Nitric oxide is naturally produced by many cells in the human body, and is known as a “signaling molecule” due to its ability to penetrate cell membranes to deliver a signal to nearby muscles to
relax. When inhaled, nitric oxide selectively relaxes the cells of the pulmonary vasculature, resulting in increased blood flow through the lungs and delivery of more oxygenated blood to the body. Inhaled nitric oxide is available as INOMAX® (nitric oxide) for inhalation, a vasodilator, which, in conjunction with ventilation and other appropriate agents, treats term and near-term newborns
(>34 weeks gestation) with hypoxic respiratory failure associated with evidence of pulmonary hypertension.

Based on this use, Ikaria is investigating the use of iNO in patients with PAH, which is hypertension in the arteries between the heart and lungs. The delivery of iNO will be pulsed to synchronize with the patient’s breathing pattern through Ikaria’s next-generation INOpulse® DS drug-delivery system, which is specially engineered for use in spontaneously breathing patients. Ikaria’s PAH development program, known as IK-7001, will investigate the use of iNO/INOpulse DS as a drugdevice combination product.

“Our receipt of orphan drug designation for the use of iNO via the INOpulse in PAH, combined with the IND we submitted last year, speaks to the solid progress of our late-stage pipeline,” stated
Daniel Tassé, Chairman and CEO of Ikaria. “We’re delighted to have PAH and bronchopulmonary dysplasia as additional indications under investigation for iNO, and also are planning its investigation with the INOpulse DS in chronic obstructive pulmonary disease.”

Orphan drug designation is reserved for rare diseases or disorders that affect fewer than 200,000 people in the United States. PAH affects fewer than 200,000 Americans. This designation offers
the sponsor tax credits on certain development costs, a waiver of the new drug application (NDA) application user fee, and an exclusivity period of seven years following marketing approval. In
addition to the seven-year marketing exclusivity period granted under the orphan drug designation, the INOpulse DS drug-delivery system would be further protected by developing a portfolio of
patents, the last of which expires no earlier than 2029.

“I am delighted that Tasos has joined us in this key position, and I am confident that his strong experience in effectively managing the financial functions of global companies will benefit Ikaria,” commented Daniel Tassé, Chairman and CEO of Ikaria. “The combination of a promising product pipeline and a well-run business, both financially and operationally, will help us achieve our vision of becoming a leader in critical care.”

Mr. Konidaris has over 20 years of global financial and operational experience, most recently with Dun & Bradstreet (D&B) Corporation, where he was Senior Vice President and CFO since 2007. Prior to joining D&B, Tasos served as Group Vice President at Schering Plough Corporation, which was acquired by Merck & Co. in 2010. As Vice President and CFO of North America and Global Business Management at Pharmacia Corporation in 2003, he played a significant role in the integration of the global pharmaceutical groups of Pharmacia and Pfizer Inc. His early career experience includes positions of increasing responsibility at Rhone-Poulenc Rorer, Novartis Corporation and Bristol-Myers Squibb Company. Mr. Konidaris holds an MBA from Drexel University and a BS from Gwynedd Mercy College in Pennsylvania.

Third-generation INOmax DSIR Utilizes Infrared Technology
Clinton, NJ, – Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients in the hospital and ICU settings, today announced the introduction of its next-generation drug-delivery system, the INOmax DSIR, in neonatal intensive care units (NICUs) within hospitals throughout the United States. The INOmax DSIR recently has been launched in Canada and Australia.

The INOmax DSIR is a proprietary drug-delivery system that delivers the drug, INOmax® (nitric oxide) for inhalation, the only drug approved by the U.S. Food and Drug Administration (FDA) to treat hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants, which includes infants born at a gestational age of at least 34 weeks. HRF is a serious condition in which blood vessels in the lungs constrict, making it difficult to oxygenate blood. INOmax relaxes pulmonary blood vessels, improves oxygenation and treats HRF in this delicate newborn population.

