Hovione announces filing of new drug application in Japan for the influenza drug CS-8958

Hovione is announcing the filing of a new drug application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione's TwinCaps(R) inhaler.

Being pre-filled, disposable and low-cost, TwinCaps(R) was specifically developed for the influenza indication and may thus be used for inhaled drug delivery to the lung in other acute indications, such as bacterial or viral infections. Since the inhaler was designed for a primarily inhaler-naive population, ease of use was the most important design criterion.

Patents for TwinCaps(R) were filed worldwide in 2006 and have already been issued in Japan, South Africa and Portugal. Hovione expects the case to proceed to grant in all jurisdictions.

CS-8958 is a laninamivir prodrug, a long-acting neuraminidase inhibitor developed as an inhaled drug by Daiichi Sankyo for the Japanese market. Clinical studies performed with adults and children suffering from type A or B influenza viruses have proven that the delivery of CS-8958 by TwinCaps(R) is effective with a single treatment course. Daiichi Sankyo have also announced the start of a Phase III clinical trial to demonstrate efficacy in influenza prevention.

Hovione has licensed its inhalation device patents to Daiichi Sankyo and Biota Holdings Ltd (Victoria, Australia) and collaborated on the formulation development.

Peter Villax, Vice-President in charge of TwinCaps(R) development, said "This filing follows four years of great collaboration between Daiichi Sankyo and Hovione and we are very honoured to be part of this project."