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. 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 www.Discoverylabs.com.
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 are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that the Company may develop, including that (i) the Complete Response to the May 2008 Approvable Letter for Surfaxin that the Company submitted to the U. S. Food and Drug Administration (FDA) in October 2008 will not satisfy the FDA, (ii) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of the Company's applications, or may not approve or may limit approval of the Company's products to particular indications or impose unanticipated label limitations, and (iii) that changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to the Company's research and development activities, including time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail; risks relating to the Company's ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by the Company, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support the Company's development efforts and, if approved, commercialization; risks that (a) market conditions, the competitive landscape or otherwise, may make it difficult to launch and profitably sell products, (b) the Company may be unable to build a successful sales and marketing organization to market its products, if approved, in a timely manner, if at all, and (c) the Company's products will not gain market acceptance by physicians, patients, healthcare payers and others in the medical community; the risk that the Company or its strategic partners or collaborators will not be able to attract or maintain qualified personnel; the risk that the Company will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of the Company to fund its activities, or that additional financings could result in substantial equity dilution; the risk that the Company will not be able to access credit from its committed equity financing facilities, or that the share price at which the Company may access the facilities from time to time will not enable the Company to access the full dollar amount potentially available under the facilities; the risk that the Company will be unable to maintain The Nasdaq Global Market listing requirements, causing the price of the Company's common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten the Company's ability to continue as a going concern; the risks that the Company may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect the Company; risks of legal proceedings, including securities actions and product liability claims; risks relating to reimbursement and health care reform; and other risks and uncertainties described in the Company's 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.