Discovery Labs provides update on Surfaxin FDA marketing authorization for RDS in premature infants

Discovery Laboratories, Inc. (Nasdaq:DSCOD), a biotechnology company developing its novel, synthetic, peptide-containing surfactant, is providing an update regarding its efforts to file a Complete Response intended to gain U.S. Food and Drug Administration (FDA) marketing authorization of Surfaxin^® for the prevention of respiratory distress syndrome (RDS) in premature infants. Discovery Labs has had multiple interactions with the FDA regarding various aspects of the final validation of an important quality control release and stability test for Surfaxin, the fetal rabbit biological activity test (BAT). In response to a proposal submitted by Discovery Labs, the FDA has recently provided detailed, written direction regarding the verification of certain parameters related to final BAT validation. The FDA indicated that several aspects of Discovery Labs' proposed approach to the BAT validation are reasonable; however, with respect to certain parameters, the FDA is requesting additional data to further support ultimate determination of BAT validation.

W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs commented, "We have made considerable progress towards the filing of a Surfaxin Complete Response. The work that we originally proposed to the FDA relating to the comprehensive preclinical program has been completed. We have generated data that demonstrate a meaningful reduction in variability in the optimized BAT and have conducted supportive side-by-side studies with the well-established pre-term lamb model of RDS. We appreciate the FDA's willingness to provide guidance and, based on our preliminary assessment, believe that we could generate the additional data and be in a position to file a Surfaxin Complete Response by early third quarter 2011."

Discovery Labs has conducted a comprehensive pre-clinical program employing an optimized BAT in a series of prospectively-designed, side-by-side preclinical studies with the well-established preterm lamb model of RDS.  Discovery Labs engaged in several interactions with the FDA intended to ensure that the comprehensive preclinical program would satisfy the FDA. At the FDA's suggestion, Discovery Labs submitted a proposal seeking clarification regarding specific and detailed aspects of final BAT validation. To address certain technical criteria relating to final BAT validation, the FDA's recent correspondence advises Discovery Labs to increase the sample size of a specific data set by testing additional Surfaxin batches. Discovery Labs currently has data from batches that have already been manufactured and, to be responsive to the FDA's advice, anticipates manufacturing additional batches in January and February of this year.

Later this month, Discovery Labs expects to provide to the public a detailed overview of its program and anticipates holding a conference call.