Hovione's TwinCaps(R) Inhaler in Phase III Clinical Trials for Influenza
The announcement follows the recent publication(1) of data indicating that the compound is as effective as Relenza(R) and Tamiflu(R) against various influenza strains. Significantly this efficacy is achieved with a single dose, as opposed to a treatment over five days for the established drugs.
A 20 mg dose of CS-8958 is inhaled from powder compartments in the TwinCaps(R) inhaler, which is made of just two plastic parts. Hovione believes this is currently the simplest inhaler being tested in clinical trials and once approved, will be the simplest in the market and have the lowest cost of goods. TwinCaps(R) has no moving parts to deaggregate the dose of powder and only requires a low inspiratory airflow to achieve optimal delivery to the lung. This means that children and the elderly will find it easier to inhale the full dose.
The design challenge for Hovione was to make TwinCaps(R) extremely simple
to use, as in the case of a pandemic requiring immediate treatment of large
populations, there is an obvious advantage for simple operation. The
TwinCaps(R) DPI (to be manufactured in
Daiichi Sankyo has indicated that they are planning to file NDA in
Peter Villax, Hovione's Vice President Pharma Business Unit stated "The unique design benefits of TwinCaps(R) including high dose capability, disposability and low cost are predicted to drive growth in Hovione's inhalation business and further leverage our already proven track record in developing inhalation APIs, formulation development and manufacturing services."
About Hovione. Hovione is an international company with 50 years'
experience in Active Pharmaceutical Ingredient development and compliant
manufacture. With four FDA inspected sites in the US,
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