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Anthera Updates Phase 3 Plans Following Results from the Phase 2b PEARL-SC Dose Ranging Study of Blisibimod
Date:6/27/2012

eceived written Scientific Advice from the European Medicines Agency (EMA) confirming the acceptability of the Company's proposed Phase 3 design for the treatment of severe systemic lupus erythematosus patients as a basis for a marketing authorization application (MAA).  The EMA feedback confirms that our development program, including the heightened SRI-5 endpoint, is acceptable and that positive results from Phase 3 clinical studies in a severe lupus population would support approval of the product. The EMA has endorsed the Company's proposed Phase 3 manufacturing plan, which includes utilization of the recently manufactured drug substance and the use of a pre-filled syringe.

"The 200mg weekly dose was clearly the most clinically effective blisibimod dose.  In the severe lupus patients the treatment effect is evident after 12 weeks with a numerically greater number of responders at all subsequent time points despite early withdrawal of background therapy.  This is particularly evident among the most severely ill patients who require aggressive corticosteroid therapy," said Colin Hislop, M.D., Chief Medical Officer and Senior Vice President. "The PEARL-SC results demonstrate an ability to clinically differentiate blisibimod from currently available lupus therapies."

In conjunction with this press release Anthera will host a conference call at 8:30 a.m. Eastern Time tomorrow, June 28, 2012.  U.S. and Canadian participants may dial (877) 312-8807; international participants may dial (253) 237-1190.  The Conference ID is 95674621. To access the 24-hour audio replay, U.S. and Canadian participants may dial (855) 859-2056; international participants may dial (404) 537-3406.  The conference ID for the replay is 95674621.  The audio replay will be available until July 5, 2012.

*SLE responder index - 5 (SRI-5) is a composite responder index evaluating various patient and physician reported clinical disease activity i
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SOURCE Anthera Pharmaceuticals
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