
IKARIA’S INOFLO (NITRIC OXIDE) FOR INHALATION APPROVED IN JAPAN
Ikaria to Market and Distribute INOflo via Partnership with Air Water Incorporated and
Sumitomo Seika Chemicals
Clinton, NJ, July 21, 2008 – Ikaria Holdings, Inc., through its subsidiary INO Therapeutics LLC, announced today that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved INOflo® (nitric oxide) for inhalation for improvement of hypoxic respiratory failure (HRF) with concurrent pulmonary hypertension in neonates. INOflo (brand name INOmax® in the United States) has been shown to improve oxygenation and reduce the need for ECMO, a highly invasive cardiopulmonary bypass procedure.
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IKARIA® STRENGTHENS RESEARCH & DEVELOPMENT TEAM
Appoints Dr. Deborah Petrowsky Vice President of Medical Affairs and Dr. Steven Knapp Vice President of Regulatory Affairs
Clinton, NJ, July 1, 2008 – Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today the addition of two executives to its Research & Development division. Deborah Petrowsky, M.D., F.C.C.P. was named Vice President for Medical Affairs and Steven Knapp, M.S., Pharm.D. was appointed Vice President of Regulatory Affairs. Both will report directly to Ralf Rosskamp, M.D., Executive Vice President for Research and Development of Ikaria.
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IKARIA INTRODUCES DR. MICHAEL COOREMAN AS
VICE PRESIDENT OF TRANSLATIONAL MEDICINE
Translational Medicine Department Strengthens Research & Development Team
Clinton, NJ, June 24, 2008 – Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced that Michael Cooreman, M.D., has been introduced as Vice President of Translational Medicine, reporting to Ralf Rosskamp, M.D., Executive Vice President for Research and Development of Ikaria.
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IKARIA’S INOFLO (NITRIC OXIDE) FOR INHALATION TO BE OFFICIALLY APPROVED IN JAPAN
Clinton, NJ, June 18, 2008 – Ikaria Holdings, Inc., through its subsidiary INO Therapeutics LLC, announced today that Japan’s Ministry of Health, Labor, and Welfare’s Council on Drugs and Food Sanitation (CDFS) has recommended approval of INOflo (nitric oxide) for inhalation. INOflo (brandname INOmax® in the United States) will be indicated for the treatment of newborns who suffer from hypoxic respiratory failure (HRF), a potentially life-threatening condition that keeps babies’ lungs from delivering enough oxygen to their bodies. INOflo is expected to be officially approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) in July 2008.
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IKARIA COMPLETES DOSING OF PHASE 1A CLINICAL STUDY FOR IK-1001
(SODIUM SULFIDE) FOR INJECTION
Clinton, NJ, May 19, 2008 – Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics
company, announced today that it has completed dosing of its Phase 1a trial for its drug candidate,
IK-1001 (sodium sulfide) for injection.
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LOTA ZOTH ELECTED TO IKARIA BOARD AND NAMED AUDIT COMMITTEE CHAIR
Clinton, NJ, January 22, 2008 – Ikaria Holdings, Inc., a fully integrated critical care biopharmaceutical company, announced today that Lota S. Zoth has been elected an independent member of the company’s Board of Directors. Zoth, the former Chief Financial Officer of MedImmune, will chair the Ikaria Audit Committee.
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IKARIA WINS SECOND CONSECUTIVE AARC ZENITH AWARD
- Award Presented at 53rd International Respiratory Congress -
Clinton, NJ, January 17, 2008 – Ikaria Holdings, Inc., a fully integrated critical care biopharmaceutical company, announced today that it has been awarded the American Association for Respiratory Care (AARC) Zenith Award for the second consecutive year. The 2007 Zenith Award was presented to Ikaria at the AARC’s 53rd Annual International Respiratory Congress in Orlando, Florida on December 3, 2007. Ikaria was one of five companies to win the award in a field of more than 400 eligible organizations.
