Biota's LANI Phase III clinical trials in Asia prove successful

10 August 2009

Australia's Biota Holdings has 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 Japan's 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 five 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.

'The success of the multifaceted Phase III trials in Asia is significant. Laninamivir offers a new therapeutic agent in the treatment of influenza with particular advantages for stockpiling applications' said Peter Cook, Biota's managing director.

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