Phase III trials for CS-8958 neuraminidase inhibitor successful

Hovione is pleased to announce that its TwinCaps(R) inhaler licensees Daiichi Sankyo Co. Ltd. (Tokyo, Japan) and Biota Holdings Ltd (Victoria, Australia) have both announced successful Phase III trials for CS-8958, a new long-acting neuraminidase inhibitor for treatment of influenza (known as a prodrug of laninamivir).

CS-8958, co-owned by Daiichi Sankyo and Biota, is delivered by TwinCaps(R), a patented dry powder inhaler which Hovione specifically designed for the treatment and prevention of influenza infections in both seasonal and pandemics situations. The device was designed to be used across a broad range of patients' inspiratory flow rates and requires a single priming action prior to use.

In the Phase III trials conducted by Daiichi Sankyo, a single inhaled dose of CS-8958 was shown to be as effective as oseltamivir (Tamiflu(R)) administered orally twice daily for 5 days (total of 10 doses). A parallel Phase II/III trial of CS-8958 in paediatric patients also met the primary and secondary endpoints compared to oseltamivir.

CS-8958 is an important new treatment against influenza as current neuraminidase inhibitors for influenza require daily or more frequent dosing, compared to CS-8958 which requires one dose for treatment and possibly once-weekly dosing for prophylaxis). The ability to dose patients on a weekly, or even less frequent, basis offers numerous benefits. Firstly, the volume of product stored in stockpile reserves may be smaller and secondly, a single-dose treatment will offer better patient compliance and convenience.

TwinCaps(R), for which patent applications were filed world-wide in 2006, is an innovative inhaler, delivering a significant dose of drug to the lung, in a simple device comprising only two plastic components. Daiichi Sankyo and Biota have a worldwide exclusive license to use TwinCaps(R) for the treatment and prevention of influenza infections. TwinCaps(R) is available for licensing for use in other indications including antibiotic and vaccine delivery.

Hovione is now planning for large-scale manufacturing of the TwinCaps(R) devices. Daiichi Sankyo is intending to submit its market authorization application for Japan by March 2010, while Biota continues to advance the clinical development program required to support registration in the United States and UK.