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Biota's flu drug succeeds in late-stage Asia trial

Mon Aug 10, 2009 4:49am EDT

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MELBOURNE, Aug 10 (Reuters) - A new influenza drug, which has been billed as a possible weapon against both H1N1 swine flu and H5N1 bird flu, has succeeded in late-stage trials in Asia, its discoverer, Australian biotech firm Biota (BTA.AX), said on Monday.

Japan

The Phase III trial on 1,000 adult patients in east Asia proved to treat symptoms and kill fever in patients with influenza A and B, the most common seasonal flu strains, with one inhaled dose as effective as 10 doses of Tamiflu, Biota said.

Tamiflu is produced by Roche (ROG.VX) and Gilead Science (GILD.O) and is the leading drug used against H1N1 and H5N1.

Daiichi Sankyo (4568.T), Japan's third-largest drug company, ran the trial on Biota's laninamivir drug and plans to apply to Japanese regulators by March 2010 to market the drug. It holds the rights to manufacture and market the drug in Japan.

Daiichi Sankyo also plans to trial the drug as a flu preventive later this year.

Biota will receive royalties on any Japanese sales.

The Australian firm said it would now pursue clinical trials in western markets and seek licensing partners to help get the drug to market in North America and Europe. The drug was effective against influenza A and B and also H5N1 in pre-clinical trials, though it was not tested against either H5N1 or H1N1 swine flu in the late-stage trials.

Biota has said in Japanese research recently published in the journal Nature that laninamivir is also active against H1N1.

Biota discovered the first generation of flu treatments called neuraminidase inhibitors, and licensed its drug, Relenza, to GlaxoSmithKline (GSK.L).

However Relenza, delivered through an inhaler, was heavily outsold by Tamiflu tablets. Relenza sales have only picked up recently as governments have sought to build stockpiles to treat swine flu.

Biota's shares soared to a near four-year high of A$2.25 on the news and closed up 5.3 percent at A$2.17. Daiichi Sankyo jumped 2.7 percent to 1,818 yen. (Reporting by Sonali Paul; Editing by Mark Bendeich)



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