WARRINGTON, Pa., March 26, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announces that it has created a lyophilized formulation of its synthetic, peptide-containing KL4 surfactant technology. Lyophilized KL4 surfactant is being developed to support Discovery Labs' pipeline of surfactant product candidates including Surfaxin(r) (lucinactant as a liquid formulation) and Aerosurf(r) (lucinactant as an aerosolized formulation). Discovery Labs is developing a pipeline of surfactant-based therapies targeted to address several respiratory disorders associated with surfactant deficiency or dysfunction. Lyophilized KL4 surfactant is manufactured as a dry powder formulation that is reconstituted prior to use. Key next steps include planned discussions with global regulatory agencies intended to determine the development pathway leading to the initiation of a late-stage neonatal clinical trial program.
The currently available surfactants are animal-derived liquid formulations that require constant refrigeration prior to use. Surfaxin, which is Discovery Labs' lead product that is currently under review by the United States FDA for potential approval for prevention of Respiratory Distress Syndrome (RDS) in premature infants, also requires refrigeration prior to use. Lyophilized KL4 surfactant is intended to eliminate continuous cold chain storage and refrigeration, greatly improving product flexibility and ease of use for healthcare practitioners. In addition, Discovery Labs believes that its lyophilized formulation has the potential to:
* simplify drug administration with reduced preparation time,
* improve drug product stability with extended shelf-life, and
* further improve product clinical performance.
Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery Labs, commented, "We have established that the key functional attributes of our liquid KL4 surfactant are preserved following lyophilization and are now completing development activities to support our regulatory and clinical development paths. A comprehensive assessment of development scale manufacturing lots is ongoing including full drug product characterization. These development lots are also actively being assessed under both real-time and accelerated stability protocols and are being evaluated in several proof-of-concept experiments in well established pre-clinical RDS models. Importantly, the results of this work may provide additional intellectual property to support our technology platform. We believe that our lyophilized KL4 surfactant technology could provide several technical advantages for our surfactant product candidates."
Discovery Labs is planning a worldwide, late-stage development program for Surfaxin LS(tm), the lyophilized formulation of Surfaxin, for the prevention of RDS in premature infants. To pursue regulatory approval for Surfaxin LS in the United States, Discovery Labs plans to request a pre-IND meeting with the FDA with a view to agreeing upon and potentially initiating a clinical trial with Surfaxin LS in 2010. Similarly, to gain regulatory approval for Surfaxin LS in Europe, Discovery Labs plans to request a scientific advice meeting with the EMEA with a view to agreeing upon and potentially initiating a clinical trial in 2010. If a similar clinical trial design satisfies both regulatory agencies, Discovery Labs anticipates conducting a single clinical program to gain regulatory approval for Surfaxin LS in the United States and Europe.
"We believe there is an unprecedented opportunity to improve the management of RDS throughout the world," commented Dr. Thomas F. Miller, Discovery Labs' Senior Vice President of Commercialization and Corporate Development. "The neonatal market is quite underserved today. We remain committed to the advancement of our KL4 surfactant technology platform to improve the quality of RDS management in the neonatal intensive care unit. Our three lead programs, Surfaxin, Surfaxin LS and Aerosurf, represent a completely new and comprehensive approach for RDS management in which the therapeutic solution is tailored to the unique need of a patient."
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.