WARRINGTON, Pa., Dec. 18, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), today announced that a new analysis of data from its SELECT and STAR Phase 3 clinical trials for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants was presented at the American Association for Respiratory Care (AARC) International Respiratory Congress. In these studies, premature infants with RDS treated with surfactant and subsequently requiring reintubation had a significantly higher rate of mortality. As previously reported, premature infants treated with Surfaxin required less reintubation as compared with those treated with the animal-derived surfactants, Survanta(r) and Curosurf(r).
Premature infants are often born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen, resulting in RDS. The current standard treatment for RDS typically requires that the infant be intubated (insertion of a breathing tube into the infant's airway) to allow for respiratory support via mechanical ventilation and surfactant administration. If therapy is successful, the breathing tube is removed from the infant's airway (extubation) to allow the infant to breathe spontaneously. Many infants have difficulty breathing spontaneously after the initial extubation and require reintubation.
Data from Discovery Labs' Phase 3 clinical trials in RDS were analyzed to evaluate reintubation rates and clinical outcomes. The following results were presented:
* Infants who were successfully extubated and did not require reintubation experienced low mortality rates across all treatment groups (0-1% range), while infants who were extubated and subsequently reintubated had a statistically significant higher mortality rate (0.5% vs. 17.65%, respectively; p less than 0.05). * Infants treated with Surfaxin demonstrated a significantly lower reintubation rate as compared with those infants treated with animal-derived surfactants, Curosurf (33% vs. 47%; p less than 0.05) and Survanta (35% vs. 43%; p less than 0.05). * Infants treated with Surfaxin demonstrated a significantly higher combined outcome of survival without reintubation as compared with those infants treated with animal-derived surfactants, Curosurf (67% vs. 53%; p less than 0.05) and Survanta (65% vs. 57%; p less than 0.05).
Dr. Robert Segal, Senior Vice President and Chief Medical Officer of Discovery Labs commented, "Premature infants with RDS are currently treated with surfactants derived from bovine and porcine sources. This new analysis of data from our Phase 3 clinical trials is important because it suggests that Surfaxin decreases reintubation frequency when compared with current standard of care. Therapies capable of improving survival while reducing complications of prematurity could represent a potentially significant advancement in neonatal care."
Surfaxin is an investigational drug for the prevention of RDS in premature infants. A New Drug Application for Surfaxin is under review by the U.S. FDA with a target date of April 17, 2009 for potential marketing approval. Surfaxin is a synthetic, peptide-containing, surfactant that is structurally similar to pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Surfaxin represents a potential alternative to the currently-available animal-derived surfactants.
About the American Association for Respiratory Care (AARC)
The American Association for Respiratory Care (AARC) is the leading national and international professional association for respiratory care. The AARC encourages and promotes professional excellence, advances the science and practice of respiratory care, and serves as an advocate for patients and their families, the public, the profession and the respiratory therapist.
The AARC International Respiratory Congress is the premier educational event in the respiratory care profession. Every year, the meeting brings together more than 6,000 respiratory therapists and other health professionals from around the world, who gather to hear the latest developments in respiratory care.
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' technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Discovery Labs' lead product from its SRT pipeline is SURFAXIN(r) for the prevention of Respiratory Distress Syndrome in premature infants. The U.S. FDA has established April 17, 2009 as its target date to complete its review of this new drug application (NDA) and potentially grant marketing approval for this product. SURFAXIN is also being developed for other neonatal and pediatric indications. AEROSURF(r), Discovery Labs' aerosolized SRT, 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, including, without limitation, the risks that: Discovery Labs' response to the recent Approvable Letter for Surfaxin may not satisfy the FDA; the FDA or other regulatory authorities may not accept, or may withhold or delay consideration of, any applications that Discovery Labs may file for its products, or may not approve any such applications or may limit marketing of such products to particular indications or impose unanticipated label limitations; changes in the national or international political and regulatory environment may make it more difficult for Discovery Labs to gain FDA or other regulatory approval of its products; Discovery Labs may be unable to raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT); Discovery Labs' lengthy and costly research and development programs, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any of its products, including Surfaxin, may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs or its contract manufacturers or materials suppliers may be unable to successfully manufacture adequate supplies of its drug product or drug substances when needed or in amounts sufficient to meet demand; Discovery Labs may be unable to develop, manufacture and successfully commercialize products that combine Discovery Labs' drug products with innovative aerosolization technologies; Discovery Labs may be unable to profitably develop and market its products; Discovery Labs may be unable to maintain and protect the patents and licenses related to its SRT technology; other companies may develop competing therapies and/or technologies or health care reform may adversely affect Discovery Labs; and Discovery Labs may become involved in securities, product liability and other litigation. The foregoing risks and others are further described in Discovery Labs 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.