Biota Pharmaceuticals, U.S. Department of Health and Human Services infectious news
Biota reported that HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA) issued a stop-work order for laninamivir octanoate. Biota is developing the influenza product under a 2011 BARDA contract worth up to $231 million. The order is in effect pending a decision from HHS following a scheduled review of the contract. Biota said it was "surprised" by the order and "does not have additional visibility or understanding" of the matter. According to a separate statement issued by Biota, BARDA Director Robin Robinson said the order is not a contract termination and that BARDA has concerns with product manufacturing, clinical study enrollment pace, costs and contractor performance. The company expects a decision from HHS on the contract "within the next week or so."
Next quarter, Biota expects to report top-line data from the Phase II IGLOO trial of laninamivir octanoate for influenza A and B infections. At Dec. 31, 2013, Biota had $51.4 million in cash. ...