Ikaria to Market and Distribute INOflo via Partnership with Air Water
Incorporated and Sumitomo Seika Chemicals
CLINTON, N.J., July 21 /PRNewswire/ -- Ikaria Holdings, Inc., through
its subsidiary INO Therapeutics LLC, announced today that Japan's Ministry
of Health, Labor and Welfare (MHLW) has approved INOflo(R) (nitric oxide)
for inhalation for improvement of hypoxic respiratory failure (HRF) with
concurrent pulmonary hypertension in neonates. INOflo (brand name INOmax(R)
in the United States) has been shown to improve oxygenation and reduce the
need for ECMO, a highly invasive cardiopulmonary bypass procedure.
INOflo is the first pharmaceutical gas approved in Japan and has been
designated as an orphan drug by Japan's MHLW, granting a statutory
exclusivity period of 10 years, during which time generic versions of
INOflo will not be approved.
INOflo will be imported and distributed through a partnership with Air
Water Incorporated and Sumitomo Seika Chemicals.
Daniel Tasse, President & CEO of Ikaria(R), remarked, "Approval of
INOflo in Japan is a significant milestone for Ikaria and a further
validation of the benefits of our therapy. Currently, INOmax remains the
only pharmaceutical vasodilator approved for the treatment of persistent
pulmonary hypertension in newborns and is used in thousands of neonates
with hypoxic respiratory failure each year."
Mr. Tasse continued, "Our partnership with Air Water Incorporated and
Sumitomo Seika Chemicals will enable us to quickly bring INOflo to the
Japanese market. Boasting one of the most highly regarded healthcare
systems in the world, Japan will provide Ikaria with an important avenue
for incremental growth and a significant foothold as we continue to expand
our portfolio of critical care products outside the US."
About INOmax
INOmax(R), 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 maximizes 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 therefore may cause airway inflammation and damage.
Methemoglobin, NO2, and FiO2 should be monitored during nitric oxide
administration.
INOflo(R) is a registered trademark in Japan, in the name of AGA
Aktiegolag.
For more information on INOmax, please visit http://www.inomax.com.
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 380
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 Jason Rando
Ikaria The Ruth Group
(908) 238-6673 (646) 536-7025
matthew.bennett@ikaria.com jrando@theruthgroup.com
SOURCE Ikaria Holdings, Inc.
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Related links:
http://www.ikaria.com
http://www.inomax.com
CONTACT:
Matthew Bennett, Ikaria, +1-908-238-6673,
matthew.bennett@ikaria.com; Jason Rando, The Ruth Group,
+1-646-536-7025, jrando@theruthgroup.com, for Ikaria
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