WARRINGTON, Pa., Oct. 10, 2006 (PRIMEZONE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), today announced that additional clinical data from its SELECT and STAR Phase 3 clinical trials of Surfaxin(r) (lucinactant), for the prevention of Respiratory Distress Syndrome (RDS) in premature infants, were presented at the European Academy of Paediatrics Congress (Europaediatrics) in Barcelona, Spain. These data demonstrate that Surfaxin-treated infants require significantly less re-intubation and experience improved key clinical outcomes compared to those treated with the animal derived surfactants, Survanta(r) and Curosurf(r), the current market-leading products in the United States and Europe, respectively.
Recent data from Discovery's pivotal and supportive Phase 3 clinical trials, SELECT and STAR, demonstrate statistically significant reductions in re-intubation rates for Surfaxin-treated infants as follows:
-- In a pooling of both studies, re-intubation rates were significantly
lower for Surfaxin-treated infants compared with those treated with
the animal-derived surfactants (34.2% vs. 43.9%, respectively;
p = .005)
-- In the SELECT trial's comparison of Surfaxin with Survanta,
re-intubation rates were significantly lower for infants treated with
Surfaxin (34.6% vs. 42.8%, respectively; p = .014)
-- In the STAR trial's comparison of Surfaxin with Curosurf, re-intubation
rates were significantly lower for infants treated with Surfaxin (32.7%
vs. 47.2%, respectively; p = .048)
Premature babies are often born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen, resulting in RDS. These babies often require endotracheal intubation -- a breathing tube inserted in the infant's fragile airway -- allowing for surfactant administration and respiratory support via mechanical ventilation. This breathing tube is removed when the infant no longer requires ventilatory support. Unfortunately, many infants suffer a relapse in respiratory function that requires re-intubation. This repeated invasive intubation and prolonged mechanical ventilation increases the risk of airway damage, hospital stay, chronic lung disease (also known as bronchopulmonary dysplasia, BPD), and death. In addition, endotracheal intubation and prolonged mechanical ventilation dramatically increases the cost of treating these babies.
These data were presented at Europaediatrics by Fernando Moya, M.D., Chair of the SELECT study Steering Committee and Director of Neonatology at the Coastal Area Health Education Center, North Carolina. Dr. Moya commented, "According to the Centers for Disease Control and Prevention, the most frequent cause of infant death in the United States is preterm birth. Premature infants often have lung dysfunction usually associated with RDS. Current surfactant treatment options for RDS are limited to animal derived surfactants harvested from bovine (cow) and porcine (pig) sources. Surfaxin has already shown a robust survival benefit compared to these animal derived surfactants. These new data are particularly important as they now show that Surfaxin decreases re-intubation procedures, which are associated with long-term respiratory morbidity, compared with animal derived alternatives. Any therapy capable of improving odds for survival while reducing complications associated with prematurity represents a potential significant advancement in neonatal care."
Dr. Moya also presented previously reported long-term clinical data derived from a pooled analysis combining data from the SELECT and STAR trials in a symposium at Europaediatrics entitled "Surfactant Therapy; Past, Present and Future." These data demonstrated that premature infants treated with Surfaxin experienced a significant survival benefit through one year of life compared with the currently available animal derived surfactants.
Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative to the animal-derived and non-protein containing synthetic surfactants. Surfactants are substances that are produced naturally in the lungs and are essential to the lungs' ability to absorb oxygen and maintain proper airflow through the respiratory system. Surfaxin, an investigational drug, is currently the subject of an Approvable Letter from the FDA for the prevention of RDS in premature infants.
RDS afflicts tens of thousands of premature infants in the United States each year, with a global at-risk population in excess of 500,000 infants. Approximately 75,000 infants are treated with surfactants in the United States annually.
About European Academy of Paediatrics Congress (Europaediatrics)
The European Academy of Paediatrics Congress (Europaediatrics) is the largest European congress of pediatrics and is a combination of two European pediatric subspecialty societies, ESPR/ESN (European Society for Paediatric Research / European Society of Neonatology) and the ESPNIC (European Society of Paediatric and Neonatal Intensive Care). This Congress provides top-level education and state-of-the-art information, particularly aimed for pediatric subspecialists and pediatricians involved in hospital based pediatrics.
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's technology produces a precision-engineered surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Discovery believes that its proprietary SRT pipeline has the potential to advance respiratory medicine and address a variety of respiratory diseases affecting premature infants, children and adults.
Discovery's lead product candidate, Surfaxin, is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. Surfaxin(r) is also being developed for the prevention and treatment of Bronchopulmonary Dysplasia in premature infants. Aerosurf(tm), Discovery's aerosolized SRT, is being developed initially to treat premature infants suffering from respiratory disorders and is intended to obviate the need for intubation and conventional mechanical ventilation. Discovery's SRT pipeline also includes programs addressing Acute Lung Injury, Acute Respiratory Failure, Cystic Fibrosis, Acute Respiratory Distress Syndrome, and other respiratory conditions. For more information, please visit our corporate website at www.Discoverylabs.com.
To the extent that statements in this press release are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of Discovery's product development, events conditioned on stockholder or other approval, or otherwise as to future events, 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. Among the factors which could affect Discovery's actual results and could cause results to differ from those contained in these forward-looking statements are the risk that financial conditions may change, risks relating to the progress of Discovery's research and development, the risk that Discovery will not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for aerosol and Surfactant Replacement Therapies), the risk that Discovery will not be able to develop or otherwise provide for a successful sales and marketing organization in a timely manner, if at all, the risk that approval by the FDA or other health regulatory authorities of any applications filed by Discovery may be withheld, delayed and/or limited by indications or other label limitations, the risk that any such regulatory authority will not approve the marketing and sale of a drug product even after acceptance of an application filed by Discovery for any such drug product, risks that the Chemistry, Manufacturing and Controls (CMC) section of Discovery's New Drug Application will not satisfy the FDA, risk in the FDA or other regulatory agency review process generally, risks relating to the ability of Discovery or Discovery's third party contract manufacturers and development partners to manufacture or provide Discovery with adequate supplies of drug substance, drug products and expertise for completion of any of Discovery's clinical studies, risks relating to drug manufacturing by Discovery, risks relating to the integration of manufacturing operations into Discovery's existing operations, other risks relating to the lack of adequate supplies of drug substance and drug product for completion of any of Discovery's clinical studies, risks relating to the ability of Discovery and its collaborators to develop, manufacture and successfully commercialize products that combine Discovery's drug products with innovative aerosolization technologies, risks relating to the significant, time-consuming and costly research, development, pre-clinical studies, clinical testing and regulatory approval for any products that we may develop independently or in connection with Discovery's collaboration arrangements, and risks relating to the development of competing therapies and/or technologies by other companies. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising earlier trial results. Data obtained from tests are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. Those associated risks and others are further described in Discovery'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.