October 21, 2016 11:34 PM ET


Company Overview of Dermira, Inc.

Company Overview

Dermira, Inc., a biopharmaceutical company, engages in identifying, developing, and commercializing therapies to enhance the lives of patients with dermatologic diseases primarily in the United States. The company’s late-stage product candidates comprise Cimzia, an injectable biologic tumor necrosis factor-alpha inhibitor, which is in Phase III clinical trial for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, a small-molecule anticholinergic product that is in Phase III clinical trial for the treatment of primary axillary hyperhidrosis or excessive underarm sweating; and DRM01, a small-molecule sebum inhibitor, which is in Phase IIb clinical trial for the treatment of a...

275 Middlefield Road

Suite 150

Menlo Park, CA 94025

United States

Founded in 2010

62 Employees



Key Executives for Dermira, Inc.

Co-Founder, Chairman and Chief Executive Officer
Age: 64
Total Annual Compensation: $465.0K
Co-Founder, Chief Medical Officer, Director and Member of Science & Technology Committee
Age: 74
Total Annual Compensation: $350.0K
Chief Financial Officer and Chief Operating Officer
Age: 48
Total Annual Compensation: $355.0K
Chief Development Officer
Age: 54
Total Annual Compensation: $300.0K
Compensation as of Fiscal Year 2015.

Dermira, Inc. Key Developments

Dermira, Inc. Announces Data from DRM01 and DRM04 Clinical Programs at Fall Clinical Dermatology Conference

Dermira, Inc. announced that data from its DRM01 and DRM04 clinical programs will be presented at the 35thAnniversary Fall Clinical Dermatology Conference being held in Las Vegas Oct. 20 – 23, 2016. Updated data regarding dose efficacy from the Phase 2b trial evaluating DRM01 as a potential option for patients with acne vulgaris will be presented. The results from two Phase 3 clinical trials evaluating DRM04 as a potential treatment for patients with primary axillary hyperhidrosis (excessive underarm sweating) will also be highlighted during the meeting. Presentations of Interest: Title:DRM01 for the treatment of acne vulgaris: Primary results from the DRM01-ACN02 Phase 2b randomized controlled trial. Date and Time: Available for the duration of the meeting. Presenter: Jim Del Rosso, D.O., an adjunct clinical professor of dermatology at Touro University College of Osteopathic Medicine. Session: General Session. Title: DRM04 for the treatment of axillary hyperhidrosis: Primary results from the ATMOS-1 and ATMOS-2 Phase 3 randomized controlled trials. Date and Time: Available for the duration of the meeting. Presenter: David Pariser, M.D., professor at Eastern Virginia Medical School’s Department of Dermatology. Session: General Session.

