Discovery Laboratories Inc has submitted a Marketing Authorization Application (MAA) to the European Medicines Evaluation Agency (EMEA) for clearance to market Surfaxin in Europe for the treatment and prevention of Respiratory Distress Syndrome (RDS) in premature infants. Surfaxin is a novel, peptide-containing, humanized lung surfactant developed from Discovery's proprietary surfactant replacement technology platform.
The MAA submission is supported, in large part, by data from Discovery's two positive phase 3 RDS clinical trials. The first was a landmark, 1294 patient pivotal-study that demonstrated Surfaxin's superiority to Exosurf, a non-protein containing synthetic surfactant. Survanta, a cow-derived surfactant and the leading surfactant used in the United States, served as a reference arm in the trial. The second trial was a 252 patient-supportive study that demonstrated Surfaxin's non-inferiority to Curosurf, a pig-derived surfactant and the leading surfactant used in Europe.
Robert J Capetola, president and chief executive officer of Discovery commented, "The data submitted to the EMEA demonstrates the benefit of Surfaxin not only for the prevention but also the treatment of RDS in these very premature babies. Surfaxin, if approved, represents for the first time, an engineered surfactant with the potential to become a new worldwide standard of care for the prevention and treatment of RDS. Surfactant replacement therapy, integrating our engineered humanized surfactants, creates a dramatic evolution in the treatment of serious and life-threatening respiratory diseases prevalent in the neonatal intensive care unit (NICU) and hospital. We now look forward to productive interactions with the EMEA to facilitate a timely and thorough review of our application."
In the United States, Discovery has filed a New Drug Application with the FDA for clearance to market Surfaxin for the prevention of RDS in premature infants. The FDA has accepted the NDA filing and has established a target date of February 13, 2005 for completion of review of the NDA.
Discovery's Surfaxin is an engineered version of natural human lung surfactant and contains a peptide, sinapultide that is designed to closely mimic the essential human lung surfactant protein B (SP-B). Surfaxin, unlike the animal products, is capable of being produced in virtually unlimited quantities, in consistent pharmaceutical grade quality, and has no risk of potential transmission of animal-associated diseases.
Discovery Laboratories Inc is a biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory diseases.