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INOflo is the first pharmaceutical gas approved in Japan and has beendesignated as an orphan drug by Japan's MHLW, granting a statutory exclusivityperiod of 10 years, during which time generic versions of INOflo will not beapproved.
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INOflo will be imported and distributed through a partnership with AirWater Incorporated and Sumitomo Seika Chemicals.
Daniel Tasse, President & CEO of Ikaria(R), remarked, "Approval of INOfloin Japan is a significant milestone for Ikaria and a further validation of thebenefits of our therapy. Currently, INOmax remains the only pharmaceuticalvasodilator approved for the treatment of persistent pulmonary hypertension innewborns and is used in thousands of neonates with hypoxic respiratory failureeach year."
Mr. Tasse continued, "Our partnership with Air Water Incorporated andSumitomo Seika Chemicals will enable us to quickly bring INOflo to theJapanese market. Boasting one of the most highly regarded healthcare systemsin the world, Japan will provide Ikaria with an important avenue forincremental growth and a significant foothold as we continue to expand ourportfolio of critical care products outside the US."
About INOmax
INOmax(R), in conjunction with ventilatory support and other appropriateagents, is used for the treatment of term and near-term (>34 weeks) neonateswith hypoxic respiratory failure associated with clinical or echocardiographicevidence of pulmonary hypertension.
INOmax is designed to help critically ill newborns breathe moreeffectively by dilating the blood vessels of the lungs, which improves oxygenuptake and maximizes oxygen supply to the tissues of the body. INOmax therapyhas been shown to reduce the need for a highly invasive surgical procedureknown as extracorporeal membrane oxygenation, or ECMO. During ECMO, aninfant's blood is mechanically oxygenated by connecting the baby to aheart-lung machine.
INOmax should not be used in the treatment of neonates known to bedependent on right-to-left shunting of blood. Abrupt discontinuation of INOmaxmay lead to a worsening condition. Methemoglobinemia is a dose-dependent sideeffect of inhaled nitric oxide therapy. Nitrogen dioxide (NO2) forms rapidlyin gas mixtures containing nitric oxide and oxygen, and therefore may causeairway inflammation and damage. Methemoglobin, NO2, and FiO2 should bemonitored during nitric oxide administration.
INOflo(R) is a registered trademark in Japan, in the name of AGAAktiegolag.
For more information on INOmax, please visit www.inomax.com.
About Ikaria Holdings, Inc.
Ikaria Holdings, Inc. is a fully integrated biotherapeutics companyfocused on the development and commercialization of innovative pharmaceuticaland biological products and drug/device combinations for the critically ill inthe hospital and ICU setting. The company's product, INOmax(R) (nitric oxide)for inhalation, is an FDA-approved drug for the treatment of hypoxicrespiratory failure in term and near-term newborns. The drug also is approvedby regulatory authorities and used in Canada, Europe, Australia and LatinAmerica. In addition to the ongoing clinical development as well as themarketing and selling of its INOmax product, Ikaria is engaged in a number ofPhase 2 trials with Covox(R) (carbon monoxide) for inhalation and Phase 1trials with hydrogen sulfide (H2S) for various critical care indicatio
