Hovione's TwinCaps inhaler in Phase III clinical trials for influenza

22-Jul-2010

Licensee Daiichi Sankyo (Tokyo, Japan) is to use Hovione\'s TwinCaps dry powder inhaler device in the launch of CS-8958, an inhaled long-acting neuraminidase inhibitor active against the influenza virus. Daiichi Sankyo has completed patient enrolment for Phase III clinical trials in Japan and other Asian countries and results are expected to be released mid year, including data to confirm the device switching. TwinCaps was specifically developed for the indication and licensed to Daiichi Sankyo and Biota Holdings in Australia.

Licensee Daiichi Sankyo (Tokyo, Japan) is to use Hovione\'s TwinCaps dry powder inhaler device in the launch of CS-8958, an inhaled long-acting neuraminidase inhibitor active against the influenza virus. Daiichi Sankyo has completed patient enrolment for Phase III clinical trials in Japan and other Asian countries and results are expected to be released mid year, including data to confirm the device switching. TwinCaps was specifically developed for the indication and licensed to Daiichi Sankyo and Biota Holdings in Australia.

A recent study in Japan indicated that the compound is as effective as Relenza and Tamiflu against various influenza strains. This efficacy is achieved with a single dose, as opposed to a treatment over five days for the established drugs.

A 20mg dose of CS-8958 is inhaled from powder compartments in the TwinCaps inhaler, which is made of two plastic parts. Hovione believes this is currently the simplest inhaler being tested in clinical trials. TwinCaps has no moving parts to deaggregate the dose of powder and only requires a low inspiratory airflow to achieve optimal delivery to the lung.

The TwinCaps DPI (to be manufactured in Japan and Europe) comprises body and shuttle components. The shuttle has two pre-filled dose chambers, left and right. In use, the shuttle is moved to one side by the patient to align one chamber of the shuttle with the mouthpiece to allow the first inhalation, creating turbulence within the dose chamber and drawing the dry powder into the lung. The process is then repeated for the second dose chamber.

Daiichi Sankyo plans to file the NDA in Japan in March 2010, while Daiichi Sankyo and Biota are together seeking licencees for the drug product for the rest of world. Hovione retains the right to commercialise TwinCaps outside the field of influenza.

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Peter Villax, vice president of Hovione\'s pharma business unit, said: "The unique design benefits of TwinCaps, including high dose capability, disposability and low cost are predicted to drive growth in Hovione\'s inhalation business and further leverage its already proven track record in developing inhalation APIs, formulation development and manufacturing services."

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