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IKARIA APPOINTS DANIEL TASSÉ AS PRESIDENT AND CHIEF EXECUTIVE OFFICER
- Former CEO David Shaw Named Executive Chairman and Chairman of the Board -
Clinton, NJ, January 9, 2008 – Ikaria Holdings, Inc., a fully integrated critical care
biopharmaceutical company, announced today that Daniel Tassé has been appointed President
and Chief Executive Officer. Mr. Tassé succeeds David Shaw, who has served as Chairman and
interim CEO since the creation of Ikaria Holdings in March 2007 and will now serve as Executive
Chairman and Chairman of the Board.
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IKARIA TO PRESENT AT 26th ANNUAL JPMORGAN HEALTHCARE CONFERENCE
Clinton, NJ, January 3, 2008 – Ikaria Holdings, Inc., a fully integrated critical care
biopharmaceutical company, announced today that its Chairman & CEO, David Shaw, will present
at the 26th Annual JPMorgan Healthcare Conference on Tuesday, January 8, 2008 at 3:00 p.m.,
PST. The conference will be held January 7-10 at The Westin St. Francis Hotel in San Francisco.
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IKARIA’S INOMAX® (NITRIC OXIDE) FOR INHALATION APPROVED IN AUSTRALIA
Expands global reach of Ikaria with approval of first pharmaceutical gas in Australia to help critically ill newborns who suffer from hypoxic respiratory failure
Clinton, NJ, November 27, 2007 – Ikaria Holdings, Inc., through its subsidiary INO Therapeutics LLC, announced today that it has received approval from Australia’s regulatory body, the Therapeutic Goods Administration (TGA), for INOmax (nitric oxide) for inhalation. INOmax has been designated an orphan drug by the TGA. The Australian Orphan Drug Act provides a pathway for the development of medical products to treat rare disorders. INOmax is the first pharmaceutical gas approved in Australia, a designation it also has received in the United States, Europe, Canada, Singapore and several countries in Latin America. INOmax is indicated for the treatment of near- and full-term newborns who suffer from hypoxic respiratory failure (HRF), a potentially life-threatening condition that keeps babies’ lungs from delivering enough oxygen to their bodies.

Ikaria expects that INOmax will be marketed and distributed in Australia beginning in January 2008 through an alliance with BOC Medical, a division of BOC Limited, a company within the Linde Group. BOC Medical is a leading supplier of medical gases and equipment to the health care sector and will supply INOmax throughout Australia.
“As we broaden the reach of INOmax to new continents, we are expanding our ability to advance critical care around the globe,” said Ikaria Chairman and CEO David Shaw. “Through our partner, BOC Medical, with its 60 years of experience in Australia, we look forward to bringing this important therapy to neonatal critical care across the Australian continent.”
About INOmax
INOmax, in conjunction with ventilatory support and other appropriate agents, is used for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.
INOmax is designed to help critically ill newborns breathe more effectively by dilating the blood vessels of the lungs, which improves oxygen uptake and oxygen supply to the tissues of the body. INOmax therapy has been shown to reduce the need for a highly invasive surgical procedure known as extracorporeal membrane oxygenation, or ECMO. During ECMO, an infant’s blood is mechanically oxygenated by connecting the baby to a heart-lung machine.
INOmax should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood. Abrupt discontinuation of INOmax may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen and thus may cause airway inflammation and damage. Methemoglobin, NO2, and the fraction of inspired oxygen (FiO2) should be monitored during nitric oxide administration.
For more information on INOmax, including important safety and complete prescribing information, please visit INOmax.com.
About Ikaria Holdings
Ikaria Holdings, Inc. is a fully integrated biotherapeutics company
focused on the development and commercialization of innovative in-hospital
pharmaceutical products and drug/device combinations that improve the lives
of patients. The company's product, INOmax (nitric oxide) for inhalation,
is an FDA-approved drug for the treatment of hypoxic respiratory failure in
term and near-term newborns and is extensively used in critical care
settings in the United States.
