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Treatment for Respiratory Distress Syndrome

Update: Surfaxin (lucinactant) Now FDA Approved - March 6, 2012

Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants

WARRINGTON, Pa., July 29, 2005 -- Discovery Laboratories, Inc. (Nasdaq:DSCO), today announced that it has submitted its response to the Approvable Letter received from the U.S. Food and Drug Administration (FDA) for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The Company believes that the response addresses the comments noted in the Approvable Letter by providing the FDA with the information necessary to complete its review of the Surfaxin New Drug Application (NDA) within six months.

In February 2005, the FDA issued an Approvable Letter indicating that it is prepared to approve the NDA when issues noted in the letter are adequately addressed. Most importantly, the FDA is not requiring additional preclinical or clinical studies. The Approvable Letter addressed certain labeling, chemistry, and manufacturing issues. With respect to Discovery's contract manufacturer, Laureate Pharma, Inc. (Laureate), the FDA previously issued a Form 483, citing inspectional observations related to compliance with current Good Manufacturing Practices (cGMPs) and other processes to be used for commercial production of the product. The general theme of the observations related to basic quality controls, process assurances and documentation requirements that support the commercial production process.

Christopher J. Schaber, Ph.D., Executive Vice President and Chief Operating Officer of Discovery commented, "Discovery and Laureate have worked aggressively to implement improved quality systems and documentation controls. We believe these efforts support our response to the FDA Approvable Letter and prepare us for the FDA's reinspection of Laureate's Totowa facility. We are confident that these actions bring Surfaxin, the first precision-engineered Surfactant Replacement Therapy, closer to the neonatal community as we anticipate approval and commercial launch in the first quarter of 2006."

Surfactants are substances that are produced naturally in the lungs and are essential to the lungs' ability to absorb oxygen and to maintain proper airflow through the respiratory system. Premature babies are born with a lack of natural surfactant in their lungs. Without surfactant, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in RDS. Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative for the animal-derived and non-protein containing synthetic surfactants. Discovery's Surfaxin has recently received an Approvable Letter from the FDA for the prevention of RDS in premature infants and is pending approval.

Source: Discovery Laboratories, Inc.

Posted: July 2005

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