Dermira to Highlight Data for Three Clinical Programs at Annual Maui Derm Meeting
March 17 2017 - 8:30AM
Dermira, Inc. (NASDAQ:DERM), 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, today announced that data from its
glycopyrronium tosylate (formerly DRM04), CIMZIA® (certolizumab
pegol) and olumacostat glasaretil (formerly DRM01) clinical
programs will be highlighted in poster presentations during the
13th Annual Maui Derm for Dermatologists 2017 meeting being held in
Maui, Hawaii, March 20-24, 2017.
New data for the Axillary Sweating Daily Diary (ASDD), Dermira’s
proprietary patient-reported outcome (PRO) instrument designed to
measure sweating severity and its impact on daily activities for
patients, will be highlighted during the meeting. Dermira developed
the ASDD instrument in accordance with the 2009 U.S. Food and Drug
Administration (FDA) guidance document for PRO instruments and
validated a portion of the instrument with input from the FDA.
Based on results from the glycopyrronium tosylate Phase 2b trial,
in which the instrument was initially evaluated and feedback from
the FDA, the selected portion of the tool was used as a co-primary
endpoint in the Phase 3 clinical program.
Additional data from the CIMPACT Phase 3 clinical trial,
evaluating the efficacy and safety of CIMZIA in adult patients with
moderate-to-severe chronic plaque psoriasis, will also be
presented. The data will show results from two secondary endpoints
in the trial: the percentage of patients on CIMZIA who achieved a
90% or greater disease improvement from baseline as measured by the
Psoriasis Area and Severity Index (PASI 90), compared with placebo,
at week 16 and the percentage of patients on CIMZIA who achieved a
75% or greater disease improvement from baseline (PASI 75) compared
to ENBREL® (etanercept) at week 12. Primary safety and efficacy
results from CIMPACT were reported in January 2017. CIMZIA is not
currently approved for the treatment of psoriasis by any regulatory
authority worldwide.
Previously reported data from the Phase 2b clinical trial for
olumacostat glasaretil in the treatment of acne will also be
featured at the meeting.
“The Maui Derm meeting is becoming an important forum to present
data on innovative and differentiated treatments for various skin
conditions,” said Eugene A. Bauer, M.D., chief medical officer of
Dermira and a dermatologist. “We are pleased to present data from
our three late-stage programs in hyperhidrosis, psoriasis and acne
and look forward to continuing our dialogue with dermatologists
about how our product candidates might one day benefit patients
living with skin conditions.”
Important Safety Information about Cimzia® in the
US
Serious and sometimes fatal side effects have been
reported with CIMZIA, including tuberculosis (TB), bacterial
sepsis, invasive fungal infections (such as histoplasmosis), and
infections due to other opportunistic pathogens (such as Legionella
or Listeria). Patients should be closely monitored for the signs
and symptoms of infection during and after treatment with CIMZIA.
Lymphoma and other malignancies, some fatal, have been reported in
children and adolescent patients treated with TNF blockers, of
which CIMZIA is a member. CIMZIA is not indicated for use in
pediatric patients.
Other serious side effects have been reported with CIMZIA,
including heart failure, anaphylaxis or serious allergic reactions,
hepatitis B reactivation, nervous system disorders, blood problems,
and certain immune reactions (including a lupus-like syndrome). It
is not recommended to administer CIMZIA with other biologic DMARDs
due to an increased risk of infections. In pre-marketing controlled
trials of all patient populations combined, the most common adverse
reactions (≥8%) were upper respiratory infections (18%), rash (9%),
and urinary tract infections (8%).
For full prescribing information, please visit www.ucb.com
CIMZIA® is a registered trademark of the UCB Group of
Companies.
ENBREL® is a registered trademark of Amgen Inc.
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 and develop
leading-edge medical dermatology programs. Dermira’s product
pipeline includes three Phase 3 product candidates that could have
a profound impact on the lives of patients: glycopyrronium
tosylate, in development for the treatment of primary axillary
hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab
pegol), in development in collaboration with UCB Pharma S.A. for
the treatment of moderate-to-severe chronic plaque psoriasis; and
olumacostat glasaretil, in development for the treatment of acne
vulgaris. Dermira is headquartered in Menlo Park, Calif. For more
information, please visit www.dermira.com.
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) and LinkedIn
page (https://www.linkedin.com/company/dermira-inc-) 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 and LinkedIn page in addition to following its SEC filings,
press releases, public conference calls and webcasts.
Forward-Looking StatementsThe information in
this press 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 press release contains forward-looking
statements that involve substantial risks and uncertainties,
including statements with respect to Dermira’s product candidates
and the benefits they may provide in the future to patients living
with skin conditions. 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 the design, implementation and outcomes of
Dermira’s clinical trials; Dermira’s dependence on third-party
clinical research organizations, manufacturers and suppliers; the
outcomes of future meetings with regulatory agencies; 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 press 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 Jefferson
Senior Director, Head of Corporate Communications
650-421-7216
erica.jefferson@dermira.com
Investors:
Andrew Guggenhime
Chief Operating Officer and Chief Financial Officer
650-421-7200
investor@dermira.com
Robert H. Uhl
Westwicke Partners
Managing Director
858-356-5932
robert.uhl@westwicke.com
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