Posted: Fri Aug 14, 2009 11:27 pm Post subject: Biota's CS-8958/ laninamivir
Biota Holdings Limited (ASX: BTA) today announced successful results from the Asian Phase III clinical trials of CS-8958, its second generation influenza treatment. CS-8958 now has been assigned the new name of 'laninamivir' by the World Health Organization under its International Non-proprietary Names (INN) drug identification system. Laninamivir is a long acting neuraminidase inhibitor (LANI) and is co-owned with Daiichi Sankyo.
In the Phase III trial in adults, a single inhaled dose of laninamivir was shown to be as effective as oseltamivir (Tamiflu) administered orally twice daily for 5 days (total of 10 doses). A parallel Phase II/III trial of CS-8958 in pediatric patients also met the primary and secondary endpoints compared to oseltamivir.
Daiichi Sankyo is seeking approval from the Japanese regulatory authority to market laninamivir in Japan, with submission anticipated by March 2010. A clinical study for prophylaxis of influenza is expected to commence in Japan in late 2009.
About LANI's (Long-Acting Neuraminidase Inhibitors)
Current neuraminidase inhibitors for influenza require daily or more frequent dosing. The ability to dose patients on a weekly, or even less frequent, basis offers numerous benefits. Firstly, any stockpile of weekly-dosing drug will last longer and protect more people, in the case of an influenza pandemic. Additionally, a weekly dose may improve patient compliance over a more frequent regime.
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