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Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update
Date:7/28/2014

IS-SC1 study.  Enrolled patient demographics and disease characteristics for the CHABLIS-SC1 study are consistent with our goal to enroll patients with higher levels of lupus activity and positive biomarkers despite the stable use of corticosteroids.  These characteristics appeared predictive of improved outcomes in our previous Phase 2 clinical study.  Additional information and publications from the CHABLIS-SC1 clinical study can be found at http://www.anthera.com/studies_chablis-sc1.htm.

We have submitted the final protocol to the US FDA for our second lupus registration study, CHABLIS-SC2. This second study is expected to enroll up to 400 patients with active lupus, including patients with glomerulonephritis who may have a previous diagnosis of Lupus Nephritis.  Consistent with the CHABLIS-SC1 clinical study, the primary endpoint of this second study will be the SRI-8 response. These two pivotal studies will form the basis of a submission for blisibimod as a treatment for patients with active lupus.

Blisibimod for the treatment of IgA Nephropathy (BRIGHT-SC)

The BRIGHT-SC clinical study is currently recruiting patients with a biopsy-proven diagnosis of IgA nephropathy in seven countries in Southeast Asia. We have begun expansion of the BRIGHT-SC study's footprint in Europe, Canada and Japan and expect to enroll patients in the new geographies in the fourth quarter of 2014.  It is our plan to conduct an interim analysis to determine the effect of blisibimod on proteinuria after eight weeks of treatment in the second half of 2014.

In April 2014, we met with Japan Pharmaceuticals and Medical Devices Agency ("PMDA") to discuss our registration program with blisibimod in patients with IgA nephropathy.  In this meeting we gained the PMDA's agreement on the acceptability of proteinuria as the primary efficacy endpoint to support marketing approval in
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SOURCE Anthera Pharmaceuticals, Inc.
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