Cornerstone Therapeutics (NASDAQ: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing niche respiratory products, today announced findings from a study comparing all-cause, in-hospital mortality in more than 14,000 preterm infants with respiratory distress syndrome (RDS). The retrospective study evaluated Cornerstone’s CUROSURF ® (poractant alfa) compared to Infasurf ® (calfactant) and Survanta ® (beractant). Overall, CUROSURF treatment for RDS was associated with a significantly reduced likelihood of death compared to Infasurf, and a trend toward reduced mortality when compared with Survanta. The findings were published in the September 1, 2011 online issue of the Journal of Perinatology. “Cornerstone is extremely pleased with the results of this study. This research, especially among the smallest infants, reinforces why CUROSURF is the market leader in the U.S. and worldwide, and why we continue to see successful hospital conversions to CUROSURF therapy,” said Craig A. Collard, Cornerstone’s Chief Executive Officer. “When paired with CUROSURF’s existing, extensive clinical evidence, we believe these data will give neonatologists further confidence that CUROSURF is an appropriate choice to treat babies with RDS.” Cornerstone licensed CUROSURF U.S. rights from Chiesi Farmaceutici S.p.A. (Parma, Italy) as part of a broader transaction it completed with Chiesi in May 2009. About Respiratory Distress Syndrome Neonatal RDS is a complication of prematurity that makes breathing difficult for infants with underdeveloped lungs. The condition is caused by a lack of adequate endogenous surfactant - a protective substance that helps to reduce surface tension in the lungs. Without adequate surfactant, it is extremely difficult for infants to fully inflate their lungs and to avoid alveolar collapse. With approximately 550,000 premature births in the United States per year 1, the National Heart Lung and Blood Institute reports that 10 of every 100 premature babies develop neonatal RDS, with nearly all infants born before 28 weeks of pregnancy developing RDS 2. To treat this condition, physicians will often administer an exogenous surfactant shortly after birth. This surfactant is meant to reduce surface tension, helping to improve oxygenation and lung function. Today, physicians have a choice of three different animal-derived surfactants in the United States: CUROSURF, Infasurf or Survanta. Each features a unique composition, volume requirements and surfactant dosage. About the Study The study was a retrospective, observational, cohort study comparing all-cause, in-hospital mortality in 14,173 preterm infants with RDS treated with one of three surfactants between 2005 and 2009. Data were collected from the research database maintained by the Charlotte, N.C.-based Premier healthcare alliance. The Premier Hospital Database is a large U.S. hospital-based database, containing information on approximately 5.5 million annual hospital discharges (approximately one-fifth of all acute care hospitalizations in the U.S.) with day-by-day service level detail.This study included discharge data from 236 hospitals across the United States. Key study findings are as follows:
- When compared to infants treated with CUROSURF, the likelihood of mortality was 49.6 percent greater for Infasurf patients (p=0.043), and 37.0 percent greater for Survanta patients (p=0.053).
- There were no differences in mortality observed between the Infasurf and Survanta groups (p=0.626).
- The unadjusted mortality rates were lowest for the infants treated with CUROSURF (3.61 percent), followed by Survanta (4.58 percent) and Infasurf (5.95 percent).
“The clinical implications of this research are important for many reasons,” said Rangasamy Ramanathan, M.D., F.A.A.P., lead author and Associate Division Chief of the Division of Neonatal Medicine at LAC+USC Medical Center and Children’s Hospital Los Angeles. “This is the first direct comparison between all three products and the largest, retrospective study with surfactants to date. This information is critical in neonatal intensive care units (NICUs) as we work to stabilize and improve outcomes in preterm infants who are struggling with RDS.”Limitations of this retrospective study include database restrictions, such as lack of information on the precise cause of death, number of surfactant doses and antenatal steroid use. This study was sponsored by Chiesi Farmaceutici S.p.A. Indication CUROSURF ® Intratracheal Suspension is indicated for the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF ® Intratracheal Suspension reduces mortality and pneumothoraces associated with RDS. Important Safety Information CUROSURF is intended for intratracheal use only. THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING CUROSURF, CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified in response to respiratory changes. CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants. TRANSIENT ADVERSE EFFECTS SEEN WITH THE ADMINISTRATION OF CUROSURF INCLUDE BRADYCARDIA, HYPOTENSION, ENDOTRACHAEL TUBE BLOCKAGE, AND OXYGEN DESATURATION. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring. Please see full prescribing information at www.curosurf.com .
|1. National Vital Statistics Reports (2009, March 18). Vol. 57, (12, p. 14)|
|2. National Heart Lung and Blood Institute (2009, September 01). What is Respiratory Distress Syndrome? Retrieved August 30, 2011, from http://www.nhlbi.nih.gov/health/health-topics/topics/rds|
CUROSURF ® is a registered trademark of Chiesi Farmaceutici, S.p.A.Infasurf ® is a registered trademark of ONY, Inc.Survanta ® is a registered trademark of Abbott Laboratories, Inc.