Dermira Provides Corporate Update
January 06 2017 - 7:30AM
Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated
to identifying, developing and commercializing innovative,
differentiated therapies to improve the lives of patients with
dermatologic diseases, today provided an update on its clinical
development programs and recent leadership additions.
“In 2016, Dermira made tremendous progress as an organization,
announcing positive clinical results from all three of our
late-stage clinical programs,” said Tom Wiggans, chairman and chief
executive officer of Dermira. “As we prepare for 2017, we look
forward to a number of milestones, including potential marketing
applications for CIMZIA and DRM04 and focusing on enrolling our
Phase 3 acne clinical program.”
Clinical Pipeline Update and Key Milestones
- Completed treatment period for DRM04 ARIDO
trial – In December 2016, the treatment period for
ARIDO, an open-label Phase 3 trial assessing the long-term safety
of DRM04, was completed. Based on a preliminary review, the safety
and tolerability profile for DRM04 appears consistent with what was
observed in the ATMOS-1 and ATMOS-2 Phase 3 clinical
trials.
- Initiated olumacostat glasaretil Phase 3 clinical
program – In January 2017, Dermira announced dosing of the
first patients in the Phase 3 program evaluating the safety and
efficacy of olumacostat glasaretil (formerly DRM01), a novel small
molecule designed to reduce sebum production following topical
application, in patients with acne vulgaris. The Phase 3 clinical
program consists of two randomized, multi-center, double-blind,
parallel-group, vehicle-controlled trials, CLAREOS-1 and CLAREOS-2,
which are expected to enroll a total of approximately 1,400
patients ages nine and older with moderate-to-severe acne vulgaris
at approximately 100 sites in the United States, Canada and
Australia. The Phase 3 program also will include an open-label
study, CLARITUDE, assessing the long-term safety of olumacostat
glasaretil, in which patients from either of the two Phase 3
studies will be permitted to continue to receive treatment for up
to an additional 36 weeks. Topline results from CLAREOS-1 and
CLAREOS-2 are expected in the first half of 2018.
- Topline results from final Phase 3 CIMZIA trial
expected in first quarter of 2017 – Topline results from
CIMPACT, the third and final trial of the CIMZIA® (certolizumab
pegol) Phase 3 psoriasis program, are expected in the first quarter
of 2017. Subject to positive results from the CIMPACT trial,
Dermira and UCB S.A. plan to submit data from the Phase 3 program
to regulatory authorities to support potential approvals for
CIMIZIA as a treatment option for patients with moderate-to-severe
chronic plaque psoriasis. Dermira and UCB previously announced
topline results from CIMPASI-1 and CIMPASI-2, two identical, Phase
3, multi-center, placebo-controlled clinical trials evaluating the
efficacy and safety of CIMZIA in adult patients with
moderate-to-severe chronic plaque psoriasis. In both the CIMPASI-1
and CIMPASI-2 trials, CIMZIA demonstrated statistically significant
improvements for both co-primary endpoints compared to placebo for
both treatment doses. CIMZIA is not currently approved for the
treatment of psoriasis by any regulatory authority
worldwide.
- Submission of New Drug Application (NDA) to U.S. Food
and Drug Administration (FDA) for DRM04 expected in second half of
2017 – Subject to a pre-NDA meeting with the FDA and other
registration-enabling activities, Dermira plans to submit a
marketing application to the FDA for approval of DRM04 for the
treatment of axillary hyperhidrosis in the second half of
2017.
Recent Leadership Updates
- Appointed Lori Lyons-Williams as Chief Commercial
Officer – In January 2017, Dermira announced the
appointment of Ms. Lyons-Williams, who will be responsible for
developing and implementing the commercial strategy for Dermira’s
Phase 3 product candidates: CIMZIA, in collaboration with UCB,
DRM04 and olumacostat glasaretil. Ms. Lyons-Williams joined after a
15-year tenure in various leadership positions at Allergan, Inc.
- Expanded Board of Directors – In January 2017,
Dermira announced the election of Emmanuel Caeymaex, Executive Vice
President, Immunology Patient Value Unit Head at UCB S.A., to its
board of directors. Mr. Caeymaex leads the worldwide development
and commercialization of innovative patient-oriented solutions for
people suffering from various auto-immune disorders and skin
conditions. Mark McDade, who formerly served as an Executive Vice
President and the Chief Operating Officer of UCB, had been UCB’s
designee to Dermira’s board of directors since 2014. Mr. McDade
will continue to serve as a director on Dermira’s board.
About DermiraDermira is a biopharmaceutical
company dedicated to identifying, developing and commercializing
innovative, differentiated therapies to improve the lives of
patients with dermatologic diseases. Dermira’s portfolio includes
three Phase 3 product candidates that target significant unmet
needs and market opportunities: CIMZIA® (certolizumab pegol), in
development in collaboration with UCB Pharma S.A. for the treatment
of moderate-to-severe chronic plaque psoriasis; DRM04, in
development for the treatment of primary axillary hyperhidrosis
(excessive underarm sweating); and olumacostat glasaretil, in
development for the treatment of acne vulgaris. Dermira is
headquartered in Menlo Park, California. 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 timing expectations for the
receipt and announcement of topline efficacy and safety data from
the CIMPACT study; expectations regarding results from the CIMZIA
Phase 3 clinical trial program; the potential submission of
marketing applications for CIMIZIA and DRM04 and the timing
expectations for such applications; potential approval of CIMZIA as
a treatment option for moderate-to-severe plaque psoriasis;
potential approval of DRM04 for the treatment of axillary
hyperhidrosis; the design, description of and enrollment
expectations for the olumacostat glasaretil Phase 3 program; the
successful completion of, and timing expectations for the receipt
of data from, the olumacostat glasaretil Phase 3 program; the
anticipated safety and tolerability profile for DRM04 based on
preliminary review of results from the ARIDO trial; and the
potential commercialization of Dermira’s product candidates. 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, including related to further analysis of the results of our
studies; the outcome of future discussions with regulatory
authorities relating to Dermira’s clinical programs; Dermira’s
dependence on third-party clinical research organizations,
manufacturers and suppliers; Dermira’s ability to attract and
retain key employees; Dermira’s ability to obtain necessary
additional capital; 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
investors@dermira.com
Robert H. Uhl
Westwicke Partners
Managing Director
858.356.5932
robert.uhl@westwicke.com
Journey Medical (NASDAQ:DERM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Journey Medical (NASDAQ:DERM)
Historical Stock Chart
From Apr 2023 to Apr 2024