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August 22, 2012

Biota Phase III Inavir study meets primary endpoint

Biota Holdings, an anti-infective drug development company, has announced that the Phase III prevention study of Inavir (laninamivir octanoate, CS-8958), conducted in Japan, met its primary endpoint.

Biota Holdings, an anti-infective drug development company, has announced that the Phase III prevention study of Inavir (laninamivir octanoate, CS-8958), conducted in Japan, met its primary endpoint.

The Phase III study, conducted by the drug’s co-owners and Japanese marketing rights holders Daiichi Sankyo, reported that Inavir significantly reduced the transmission of influenza within a household.

Biota CEO Peter Cook said the results would expand the market applicability for Inavir and cement its role as a pandemic control drug.

"We continue to believe that Inavir’s demonstrated efficacy, combined with its ease of use, have the opportunity to significantly improve clinical outcomes for the treatment and now prevention, of influenza," Cook said.

The multi-centred, placebo controlled, double blind study measured the prophylactic effect of the two dosage regimes against placebo and the protective efficacy calculated.

Compared to placebo, Inavir in two dose regimes significantly reduced the proportion of patients contracting influenza (p < 0.0001), and produced protective efficacies in excess of 70%.

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According to the study data, Inavir was generally well tolerated, and its safety profile remained consistent with that seen previously in the clinical development programme.

Daiichi Sankyo plans to seek marketing approval for the drug in the prevention of influenza before the end of 2012.

 

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