Discovery Laboratories Reports on Surfaxin Manufacturing Issues

The biotechnology company Discovery Laboratories Inc. (Warrington, PA, www.discoverylabs.com) reports that analysis of ongoing stability data from "Surfaxin" process validation batches indicates that certain stability parameters have not been achieved, and additional process validation batches will likely have to be produced.

The process validation batches were previously manufactured as a requirement for the company's new drug application before the US Food and Drug Administration. The batches have been undergoing periodic stability testing, reports the company. 

"Discovery anticipates a potentially significant delay in the US regulatory approval process for Surfaxin for the prevention of respiratory distress syndrome in premature infants," said the company in an official release. "At this time, it is not known whether this issue will have any impact on the Surfaxin European regulatory approval process."

Surfaxin is a peptide-containing synthetic surfactant designed to mimic the function of natural human lung surfactant closely and it represents a potential alternative to animal-derived surfactants. Surfaxin received an approvable letter from FDA and is under regulatory review by the European Medicines Agency. Surfaxin also is being developed to treat chronic lung disease in premature infants. 

Discovery Laboratories says it will focus on remediating its manufacturing issues, developing its surfactant replacement therapy pipeline, and potentially entering into strategic partnerships. The company is analyzing all aspects of its business with an immediate intention to conserve cash. The establishment of a commercial infrastructure is no longer in its near-term plans, said the company.