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Strong Secondary PEARL-SC Results Support Phase 3 Development Strategy


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-29%/31% Treatment Effects Observed in SRI-7/SRI-8-

-Responder Benefit May be Greater Than Benlysta-


Report is Available for Download at: www.lifesciadvisors.com/clients/anthera

In this follow-up note, we discuss Anthera Pharmaceuticals’ (NASDAQ: ANTH) recently released Phase 2b PEARL-SC secondary endpoint results, which demonstrated 29% (p=0.002) and 31% (p<0.001) treatment effects in the SRI-7 and SRI-8 endpoints, respectively. We believe this data should help clear up the misguided conclusions investors drew from the top-line data and supports the advancement of blisibimod into Phase 3 development.

Previously-Reported Top-Line Blisibimod 200 mg QW Results Demonstrated Favorable Response Trends. Previously (7/9), we conducted an in-depth analysis of Anthera Pharmaceuticals’ (NASDAQ: ANTH) top-line Phase 2b PEARL-SC study results for blisibimod, which demonstrated that the 200 mg QW dose showed a clear efficacy signal. We believe investors’ negative reaction to the data was due to the simple comparison on PEARL-SC top-line data to BLISS-52/76 top-line data. In our previous note, we argued that this comparison is not appropriate and when the data is analyzed properly, we believe that the PEARL-SC results compared favorable to Benlysta. Currently, we do not believe that Anthera’s valuation (price=$1.60, market cap=$66MM, enterprise value=$46MM) accurately reflects blisibimod’s potential to capture a portion of the ~$3-4B lupus market potential.

In addition to the initial blisibimod SRI-5 results in severe lupus patients (SS>10) that showed a 13.8% treatment effect (see our note here http://lifesciadvisors.com/news/how-to-interpret-blisibimods-pearl-sc-results/), Anthera recently reported strong results for the SRI-6, SRI-7, and SRI-8 measures.

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