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Ohmeda Submits New Drug Application For Nitric Oxide Inhalation Therapy.

LIBERTY CORNER, N.J.--(BW HealthWire)--June 17, 1997--Ohmeda, the healthcare business of The BOC Group (NYSE:BOX), has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of nitric oxide inhalation therapy in conjunction with mechanical ventilation for the treatment of hypoxic respiratory failure in term and near-term (34 weeks or more gestation) newborns. Nitric oxide inhalation's therapeutic potential as a selective pulmonary vasodilator (a drug that dilates blood vessels only in the lung) was evaluated in multi-center clinical trials sponsored by the National Institute of Child Health and Human Development (NICHD), Massachusetts General Hospital (MGH) and Ohmeda.

Ohmeda, which specializes in anesthesia and critical care products, also has submitted a 510(k) premarket notification for a nitric oxide inhalation delivery system. A 510(k) is an FDA requirement for the commercial distribution of medical devices. The FDA has approved Ohmeda's application for an Investigational Device Exemption (IDE) for its nitric oxide inhalation delivery system. This particular IDE approval allows Ohmeda to provide the nitric oxide inhalation delivery system to qualified holders of Investigational New Drug Applications for nitric oxide inhalation, which are granted by the FDA to investigators to conduct clinical research. The nitric oxide inhalation delivery system was developed and validated concurrently with Ohmeda's clinical trials.

Ohmeda is also evaluating the safety and effectiveness of nitric oxide inhalation therapy for other life-threatening diseases in adults at major medical centers throughout the U.S. These studies are ongoing.

Nitric oxide is a biological "messenger" found in the body that is involved in a variety of physiological processes. In clinical settings, such as hypoxic respiratory failure, when nitric oxide is inhaled it dilates pulmonary blood vessels in ventilated parts of the lung. Because nitric oxide is rapidly inactivated by hemoglobin in red blood cells, the effect is restricted to the lungs and no changes in systemic blood pressures are observed. This effect of nitric oxide in the lung produces greater blood flow to the ventilated regions and results in improved oxygen delivery in the patient.

In the U.S., more than 70,000 newborns each year suffer from hypoxia, or insufficient oxygenation of the blood. These newborns experience hypoxic respiratory failure and require mechanical ventilation to help them breathe. Hypoxic respiratory failure may be caused by several disorders, including Persistent Pulmonary Hypertension of the Newborn (PPHN), also known as persistent fetal circulation. PPHN is a life-threatening condition in which a newborn=s blood continues to be shunted away from, rather than be oxygenated by the lung. Other causes include congenital pneumonia or sepsis, meconium aspiration, infant respiratory distress syndrome and congenital diaphragmatic hernia. It may also be associated with premature birth, or it may be the result of a condition whose causes are unknown. Babies who survive may develop chronic lung disease and neurological problems.

Hypoxic respiratory failure is currently treated with mechanical ventilation, systemic vasodilators and ECMO (extracorporeal membrane oxygenation), a procedure to oxygenate blood while bypassing the lungs.

The nitric oxide inhalation NDA includes data from studies at 50 leading medical centers throughout the U.S. and Canada. One major study involving 18 centers was sponsored by the NICHD Neonatal Research Network and the Canadian Inhaled Nitric Oxide Study Group. The NICHD study was led by Richard A. Ehrenkranz, M.D., Yale University, and Neil N. Finer, M.D., University of California, San Diego. In addition, Jesse D. Roberts, M.D., Massachusetts General Hospital (MGH), Boston, led a multi-center research collaboration involving seven sites. Ohmeda-sponsored clinical trials were conducted at 25 U.S. medical centers and led by Dennis Davidson, M.D., Schneider Children's Hospital (LI), Albert Einstein College of Medicine, New York. Results of the NICHD and MGH studies were published in the February 27, 1997 issue of the New England Journal of Medicine.

Roger Stoll, Ph.D., president and CEO of Ohmeda, said: "This is an important milestone for Ohmeda and BOC, reflecting years of hard work and commitment. We consider it a significant achievement because it capitalizes on Ohmeda's strong presence in anesthesia and adult and neonatal intensive care, and on Ohmeda's and BOC's combined strengths in inhalation anesthetics, acute care pharmaceuticals, delivery systems and compressed cylinder gases."

Ohmeda is developing an integrated therapeutic package, including the pharmaceutical gas, delivery system, calibration gases, technical support and service, according to Stoll. If it is approved, nitric oxide inhalation will be manufactured in a facility dedicated for pharmaceutical nitric oxide inhalation production and designed to meet FDA current Good Manufacturing Practices (cGMP) regulations for pharmaceuticals.

Ohmeda is a member of The BOC Group, the UK-based industrial gases, health care, vacuum technology and distribution services company, which had sales of $6.3 billion last year. Headquartered in Liberty Corner, NJ, Ohmeda employs nearly 5000 people in 30 countries and has annual revenues of about $800 million. Specializing in anesthesia and critical care, Ohmeda=s pharmaceuticals, medical equipment and devices are used in operating rooms, post-anesthesia care units and neonatal and adult intensive care units worldwide. BOC Gases is a worldwide leader in the manufacture and supply of industrial and medical gases and gas handling technology.

World Wide Web address:

CONTACT: Ohmeda, Liberty Corner

Judee Shuler

Director, Health Care Communications

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Publication:Business Wire
Date:Jun 17, 1997
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