Represents approval of first pharmaceutical nitric oxide product in Japan to help critically ill newborns who suffer from hypoxic respiratory failure CLINTON, N.J., June 18
CLINTON, N.J., June 18 /PRNewswire/ -- 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(R) 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.
INOflo, which has been designated an orphan drug in Japan, was recommended
for approval by Japan's First Committee on Drugs in May of this year.
However, because INOflo represents a new mechanism of action not previously
approved in Japan, it was reviewed again by the CDFS Department on Drugs.
INOflo is the first pharmaceutical gas approved in Japan, a designation it
also has received in the United States, Europe, Canada, Australia, Singapore
and several countries in Latin America.
Daniel Tasse, President & CEO of Ikaria, remarked, "As we broaden the
reach of INOmax to new continents, we are expanding our ability to advance
critical care around the globe. We look forward to bringing this important
therapy in neonatal critical care to Japan."
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 thus may cause airway
inflammation and damage. Methemoglobin, NO2, and FiO2 should be monitored
during 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 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 360 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
www.ikaria.com.
CONTACTS
Matthew Bennett
Ikaria
(908) 238-6673
matthew.bennett@ikaria.com
Jennifer Saunders
The Ruth Group
646-536-7011
jsaunders@theruthgroup.com
SOURCE Ikaria Holdings, Inc.
