Discovery Labs Expands Exclusivity Portfolio with Three New US Patents

WARRINGTON, Pa., May 7, 2014 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, today announced that the United States Patent and Trademark Office (USPTO) has issued a new patent and Notices of Allowance for patents covering critical aspects of its KL4 surfactant and drug delivery technology platform.

The Company announced the issuance of U.S. Patent No. 8,701,658 entitled "Ventilation Circuit Adaptor and Proximal Aerosol Delivery System" which provides coverage for our novel disposable aerosol airway connectors which are intended to simplify the delivery of inhaled therapies including aerosolized KL4 surfactant to infants requiring ventilatory support. This patent will expire in April 2029.

Additionally, the Company has received Notices of Allowance for two patents, titled "Lyophilization of Synthetic Liposomal Pulmonary Surfactant." The claims of these patents (U.S. Patent Application Numbers 14/091,608 and 14/091,712) cover composition of matter and methods of manufacturing for lyophilized KL4 surfactant. The patent term of these patents will expire in 2033. The company is initially developing its lyophilized KL4 surfactant for use in its AEROSURF® program.

"Our goal at Discovery Labs is to build a company focused on addressing the needs of critical care patients suffering from respiratory diseases, beginning with respiratory distress syndrome in premature infants," commented John G. Cooper, Chief Executive Officer of Discovery Labs. "These important new patents are indicative of our efforts to protect the long-term commercial potential of our platform technology. We initially are utilizing lyophilized KL4 surfactant for our AEROSURF development program. And while providing new technologies for these premature infants is our top priority, our longer term goal is to leverage our technology into developing products for other potential indications for which our proprietary KL4 surfactant could be of use."

About AEROSURF
AEROSURF is a novel investigational combination drug-device product being developed to deliver Discovery Labs' synthetic, peptide-containing KL4 surfactant in aerosolized form to premature infants with respiratory distress syndrome (RDS). AEROSURF could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated. Discovery Labs has initiated a phase 2a clinical study to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in escalating doses in premature infants 29 to 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to infants receiving nCPAP alone.

About Discovery Labs
Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care. Discovery Labs' technology platform includes its novel proprietary KL4 surfactant, a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant, and its proprietary drug delivery technologies being developed to enable efficient delivery of aerosolized KL4 surfactant. Discovery Labs' strategy is initially focused on neonatology and improving the management of respiratory distress syndrome (RDS) in premature infants. Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.

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' efforts to secure exclusivity protections for its drug and medical device products through patents and its efforts to build a respiratory critical care company focused initially on RDS, 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. Any forward-looking statement in this release speaks only as of the date on which it is made. Discovery Labs assumes no obligation to update or revise any forward-looking statements.

SOURCE Discovery Laboratories, Inc.