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Discovery Labs Provides Update Regarding Surfactant Aerosol Generation Technology
Tuesday, April 14, 2009 7:04 AM


WARRINGTON, Pa., April 14, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announces that it continues to make significant progress in the development of its proprietary Capillary Aerosolization Technology. Since obtaining exclusive development rights in June 2008, Discovery Labs has successfully advanced the fundamental design, improving the reliability and performance of the capillary aerosol generating systems. The Capillary Aerosolization Technology is designed to produce a consistent, high capacity aerosol with a defined particle size, intended to deliver aerosolized KL4 surfactant to the deep lung. Discovery Labs believes that its novel Capillary Aerosolization Technology will support delivery of surfactant therapy without the risk associated with invasive endotracheal intubation and mechanical ventilation, potentially addressing a broad range of respiratory disorders associated with surfactant dysfunction for which current treatment options are limited.

Discovery Labs has refined and optimized key design characteristics of the capillary aerosol generating system. Selected key accomplishments are:


 . Successfully completed comprehensive engineering confidence testing,
   thereby demonstrating that the reliability and performance
   consistency of the system is sufficiently robust to meet performance
   criteria for clinical use.
 . Improved, by 30%, the efficiency of the emitted dose (the amount of
   aerosolized drug product that is available for delivery to the
   lung), potentially allowing for shorter and more effective dosing
   regimens and lower cost of surfactant administration.

Chuck Katzer, Senior Vice President, Manufacturing of Discovery Labs, commented, "We have implemented a multi-stage plan to develop our Capillary Aerosolization Technology and have made significant progress in the development of this system, taking it from an early prototype aerosolization device to a combination drug/device product that we plan to use in a Phase 2 clinical trial. We have initiated full drug product characterization to establish a dataset to support a series of pipeline programs employing our novel aerosolized KL4 surfactant technology to potentially treat a wide range of respiratory disorders."

The following pipeline programs now employ the use of this technology:


 . Discovery Labs' first clinical program delivering KL4 surfactant
   using the Capillary Aerosolization Technology is planned as a
   Phase 2 clinical trial with Aerosurf(tm) to treat premature infants
   at risk of developing RDS. In a pre-IND (investigational new drug
   application) meeting, Discovery Labs received guidance from the
   U.S. Food and Drug Administration (FDA) with respect to the design
   of this Phase 2 clinical program. Discovery Labs is conducting
   activities, including performance release testing for the
   aerosolization system, to support the IND for Aerosurf.
   Additionally, Discovery Labs has initiated development of the
   next-generation capillary aerosolization systems intended to be
   used in future Phase 2/3 clinical trial and subsequent commercial
   applications.
 . Discovery Labs has initiated a research collaboration with
   respiratory critical care experts at a leading academic institution
   to assess the potential use of aerosolized KL4 surfactant as a
   preventive treatment for patients at risk for Acute Lung Injury
   (ALI), a syndrome associated with conditions that either directly or
   indirectly injure the air sacs of the lung, resulting in
   inflammation and increased permeability of the lungs with an
   associated breakdown of the surfactant layer.
 . Discovery Labs is initiating feasibility studies to assess the
   potential of combining aerosolized KL4 surfactant with other active
   therapeutic agents.


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