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Anthera Pharmaceuticals, Inc. (ANTH) Announces Data from the Phase 2b PEARL-SC Study Presented at the 2012 Asian Lupus Summit


11/28/2012 8:50:31 AM

HAYWARD, Calif., Nov. 28, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced additional data from its Phase 2b PEARL-SC study was presented in a poster at the 2012 Asian Lupus Summit. The poster entitled "The Subcutaneous BAFF Inhibitor, Blisibimod, Significantly Reduces Proteinuria in Subjects with Moderate-to-Severe Systemic Lupus Erythematosis," is being displayed at the conference today Wednesday, November 28, 2012.

In addition to the effects seen in the modified intent to treat population in the PEARL-SC study, which was presented at the recent 2012 ACR/ARHP conference, the poster highlights additional data related to the effect of blisibimod on renal disease in lupus. Both the pooled blisibimod treatment group and the 200 mg weekly blisibimod treatment group showed a statistically significant treatment reduction in proteinuria.

"These data provide further rationale for broadening the CHABLIS-SC2 study population to include both patients with severe disease and patients suffering from lupus nephritis," said Colin Hislop, MD, Anthera's Senior Vice President and Chief Medical Officer. "These data will also guide our plans to pursue studies in IgA nephropathy and other renal diseases that involve B-cells."

The poster will be available on www.anthera.com.

About Blisibimod and PEARL-SC

BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, vasculitis, IgA nephropathy, immune thrombocytopenic purpura and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications. The PEARL-SC Phase 2 study was designed as a randomized, double-blind, placebo-controlled, dose-ranging superiority trial to evaluate the safety, tolerability and efficacy of blisibimod plus standard of care, versus placebo plus standard of care. A total of 547 patients with active SLE were randomized to receive one of three different doses of blisibimod or placebo (100 mg weekly, 200 mg weekly or 200 mg monthly) administered subcutaneously over a minimum 24-week treatment period, in addition to standard-of-care therapy. The study was conducted at multiple centers worldwide.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune diseases.

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2011 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.

SOURCE Anthera Pharmaceuticals, Inc.


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