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Anthera Pharmaceuticals Announces Emerging Data from Phase 2 Open-Label Extension Study to be Presented at the ACR/ARHP 2013 Annual Scientific Meeting
Date:9/25/2013

HAYWARD, Calif., Sept. 25, 2013 /PRNewswire/ -- Anthera Pharmaceuticals (NASDAQ: ANTH), a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, announced today that emerging data from its Phase 2b PEARL-SC study and subsequent Open-Label Extension study will be presented by Dr. Richard Furie at the 2013 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP).

Two abstracts, an oral presentation and a poster, will summarize interim findings from analyses of the Open-Label Extension study pertaining to the durability of effects of blisibimod over 52 weeks on renal biomarkers, including proteinuria and Complement C3, and serum immunoglobulins, including IgG and IgM.

The immunoglobulins IgG and IgA are thought to play a significant role in IgA nephropathy (IgAN). According to the Journal of Clinical Investigation, IgAN is characterized by immune complexes composed of galactose-deficient IgA1 (immunogenic IgA) and a glycan-specific IgG antibody that deposit in the kidneys.

"IgG and immunogenic IgA, when combined, form a complex that deposits in the kidney leading to a slow, insidious loss of kidney function," said Dr. Jonathan Barratt, an IgA nephropathy specialist from the University of Leicester. "Any data that demonstrate a decrease in serum immunoglobulin levels provide further evidence for blisibimod's potential effectiveness in treating patients with IgA nephropathy."

"We're very excited to be able to present data which provides additional insight into the role of blisibimod administration on immunoglobulin levels in patients with autoimmune diseases. They are a key component of what we discussed with the FDA and are exploring in the BRIGHT-SC clinical trial," said Dr. Colin Hislop, Anthera's Chief Medical Officer. "The pathology of IgA nephropathy is heavily centered on the abundance of these proteins."

Oral Presentation: "Effects of Blisibimod, an Inhibitor of B Cell Activating Factor, on Serum Immunoglobulins and Infection Risk in Patients with Systemic Lupus Erythematosus: Observations from the Placebo-Controlled PEARL-SC and Open-Label Extension Studies": Clinical Aspects and Treatment: Biologic Therapy (2:30PM-4:00PM, October 28th)

Poster: "Effects of Chronic Treatment with Blisibimod, an Inhibitor of B Cell Activating Factor, on Renal and Inflammation Biomarkers in Patients with Systemic Lupus Erythematosus: Observations from the Placebo-Controlled PEARL-SC and Open-Label Extension Studies": Clinical Aspects Poster II: Central Nervous System Manifestation (8:30AM – 4:00PM, October 28th)

Anthera will be hosting a breakout session following the presentations by Dr. Furie. Please contact ir@anthera.com for the event details.

About Blisibimod and PEARL-SC

Anthera is developing blisibimod, a selective inhibitor of B-cell activating factor (BAFF), to explore its clinical utility in various autoimmune diseases including systemic lupus erythematosus (SLE) and IgA nephropathy. Blisibimod is a novel fusion protein, or peptibody, and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications. BAFF, also known as BLyS (B lymphocyte stimulator), is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. B-cells represent a critical component of human immune response to infection and other pathogens.  However, abnormal elevations of B-cells and BAFF may lead to an overactive immune response which may damage normal healthy tissues and organ systems. Multiple clinical studies with BAFF antagonists have reported the potential benefit of BAFF inhibitors in treating patients with lupus and rheumatoid arthritis.

In April 2012, Anthera completed the PEARL-SC Phase 2b clinical study to evaluate the efficacy and safety of subcutaneous blisibimod in patients with active and seropositive lupus. In June and July of 2012 Anthera announced results from PEARL-SC which led to the initiation of a Phase 3 registration plan utilizing the 200mg weekly dose of blisibimod in patients who were afflicted with active lupus despite receiving corticosteroids.

About Anthera Pharmaceuticals

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

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. Such statements are based on the Company'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, including but not limited to the risks and uncertainties associated with market conditions, as well as those set forth in the Company's public filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the quarter ended June 30th, 2013. The Company 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: Dennis Lutz of Anthera Pharmaceuticals, Inc., dlutz@anthera.com or 510.856.5598.


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SOURCE Anthera Pharmaceuticals, Inc.
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