Biota flags positive Phase III flu drug data

Australia's Biota says a late-stage Asian trial of a new influenza therapy aimed at the blockbuster space occupied by Tamiflu delivered positive data, setting it up to begin commercialization as it pursues new development pacts for Europe and the U.S.

Japan's Daiichi Sankyo organized the trial of laninamivir, concluding that one inhaled dose was as effective as 10 doses of Tamiflu in guarding against influenza A and B. The data arrived at an opportune moment, with governments around the globe looking to stock up on influenza meds that could protect their populations against the swine flu pandemic. Laninamivir could also represent a backup to Tamiflu if swine flu mutates and becomes resistant to the marketed anti-viral. And the new influenza therapy might also be stockpiled in the event of a bird flu pandemic. Laninamivir was effective against H5N1 in a preclinical study.

Laninamivir fits into a class of therapies called neuraminidase inhibitors, which prevents the virus from replicating and releasing itself from a lung cell. "All influenza viruses use this same mechanism and these drugs all block that occurring, so effectively creating a `still birth' of the new virus," Biota managed director Peter Cook told the Sydney Morning Herald. Cook says that Biota is ready to start commercializing the therapy now.

Biota is an experienced player in this field. It developed Relenza, another key antiviral, and licensed it to GlaxoSmithKline. Biota now plans late-stage studies to demonstrate the flu drug's effectiveness in preventing flu.

- read the report [1] from Reuters
- check out the story [2] in the Sydney Morning Herald

ALSO: While some of the world's biggest pharma players are looking to cash in on orders for swine flu vaccine, the pandemic also may offer opportunities for smaller biotechs like Vical and Inovio in San Diego. Report [3]