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Discovery Labs Reports First Quarter 2013 Financial Results
Date:5/7/2013

WARRINGTON, Pa., May 7, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today reports financial results for the first quarter ended March 31, 2013 and also provides certain program updates.

Selected operational updates:

  • SURFAXIN®:  On April 15, 2013, the Company reported that it had received from the U.S. Food and Drug Administration (FDA) a response to a previous Company submission regarding an improved and revalidated analytical chemistry method and updated SURFAXIN drug product specifications. The FDA requested information and provided recommendations intended to clarify certain aspects of the revalidated analytical chemistry method and updated product specifications.  The Company believes it can respond to the FDA by early-June.  FDA procedure allows for up to four months for the FDA to review such submissions.  If its plan is successful and the FDA agrees with its response, the Company expects to proceed with the commercial introduction of SURFAXIN in the fourth quarter of 2013.
  • AEROSURF®: AEROSURF is a drug/device combination product that combines the Company's KL4 surfactant with its capillary aerosol generator (CAG) technology. The Company is developing AEROSURF with the goal of administering aerosolized KL4 surfactant to premature infants without having to use invasive endotracheal intubation.  The Company believes that AEROSURF could enable the treatment of a significantly greater number of premature infants with respiratory distress syndrome (RDS).  The Company, with the assistance of a third-party medical device expert, is advancing its efforts to optimize and manufacture its CAG for use in its planned phase 2 AEROSURF clinical program. 
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  • SOURCE Discovery Laboratories, Inc.
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