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Press Release / Apr 15, 2009

TwinCaps® in Phase III clinical trials for influenza

Hovione’s TwinCaps® inhaler in Phase III clinical trials for influenza

April 15, 2009. Hovione is pleased to announce that its licensee Daiichi Sankyo (Tokyo, Japan) has informed that it intends to use Hovione’s TwinCaps® dry powder inhaler device in the launch of the compound CS-8958, an inhaled long-acting neuraminidase inhibitor active against the influenza virus. Daiichi Sankyo has completed patient enrollment 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 by Hovione for the indication and licensed to Daiichi Sankyo and Biota Holdings Ltd (Victoria, Australia). 



The announcement follows the recent publication [1] of data indicating that the compound is as effective as Relenza® and Tamiflu® 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® 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® 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® 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® DPI (to be manufactured in Japan and Europe) is a two-piece unit comprising 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 mouth piece to allow the first inhalation, creating turbulence within the dose chamber and drawing the dry powder into the lung of the patient. The process is then repeated for the second dose chamber, as the shuttle is moved to the opposite side to permit another inhalation to take place.



Daiichi Sankyo has indicated that they are planning to file NDA in Japan in March 2010 and get approval within 2010, while Daiichi Sankyo and Biota are seeking licensees for the drug product collaboratively for the rest of world market. Hovione retains the right to commercialize TwinCaps® outside the field of influenza.



Peter Villax, Hovione’s Vice President Pharma Business Unit stated ”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 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, China, Ireland and Portugal the company focuses on the most demanding customers, in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.



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[1] Makoto Yamashita et al. “CS-8958, a prodrug of the new neuraminidase inhibitor R-125489, shows long-acting anti-influenza virus activity”, Antimicrobial Agents and Chemotherapy, Jan.2009, p.186-192

 

For further information about Hovione, please contact Corporate Communications (Isabel Pina, + 351 21 982 9362)

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