Discovery Labs Sorts Out Manufacturing Issues, on Track for FDA Approval Letter

Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.

Discovery announced that process validation batches of Surfaxin, an engineered version of natural human lung surfactant, have demonstrated acceptable stability at six months under its comprehensive stability testing protocol. These six-month stability data will be included, along with other data and information, in a formal response to the US Food and Drug Administration’s April 2006 approvable letter. Surfaxin was developed for the prevention of respiratory distress syndrome in premature infants.

This latest development represents the end of the company’s problems with Surfaxin that began in February 2005 when the contract manufacturer of Surfaxin, Laureate Pharma, received a notice of inspectional observations (483 form) from the FDA alerting it to issues regarding the quality assurances systems, documentation, and controls in the manufacturing of the drug. To take control of the manufacturing of Surfaxin, Discovery ended its contract manufacturing agreement with Laureate in December 2005 and bought, for $16 million, the New Jersey facility where Laureate was producing Surfaxin.