Ikaria continually develops new technologies to improve upon its existing drug-delivery systems. The third generation INOmax DSIR, which has been in development since 2008, is an advance over the second generation INOmax DS and the early-generation INOvent® drug-delivery systems.

The INOmax DSIR utilizes infrared technology to link the device and cylinder allowing expanded informatics on use of INOmax therapy. The INOmax DSIR, like the INOmax DS, is constructed for ease of use and contains multiple back-up warnings and alarm features to ensure the safe, consistent and reliable delivery and monitoring of INOmax. With its compact size and weight, the INOmax DSIR offers improved system management, such as drug usage tracking and various reminders to assist in the proper administration of INOmax therapy. Like the INOmax DS, the INOmax DSIR is compatible with more than 45 makes of ventilation devices and anesthesia machines to offer flexibility of use with patients at many ventilator settings.

“The launch of the INOmax DSIR represents Ikaria’s commitment to continually advance the technology of our delivery systems so that clinicians can safely and effectively deliver INOmax to critically ill patients,” said Daniel Tassé, Chairman and Chief Executive Officer of Ikaria. “It is our goal to continue to meet the current and future needs of our customers with our clinically important drug, INOmax, our ever-evolving, technologically advanced drug-delivery systems, and our one-of-a-kind technical and service support offering.”

The INOmax DS and INOmax DSIR drug-delivery systems are part of a comprehensive offering known as the INOmax therapy package. In addition to use of Ikaria’s proprietary, FDA-cleared drug-delivery systems, the INOmax therapy package includes INOmax (nitric oxide) for inhalation, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, 24/7/365 customer service, and all related disposable items.

The INOMAX DSIR is a proprietary drug-delivery system that delivers the drug, INOMAX (nitric oxide) for inhalation, to term and near-term infants with hypoxic respiratory failure. The INOMAX DSIR utilizes infrared technology to expand the informatics connecting the delivery system with the cylinder containing INOMAX therapy, contains multiple back-up warnings and enhanced alarm features to ensure the consistent and reliable delivery and monitoring of INOMAX to patients, and is improved for overall ease of use.

The INOMAX DSIR is an advance over the existing INOMAX DS drug-delivery system and the early-generation INOvent drug-delivery systems. With its improved connectivity, the INOMAX DSIR provides enhanced key features within the independent delivery and monitoring components of the system. Like the INOMAX DS, the INOMAX DSIR is compatible with more than 45 makes of invasive and non-invasive ventilation devices and anesthesia machines to offer flexibility of use with patients at many ventilator settings.

“I’m delighted that we’ve launched the INOMAX DSIR in Canada and that we continue to deliver on our commitment to advance our delivery systems to insure ease of use for clinicians and the safe
and effective delivery of INOMAX to critically ill patients,” said Daniel Tassé, President and Chief Executive Officer of Ikaria.

The INOMAX DS and INOMAX DSIR drug-delivery systems are part of a comprehensive offering known as INOtherapy®. In addition to use of Ikaria’s proprietary, FDA-cleared drug-delivery systems, INOtherapy includes INOMAX (nitric oxide) for inhalation, all related disposable items, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, and 24/7/365 customer service.

This offering is made available in Canada through Ikaria Canada Inc in Ottawa, Ontario. Ikaria Canada Inc was established in 2008, and provides INOtherapy to 65 hospitals across the provinces. “We’re pleased to offer our customers the latest advancement in our drug-delivery system so that they can continue to provide INOMAX therapy to their most fragile patients,” said Jared Rhines, Vice President and General Manager of Ikaria Canada Inc.

Clinton, NJ, – Ikaria, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted INOmax® (nitric oxide) for inhalation an additional six months of marketing exclusivity, known as “pediatric exclusivity.” The action extends exclusivity for INOmax from January 2013 to July 2013. This decision was based on data submitted from three clinical trials of INOmax in pre-term infants at risk for bronchopulmonary dysplasia (BPD), a serious respiratory condition resulting from lung injury.