The drug also is approved by regulatory authorities and used in Canada,
Europe and Latin America. In addition to marketing and selling its INOmax
product, Ikaria is engaged in both Phase II trials with Covox(R) (carbon
monoxide) for inhalation and Phase I trials with hydrogen sulfide (H2S) for
various indications. Ikaria has a staff of over 300 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.
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IKARIA NAMES EXECUTIVE VICE PRESIDENT OF RESEARCH AND DEVELOPMENT
Clinton, NJ, October 1, 2007 – Ikaria Holdings, Inc. announced today that Ralf Rosskamp, M.D., has been appointed Executive Vice President of Research and Development, reporting to Chairman and CEO David Shaw.
Dr. Rosskamp most recently was Executive Vice President of R&D at Kos Pharmaceuticals. Prior to joining Kos, Ralf was Vice President of Global Therapeutic R&D for Endocrinology, Metabolism, Rheumatology and Bone at Aventis Pharmaceuticals. Earlier in his career he held executive positions at Hoechst Pharmaceuticals and served as a senior physician in the Department of Pediatrics at the University of Bonn (Germany), where he earned his M.D.

“Ralf has extensive experience in a wide range of important drug development activities, including clinical research, regulatory affairs, clinical pharmacology, aerosol and solid dose R&D, biomedical engineering, pharmacovigilance, medical affairs and project/portfolio management,” stated Mr. Shaw. “He has been very successful in managing pharmaceutical R&D efforts in both large and small companies. We expect Ikaria to benefit significantly from his knowledge, experience and leadership as we build a leading company in critical care medicine.” |
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IKARIA FOUNDING SCIENTIST NAMED 2007 MACARTHUR FELLOW
Clinton, NJ, September 26, 2007 – Mark Roth, Ph.D., an advisor and founding scientist of Ikaria, this week received a MacArthur Fellowship award, which includes a grant to further his research over the next five years.
Roth, a member of the Fred Hutchinson Cancer Research Center’s Basic Sciences Division, received five years of “no-strings-attached” support from the John D. and Catherine T. MacArthur Foundation for his pioneering research in basic biology. Most notably, his research has pioneered reversible metabolic hibernation – a finding that may have clinical benefits in humans.

“Mark is an extraordinarily talented scientist, as well as a great friend and colleague to the Ikaria team,” said Ikaria Chairman and CEO David Shaw. “We are very pleased that the MacArthur Foundation recognized the importance of Mark’s groundbreaking research through this prestigious award. We look forward to making the benefits of this research available to patients in the future.”
In April 2005, Roth demonstrated the ability of the biological gas hydrogen sulfide to induce a state of reversible metabolic hibernation in mice, which may be a latent ability in all mammals. Temporary slowing of the metabolic rate, or inducing hibernation on demand, has the potential to lengthen the window of time that patients with trauma, stroke, cardiac arrest or surgery can be treated. In addition to increasing the time that transplant organs or tissues are viable outside the body, this expanded time window could help prevent injury and death from insufficient or inappropriate oxygen supply to organs and tissues.
Ikaria has submitted regulatory documents for hydrogen sulfide as an experimental drug. The company is expected to start a Phase I trial later this year.
The MacArthur Fellowship Program recognizes talented individuals who have shown exceptional originality and dedication in their creative pursuits. Its purpose is to invest in a person's “originality, insight, and potential,” enabling recipients to exercise their own creative instincts for the benefit of human society. Since its start in 1981, the program has named 756 Fellows, including Roth, who was among the 24 recipients announced this week. |
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NEW STUDY SHOWS PROMISE FOR HYDROGEN SULFIDE IN REDUCING HEART-ATTACK DAMAGE, IKARIA ANNOUNCES
Study led by Albert Einstein College of Medicine researchers published in major scientific journal
Clinton, NJ, September 25, 2007 – Producing a state of “hibernation on demand" in mice by administering an experimental drug from Ikaria (an injectable formulation of the biological gas hydrogen sulfide) showed promise in a study designed to reduce damage from heart attacks. The study was published in the online edition of the Proceedings of the National Academy of Sciences.

