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Anthera Pharmaceuticals Reports 2012 Second Quarter Financial Results And Provides Clinical Progress Update
Date:8/7/2012

s week 8 and sustained through 24 weeks utilizing 6, 7, and 8-point improvements in the SELENA-SLEDAI disease-scoring index (treatment effects versus 200mg weekly placebo were 15.9%, 28.9%, and 31.1%, respectively). Details regarding the study can be found on our press release dated July 16, 2012 at www.anthera.com.
  • Following the completion of the PEARL-SC study, the Open Label Extension (OLE) study is now fully enrolled with 382 patients. All patients who participated in the PEARL-SC study were eligible for rollover into the OLE clinical study to assess the long-term safety of blisibimod.

    • Manufacturing

  • The Company selected a pre-filled syringe to allow the self-administration of subcutaneously delivered blisibimod in Phase 3 clinical studies.

    • Regulatory

  • The Company received written Scientific Advice from the European Medicines Agency (EMA) confirming the acceptability of the Company's proposed Phase 3 strategy for the treatment of severe systemic lupus erythematosus patients as a basis for a marketing authorization application (MAA), including the utilization of recently manufactured drug substance and the use of a pre-filled syringe.
  • The Company scheduled an End of Phase 2 meeting to review the results of the PEARL-SC study and to discuss their Phase 3 strategy with the US Food and Drug Administration in Q3 2012.  Final minutes from this meeting are anticipated in the fourth quarter of 2012.

    • *SELENA-SLEDAI -- Safety of Estrogen in Lupus Erythematosus National Assessment / Systemic Lupus Erythematosus Activity Index is a cumulative, weighted index of systemic lupus erythematosus disease activity.

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

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    SOURCE Anthera Pharmaceuticals, Inc.
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