Daiichi Sankyo Close To Finishing New Influenza Drug Studies
23 January 2009 - 12:49AM
Dow Jones News
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;
kazuhiro.shimamura@dowjones.com
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