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Anthera Pharmaceuticals Reports 2013 Third Quarter Financial Results, Clinical and Regulatory Update
Date:10/29/2013

ntries in South East Asia. To date 10 of 22 sites have been activated with all sites expected to be actively screening patients by the end of the year.  After the first 48 patients have completed eight weeks of treatment, the Company plans to conduct an interim analysis to determine the effect of blisibimod on proteinuria and other relevant biomarkers such as IgA and IgG levels in early 2014.Regulatory

In May 2013, the Company met with the US FDA to discuss the IgA nephropathy development program for blisibimod. As a result of receiving feedback from the US FDA on the potential use of a change in proteinuria as the endpoint for Subpart E approval for blisibimod, the Company has amended the BRIGHT-SC study endpoints accordingly.  Upon implementation of this new amendment it is the Company's intention to use the BRIGHT-SC study as one of two studies necessary to support the marketing approval of blisibimod for the treatment of IgA nephropathy under the accelerated approval pathway (US FDA Subpart E).  In addition, the US FDA indicated a requirement for the Company to provide data from a post-marketing study which would include measurements of clinical endpoints, such as changes in kidney function, progression to dialysis and death in patients previously enrolled in the two registration studies.

In June 2013, we met with the Japanese Pharmaceutical and Medical Devices Agency, or PMDA to discuss the development of blisibimod for the treatment of IgA nephropathy in Japan.  At this initial meeting the PMDA also agreed to consider change in proteinuria as the basis for an initial approval of blisibimod for the treatment of IgA nephropathy.  Further discussions with the PMDA regarding development of blisibimod in Japan are planned for early 2014.

Prior to the end of 2013, the Company plans to submit an Investigational New Drug application, or IN
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SOURCE Anthera Pharmaceuticals, Inc.
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2. Anthera Pharmaceuticals Reports 2013 Second Quarter Financial Results
3. Anthera Announces Initiation of BRIGHT-SC Phase 2 Clinical Study in IgA Nephropathy with Blisibimod
4. Anthera Pharmaceuticals Announces Receipt of Nasdaq Notice
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