WARRINGTON, Pa., Nov. 4, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) is providing an update on its strategic business activities and its KL4 surfactant pipeline clinical development programs. Discovery Labs is developing its proprietary KL4 surfactant technology platform to potentially significantly improve the medical outcomes of patients, from premature infants to adults, suffering debilitating respiratory diseases and conditions. Discovery Labs is actively assessing various strategic and financial alternatives to secure the necessary capital to potentially advance its development programs.

W. Thomas Amick, Discovery Labs Chairman and interim Chief Executive Officer, commented, "We are developing a robust pipeline of KL4 surfactant products to potentially address a broad range of respiratory diseases, such as respiratory distress syndrome (RDS), acute respiratory failure, acute lung injury and cystic fibrosis. Our most advanced pipeline programs, Surfaxin(R), Surfaxin LS(TM) and Aerosurf(R), have the potential to greatly improve the management of RDS and represent the opportunity, over time, to expand the current RDS estimated worldwide annual market of $200 million to a $1 billion opportunity. Our efforts with potential strategic and financial partners are centered on building an RDS franchise for the U.S. and international markets.

"We are encouraged that discussions, related due diligence activities and valuation assessments are progressing with several interested strategic and financial parties. Our Board of Directors and management are focused on securing the strategic resources necessary to potentially advance our KL4 surfactant pipeline, drive our company forward and maximize shareholder value."

Although Discovery Labs believes that it will be successful in securing strategic partners and capital to support its ongoing research and development activities and its future financial condition, there can be no assurance that any strategic alliance or other financing alternatives will be successfully concluded. Furthermore, until any such strategic alliances or other financing alternatives are successfully secured, Discovery Labs will continue to conserve its financial resources by predominantly curtailing investments in its pipeline programs.

The following are selected updates on Discovery Labs' KL4 surfactant pipeline.

Respiratory Distress Syndrome (RDS) - RDS is one of the most common, potentially life-threatening pediatric respiratory disorders, with more than 500,000 low-birth-weight premature infants at risk globally each year. However, today fewer than 200,000 infants receive the currently-approved, animal-derived surfactants. Discovery Labs' portfolio of programs focusing on RDS has the potential to redefine the management of RDS and expand the use of surfactants in the neonatal intensive care unit (NICU). Discovery Labs' advanced-staged RDS programs include:

       Surfaxin(R)

Surfaxin, Discovery Labs' first KL4 surfactant product candidate, has demonstrated clinically meaningful survival and morbidity-lessening advantages versus comparator surfactants (the current standard of care). Discovery Labs participated in a September 29, 2009 meeting with the FDA to discuss the key remaining issue that must be addressed to potentially gain U.S. marketing approval of Surfaxin for the prevention of RDS in premature infants, as well as 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 clinical trial. The trial would be designed to primarily assess a pharmacodynamic (PD) response following Surfaxin administration in premature infants diagnosed with RDS. During the conduct of this trial, the newly-optimized BAT would be employed as a quality test of the Surfaxin drug product used in the proposed clinical trial. As a result of this meeting, Discovery Labs believes that it has reached an understanding with the FDA and that it will be able to optimize the BAT to the satisfaction of the FDA. The FDA has indicated that a PD-based approach is consistent with their expectation for a limited clinical trial and also provided direction regarding trial design specifics.