Discovery Labs Files Corrective Plan for Manufacturing Issues to Gain Looming FDA Approval

Biotech drugmaker Discovery Laboratories Inc. said Thursday that it formally filed a briefing with the Food and Drug Administration addressing concerns that are holding up the approval of the company's lung treatment.

The announcement caused shares to jump before the opening bell. Discovery shares climbed 69 cents, or 35.2 percent, to $2.65 in premarket activity on the INET electronic exchange, after closing at $1.96 Wednesday on the Nasdaq.

The company also requested a meeting with the FDA to determine the appropriate path to approval for Surfaxin, a synthetic substance that reduces surface tension that allows lung tissue to absorb oxygen. The agency has already indicated the drug is approvable for premature infants who are born with little or none of the natural substance that Surfaxin mimics in their lungs. The FDA should notify the company within 14 days of a date for the scheduled meeting, which should occur within the next 75 days.

In April, the FDA once again delayed a decision on Surfaxin, saying the company needed to address issues on how long the treatment can be stored before it degrades. Similar issues caused Discovery Labs to withdraw its marketing application for the treatment in Europe in June.

The filing with the FDA covers how Discovery plans to correct chemistry, manufacturing and control matters addressed in the April letter. The company also said it is on track to make new batches of Surfaxin showing that manufacturing is up to code by the fourth quarter.