Positive Phase 3 clinical study results for Inavir(R) Dry Powder Inhaler for the Prevention of Influenza

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that the influenza antiviral product Inavir® Dry Powder Inhaler (laninamivir octanoate hydrate) significantly reduced the incidence of influenza infection compared to placebo in a phase 3 clinical study. Based on these results, Daiichi Sankyo intends to seek approval for a prophylaxis indication for Inavir®.

The objective of the study was to investigate the efficacy in the prevention of influenza virus infection among household contacts of patients with influenza A or B virus infection. In a placebo-controlled, randomized, double-blind study, the prophylactic efficacy of Inavir® was examined against influenza infection. Inavir® statistically significantly reduced the incidence of the clinical influenza virus infection among household contacts, the primary endpoint of efficacy, demonstrating its protective efficacy. Additionally, the study medication was well-tolerated.

Details of the study results, including the actual numbers of subjects and data related to efficacy and safety, will be submitted to a scientific journal or academic society at a later date, and currently the dates for the publication and presentation of the comprehensive results have not been determined.

Daiichi Sankyo intends to apply for approval to manufacture and sell of Inavir® in Japan for a prophylaxis indication by the end of 2012.