Discovery Labs Reports That It Has Not Yet Received FDA Notification Regarding Complete Response
WARRINGTON, Pa., Nov. 4, 2008 (GLOBE NEWSWIRE) — Discovery Laboratories, Inc. (Nasdaq:DSCO), reports that, as of the close of business on November 3, the U.S. Food and Drug Administration (FDA) had not yet notified Discovery Labs regarding the target action date and review classification of its Complete Response to the May 2008 Approvable Letter for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Taking FDA guidelines into consideration, Discovery Labs had anticipated receipt of notification by October 31, 2008. Discovery Labs will provide another update only after it receives notification from the FDA.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs’ technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Surfaxin(r), the Company’s lead product from its SRT pipeline, is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. Surfaxin is also being developed for other neonatal and pediatric indications. Aerosurf, Discovery Labs’ aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at www.Discoverylabs.com.
This news release was distributed by GlobeNewswire, www.globenewswire.com
CONTACT: Discovery Laboratories, Inc. Lisa Caperelli, Investor Relations 215-488-9413