Data from three large, multi-center, double-blind, placebo-controlled clinical trials examining the efficacy and safety of INOmax in pre-term infants less than or equal to 34 weeks gestational age were submitted to the FDA. Although the safety and tolerability of INOmax has been shown in these trials, substantial evidence of efficacy has not been demonstrated. Therefore, Ikaria continues to study the efficacy of INOmax for the prevention in BPD in pre-term infants through its Phase III clinical trial, which commenced in December 2009. INOmax is not indicated for the prevention of BPD in pre-term infants.

INOmax is indicated for the treatment of hypoxic respiratory failure, or HRF, in term and near-term (>34 weeks) infants. HRF occurs when the cells in the body are unable to receive enough oxygen, and is a life-threatening condition for newborns. INOmax helps critically ill newborns breathe more effectively by dilating the blood vessels of the lungs, which improves oxygen uptake and maximizes oxygen supply to the tissues of the body. Use of INOmax reduces the need for extracorporeal membrane oxygenation (ECMO), a highly-invasive and expensive surgical procedure in which an infant’s blood is mechanically oxygenated by connecting the newborn to a heart-lung machine.

INOmax is delivered as part of a comprehensive offering known as INOtherapy®. In addition to INOmax, INOtherapy includes use of Ikaria’s proprietary, FDA-cleared drug-delivery system, all related disposable items, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, and 24/7/365 customer service.

Clinton, NJ, – Ikaria, Inc. announced that it has enrolled the first patients in its pivotal Phase III trial for LUCASSIN® (terlipressin). The multi-center, randomized, placebo controlled, double-blind trial is known as the REVERSE Trial.
LUCASSIN is being developed for the treatment of hepatorenal syndrome (HRS) Type 1, a orphan-designated condition for which there currently are no approved drugs in the United States. HRS Type 1 is the development of kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause. It is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80% within three months.

The REVERSE Trial will compare terlipressin in combination with albumin to placebo with albumin, and will have a primary endpoint of HRS reversal, which is defined as two serum creatinine values of less than or equal to 1.5 mg/dL taken at least 48 hours apart, without any intervening hemodialysis, transplant or elevation of creatinine above a pre-specified level. Transplant-free survival and overall survival are among the secondary endpoints of the trial.

“The start of the REVERSE trial marks Ikaria’s intent to provide the data necessary to fulfill the regulatory requirement to seek U.S. marketing approval to bring an approved treatment option to the patients with HRS Type 1,” commented Douglas Greene, MD, Executive Vice President, Research & Development, Ikaria.

In November 2009, Orphan Therapeutics received a complete response to its marketing application from the U.S. Food & Drug Administration (FDA), citing the need for an additional clinical trial. Ikaria acquired ownership of the LUCASSIN in North America and Australia from Orphan Therapeutics in March 2010.

LUCASSIN is a synthetic vasopressin analogue that acts via the vasopressin V1a receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS. Terlipressin is approved in France, Ireland, Spain and South Korea for the treatment of patients with HRS Type 1. Terlipressin is not approved by the FDA for use in the United States.

Clinton, NJ – Ikaria, Inc. today announced that Martin Meglasson, Ph.D., will join Ikaria as Chief Science Officer. Dr. Meglasson will be responsible for activities related to early-stage drug development. He will assume his new role at the end of July.

“We are delighted to welcome Martin, who will help drive our early-stage assets forward by leveraging his experience and knowledge,” commented Douglas Greene, M.D., Executive Vice President of Research and Development at Ikaria. “We believe Martin can help us achieve our vision of becoming a leader in critical care by driving the development of our two early-stage product candidates, IK-1001 and the IK-600X portfolio. He will also play a significant role as we expand and develop our portfolio of critical care products.”

