July 22, 2008
Ikaria’s Respiratory Drug Wins Japanese Approval
Ikaria Holdings, through its subsidiary Ino Therapeutics, has announced that Japan's Ministry of Health, Labor and Welfare has approved INOflo for inhalation for improvement of hypoxic respiratory failure with concurrent pulmonary hypertension in neonates.
INOflo is said to be the first pharmaceutical gas approved in Japan and has been designated as an orphan drug by Japan's Ministry of Health, Labor and Welfare, granting a statutory exclusivity period of 10 years, during which time generic versions of INOflo will not be approved.
Ikaria's INOflo has been shown to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO), a highly invasive cardiopulmonary bypass procedure.
INOflo will be imported and distributed through a partnership with Air Water and Sumitomo Seika Chemicals.
Daniel Tasse, president and CEO of Ikaria, said: "Currently, INOmax remains the only pharmaceutical vasodilator approved for the treatment of persistent pulmonary hypertension in newborns and is used in thousands of neonates with hypoxic respiratory failure each year."