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Anthera Announces Last Patient Enrolled in PEARL-SC Study
Date:10/25/2011

HAYWARD, Calif., Oct. 25, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has completed enrollment in the Phase 2b PEARL-SC study.  PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of weekly and monthly subcutaneous injections of blisibimod in patients with active and antibody positive systemic lupus erythematosus (SLE).  The targeted number of five hundred and forty (540) patients has been randomized in 11 countries and 72 clinical sites worldwide.

Also, as part of the Company's efforts to improve treatment options for patients with SLE, the Company submitted a protocol amendment to the FDA for the PEARL-SC clinical study that proposes a modification in the primary efficacy SLE response index to require a larger decrease in the SELENA-SLEDAI* clinical assessment score.  The proposed primary endpoint will require patients to demonstrate a greater than or equal to five (>5) point reduction in the SELENA-SLEDAI, a well-recognized clinical assessment of lupus activity.  The remainder of the responder index will remain unchanged with no new BILAG A or two new BILAG B organ domain flares, and less than a 0.3 (<0.3) increase on a three point scale in Physician's Global Assessment.

"As we move forward with the development of blisibimod, we are incorporating feedback from industry experts, physicians, and key opinion leaders regarding the potential for blisibimod to provide incremental benefits to patients with systemic lupus erythematosus compared to currently available therapies and other advanced stage clinical treatments," said Colin Hislop
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