CLINTON, N.J., June 18 Ikaria Holdings, Inc., through itssubsidiary INO Therapeutics LLC, announced today that Japan's Ministry ofHealth, Labor, and Welfare's Council on Drugs and Food Sanitation (CDFS) hasrecommended approval of INOflo (nitric oxide) for inhalation. INOflo(brandname INOmax(R) in the United States) will be indicated for the treatmentof newborns who suffer from hypoxic respiratory failure (HRF), a potentiallylife-threatening condition that keeps babies' lungs from delivering enoughoxygen to their bodies. INOflo is expected to be officially approved byJapan's Ministry of Health, Labor and Welfare (MHLW) in July 2008.
INOflo, which has been designated an orphan drug in Japan, was recommendedfor approval by Japan's First Committee on Drugs in May of this year.However, because INOflo represents a new mechanism of action not previouslyapproved in Japan, it was reviewed again by the CDFS Department on Drugs.INOflo is the first pharmaceutical gas approved in Japan, a designation italso has received in the United States, Europe, Canada, Australia, Singaporeand several countries in Latin America.
Daniel Tasse, President & CEO of Ikaria, remarked, "As we broaden thereach of INOmax to new continents, we are expanding our ability to advancecritical care around the globe. We look forward to bringing this importanttherapy in neonatal critical care to Japan."
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 thus may cause airwayinflammation and damage. Methemoglobin, NO2, and FiO2 should be monitoredduring nitric oxide administration.
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 indications.Ikaria has a staff of approximately 360 people and is headquartered inClinton, NJ, with research facilities in Seattle, WA and Madison, WI andmanufacturing in Port Allen, LA. For more information on Ikaria, please visitwww.ikaria.com.CONTACTS Matthew Bennett Ikaria (908) 238-6673 [email protected]
Jennifer Saunders The Ruth Group 646-