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Anthera Pharmaceuticals Announces Additional Data From Phase 2b PEARL-SC Blisibimod Study





HAYWARD, Calif., May 7, 2013 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, today announced that additional data from its Phase 2b PEARL-SC study will be presented in two lecture sessions at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, Spain.

Dr. Richard Furie, M.D., Chief of the Division of Rheumatology and Allergy-Clinical Immunology at the North Shore-Long Island Jewish Health System, will give two presentations summarizing the findings from the recently completed PEARL-SC Phase 2 trial with blisibimod in patients with SLE: 

Novel Treatment in SLE and Sjögren's Syndrome ( 10:15-11:45 AM, June 13 th), " Effects of Blisibimod, a Subcutaneous Inhibitor of B-Cell Activating Factor, in Patients with SLE"

New Drugs for Lupus: State of the Art ( 1:30-3:00 PM June 13 th), "Effects of Blisibimod, an Inhibitor of B-Cell Activating Factor, on Markers of Renal Disease in Patients with SLE."

The presentations will summarize findings from a prospective analysis of the PEARL-SC clinical study demonstrating the treatment benefit of blisibimod on markers of renal disease including proteinuria Complement C3 and double-stranded DNA antibodies (ds-DNA).  The presentation will also summarize the clinical effect of blisibimod on a predefined subgroup of lupus patients with more severe disease characterized by a SELENA-SLEDAI greater than or equal to 10 despite receiving corticosteroid therapy at baseline.   

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

Two recent presentations by Dr. Morton Scheinberg, M.D., at the 10 th International  Congress on Systemic Lupus Erythematosus in Buenos Aires, Argentina, highlighted the effects of blisibimod on patients with more severe SLE. "Blisibimod looks promising when evaluated using the SRI-8 endpoint in patients with more severe lupus," said Dr. Scheinberg. "The corroboration of the main study findings in the subgroup of patients from Latin America lends greater confidence to the observed outcomes.  The significant improvements in proteinuria observed with blisibimod are clearly important to patients with lupus, and possibly also to patients with other autoimmune renal diseases with autoantibody-associated kidney damage." The poster "Clinical Experience in Latin America with Blisibimod Amongst Subjects with Active, Moderate-to-Severe Systemic Lupus Erythematosus: Data from the Phase 2b PEARL-SC Study" and presentation " Blisibimod, an Emerging Subcutaneous Biologic Therapy for Patients with Active, Moderate-to-Severe Systemic Lupus Erythematosus" are available on www.anthera.com.

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.

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