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Discovery Labs Receives FDA Recommendations And Request For Clarification Regarding Recently-Submitted SURFAXIN® (lucinactant) Updated Product Specifications

Stocks in this article: DSCO

For more information about SURFAXIN, please visit www.surfaxin.com.

ABOUT AFECTAIRThe AFECTAIR technology was developed as a proprietary, disposable device that simplifies the delivery of aerosolized medications to critical-care patients requiring ventilatory support such as intermittent mechanical ventilation or continuous positive airway pressure.  To date, in vitro studies suggest that the AFECTAIR technology may be an effective new solution for delivering aerosolized medicine to infants receiving ventilatory support while providing healthcare professionals with a simplified alternative to current practices.  According to national health statistics and internal market assessment data, it is estimated that each year approximately 355,000 pediatric patients in the United States are eligible to receive aerosolized medications while requiring ventilator support.

Discovery Labs is also pursuing European Conformity (CE) marking for potential commercialization of AFECTAIR for infants in the European Union (EU) in 2013.

ABOUT AEROSURFAEROSURF (lucinactant for inhalation), Discovery Labs' initial aerosolized KL 4 surfactant product, is under development to address respiratory distress syndrome in premature infants.  Through the effective delivery of aerosolized KL 4 surfactant using Discovery Labs' proprietary capillary aerosol generator technology, AEROSURF may significantly expand the surfactant-eligible treatment population by providing neonatologists with a means of administering surfactant without the risks currently associated with invasive endotracheal intubation and mechanical ventilation.

ABOUT DISCOVERY LABSDiscovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care.  Discovery Labs' novel proprietary KL 4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant.  Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL 4 surfactant and other inhaled therapies.  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, significantly expand the current worldwide RDS market.

For more information, please visit the Company's website at www.Discoverylabs.com.

DISCLOSURE NOTICEReaders are referred to, and encouraged to read in their entirety, the Form 8-K that Discovery Labs filed with the Securities and Exchange Commission (SEC) concurrently with the issuance of this press release, and Discovery Labs' Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 to be filed with the SEC on or before May 10, 2013, which includes further detail on the Company's business plans and operations, financial condition and results of operations.

Forward-Looking Statements The information in this press release includes certain "forward-looking" statements relating, among other things, to Discovery Labs' plans related to the recommendations and requests included in a recently-received FDA communication, its plans to manufacture and release SURFAXIN drug product, including to generate data for inclusion in its response to the FDA and for commercial sale in the fourth quarter of 2013, and its plans to prepare and submit to the FDA additional information supporting a request to update SURFAXIN product specifications within an anticipated two months.  These and other similar statements included herein are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  While Discovery Labs currently believes that it will succeed in meeting the timelines outlined above, such forward-looking statements are subject to a variety of risks and uncertainties that could cause actual results to be materially different.  Examples of such risks and uncertainties, including those related to the Company's research and development and commercialization programs, are described in Discovery Labs' filings with the SEC, 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.

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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