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New Research Indicates Treating Neonatal Respiratory Distress Syndrome With CUROSURF® Results In Lower Rate Of Mortality Compared To Competitive Surfactants

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).

When stratified by birth weight, the greatest benefits were recognized by the smallest infants (500-749g), the population with the highest mortality in the study. In this group, the unadjusted mortality rate was significantly lower for CUROSURF treated infants (11.72 percent) versus those treated with Survanta (17.39 percent) or Infasurf (20.67 percent).

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