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Newly Published Nonclinical Data Highlight the Role of Olumacostat Glasaretil in Sebum Inhibition

MENLO PARK, Calif., June 26, 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 findings from nonclinical studies evaluating the mechanism of action for olumacostat glasaretil (formerly DRM01) in sebum inhibition were published in the Journal of Investigative Dermatology (JID).

In cultures of sebaceous cells, Dermira analyzed the effects of olumacostat glasaretil on the composition of sebum lipids. These studies revealed a reduction in saturated and monounsaturated fatty acyl chains that can give rise to the inflammatory response in acne. In addition, in animal models, it was shown that topical application of olumacostat glasaretil accumulated in sebaceous glands relative to the surrounding dermis and significantly reduced sebaceous gland size. The paper titled, “Inhibition of Sebum Production with the Acetyl Coenzyme A Carboxylase Inhibitor Olumacostat Glasaretil” appears in the July 2017 issue.

Olumacostat glasaretil is a novel, small molecule designed to target sebum production following topical application in Phase 3 development as a treatment for patients with acne vulgaris. Olumacostat glasaretil is designed to exert its effect by inhibiting acetyl coenzyme-A carboxylase (ACC), the enzyme that plays an important role in the synthesis of more than 80 percent of the lipids that make up sebum. Sebum, an oily substance made up of lipids, is produced by glands in the skin called sebaceous glands. An approved topical product that targets sebum production does not currently exist.

“These findings are compelling and will help us understand the mechanism of action of olumacostat glasaretil and the role ACC plays in sebum production, a key factor in the development of acne,” said Hans Hofland, Ph.D., Vice President, Research and Nonclinical Development at Dermira and a co-author of the paper.

Results from a Phase 2b clinical trial evaluating topically applied olumacostat glasaretil in patients with facial acne vulgaris were reported in May 2016. Olumacostat glasaretil is currently being evaluated in two Phase 3 trials, CLAREOS-1 and CLAREOS-2, assessing its safety and efficacy in adults and adolescents with facial acne vulgaris. An additional open-label trial, CLARITUDE, is evaluating the long-term safety of olumacostat glasaretil. Topline results from the CLAREOS-1 and CLAREOS-2 trials are expected in the first half of 2018.

About Acne
According to the American Academy of Dermatology, acne is the most common skin condition in the United States, affecting approximately 50 million Americans and 85% of all teenagers. Acne is caused by the accumulation of dead skin cells, oil and bacteria in pores. It is characterized by clogging of the pores and associated local skin lesions. Acne lesions are believed to result from an interaction of multiple pathogenic, or contributing, factors, including excessive sebum production. Acne is not just about blemishes on the skin; it can also affect a person’s quality of life, resulting in social, psychological and emotional impairments.

About Dermira
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 late-stage product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil (formerly DRM01), in Phase 3 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.

Forward-Looking Statements
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 the successful completion of, and timing expectations for the receipt of data from, the olumacostat glasaretil Phase 3 program. 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.

Media:
Erica Jefferson
Senior Director, Head of Corporate Communications
650-421-7216
media@dermira.com

Investors:
Ian Clements, Ph.D.
Vice President, Investor Relations
650-422-7753
investor@dermira.com

Robert H. Uhl
Westwicke Partners
Managing Director
858-356-5932
robert.uhl@westwicke.com

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