12:00 AM
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Jun 23, 2003
 |  BioCentury  |  Product Development

Baby's breath

Developing compounds for pediatric indications usually entails additional safety and efficacy hurdles, which is why pediatric indications are seldom the basis for a compound's first approval. However, Discovery Laboratories Inc. and Stressgen Biotechnologies Inc., driven by the incentives of Orphan Designation, each plan to file for initial regulatory approval of their lead compounds in pediatric indications.

For DSCO, which is pursuing respiratory distress syndrome (RDS) in premature infants, the approval of three animal-derived surfactants over the last decade provides a clear regulatory path, yet leaves an unmet need based on supply and safety issues. For SSB, prodding by FDA to test its HspE7 in children and the resulting positive data are motivating the company to seek approval for recurrent respiratory papillomatosis (RRP).

DSCO: Some breathing room

According to DSCO EVP and COO Christopher Schaber, all forms of respiratory distress are related to insufficiencies of naturally occurring lung surfactants. Premature infants are especially at risk because they have yet to produce their own surfactant. While several lung surfactants have been developed and approved over the last decade, most of these, including Curosurf poractant alfa, Survanta beractant, and Infasurf calfactant, are animal-derived.

All of the animal-derived surfactants are comprised of protein C, a suboptimal result of how the animal lungs are processed. And while protein C acts as a...

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