Date: Nov 08, 2013 Author: John George Source: Philadelphia Business Journal (
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Discovery Laboratories Inc. launched Surfaxin Friday, eight years after first seeking Food and Drug Administration approval for the product.
Surfaxin was approved last year for use in preventing respiratory distress syndrome in premature infants. The compound is the first FDA-approved synthetic, peptide-containing surfactant — a substance found in the lungs that is essential for breathing. The drug is the only alternative to animal-derived surfactants available in the United States.
The launch of the drug was delayed while the Warrington, Pa., company worked with the FDA to update Surfaxin's product specifications after an internal review by Discovery Labs determined one of its analytical chemistry methods used to assess the product's conformance to specifications required improvement.
"The commercial launch of Sufaxin marks a significant milestone for Discovery Labs, but more importantly represents a long-awaited therapeutic option for the neonatology community and the fragile premature infants in its care," said John G. Cooper, CEO of Discovery Labs (NASDAQ: DSCO).
Discovery Labs also said Friday that, in accordance with the terms of its February 2013 $30 million secured loan with Deerfield Management Co., it will be notifying Deerfield that it has now met the conditions to receive the final $20 million advance under the facility.
Once it receives the $20 million advance, which is expected to occur in early December 2013, the company will issue warrants to Deerfield for approximately 4.7 million shares of stock at an exercise price of $2.81 per share.
Early this month, Discovery Labs raised $50 million in a public stock sale to support the launch of Surfaxin.
