Discovery Labs Receives SBIR Grant Valued up to $3.0 Million to Support Development of Aerosolized KL4 Surfactant to Address Radiation-Induced Lung Injury

WARRINGTON, Pa., Oct. 1, 2014 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced that the Company has been awarded a Phase II Small Business Innovation Research Grant (SBIR) valued at up to $3.0 million from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to support the development of the Company's aerosolized KL₄ surfactant as a medical countermeasure to mitigate acute and chronic/late-phase radiation-induced lung injury. The company has been awarded $1.0 million, and over the next three years may be awarded up to an additional $2.0 million as part of this grant. This program will be conducted in conjunction with Melpo Christofidou-Solomidou, Ph.D., a leading expert in novel antioxidant approaches to acute and chronic lung diseases from the University of Pennsylvania's Perelman School of Medicine. In fiscal year 2010, the Perelman School of Medicine received $583 million in support for its research activities from extramural sponsors, including $408 million from the National Institutes of Health, ranking third in the nation among all academic medical institutions.

"While we remain focused on respiratory distress syndrome in premature infants, we believe that our proprietary KL₄ surfactant also has the potential to address a number of other lung diseases and complications, including certain acute lung injuries," commented John G. Cooper, Discovery Lab's President and Chief Executive Officer. "The NIH has previously provided Discovery Labs funding to assess these potential opportunities, and based on the encouraging results of that preliminary work, has provided additional funding to continue research in this area. Radiation-induced pulmonary injury is a common and complicated manifestation of radiation exposure, and we look forward to developing data that may help define the role of KL₄ surfactant in protecting irradiated lungs."

The Company believes that its proprietary KL₄ surfactant may have utility in a variety of radiation-induced lung injuries, a common term referencing not only damage to the lungs occurring as a result of a radiological accident or terrorism threat agent, but also lung damage occurring as a result of radiation therapy as a treatment modality for a number of thoracic malignancies.  Studies have suggested that radiation-induced pneumonitis may occur in up to 15 percent of patients receiving radiation therapy for lung cancer.

KL₄ surfactant is a novel synthetic, peptide-containing surfactant designed to closely mimic the essential attributes of human lung surfactant.  Discovery Labs is currently evaluating aerosolized KL₄ surfactant in an ongoing phase 2a clinical program to assess safety and tolerability of aerosolized KL₄ surfactant delivered to premature infants receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS).

Government support and interest in Discovery Labs' aerosolized KL₄ surfactant program stems from the passing of the Project Bioshield Act of 2004 and the Pandemic & All-Hazards Preparedness Act of 2006 by the U.S. Congress.  Both Acts encourage private sector development of medical countermeasures against chemical, biological, radiological, and nuclear terrorism threat agents, and pandemic influenza, and provide a mechanism for federal acquisition of such countermeasures.

About Discovery Labs
Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care.  Discovery Labs' technology platforms include its novel proprietary KL₄ surfactant, a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant, and 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, to enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.  SURFAXIN® (lucinactant), Discovery Labs' first KL₄ surfactant-based product, is the only available synthetic alternative to animal-derived surfactants approved by the U.S. Food and Drug Administration (FDA). Full prescribing information can be found at http:///www.surfaxin.com. 

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 risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those affecting Discovery Labs' ability successfully to complete its development programs and realize the potential benefits of its RDS product portfolio, 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.