- New data for the Axillary Sweating Daily Diary patient-reported outcome instrument from the glycopyrronium tosylate Phase 2 trial in primary axillary hyperhidrosis to be highlighted
- Additional data from the CIMPACT Phase 3 trial of CIMZIA® (certolizumab pegol) in patients with moderate-to-severe psoriasis will be presented
MENLO PARK, Calif., March 17, 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), 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.
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 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.
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 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.
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