Anthera Pharma (ANTH) Reports Q3 Loss of 31c/Share
Anthera Pharma (NASDAQ: ANTH) reported Q3 EPS of ($0.31), versus ($0.30) reported last year.
Third Quarter Operational Update:
Blisibimod
Our Phase 3 systemic lupus erythematosus clinical study, CHABLIS-SC1, is recruiting patients in Eastern Europe, Latin America and Southeast Asia. To date, we have enrolled over 260 of the 400 patients planned for the CHABLIS-SC1 study. Enrolled patient demographics and disease characteristics for the CHABLIS-SC1 study continued to be 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.
Our Phase 2/3 IgA nephropathy study, BRIGHT-SC, is currently recruiting patients with a biopsy-proven diagnosis of IgA nephropathy primarily in Southeast Asia. Our expansion of BRIGHT-SC study's footprint in Europe and Canada is underway with sites in the European Union likely to be initiated in the fourth quarter of 2014. The baseline characteristics of patients enrolled in the BRIGHT-SC study continued to be consistent with our objectives to enroll patients with a biopsy diagnosis of IgA nephropathy, high levels of proteinuria, and kidney function indicative of progressive kidney disease.
Interim analyses of CHABLIS-SC1 and BRIGHT-SC were planned for the third quarter of 2014 to confirm the clinical assumptions of the designs of these two studies. However, due to our on-going partnership negotiations for Asian rights for blisibimod for both lupus and IgA nephropathy, we elected to delay these analyses. We expect these discussions will be completed during the fourth quarter of 2014. There can be no assurance that a definitive agreement will be executed relating to any proposed partnership, or that any partnership will be approved or consummated.
Sollpura™ (liprotamase)
As part of our portfolio expansion strategy, we licensed a novel pancreatic enzyme replacement therapy, Sollpura™ (liprotamase), from Eli Lilly and Company ("Lilly") in July 2014. The active IND and NDA have been successfully transferred from Lilly to Anthera. We have commenced drug product formulation development and scheduled the manufacture of new clinical trial material for the first quarter of 2015. Our plan to begin a Phase 3 pivotal trial in patients who suffer from exocrine pancreatic insufficiency due to cystic fibrosis in the United States and Europe in 2015 remains on track.
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