Surfaxin

lucinactant

Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application

DOYLESTOWN, Pa., June 15, 2004 -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that the United States Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) filing for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA has granted a Standard Review designation and has established a target date of February 13, 2005 for completion of review of the Surfaxin NDA.

Christopher J. Schaber, Ph.D., Executive Vice President and Chief Operating Officer of Discovery, stated, "We believe the data included in the NDA strongly supports the therapeutic benefit of Surfaxin for patients who suffer from RDS. Surfaxin, if approved, has the potential to set a new standard for the prevention of RDS and would begin a dramatic evolution in the use of engineered humanized surfactants for the treatment of serious and life-threatening respiratory diseases prevalent in the neonatal intensive care unit. Surfaxin serves as the cornerstone of our portfolio of Surfactant Replacement Therapies to treat various respiratory diseases. We will continue to work closely with the FDA to facilitate a thorough and proper review of our NDA."

The NDA filing was supported, in large part, by data from Discovery's two positive Phase 3 RDS clinical trials. The first was a landmark, 1,294 patient pivotal study that demonstrated Surfaxin's superiority to Exosurf(r), a non-protein containing synthetic surfactant. Survanta(r), a cow-derived surfactant and the leading surfactant used in the United States, served as a reference arm in the trial. The second trial was a 252 patient supportive study that demonstrated Surfaxin's non-inferiority to Curosurf(r), a pig-derived surfactant and the leading surfactant used in Europe.

Discovery also is preparing a Marketing Authorization Application (MAA) to be filed with the European Medicines Evaluation Agency (EMEA) in the second half of 2004 for Surfaxin for the prevention and treatment of RDS.

About Discovery Laboratories
Discovery Laboratories, Inc. is a biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases. Surfactants are compositions produced naturally in the lungs and essential for breathing. Discovery's technology produces an engineered version of natural human lung surfactant that is designed to closely mimic the essential properties of human lung surfactant. Discovery believes that through its technology, pulmonary surfactants have the potential, for the first time, to be developed into a series of respiratory therapies for critical care and other hospitalized patients where there are few or no approved therapies available.

Discovery has filed a New Drug Application with the FDA for clearance to market Surfaxin, the Company's lead product, for the prevention of Respiratory Distress Syndrome in premature infants. Discovery is also conducting a Phase 2 clinical trial for Acute Respiratory Distress Syndrome in adults, Phase 3 and Phase 2 clinical trials for Meconium Aspiration Syndrome in full-term infants and (with aerosolized surfactant) is preparing to initiate a Phase 2 trial for asthma (development name DSC-104) and a Phase 2 trial for Respiratory Dysfunction in premature infants.

More information about Discovery is available on the Company's Web site at www.DiscoveryLabs.com.

Related Articles:

Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS - May 2, 2008

Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA - November 16, 2007

Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - November 1, 2007

Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter - October 1, 2007

Discovery Labs Provides Update On Progress for Surfaxin for RDS - August 2, 2007

Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval - January 22, 2007

Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters - September 28, 2006

Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS - April 5, 2006

FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin - October 21, 2005

Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin - August 19, 2005

Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin - August 15, 2005

Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - July 29, 2005

Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants - February 14, 2005

Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants - April 14, 2004

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