Dr. Meglasson, who has over 20 years of experience in the pharmaceutical industry, joins Ikaria from Ligand Pharmaceuticals Incorporated, where he is Vice President of Discovery Research. Prior to his tenure at Ligand, he held several leadership positions at Pharmacia Inc. and its predecessor companies, Pharmacia & Upjohn and The Upjohn Company. Dr. Meglasson has participated in the discovery and development of two marketed drugs, and is an inventor of 18 U.S. patents.

Clinton, NJ – Ikaria, Inc. today announced that Craig Tooman will join Ikaria as Senior Vice President and Chief Financial Officer (CFO). In this role, Mr. Tooman will be responsible for all financial functions of the company, as well as for information technology services. Mr. Tooman succeeds Elizabeth Larkin, who left the company in March to pursue other interests. He will assume his new role at the beginning of August.

I am delighted that Craig will join us in this key executive role, and am confident that we will benefit greatly from his knowledge and experience in effectively managing the financial aspects of our business,” commented Daniel Tassé, Chairman and CEO of Ikaria. “I believe that Craig’s expertise — combined with our product pipeline and commercial capabilities — will help us achieve our vision of becoming a leader in critical care. I also wish to thank Liz for building a strong foundation from which we can build.”

Mr. Tooman has over 20 years of experience in the pharmaceutical industry, and joins Ikaria from Enzon Pharmaceuticals, where he was Executive Vice President of Finance and CFO since 2005. Prior to joining Enzon, he served as Senior Vice President of Strategic Planning and Corporate Communications at ILEX Oncology, Inc., which was acquired by Genzyme in 2004. He also played a significant role in the 2001 merger between Pharmacia & Upjohn and Monsanto that created the Pharmacia Corporation, having served in various positions within its predecessor companies Pharmacia & Upjohn and The Upjohn Company. Mr. Tooman holds an MBA from the University of Chicago, and a BA from Kalamazoo College.

Clinton, NJ – Ikaria, Inc. today announced that Geoffrey Nichol, M.D., has been appointed Chief Medical Officer. In this newly created role, Dr. Nichol will be responsible for activities related to late-stage drug development.

“We are delighted to welcome Geoff, who will leverage his extensive experience in driving our late stage assets forward,” commented Daniel Tassé, Chairman and CEO of Ikaria. “We believe he can help us achieve our vision of becoming a leader in critical care by driving the commercialization process of our two late-stage product candidates, as well as the FDA approval process for the additional indications we are pursuing for our marketed product INOmax®.”

Dr. Nichol, who has over 20 years of experience in the pharmaceutical industry, joins Ikaria from Medarex, Inc., where he was Senior Vice President of Product Development. Prior to his tenure at Medarex, Dr. Nichol held several leadership positions at Novartis Pharmaceuticals, and began his industry career at SmithKline Beecham Pharmaceuticals.

Clinton, NJ – Ikaria, Inc. today announced that Douglas Greene, M.D., has been appointed Executive Vice President of Research and Development (R&D). In this role, Dr. Greene will be responsible for drug-development activities, including pre-clinical and clinical research, translational science, regulatory affairs, clinical pharmacology, pharmacovigilance, medical affairs, and project and portfolio management. Dr. Greene succeeds Ralf Rosskamp, M.D., who served as Executive Vice President of R&D since 2007.

“We are proud of our product pipeline, which is a testament to Ralf’s strategy and vision, and we thank him for developing a promising pipeline of product candidates, including two which are in late-stage development,” commented Daniel Tassé, Chairman and CEO of Ikaria. “However, I am delighted that Doug has joined us, and am confident that we will benefit greatly from his knowledge, experience and leadership in driving the further development of our early- and latestage pipeline, which we believe will help us achieve our vision of becoming a leader in critical care.”
Dr. Greene has over 30 years of experience in academia, and 10 years of experience in the pharmaceutical industry. He joins Ikaria from Sanofi-aventis, where he served in various leadership roles since 2003, including Chief Medical Officer of its US business from 2006-2009. Dr. Greene was a member of the US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drug Advisory Committee from 1988-1994, and acted as Chairman of the Advisory Committee from 1990-1994.