The Office of Biomedical Advanced Research and Development Authority (BARDA), an agency within the US Department of Health and Human Services under the Office of the Assistant Secretary for Preparedness and Response, has awarded a $231 million contract to Australian drug development company Biota for development of a laninamivir dry powder inhaler. The product, called CS-8958, is a long-acting single-dose antiviral DPI that has been marketed in Japan under the name Inavir since October 2010.
The contract will fund US manufacturing of the drug, along with clinical trials to develop data to support a new drug application for FDA approval.
BARDA director Robin Robinson commented that, “The ability to treat influenza by delivering a single dose of medicine would provide real advantages to doctors and patients during an emergency and would be an important addition to our pandemic influenza arsenal,” while Biota CEO Peter Cook said, “The award provides visible recognition of the potential medical value of laninamivir to the world’s major market. The BARDA contract will be a major contributor to a timely introduction of the product and will create the opportunity to significantly develop Biota’s business in the USA”.
