US awards contract for long-acting flu antiviral

Robert Roos

Mar 31, 2011 (CIDRAP News) – The US government today announced the award of a $231 million, 5-year contract to an Australian company for advanced development of a single-dose, long-acting influenza drug in the neuraminidase inhibitor class.

The contract was awarded to Biota Scientific Management Pty, Ltd., of Melbourne, according to the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services.

The drug, CS-8958, is already licensed in Japan as Inavir, known generically as laninamivir. BARDA said the antiviral requires only one dose for full treatment, as compared with 5 days of twice-daily dosing for oseltamivir and zanamivir. Like zanamivir, it is delivered with a powder inhaler.

"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," BARDA Director Dr. Robin Robinson commented in the release.

The contract calls for Biota to establish US manufacturing, optimize its manufacturing processes, and conduct clinical trials of the drug in adults and children, BARDA said. The trials would be in preparation for applying for US licensing of the drug.

"The contract is fully funded over an estimated five-year period and is contingent on the delivery of key milestones throughout the period," Biota Holdings Ltd., parent company of Biota Scientific, said in a press release.

In August 2009, Biota reported that laninamivir compared well with oseltamivir in a phase 3 trial in adults. The trial, conducted in Japan, Korea, Taiwan, and Hong Kong, showed that a single dose of the new antiviral was as effective as oseltamivir given twice a day for 5 days, the company said.

The drug was approved in Japan in September 2010. It is marketed there by Daiichi Sankyo Co. Ltd.