WARRINGTON, Pa., Sept. 30, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) held a teleconference on September 29, 2009 with the U.S. Food and Drug Administration (FDA). The meeting established an approach to potentially resolve the remaining primary issue that Discovery Labs must address to gain U.S. marketing approval of Surfaxin(R) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The meeting focused on Discovery Labs' plans regarding optimization and final method validation of its fetal rabbit Biological Activity Test (BAT, a quality control and stability release test) and a proposed limited Surfaxin clinical trial design, which would simultaneously employ the newly-optimized BAT.

At the meeting, the FDA indicated that Discovery Labs' proposed program to optimize and validate the BAT is reasonable. The program is intended, among other things, to confirm that the BAT can adequately distinguish change in Surfaxin biological activity over time. As a result of the meeting, Discovery Labs believes that it has reached an understanding with the FDA and is confident that it will be able to optimize the BAT to the satisfaction of the FDA. Discovery Labs intends to employ the optimized BAT in conjunction with all of Discovery Labs' KL4 surfactant pipeline programs, including the potential limited Surfaxin clinical trial.

In addition, Discovery Labs received guidance from the FDA on its proposed limited clinical trial design. The trial design is intended to primarily assess a pharmacodynamic (PD) response following Surfaxin administration in preterm infants with RDS. This design was selected to address FDA requirements for Surfaxin approval while limiting trial expense and duration. The FDA indicated that a PD-based approach is consistent with their expectation for a limited clinical trial and also provided direction regarding trial design specifics. The final clinical trial design will be subject to FDA review following submission of a formal protocol. Discovery Labs expects to finalize a protocol and anticipates submitting it to the FDA in mid-fourth quarter of 2009.

W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs, commented, "We are pleased with the guidance received and outcomes obtained from our interaction with the FDA. This guidance provides a viable option for Surfaxin and meaningfully supports advancing our pipeline initiatives to potentially address a broad range of respiratory diseases such as RDS, Acute Respiratory Failure, Acute Lung Injury and Cystic Fibrosis. We look forward to continued productive dialogue with the FDA.

"Our most advanced programs from our KL4 surfactant pipeline, Surfaxin, Surfaxin LS(TM) and Aerosurf(R), have the potential to greatly improve the management of RDS and to redefine the RDS market. Our top priority is to secure strategic alliance partners and access capital to advance our pipeline and build shareholder value. As we move forward, we will take into account further interaction with the FDA and make strategic assessment, together with existing and potential new partners to determine the appropriate level and timing of Surfaxin investment and to maximize the value of our KL4 pipeline for RDS."

Background

On April 17, 2009, Discovery Labs received a Complete Response letter from the FDA for Surfaxin for RDS and on June 2, 2009, conducted a related meeting focusing primarily on certain aspects of the BAT, specifically whether preclinical data generated using both the BAT and a well-established preterm lamb model of RDS adequately supports the comparability of Surfaxin clinical drug product to the to-be-manufactured Surfaxin, and whether the BAT can adequately distinguish change in Surfaxin biological activity over time.

During the conduct of Phase 3 clinical trials for Surfaxin, Discovery Labs employed an array of quality control tests, but did not employ the BAT to evaluate biological activity of the Surfaxin clinical drug product. After completing the Phase 3 clinical trials, in accordance with discussions with the FDA, Discovery Labs validated and implemented the BAT as a recurring quality control test to confirm biological activity for Surfaxin release and stability testing. Based on guidance received from the FDA in meetings with the FDA in 2006 and 2008, Discovery Labs conducted a series of preclinical experiments to establish comparability between Surfaxin drug product used in Phase 3 clinical trials and the Surfaxin drug product intended to be manufactured for commercial use.