BioCentury
ARTICLE | Company News

Biota Pharmaceuticals, U.S. Department of Health and Human Services infectious news

May 5, 2014 7:00 AM UTC

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. ...