Discovery Laboratories, Inc. has received an Approvable Letter from the US FDA for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

The Approvable Letter is an official notification that the FDA is prepared to approve the Surfaxin New Drug Application and contains conditions that the applicant must meet prior to obtaining final US marketing approval.

The conditions that Discovery must meet primarily involve finalizing labelling and correcting previously reported manufacturing issues. The FDA is not requiring additional preclinical or clinical trials for final approval. The Company anticipates potential approval and commercial launch of Surfaxin to occur in the fourth quarter of 2005 or first quarter of 2006, release from Discovery Labs says.

Surfaxin is the first precision-engineered lung Surfactant Replacement Therapy (SRT). Surfaxin contains a peptide, sinapultide, which is designed to closely mimic the essential properties of human lung surfactant protein B (SP-B). 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.

Robert J. Capetola, president and CEO of Discovery, commented, "Surfaxin is the cornerstone of our Surfactant Replacement Therapy pipeline and potentially sets a new standard for the prevention of RDS. Our mission is to advance to market precision-engineered Surfactant Replacement Therapies with the promise to revolutionize the treatment of respiratory diseases prevalent in the neonatal intensive care unit, critical care, and hospital settings."

RDS is a life-threatening and costly breathing disorder that strikes tens of thousands of premature infants in the United States each year, with a global at risk population in excess of 500,000 infants. Current surfactant treatment options are limited to animal-derived surfactants harvested from bovine (cow) and porcine (pig) sources.