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Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants
Date:8/10/2008

rned to damaged tissue, leading to an inflammatory response that could result in poor organ function. In the United States, approximately 28,000 patients received a solid organ transplant in 2007.

Orphan drug designation provides an accelerated FDA review process, tax advantages and a seven-year period of market exclusivity in the US upon product approval.

About Ikaria Holdings, Inc.

Ikaria Holdings, Inc. is a fully integrated biotherapeutics company focused on the development and commercialization of innovative pharmaceutical and biological products and drug/device combinations for the critically ill in the hospital and ICU setting. The company's product, INOmax(R) (nitric oxide) for inhalation, is an FDA-approved drug for the treatment of hypoxic respiratory failure in term and near-term newborns. The drug also is approved by regulatory authorities and used in Canada, Europe, Australia and Latin America. In addition to the ongoing clinical development as well as the marketing and selling of its INOmax product, Ikaria is engaged in a number of Phase 2 trials with Covox(R) (carbon monoxide) for inhalation and Phase 1 trials with hydrogen sulfide (H2S) for various critical care indications. Ikaria has a staff of approximately 400 people and is headquartered in Clinton, NJ, with research facilities in Seattle, WA and Madison, WI and manufacturing in Port Allen, LA. For more information on Ikaria, please visit http://www.ikaria.com.

CONTACTS: Matthew Bennett, Ikaria, (908) 238-6673, matthew.bennett@ikaria.com; or Jason Rando, The Ruth Group, 646-536-7025, jrando@theruthgroup.com


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