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Discovery Labs' Aerosolized KL4 Surfactant Program Data Presented at the Pediatric Academic Societies Annual Meeting

WARRINGTON, Pa., May 4, 2011 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc., announced that new data from two scientific studies regarding the Company's aerosolized KL4 surfactant program were presented at the 2011 Pediatric Academic Societies (PAS) Annual Meeting, internationally recognized as the largest, most relevant medical meeting dedicated to pediatric research. The studies presented were as follows:

Aerosolized KL4 Surfactant Dose-Response in the Spontaneously Breathing CPAP-Supported Preterm Lamb; Dr. Marla Wolfson, et al.

* This study was conducted to determine which dose of aerosolized KL4 surfactant would produce the optimal physiologic response in a preterm lamb model of respiratory distress syndrome (RDS) in which spontaneously breathing preterm lambs were supported by continuous positive airway pressure (CPAP). This model is widely recognized by the scientific community as a well-established pre-clinical model of RDS.

* Relative to treatment with CPAP alone, treatment with aerosolized KL4 surfactant, delivered via Discovery Labs' proprietary capillary aerosol generator (CAG), improved gas exchange (p < 0.05), pulmonary mechanics (p < 0.05), lung structure integrity (p < 0.05), and reduced levels of inflammatory mediators in the lung (p < 0.05) in a dose-dependent manner in the preterm lamb RDS model. The data also suggest that of the doses tested, KL4 surfactant delivered via the CAG during a 20 to 30 minute dosing interval results in the most desirable overall dosing strategy. Additionally, aerosolized KL4 surfactant was well tolerated and interfaced effectively with CPAP respiratory support.

A Novel Ventilator Circuit Adaptor for Combined Delivery of CPAP and Aerosolized Drugs to Premature Infants; Dr. Jan Mazela, et al.

* The objective of this study was to test a series of proprietary patient interface adaptors designed to interface with conventional ventilation technologies and to optimize delivery of aerosolized drugs to preterm children receiving positive pressure ventilator support.

* The investigators concluded that the novel patient interface adaptor reduced gas dilution when administered during CPAP respiratory support without increasing flow resistance, potentially improving efficiency of aerosolized drug delivery to preterm neonates receiving positive pressure ventilator support.

Dr. Thomas F. Miller, Chief Operating Officer of Discovery Labs, commented, "We are excited that these new data were presented to the pediatric critical care community, given the substantial unmet medical need for an aerosolized surfactant. While remaining focused on Surfaxin Complete Response activities, we have meaningfully advanced our aerosolization technology. Dr. Wolfson's study provides guidance for future clinical dosing strategies for our Aerosurf program. Dr. Mazela's study highlights the novelty of our proprietary patient interface technology, a key component of efficient aerosolized drug delivery. We are actively exploring the potential of this new technology to meaningfully increase the efficiency of aerosolized drug delivery to patients requiring ventilation support."

The data listed above include information that may be of interest to healthcare practitioners however, the clinical relevance of this information has not been fully established. Aerosolized KL4 surfactant is an investigational drug product and is not approved by the FDA or any other world health regulatory authority for use in humans. The capillary aerosol generator (CAG) and the proprietary patient interface are investigational devices and are not approved by the FDA or any other world health regulatory authority for use in humans.

About Discovery Labs' KL4 Surfactant and Aerosol Delivery Technology

Discovery Labs' novel KL4 surfactant is a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant, a substance produced naturally in the lung and essential for survival and normal respiratory function. Discovery Labs aerosol technology platform includes the development of a proprietary capillary aerosolization generation (CAG) technology and a series of novel patient interfaces. The CAG has the potential to enable targeted upper respiratory or alveolar delivery of therapies for pulmonary applications and has been initially designed to produce high-quality, low-velocity aerosolized KL4 surfactant for intra-pulmonary delivery. The proprietary patient interface technology has the potential to increase the efficiency of aerosol delivery to the patient, reduce drug wastage, and result in more precise aerosol dosing.

Surfaxin is Discovery Labs' lead product and represents the first synthetic, peptideā€“containing surfactant that, if approved, will provide healthcare practitioners with an alternative therapy to the currently-approved, animal-derived surfactants that are standard of care today. The safety and efficacy of Surfaxin for the prevention of RDS has previously been demonstrated in a comprehensive Phase 3 clinical program. Discovery Labs anticipates filing a Complete Response to the FDA in the third quarter of 2011 and could gain marketing approval in the United States as early as the first quarter of 2012.

Aerosurf is Discovery Labs' initial aerosolized KL4 surfactant, and holds the promise to significantly expand the use of surfactant therapy in premature infants by potentially providing neonatologists with a means of administering KL4 surfactant to infants without the risks currently associated with administration of currently-approved surfactants, which require invasive endotracheal intubation and mechanical ventilation.

About The Pediatric Academic Societies Annual Meeting

The Pediatric Academic Societies (PAS) consists of the American Pediatric Society, the Society for Pediatric Research and the Ambulatory Pediatric Association. The PAS annual meeting is recognized as the largest, most prestigious meeting dedicated to pediatric research and education in the world and brings together scientists and physicians with expertise in all areas of pediatrics. More than 5,000 pediatric healthcare providers, including approximately 1,100 neonatologists attend this meeting annually.

About Discovery Labs

Discovery Laboratories, Inc. is a specialty biotechnology company developing surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. Discovery Labs is also developing its proprietary capillary aerosolization technology and novel patient interfaces, to enable efficient, targeted upper respiratory or alveolar delivery of aerosolized KL4 surfactant. Discovery Labs believes that its proprietary technology makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at <><>.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to Discovery Labs' pre-clinical and clinical research and development programs, including the potential development of aerosolized KL4 surfactant and the proprietary patient interface technology, are described in Discovery Labs' filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Except as otherwise required by law, Discovery Labs undertakes no obligation to update or revise any forward-looking statements.

CONTACT: John G. Cooper, President and Chief Financial Officer 215-488-9300

Source: Discovery Laboratories, Inc.


Posted: May 2011