Discovery Labs anticipates 'significant' delay in Surfaxin approval

By Elaine Rigoli

Tampa, Fla., April 24 - Discovery Laboratories, Inc. announced Monday that analysis of ongoing stability data from Surfaxin process validation batches indicates that certain stability parameters have not been achieved and, therefore, additional process validation batches will likely have to be produced.

These process validation batches were previously manufactured as a requirement for Discovery's New Drug Application regulatory approval and have been undergoing periodic stability testing, the company said in a news release.

Discovery anticipates a potentially significant delay in the U.S. regulatory approval process for Surfaxin for the prevention of respiratory distress syndrome in premature infants, though it remains uncertain over the impact on the Surfaxin European regulatory approval process, the release said.

Discovery said it will analyze all aspects of its business with an immediate intention to conserve cash. The establishment of a commercial infrastructure is no longer in Discovery's near-term plans.

The focus will be on remediating these manufacturing issues, developing its surfactant replacement therapy pipeline and potentially entering into strategic partnerships.

Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative to animal-derived surfactants.

Discovery is a biotechnology company developing surfactant technology for respiratory diseases and is located in Warrington, Pa.

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