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Discovery Labs Provides Update Regarding Surfactant Aerosol Generation Technology
Tuesday April 14, 2009, 7:00 am EDT
WARRINGTON, Pa., April 14, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (NasdaqGM:DSCO - News) 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. KL4 surfactant has been designed to functionally
coat the entire surface area of the respiratory tree and, in
aerosolized form, may be used in combination with other drugs (small
or large molecule) to enhance a desired therapeutic effect.
About the Capillary Aerosolization Technology
Discovery Labs' novel Capillary Aerosolization Technology has the potential to enable targeted upper-respiratory, airway, or alveolar delivery of therapies for either local or system-wide pulmonary applications and has been initially designed to produce high-quality, low-velocity aerosols for possible deep lung aerosol delivery. Aerosol is created by pumping KL4 surfactant drug formulation through a heated capillary wherein the excipient system is converted to the vapor state. Upon exiting the capillary, the vapor stream quickly cools and slows in velocity, yielding a dense aerosol with a defined particle size.
In June 2008, Discovery Labs assumed sole responsibility for future development of its proprietary Capillary Aerosolization Technology following restructuring of a December 2005 strategic alliance with the technology licensor. Under the alliance, Discovery Labs was primarily responsible for drug formulation development, manufacturing and regulatory matters and the licensor was primarily responsible for device development. Prior to the restructuring, developmental studies were conducted by Discovery Labs demonstrating that KL4 surfactant maintains its chemical composition and essential functional activity post-aerosolization and that the capillary aerosolization system generates as much as a 10-fold higher aerosol output rate compared with other devices that Discovery Labs had evaluated for potential delivery of aerosolized KL4 surfactant to the deep lung.
Discovery Labs currently holds worldwide exclusive licenses to the Capillary Aerosolization Technology for use with pulmonary surfactants, alone or in combination with other pharmaceutical compounds, for all respiratory diseases and conditions. In addition, Discovery Labs holds in the United States exclusive rights to the Capillary Aerosolization Technology for use with other (non-surfactant) drugs to treat a wide range of pediatric and adult respiratory indications in hospitals and other health care institutions.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) 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. In addition, our proprietary capillary aerosol generating technology produces a dense aerosol with a defined particle size, to potentially deliver our aerosolized KL4 Surfactant to the deep lung. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products targeted to address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Discovery Labs' lead product from its KL4 Surfactant pipeline is SURFAXIN(r) for the prevention of Respiratory Distress Syndrome in premature infants. The U.S. Food and Drug Administration (FDA) has established April 17, 2009 as its target action date to complete its review of this new drug application (NDA) and potentially grant marketing approval for SURFAXIN. SURFAXIN is also being developed for other neonatal and pediatric indications. AEROSURF(r), Discovery Labs' aerosolized KL4 Surfactant, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at discoverylabs.com.
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