CIMZIA®

A potential new treatment for patients with moderate-to-severe chronic plaque psoriasis.

Dermira is currently developing CIMZIA® (certolizumab pegol), with its collaboration partner UCB as a treatment for moderate-to-severe chronic plaque psoriasis. CIMZIA is a tumor necrosis factor-α (TNF) inhibitor that specifically targets the overproduction of the human protein TNF, which has been shown to cause inflammation when not regulated properly. TNF is also a factor in the development of psoriasis.

In the United States, CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis; for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; for the treatment of adults with active psoriatic arthritis; and for the treatment of adults with active ankylosing spondylitis. CIMZIA is not approved to treat psoriasis. To learn more about the approved indications for CIMZIA and important safety information for the therapy, visit www.cimzia.com.

Under the terms of an agreement announced in July 2014, Dermira obtained exclusive rights to develop CIMZIA in psoriasis in the U.S., Canada and the European Union, and obtained an exclusive commercial license to market CIMZIA to dermatologists for psoriasis in the U.S. and Canada upon approval.

Evaluated in a three-study, Phase 3 program.

Dermira evaluated this unique TNF inhibitor in a three-study Phase 3 program, comprised of the CIMPACT, CIMPASI-1 and CIMPASI-2 studies, which collectively enrolled 1,020 adult patients with moderate-to-severe chronic plaque psoriasis.

Dermira reported key data from three Phase 3 randomized, blinded, placebo-controlled, multi-center trials.

Potential to be a new TNF treatment option for psoriasis patients.

TNF inhibitors are the most widely prescribed class of biologic agents to treat psoriasis. Although all therapies in this class have the same primary mode of action, patient responses to these therapeutics remain variable, underscoring the need for additional treatment options. CIMZIA, if approved for psoriasis, could offer a benefit to patients whose needs are not being met by existing treatment options.

In July 2017, Dermira and UCB announced that UCB submitted a supplemental Biologics License Application to the U.S. FDA for CIMZIA. Separately, UCB also submitted a regulatory filing with the European Medicines Agency (EMA). Both regulatory filings seek to expand the approved indications for CIMZIA to include treatment of adult patients with moderate-to-severe chronic plaque psoriasis. An additional submission to expand the use of CIMZIA in this patient population is also planned with Health Canada.