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Discovery Labs Notified of PDUFA Date for SURFAXIN®
Date:9/28/2011

859-2056 or (404) 537-3406.  The passcode for the replay is 11540927.

About RDS and SURFAXIN

RDS is a condition in which premature infants are born with an insufficient amount of their own natural pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing.  This condition often requires that infants receive surfactant replacement therapy (currently animal-derived surfactants) along with mechanical ventilation to survive.  Approximately 90,000 premature infants in the United States are treated annually with the currently available animal-derived surfactants.  

SURFAXIN is an investigational drug for the prevention of RDS in premature infants.  A New Drug Application for SURFAXIN is under review by the U.S. FDA with a target date of March 6, 2012 for potential US marketing approval.  If approved, SURFAXIN would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine and provide healthcare practitioners with a potential alternative to the currently approved, animal-derived surfactants that today are the standard of care to manage RDS in premature infants.

The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants has been previously demonstrated in a large, multinational Phase 3 clinical program. In April 2009, the FDA issued to Discovery Labs a Complete Response Letter, which contained the requirements that must be addressed to gain U.S. marketing approval for SURFAXIN.  The FDA Complete Response Letter did not question the quality of the clinical trial data or call for additional clinical trials to demonstrate the safety or efficacy of SURFAXIN. Rather, it focused primarily on certain aspects of an important quality control release and stability test for SURFAXIN, the fetal rabbit biological activity test (BAT). Discovery Labs believes that a key step to potentially gain FDA marketing approval for
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SOURCE Discovery Laboratories, Inc.
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