Daiichi Sankyo Close To Finishing New Influenza Drug Studies

Daiichi Sankyo Co. (4568.TO) is aiming to apply for Japanese government approval during the next fiscal year from April on its new influenza drug which is expected to work long with a single dose and be safe to use in children, company officials said Thursday.

Daiichi Sankyo's CS-8958 is near the end of the phase-3 studies in Japan, Taiwan, Hong Kong and South Korea. Several studies are currently running for use by both adults and children, the officials said.

Side effects of CS-8958 have been very minor, the company said.

Already available influenza drugs include Roche Holding AG's (ROG.VX) Tamiflu and GlaxoSmithKline PLC's (GSK) Relenza. In the U.S., Relenza is for children seven years or older.

Once its dosing range is set, the Tokyo-based company hopes to start studies by the end of this year, on CS-8958 for preventing infection by influenza virus, Daiichi Sankyo's Clinical Development Director Daisuke Hiro told reporters.

The company hasn't yet started studies linked to the elderly who face a higher risk of death when infected by the influenza virus.

Daiichi Sankyo expects CS-8958 to be more effective on mutated bird flu viruses which develop resistance to Tamiflu and Relenza, the company officials said.

CS-8958, like Relenza, is an inhaled powder medication and a single dose will be effective for a week.

As Tamiflu and Relenza do, CS-8958 inhibits a protein called neuraminidase which influenza viruses use to expand infection.

Daiichi Sankyo and Biota Holdings Ltd. (BTA.AU), the original developer of Relenza, are jointly seeking a partner to which the Japan company can license CS-8958 in the U.S. and Europe.

The company hopes to have enough production capacities for CS-8958 at the time of approval for possible stocking by the Japanese government in case of a bird flu pandemic, Daiichi Sankyo's Hiro said.

-By Kazuhiro Shimamura, Dow Jones Newswires; 813-5255-2929; [e-mail]

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