Discovery Labs says FDA steps for infant drug are clearer

Wed. September 30, 2009; Posted: 12:15 PM

Sep 30, 2009 (The Philadelphia Inquirer - McClatchy-Tribune Information Services via COMTEX) -- DSCO | Quote | Chart | News | PowerRating -- Discovery Laboratories Inc. announced today that it has established with the FDA a way to resolve the remaining issues as it seeks approval for its drug to prevent respiratory distress syndrome in premature babies.

Shares of the Warrington-based biotechnology firm gained more than 50 percent in pre-market trading, and were up 34.23 percent (38 cents) over yesterday's close, to $1.49, once Nasdaq trading opened this morning.

Discovery said a teleconference yesterday with the FDA should lead to its meeting requirements on validating tests that the company will perform and on a limited clinical trial. The company said in a release that those steps were expected to help the company meet government requirements while keeping down the duration and cost of the trial.

"This guidance provides a viable option for Surfaxin and meaningfully supports advancing our pipeline initiatives to potentially address a broad range of respiratory diseases such as RDS, acute respiratory failure, acute lung injury and cystic fibrosis," said W. Thomas Amick, chairman and chief executive officer of Discovery Labs.

Discovery Labs has been seeking FDA approval since April 2004 for Surfaxin, a synthetic lung substance for premature babies who are born with insufficient natural surfactant in their lungs and are prone to life-threatening diseases. Surfactant is a critical substance that helps breathing and prevents tiny air sacs in the lungs from collapsing. Treatments for the disorder are limited.

The FDA has issued three "approvable" letters, but not final approval, saying it needed more information about the chemistry and manufacturing.

The company has faced a string of setbacks, including a validation batch of the drug manufactured in summer 2005 that did not meet a six-month stability test.

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For full details on Discovery Labs Inc (DSCO) click here. Discovery Labs Inc (DSCO) has Short Term PowerRatings of 5. Details on Discovery Labs Inc (DSCO) Short Term PowerRatings is available at This Link.

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