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Biotech / Medical : dsco Discovery Laboratories

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To: tuck who wrote (110)	10/16/2006 9:50:03 AM
From: Sidney Street	of 318

Two PR's from last week: WASHINGTON (Dow Jones)--Discovery Laboratories Inc. (DSCO) is set to meet with U.S. Food and Drug Administration officials Dec. 21 to discuss the approval process for a drug to prevent respiratory distress syndrome in premature infants, according to a filing Thursday with the Securities and Exchange Commission. In late September, the Warrington, Pa., drug developer sought a meeting with the FDA over its lead product Surfaxin, saying it submitted a briefing package responding to the agency's concerns and expected a meeting sometime during the fourth quarter. A letter from the FDA in April raised concerns about the drug's manufacture and stability profile but didn't require any additional clinical trials, the company had said. Discovery Laboratories said it addressed the issues and remains on track to begin the manufacture of new process-validation lots in the fourth quarter. >>>>>>>>> Discovery Labs Says Surfaxin Trial 'Encouraging' >DSCO DOW JONES NEWSWIRES October 11, 2006 6:17 p.m Discovery Laboratories Inc. (DSCO) late Wednesday reported "encouraging" results from its Phase II clinical trial of Surfaxin for the prevention and treatment of bronchopulmonary dysplasia. BPD is a chronic lung disease typically affecting premature infants who have suffered respiratory distress syndrome. The results suggest that Surfaxin, administered up to five times, may represent a novel therapeutic option for infants at risk for BPD, the Warrington, Pa.-based biotechnology company said. There are no approved therapies for the disease at this time, Discovery Labs said. Surfaxin has received an approvable letter from the Food and Drug Administration for the prevention of respiratory distress syndrome and has orphan drug status and fast track designation from the FDA for the prevention and treatment of BPD.

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