Preterm Infants with Respiratory Distress Syndrome: Incidence Rates of Death when Treated with Surfactant Replacement Therapies

-- Large multi-year, multi-hospital retrospective database analysis demonstrates RDS treatment with Curosurf(R) (poractant alfa) Intratracheal Suspension provides significantly improved neonatal survival --

NAPA, Calif. and PARMA, Italy, May 07, 2007 /PRNewswire/ -- Data presented today at the Pediatric Academic Societies' Annual Meeting demonstrate that premature infants with neonatal Respiratory Distress Syndrome (RDS) have a nearly 20% better chance of survival if they are treated with Curosurf(R) (poractant alfa) Intratracheal Suspension rather than either of two competing surfactant therapies. "Differences in Mortality Among Infants Treated with Three Different Natural Surfactants for Respiratory Distress Syndrome (RDS)," a retrospective analysis of a very large database maintained by Premier Inc., considered specific procedures and clinical outcomes for 24,883 premature infants treated for RDS at 191 U.S. hospitals from January 2003 to June 2006. The alternative surfactant therapies over which Curosurf(R) Intratracheal Suspension showed a nearly 20% mortality advantage are Survanta(R) (beractant) and Infasurf(R) (calfactant). Full disclosure of the data are being held pending publication.

Jatinder J. Bhatia, MD, Professor and Chief, Section of Neonatology in the Department of Pediatrics, Medical College of Georgia, commented, "Clinicians have long needed a robust basis upon which to choose surfactant therapies for premature babies suffering form RDS. Even though natural surfactants have appeared for some time to perform better than synthetic ones, and despite the significant differences in mortality that randomized trials have suggested among the three commonly available natural surfactants, there has been no single study comparing the mortality rates of all three natural surfactants."

According to Dr. Bhatia, "The present research analyzes summary data from an extensive administrative database of actual 'real-world' clinical outcomes. The sheer size of the sample as well as the consistency of its results across different hospital settings underscores the validity of the findings. The study controlled for six variables that could have confounded results, and derived data both for the total sample of nearly 25,000 babies as well as for a somewhat smaller group of more than 21,000 babies for whom complete and comparable data are available. For both groups, death rates were nearly 20% lower for babies treated with poractant alfa than for those treated with either beractant or calfactant."

RDS is a condition caused by a deficit in lung surfactant in infants who are born prematurely. Surfactant, a necessary and natural substance, is typically produced in the body about two months prior to birth and is required for proper respiratory function. By reducing the surface tension within the lungs, surfactant enables the lungs to inflate and normal breathing to begin at birth. However, when infants are born pre-term, surfactant may either be absent or be present only in insufficient quantities, preventing the lungs from inflating properly and possibly leading to the development of RDS. The administration of surfactants such as Curosurf(R) Intratracheal Suspension has been widely used to increase infant lung function and decrease the morbidity and mortality associated with RDS.

Rangasamy Ramanathan, MD, Professor of Pediatrics, Keck School of Medicine of the University of Southern California, Associate Division Chief, USC Division of Neonatal Medicine, and Section Head, Division of Neonatology and Neonatal Intensive Care Unit, LAC and USC Women's & Children's Hospital, noted: "I find it intriguing that this very large retrospective study confirms the direction of our own research a few years ago. In a randomized, multi- center trial that was published in the American Journal of Perinatology in 2004, we found a significantly higher survival rate among RDS babies treated with poractant alfa at an initial dose of 200 mg/kg than with beractant. Results from this large database analysis are consistent with the findings of our trial and other similar trials comparing poractant alfa and beractant. Furthermore, these analyses also demonstrated statistically significant survival benefits with poractant alfa treatment when compared with the other two natural surfactants available for clinical use in the United States. These results suggest that neonatologists should carefully weigh their choice of surfactant therapy in their clinical practice."

The study presented today was supported by a research grant from Chiesi Farmaceutici of Parma, Italy, manufacturer of Curosurf(R) Intratracheal Suspension, and Dey, L.P., US marketer of Curosurf(R).

"We are pleased to have supported this study and are impressed with its results," said J. Melville Engle, President and Chief Executive Officer of Dey, L.P. "To the extent that these data will affect clinical practice, these outcomes bode well for the health of premature infants and the peace of mind of their families."

Paolo Chiesi, Vice President, R&D Director of Chiesi Farmaceutici, concurred: "Curosurf(R) is already the most widely used surfactant in the world, and we look forward to its being used to treat more babies suffering from RDS in the United States. We are delighted that this large data analysis so strongly validates the clinical value of Curosurf(R)."

About Curosurf(R)

Curosurf(R) Intratracheal Suspension is indicated for the treatment (rescue) of RDS in premature infants. Curosurf(R) reduces mortality and pneumothoraces associated with RDS.

Curosurf(R) Intratracheal Suspension compensates for the deficiency of surfactant in preterm infants with RDS and restores surface activity to the lungs of these infants. Because Curosurf(R) works rapidly, infants should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. Physiological endpoints have not proven to impact key clinical outcomes such as mortality due to RDS. Clinical studies have not evaluated whether fewer doses or longer dosing intervals result in superior safety or efficacy based on clinically relevant endpoints. Transient adverse effects seen with administration of Curosurf(R) include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation

About Dey, L.P.

Dey, L.P. is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, respiratory-related allergies, and emergency care medicine. As the U.S. leader in nebulized respiratory medication, DEY puts patients first through its development of innovative and affordable therapies. The Web sites for DEY include http://www.dey.com, http://www.accuneb.com, http://www.curosurfusa.com, http://www.cyanokit.com, http://www.duoneb.com, and http://www.epipen.com. Dey, L.P. is an affiliate of Merck KGaA, Darmstadt, Germany.

Curosurf is a registered trademark of Chiesi Farmaceutici, Parma, Italy.

Survanta is a registered trademark of Ross Product Division, Abbott Laboratories Inc.

    Infasurf is a registered trademark of Forest Pharmaceuticals, Inc.



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    Linda Storari

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          or

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    Chiesi Farmaceutici SpA

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hullman@fkhealth.com L.Storari@chiesigroup.com M.Zaninelli@chiesigroup.com

CONTACT: Dey, L.P. Media Line, +1-800-755-5560, ext. 8363; Harriet Ullmanof Feinstein Kean Healthcare, +1-617-761-6776, ; LindaStorari, +39 0521 279 620, , or Massimo Zaninelli,+39 0521 279 084, , both of Chiesi FarmaceuticiSpA hullman@fkhealth.com L.Storari@chiesigroup.com M.Zaninelli@chiesigroup.com

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Posted: May 2007

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