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Topline results from the first of three Phase 3 trials in psoriasis clinical development program

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| Source: Dermira, Inc.

BRUSSELS, Belgium and MENLO PARK, Calif., Oct. 03, 2016 (GLOBE NEWSWIRE) -- UCB (Euronext:UCB) and Dermira, Inc. (NASDAQ:) today 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. 1

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. 1

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. 1

“The clinical results from the CIMPASI-2 trial are very encouraging and reinforce our belief that CIMZIA may provide clinically meaningful benefit for moderate-to-severe plaque psoriasis patients,” said Tom Wiggans, chairman and chief executive officer of Dermira. “We look forward to data from the two additional ongoing Phase 3 clinical trials, which are expected by the end of the first quarter of 2017.”

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