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BARDA Contract Awarded for Antiviral Influenza Drug

H1N1 illustration (Dan Higgins, CDC)

Influenza ultrastructure illustration (Dan Higgins, CDC)

The U.S. Biomedical Advanced Research and Development Authority (BARDA) awarded a contract to Biota Scientific Management Pty in Melbourne, Australia for an antiviral drug to combat influenza. The contract for advanced development and testing of the drug is valued at $231 million over five years.

The drug, CS-8958, is a long-acting neuraminidase inhibitor, which prevents the flu virus from spreading in the body’s cells. The drug is delivered using a dry powder inhaler.

CS-8958 is in same class of drugs as the currently approved influenza antiviral drugs Tamiflu and Relenza. However, CS-8958 requires only a single dose for full treatment, as opposed to the five days of twice daily dosing required for Tamiflu and Relenza. CS-8958 also may be effective against influenza viruses known to be resistant to Tamiflu.

Under the contract, the company will establish U.S. manufacturing of the drug and conduct clinical trials for safety and efficacy in adult and pediatric populations. These studies are needed to apply for Food and Drug Administration approval.

Biota currently markets CS-8958 under the name Laninamivir. The drug is approved for sale in Japan, and marketed by Daiichi Sankyo under the name Inavir.

Read more: Contracts Awarded for Countermeasure Upgrades

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