The preclinical study, conducted by researchers at New York’s Albert Einstein College of Medicine and the University of Alabama, was funded in part by Ikaria and examined whether hydrogen sulfide could prevent “reperfusion injury” – caused when blood flow and oxygen supply to heart tissue plummet during a heart attack, then are abruptly restored when the heart attack is treated. This dramatic change in oxygen levels can be heavily damaging to the heart.
“Over the last few years, a number of reports have demonstrated the protective effects of hydrogen sulfide in various models of cardiovascular disease and inflammation,” said Csaba Szabo, M.D., Ph.D., chief scientific officer of Ikaria and a study co-author. “This study can be considered a milestone not only because it defines the significant therapeutic potential of hydrogen sulfide during heart attacks, but also because it links these therapeutic effects to hydrogen sulfide-induced on-demand metabolic modulation, a new field of biological research championed by Ikaria.”
The senior study author was David Lefer of Albert Einstein College of Medicine's department of pathology and the division of cardiology within Albert Einstein's department of medicine.
While hydrogen sulfide is more commonly known as a toxic gas when it occurs at high levels, it has demonstrated a biologically protective role when delivered in very low doses, Dr. Szabo said. Ikaria has submitted regulatory documents and is expected to start a Phase I trial later this year.
“The development of hydrogen sulfide as an ethical pharmaceutical may offer exciting new opportunities in the treatment of cardiovascular and inflammatory diseases,” said David Shaw, chairman and CEO of Ikaria. “We are encouraged by the compelling results of this and other studies of our product as part of our overall efforts to improve outcomes for critically ill patients.”
Ikaria’s hydrogen sulfide clinical platform is based on its exclusive, worldwide license from the Fred Hutchinson Cancer Research Center (FHCRC). In April 2005, Mark Roth, Ph.D., a member of the research faculty of the FHCRC, demonstrated the ability of hydrogen sulfide to induce a state of reversible metabolic hibernation in mice, which was published in a landmark article in the prestigious journal Science.
Hibernation may be a latent ability in all mammals – a finding that may have important clinical benefits in humans. Temporary slowing of the metabolic rate, or inducing hibernation on demand, has the potential to lengthen the window of time that patients with trauma, stroke, cardiac arrest or surgery can be treated. This lengthened time window could help prevent injury and death from insufficient or inappropriate oxygen supply to organs and tissues. It also could increase the time that organs or tissues for transplant are viable outside the body during transportation over long distances. On-demand metabolic modulation of damaged tissue creates therapeutic benefit (a “protective pause”) during which transportation or critical care procedures can be performed.
In addition to metabolic modulation, hydrogen sulfide offers therapeutic benefits as a cytoprotective and anti-inflammatory molecule: research previous to the present study has shown it to be effective in experimental models of inflammation, lethal hypoxia and a number of other diseases. |
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Matthew Bennett joins Ikaria as Vice President and General Counsel
Clinton, NJ, July 23, 2007 – Ikaria Holdings, Inc., a company recently formed by the merger of INO Therapeutics, LLC and Ikaria, Inc., a Seattle-based biotech company, is very pleased to announce the addition of Matthew M. Bennett to its Senior Management Team. Matthew joins Ikaria as Vice President and General Counsel, reporting to Ikaria’s Chief Executive Officer, David E. Shaw. Matthew has a broad range of experience that includes M&A, litigation, licensing, securities, and regulatory affairs. He will responsible for overseeing all legal and regulatory matters for Ikaria.

Prior to joining Ikaria, Matthew spent four years with Viasys Healthcare Inc., where he most recently served as Executive Vice President and General Counsel, which included responsibility for the Business Development, Quality and Regulatory Affairs, and Human Resources functions. Prior to Viasys, Matthew was an attorney with the firm, Morgan, Lewis & Bockius LLP, based in Philadelphia, PA. |
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DAVID SHAW TO SERVE AS PRESIDENT OF IKARIA AND INO THERAPEUTICS
Seattle and Clinton, N.J., May 2, 2007 - David E. Shaw, chairman and chief executive officer of Ikaria Holdings Inc., has succeeded Dennis Smith as president of INO Therapeutics, and Steven Gillis as president of Ikaria Inc. INO Therapeutics and Ikaria Inc were acquired by Ikaria Holdings, a newly formed investment company, on March 27, 2007. The combined company is a leader in therapeutic gases and critical care medicine, with headquarters in Clinton, New Jersey.

