
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 DermiraConnectTo ensure seamless,
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.
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 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 and develop leading-edge medical dermatology programs. 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 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; the intended benefits
of DermiraConnect of providing seamless and affordable access to
QBREXZA; and the hope that patients treated with QBREXZA will not
only experience a reduction in sweat, but also a renewed
confidence. 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 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 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 Communications650-422-7746
erin.murphy@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650-422-7753investor@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.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/f86b8ca3-6298-474c-a8a8-ba7e6fe53ab2
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