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Discovery Labs Reports Third Quarter Financial Results and Progress on Lead Programs
Date:11/10/2011

WARRINGTON, Pa., Nov. 10, 2011 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to improving the standard of respiratory critical care, today reports financial results for the third quarter ended September 30, 2011, as well as the status of the SURFAXIN® and AFECTAIR™ programs.  The Company will host a conference call this morning at 10:00 AM ET.  Conference call details are below.

Selected third quarter highlights include:

  • SURFAXIN® – The U.S. Food and Drug Administration ("FDA") accepted the Company's Complete Response for SURFAXIN and has established March 6, 2012 as the target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant U.S. marketing approval of SURFAXIN for the prevention of respiratory distress syndrome (RDS) in premature infants.  If approved, SURFAXIN would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine and provide a potential alternative to the currently approved, animal-derived surfactants that today are the standard of care to manage RDS in premature infants.

  • AFECTAIR™ – The Company introduced AFECTAIR as a new product candidate in the third quarter of 2011.  AFECTAIR is intended to simplify the delivery of inhaled therapies for critical care patients requiring ventilatory support and was originally developed for the Aerosurf program.  According to national health statistics and recent market assessment data, it is estimated that more than 1.3 million patients annually in the United States and European Union receive aerosolized medications while requiring ventilatory support.  The Company is implementing a regulatory plan that will potentially allow for market introduction of the first AFECTAIR produc
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