Pharmacology
Lucinactant Shows Potential Advantages versus Existing Surfactant Therapy in Preterm Infants at Risk for Respiratory Distress Syndrome
By Discovery Labs
Apr 5, 2005, 09:06

Discovery Laboratories, Inc. (Nasdaq:DSCO), announces publication of the results from its SELECT and STAR Phase 3 clinical trials for Surfaxin�, in Pediatrics, a premier medical journal for pediatric healthcare practitioners. Published results from the SELECT and STAR trials concluded that Surfaxin provides potential advantages versus existing surfactant therapy and may be an effective therapeutic option for preterm infants at risk for Respiratory Distress
Syndrome (RDS).

Presentation of these data at multiple international medical congresses including the Pediatric Academic Societies, European Society for Pediatric Research and Hot Topics in Neonatology, and publication in a peer-reviewed journal such as Pediatrics validate these important studies.

Surfaxin is pending approval and has recently received an Approvable Letter from the United States Food and Drug Administration (FDA) for the prevention of RDS in premature infants.

Robert J. Capetola, President and CEO of Discovery commented,"We are extremely pleased that Pediatrics has published this data to make it available to the medical community.This publication, combined with our Approvable Letter from the FDA for Surfaxin for the prevention of RDS in premature infants, validates the potential for Surfaxin to increase survival and transform the treatment of respiratory disease in the Neonatal Intensive Care Unit (NICU)."

As previously reported, in the pivotal SELECT trial, Surfaxin significantly increased survival of premature babies with RDS compared with Exosurf(r), a non-protein containing synthetic surfactant, and Survanta(r), the leading animal-derived product prescribed in the United States.In addition, when treated with Surfaxin, more babies survived without developing debilitating chronic lung disease, also known as bronchopulmonary dysplasia (BPD), compared with those treated with Exosurf.

Surfactants are protein and lipid (fat) compositions that are produced naturally in the lungs and are essential for breathing. Presently, the FDA has approved surfactants as replacement therapy only for RDS in premature infants, a condition in which infants are born too soon and thus have an insufficient amount of their own natural surfactant. The FDA approved surfactants available today are either animal-derived or non-protein containing synthetic products. Animal-derived surfactants contain variable amounts of surfactant apoproteins, whereas the older-generation synthetic products contain only phospholipids and lack surfactant proteins which are necessary to optimize function.

Discovery's Surfaxin is a synthetic,peptide-containing, precision- engineered surfactant that contains sinapultide, a novel 21-amino acid peptide designed to mimic the function of the critical human surfactant protein, SP-B. Surfaxin is completely synthetic and thus avoids any potential risks associated with therapies derived from
animal origin.

The articles selected for publication in Pediatrics are:

-- A Multicenter, Randomized, Masked, Comparison Trial of
Lucinactant, Colfosceril Palmitate, and Beractant for the Prevention of Respiratory Distress Syndrome Among Very Preterm Infants (Moya et al.) Pediatrics Vol. 115 No. 4 April 2005
-- A Randomized, Controlled Trial of Lucinactant Versus Poractant Alfa Among Very Premature Infants at High Risk for Respiratory Distress Syndrome (Sinha et al.)Pediatrics Vol. 115 No. 4 April 2005

The pivotal SELECT trial was the largest, adjudicated, regulatory trial conducted in this therapeutic category's evolution.The SELECT trial was designed as a superiority trial to compare the efficacy and safety of Surfaxin with the non-protein containing synthetic surfactant,Exosurf and a bovine-derived surfactant,Survanta in the prevention of RDS and RDS-related deaths in premature infants.Based on the results, it was determined that Surfaxin is a significantly more effective surfactant preparation than Exosurf for the prevention of RDS and decreased RDS related mortality rates when compared with both comparators, Exosurf and Survanta. In the surviving population,Surfaxin also significantly reduced the incidence of BPD, compared with Exosurf.

"The data from the SELECT trial indicates that a new-generation surfactant replacement therapy such as Surfaxin will save more babies' lives while improving their chances for a healthy future," commented Fernando Moya, M.D., Chair of the SELECT study Steering Committee and Richard W. Mithoff Professor of Neonatal-Perinatal Medicine, Department
of Pediatrics UT-Houston School of Medicine. "The successful conduct of this trial, which for the first time in this therapeutic class, included strict adjudication of all primary outcomes by an independent committee of leading neonatologists and pediatric radiologists, represents a new quality standard in surfactant clinical trials."

The supportive,multinational STAR trial was designed as a non- inferiority trial comparing Surfaxin�, to Curosurf,the
porcine- derived surfactant which is the market leader in Europe.Curosurf is considered by many of the world's leading neonatologists to be the best surfactant currently approved. In the trial, Surfaxin was shown to be non-inferior to Curosurf and was well-tolerated.

Sunil Sinha, M.D., Ph.D., F.R.C.P, a leading European neonatologist and a Professor of Paediatrics at South Cleveland Hospital, United Kingdom,stated, "The results from the STAR trial are very exciting for the pediatric community. Surfaxin is a surfactant of the highest quality
and is designed to overcome the potential limitations of animal-derived surfactants. The medical community will embrace a synthetic surfactant that can increase the odds for survival and reduce some of the long-term complications associated with prematurity such as BPD."

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