- 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
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.
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
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
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
ENBREL® is a registered trademark of Amgen Inc.
In addition to filings with the
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
Erica JeffersonSenior Director, Head of Corporate Communications 650-421-7216 firstname.lastname@example.org Investors: Andrew GuggenhimeChief Operating Officer and Chief Financial Officer 650-421-7200 email@example.com Robert H. Uhl Westwicke PartnersManaging Director 858-356-5932 firstname.lastname@example.org