AGA Will File for FDA Approval of Worlds's First Selective Pulmonary Vasodilator

AGA will file for FDA approval of world's first selective pulmonary vasodilator AGA has successfully concluded a clinical study with nitric oxide on hypoxemic respiratory failure in new-born babies. Nitric oxide is the world's first selective pulmonary vasodilator. During the second quarter AGA will submit a new drug application to the US Food and Drug Administration. AGA will file an application with the US Food and Drug Administration (FDA) for approval of INOmax (nitric oxide) for inhalation treatment in hypoxemic respiratory failure in term and near term neonates. This is a potentially life threatening condition in which a new-born cannot get enough oxygen because its lungs do not work properly at birth. INOmax , as a selective pulmonary vasodilator, dilates constricted blood vessels in the lungs without affecting the blood vessels in other parts of the body. This permits better delivery of oxygen to well ventilated areas of the lung, enabling the lung to work more efficiently. AGA's decision to file a new drug application (NDA) is founded on the positive results of several studies completed over the past three years combined with the positive results obtained from the preliminary analysis of the recently concluded CINRGI study. This study was a double blind, placebo controlled, multi-center trial led by principal investigator, Reese Clark, M.D., a leading US neonatologist. The application is scheduled to be filed in the second quarter of 1999 by AGA's US pharmaceutical subsidiary, INO Therapeutics, Inc. A decision is expected from the FDA within six months of NDA submission. It is anticipated that neonatal hypoxemic respiratory failure will be the first of several possible indications for INOmax . It is estimated that the US market potential for this first indication is USD 50-100 million. AGA is the exclusive world-wide licensee of rights to patents owned by Massachusetts General Hospital in Boston covering the use and delivery of nitric oxide for inhalation treatment of certain lung and blood diseases. INOmax represents a new generation of pharmaceutical gases upon which AGA is beginning to focus its research and development efforts. For further information please contact Per Blom, Medical Director, phone +46 70 652 2514, Maris Sedlenieks, Corporate Communications, phone +46 70 530 6754 or Anders Häger, Business Control, phone +46 8 731 1223. Lidingö March 9, 1999 AGA Aktiebolag (publ) Corporate Communications ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/1999/03/09/19990309BIT00040/bit0001.doc http://www.bit.se/bitonline/1999/03/09/19990309BIT00040/bit0002.pdf