“On behalf of my fellow directors and associates”, Shaw stated, “we are very grateful for the important contributions of Dennis Smith and Steven Gillis.” Steven Gillis served as acting president of Ikaria since August 2006. He is a Managing Director of ARCH Venture Partners and the founder and former CEO of Immunex and Corixa Corporations. Dennis Smith served as president of INO Therapeutics for approximately five years.
Shaw was named chairman and CEO of Ikaria Holdings on March 27, 2007 and continues to serve in those capacities. He is a senior advisor to New Mountain Capital and Venrock Associates, and general partner of Black Point Group. Shaw is the founder and retired CEO of IDEXX Laboratories, Inc., and has been a director or founding investor of several other high technology companies including Ikaria, Microbia, Magen BioSciences and Cytyc. He serves on the board of the Center for Public Leadership at Harvard’s John F. Kennedy School of Government and has been chair of The Jackson Laboratory, a member of the executive committee of the US-Israel Science and Technology Commission, a member of the Council on Foreign Relations, a trustee of Maine Medical Center and other non-profit institutions. |
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IKARIA AND INVESTOR GROUP CLOSE TRANSACTION TO ACQUIRE INO THERAPEUTICS FROM LINDE IN $670 MILLION CASH AND STOCK MERGER, CREATING A WORLD LEADER IN CRITICAL CARE THERAPEUTICS
Seattle and Clinton, N.J., March 28, 2007 - Combined Company Has More Than $160 Million in Revenue, Significant Earnings and a High-Potential Product Pipeline Based On Breakthrough Research in Hydrogen Sulfide, Nitric Oxide, Carbon Monoxide and Other Novel Drug Candidates Innovative Transaction Led by New Mountain Capital, ARCH Venture Partners, Venrock Associates, 5AM Ventures and Black Point Group
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Ikaria Announces In-Licensing of “Thyronamine Technology” from the University of California, San Francisco and Oregon Health & Science University
Seattle - February 25, 2007 - Ikaria, a Seattle biotechnology company developing novel human therapeutics to meet the unmet needs of critical care patients, announced today that it had completed an exclusive, worldwide license to “Thyronamine Technology” from the University of California, San Francisco (UCSF) and Oregon Health & Science University (OHSU).
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INO Therapeutics wins Zenith Award
Clinton, NJ, December, 2006 – INO Therapeutics wins Zenith Award
INO Therapeutics has won the American Association for Respiratory Care (AARC) Zenith Award for 2006. The Zenith Award, AARC's top industry recognition award, is presented to companies that the membership of AARC select based upon the company’s reputation for providing superior products and services.

The 2006 Zenith Award was presented to INO Therapeutics at the AARC 52nd Annual International Respiratory Congress in Las Vegas, Nevada on Monday, December 11, 2006.
"We are honored to be recognized by the membership of the AARC. INO Therapeutics strives to provide great products and services to our Respiratory Care customers, and winning the 2006 Zenith Award is proof that we are achieving our goal,” said Gary Pyner, Senior Director of Global Marketing and Business Development at INO Therapeutics. "INO Therapeutics will continue to work diligently to please the Respiratory audience."
The AARC established the Zenith Award program in 1989 to honor respiratory care product and service providers for exemplary service. Members of the AARC, greater than 41,000 in number, choose the recipients in a special election. Candidates are judged using a number of criteria, including: the quality of delivered goods; the accessibility and clinical helpfulness of the sales force; the responsiveness and service record; of the service group; and the overall support provided by the company to respiratory care professionals. In 2006 INO Therapeutics joins the ranks of the best companies in the respiratory market. |
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