Dermira Presents New Data On Late-Stage Programs At Leading European Dermatology Congress
- New findings from the glycopyrronium tosylate Phase 3 program highlight potential benefits of the investigational treatment and the impact of primary axillary hyperhidrosis on patients’ daily activities
- In collaboration with UCB, new 48-week data and quality of life findings from three clinical trials evaluating CIMZIA® (certolizumab pegol) in patients with moderate-to-severe chronic plaque psoriasis will also be presented
MENLO PARK, Calif., Sept. 07, 2017 (GLOBE NEWSWIRE) -- 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) and CIMZIA® (certolizumab pegol) Phase 3 clinical programs will be presented in poster sessions at the 26th European Academy of Dermatology and Venereology (EADV) Congress, taking place in Geneva, Switzerland, September 13 – 17.
Newly reported data from the Phase 3 glycopyrronium tosylate clinical program will highlight the impact of primary axillary hyperhidrosis (excessive underarm sweating) on the daily lives of patients before and following four weeks of treatment with glycopyrronium tosylate. Primary axillary hyperhidrosis is a medical condition in which sweating occurs beyond what is needed for normal body temperature regulation. Glycopyrronium tosylate is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
Dermira and UCB will also present new 48-week clinical efficacy data and quality of life findings from the Phase 3 clinical program evaluating CIMIZA in patients with moderate-to-severe chronic plaque psoriasis. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
“We are pleased to be presenting data that allow us to share the advancements made toward the treatment of skin conditions like plaque psoriasis and hyperhidrosis, which research shows can have a profound negative impact on a person’s overall quality of life,” said Eugene A. Bauer, M.D., chief medical officer of Dermira and a dermatologist. “The new findings that will be presented for the glycopyrronium tosylate and CIMZIA Phase 3 programs provide important new insights into how these potential treatment options could one day have both a meaningful clinical benefit and offer improvements in how patients manage these conditions.”
Glycopyrronium tosylate abstracts of interest:
Title: Burden of Axillary Hyperhidrosis Using a Patient-Reported Outcome Measure to Assess Impact on Activities and Bothersomeness
Date and Time: September 13, 2017 at 08:00 - 16:00 GMT
Location: Available in ePoster area
ePoster ID: P2145
Title: Patient-Reported Outcomes From Two Randomized, Double-Blind, Vehicle-Controlled Phase 3 Trials in Axillary Hyperhidrosis (ATMOS-1 & ATMOS-2)
Date and Time: September 13, 2017 at 08:00 - 16:00 GMT
Location: Available in ePoster area
ePoster ID: P2144
Title: Confirmatory Psychometric Evaluation of the Axillary Sweating Daily Diary: A Validated Patient-Reported Outcome Measure to Assess Axillary Hyperhidrosis Sweating Severity
Date and Time: September 13, 2017 at 08:00 - 16:00 GMT
Location: Available in ePoster area
ePoster ID: P2143
Abstract Number: TBD
CIMZIA abstracts of interest:
Title: Maintenance of Response With Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results of a 32-Week Re-Randomized Maintenance Period From an Ongoing Phase 3, Multicenter, Randomized, Active- and Placebo-Controlled Study (CIMPACT)
Date and Time: September 13, 2017 at 08:00 - 16:00 GMT
Location: Psoriasis (e-Poster presentation)
ePoster ID: P1969
Title: Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: DLQI and WPAI Patient-Reported Outcomes From an Ongoing Phase 3, Multicenter, Randomized, Active- and Placebo-Controlled Study (CIMPACT)
Date and Time: September 13, 2017 at 08:00 - 16:00 GMT
Location: Psoriasis (e-Poster presentation)
ePoster ID: P1967
Title: Maintenance of Response With Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: 48-Week Results From Two Ongoing Phase 3, Multicenter, Randomized, Placebo-Controlled Studies (CIMPASI-1 and CIMPASI-2)
Date and Time: September 13, 2017 at 08:00 - 16:00 GMT
Location: Psoriasis (e-Poster presentation)
ePoster ID: P1973
Title: Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: DLQI and WPAI Patient-Reported Outcomes From Two Ongoing Phase 3, Multicenter, Randomized, Placebo-Controlled Studies (CIMPASI-1 and CIMPASI-2)
Date and Time: September 13, 2017 at 08:00 - 16:00 GMT
Location: Psoriasis (e-Poster presentation)
ePoster ID: P1971
About Glycopyrronium Tosylate
Glycopyrronium tosylate is formulated as a once-daily anticholinergic agent, administered as a topical wipe that is currently in clinical development for the treatment of primary axillary hyperhidrosis. Glycopyrronium tosylate is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
About Cimzia® In the US
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
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.
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. Dermira’s pipeline includes three late-stage candidates that could have a profound impact on the lives of patients: CIMZIA® (certolizumab pegol), for which marketing applications have been submitted for potential approval for the treatment of moderate-to-severe chronic plaque psoriasis in collaboration with UCB Pharma S.A.; glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and olumacostat glasaretil (formerly DRM01), in Phase 3 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 Statements
The 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 glycopyrronium tosylate and CIMZIA as potential treatment options that could have a meaningful clinical benefit and offer improvements in how patients manage excessive sweating and plaque psoriasis, respectively. 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.
Dermira Contacts: Media: Erica Jefferson Senior Director, Head of Corporate Communications 650-421-7216 media@dermira.com Investors: Ian Clements Vice President, Investor Relations 650-421-7200 investors@dermira.com Robert H. Uhl Westwicke Partners Managing Director 858-356-5932 robert.uhl@westwicke.com