Dermira, Inc. Announces Encouraging Data from Phase III Hyperhidrosis Study

Dermira, Inc. has announced encouraging data, including new disease-related quality of life data, from its DRM04 Phase III clinical program in patients with primary axillary hyperhidrosis. In June 2016, positive top line results from the Phase III ATMOS-1 and ATMOS-2 pivotal trials evaluating the safety and efficacy of DRM04, a topical anticholinergic product candidate, compared to vehicle were reported showing significant improvements in patient-reported disease severity following four weeks of treatment. New findings presented found that patients treated with DRM04 reported significant improvements in their disease-related quality of life compared to patients who received vehicle only. DRM04 showed a mean improvement from baseline in the Dermatology Life Quality Index (DLQI) score compared to vehicle in both the ATMOS-1 (decrease of 8.1 vs. 4.3; p 5.0; p<0.001) clinical trials, at week 4. A decrease in a patient's DLQI score translates to overall improved satisfaction in the management of their skin condition. DLQI is a widely used and recognized quality of life measurement instrument frequently used across several dermatologic conditions. Dermira intends to present additional patient quality of life data as measured by the Axillary Sweating Daily Diary (ASDD), its proprietary patient-reported outcome (PRO) instrument, in peer-reviewed forums. The ASDD instrument was developed and validated by Dermira in accordance with the 2009 FDA guidance document for PRO instruments. In June 2016, Dermira reported topline results from two DRM04 Phase III clinical trials, ATMOS-1 and ATMOS-2, which were designed as identical, multi-center, randomized, double-blind, vehicle-controlled trials to assess the safety and efficacy of DRM04 at a concentration of 3.75% compared to vehicle in adolescent and adult patients (ages nine and older) with primary axillary hyperhidrosis. Both clinical trials evaluated the safety and efficacy of DRM04 compared to vehicle. The co-primary endpoints for the ATMOS-1 and ATMOS-2 Phase III trials were the proportion of patients who achieved at least a four-point improvement from baseline in sweating severity as measured by the ASDD, and the average absolute change from baseline in gravimetrically-measured sweat production. The secondary endpoints in both trials measured the proportion of patients who had at least a two-grade improvement from baseline as measured by the Hyperhidrosis Disease Severity Scale (HDSS) and the proportion of patients with at least a 50% reduction from baseline in gravimetrically-measured sweat production. Each endpoint was measured at the end of the four-week treatment period. The ATMOS-1 trial enrolled 344 patients at 29 sites in the US and Germany, and the ATMOS-2 trial enrolled 353 patients at 20 sites in the US. Inclusion criteria required that prior to the start of treatment; all patients produce at least 50 mg of sweat in each underarm over a five-minute period and rate the severity of their sweating as a four or higher on the 11-point ASDD scale and as a three or a four on the four-grade HDSS. In the ATMOS-1 trial, 229 patients were andomized to receive DRM04 and 115 patients were randomized to receive vehicle; and in the ATMOS-2 trial, 234 patients were randomized to receive DRM04 and 119 patients were randomized to receive vehicle. Patients were instructed to apply the study product to each underarm once daily for four weeks using topical wipes containing either DRM04 or vehicle only. In the ATMOS-2 trial, DRM04 demonstrated statistically significant improvements for both co-primary endpoints and both secondary endpoints compared to vehicle. In the ATMOS-1 trial, DRM04 demonstrated statistically significant improvements for one of the co-primary endpoints and both secondary endpoints. These results were based on the overall dataset from the intent-to-treat population. For the second co-primary endpoint in the ATMOS-1 trial, when extreme outlier data from one analysis center were excluded in accordance with the pre-specified statistical analysis plan submitted to the FDA, DRM04 demonstrated statistically significant results compared to vehicle. Consistent with previous results, DRM04 was generally well-tolerated with side effects that were primarily mild to moderate in severity. Dermira is also conducting ARIDO, an open-label trial assessing the long-term safety of DRM04 as part of its Phase III program to provide safety data for a minimum of 100 patients who have received DRM04 for at least 12 months per the International Council on Harmonization guidelines. Patients from the ATMOS-1 and ATMOS-2 trials were permitted to enroll in the ARIDO trial and continue to receive DRM04 (active treatment) for up to an additional 44 weeks from the end of the four-week treatment periods in the ATMOS-1 or ATMOS-2 trials. A total of 564 patients, more than 80%, elected to enroll in ARIDO. Dermira expects to complete the treatment period for the ARIDO trial by the end of 2016. Based on the results of the ATMOS-1 and ATMOS-2 trials, Dermira plans to submit a New Drug Application (NDA) to the FDA for potential approval of DRM04. The NDA submission is targeted for the second half of 2017, subject to the comp letion of the ARIDO trial, other registration-enabling activities and a pre-NDA meeting with the FDA.

UCB and Dermira, Inc. Announces Topline Results from CIMPASI-2, a Phase 3, Multi-Center, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of CIMZIA

UCB and Dermira, Inc. announced topline results from CIMPASI-2, a Phase 3, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of CIMZIA (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. The CIMPASI-2 trial results are from the first of three Phase 3 clinical trials to be reported evaluating CIMZIA in this patient population. The co-primary endpoints evaluated in the trial were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16. A total of 227 patients with moderate-to-severe chronic plaque psoriasis were randomized to three dosing arms—400 mg every two weeks (n=87), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=91), or placebo every two weeks (n=49). At week 16, the response rate for patients who achieved a PASI 75 was 82.6% for patients receiving the 400 mg dose every two weeks and 81.4% for patients receiving the 200 mg dose every two weeks, compared to 11.6% for patients receiving placebo. The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 71.6% for the 400 mg dose-treated patients and 66.8% for the 200 mg dose-treated patients, compared to 2.0% for the patients receiving placebo. CIMZIA demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses. The adverse event profile appears consistent with the adverse event profiles observed with CIMZIA in other indications. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide. The data from this study will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.

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