Discovery Labs Gets Surfaxin Guidance

Discovery Labs Gets FDA Guidance on How to Improve Surfaxin Approval Chances; Shares Surge

WARRINGTON, Pa.-- Discovery Laboratories Inc. said Monday that the Food and Drug Administration provided the company with guidance on how to improve chances on getting its Surfaxin lung treatment approved.

Shares of the company jumped on the news, adding 65 cents, or 25.2 percent, to $3.20 in premarket trading, after closing Friday at $2.55 on the Nasdaq.

In April, the biotech drug developer received an "approvable" letter from the FDA, meaning the agency considered the company's drug application in order but needed additional information for approval. Discovery expects to have a formal response to the letter by October, and anticipates a six-month FDA review period to follow.

The guidance resulted from meetings with the FDA in September and December 2006.

The company is trying to get Surfaxin approved to treat Respiratory Distress Syndrome in premature infants.

Surfaxin is a synthetic substance that reduces surface tension that allows lung tissue to absorb oxygen. The FDA said Surfaxin is already approvable for premature infants who are born with little or none of the natural substance that the drug mimics. However, the company has been plagued with manufacturing problems.

The FDA approvable letter focused on the company's chemistry, manufacturing and controls.

Here's a briefing of a previous post I wrote on Discovery Labs:
DSCO makes a fully synthetic surfactant for use in infants with respiratory distress. Basically surfactants are a types of proteins and lipids that help oxygen diffuse into the blood stream within the lung. The cool thing about DSCO's Surfaxin is that it is non immunogenic meaning the body wont see it as foreign an mount an immune response against it.

DSCO closed today's trading at 2.66 per share.