(Adds details, shares, background)
NEW YORK May 2 The U.S. Food and Drug
Administration declined to immediately approve Discovery
Laboratories Inc's DSCO.O drug to help prevent respiratory
distress syndrome in premature babies, the company said on
Friday, sending shares down 41 percent.
The small biotechnology company said it received a
so-called "approvable letter" from the FDA about the drug,
Discovery Laboratories is assessing the agency's comments
and plans to contact the FDA within a few days. It expects by
early next week to be able to provide further details about the
timeline to address the agency's concerns.
Approvable letters generally mean a company must satisfy
certain conditions before the FDA will approve its drug.
The FDA has completed its pre-approval inspection of the
company's manufacturing plant in Totowa, New Jersey, and
recently issued a report reflecting a successful inspection,
the company said.
Babies born too early -- less than the normal 38 to 42
weeks -- can suffer from underdeveloped lungs. The resulting
breathing difficulty is known as respiratory distress
While normal lungs produce a liquid coating called
surfactant to help keep them open, premature babies do not, and
fight hard against lung collapse, struggling to breathe and
eventually dying from exhaustion.
Pennsylvania-based Discover Labs specializes in developing
surfactant replacement therapies for respiratory diseases.
The company is also studying Surfaxin as a treatment for
bronchopulmonary dysplasia, also known as chronic lung disease,
and other respiratory conditions.
Discovery Laboratories shares fell to $1.70 in premarket
electronic trading from its Thursday close of $2.90 on Nasdaq.
(Reporting by Lewis Krauskopf, additional reporting by Susan
Heavey in Washington; Editing by Derek Caney/Jeffrey Benkoe)