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February 11, 2013
17:22 EDTANTHOrbiMed Advisors reports 6.24% stake in Anthera Pharmaceuticals
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October 2, 2015
12:36 EDTANTHAnthera begins SOLUTION clinical study of CF treatment
Anthera Pharmaceuticals announced the initiation of the SOLUTION Phase 3 clinical study evaluating the efficacy and safety of Sollpura, a microbial derived, biotech pancreatic enzyme replacement therapy, compared to an approved, porcine-derived, enteric-coated product for the treatment of exocrine pancreatic insufficiency. The Phase 3 SOLUTION clinical study is a multicenter, randomized, open-label, assessor-blind, non-inferiority, active-comparator study designed to evaluate the efficacy and safety of Sollpura in people with EPI due to cystic fibrosis. This pivotal study is intended to evaluate the non-inferiority of Sollpura compared with a commercially available PERT in a population enriched for PERT responders. The primary efficacy endpoint of this study will be comparative efficacy measured as the change in the coefficient of fat absorption at the end of therapy. Results from the SOLUTION clinical study are anticipated to support marketing approval for Sollpura as a treatment for exocrine pancreatic insufficiency.

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