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 [email protected] 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.

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, Inc. is a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases.  Anthera's Phase 3 development product candidate, blisibimod, targets elevated levels of B-cell activating factor, or BAFF, which has been associated with a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus (SLE), or lupus, Immunoglobin A nephropathy, or IgAN, lupus nephritis, vasculitis, rheumatoid arthritis, idiopathic thrombocytopenia purpura, and others.

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, 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: Dennis Lutz of Anthera Pharmaceuticals, Inc., [email protected] or 510.856.5598.

SOURCE Anthera Pharmaceuticals, Inc.