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Biota Flu Trial Reaches Northern Hemisphere

Begins dosing patients with LANI under BARDA trial

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Biota Pharmaceuticals has begun dosing patients in the northern hemisphere portion of its ongoing Phase II, randomized, double blind, placebo controlled, parallel arm clinical trial of laninamivir octanoate (LANI). The trial compares the safety and efficacy of 40 mg and 80 mg of LANI with placebo, all delivered by a TwinCaps inhaler in adults with presumed influenza A or B infection.

The trial was initiated in the southern hemisphere in June and is now continuing in multiple countries in the northern hemisphere. Biota’s goal is to complete enrollment in the trial by the end of the influenza season in the northern hemisphere and have top-line data available in mid-2014. The trial is being conducted in connection with Biota’s contract with the U.S. Office of Biomedical Advanced Research and Development Authority (“BARDA”).

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