After surfaxin setbacks, Discovery Labs appoints new leader

Discovery Labs announced Thursday the resignation of Robert Capetola, its CEO since the company's founding 13 years ago. Board Chairman Thomas Amick, a Johnson & Johnson alum, has been appointed as interim CEO and remain in the position until Discovery secures much-needed cash or partnerships. "Dr. Capetola, together with the Board, felt that a transition in leadership at this time is appropriate for Discovery Labs to capitalize on its strategic endeavors," the company said in a statement.

This comes as Discovery faces a going concern warning and has had to make the difficult decision to redirect its resources away from its lead drug candidate to other development programs. The Warrington, PA-based developer has devoted a great deal of its resources to surfaxin, a synthetic surfactant designed to treat respiratory illness in infants born prematurely. Discovery submitted an NDA for the drug candidate back in 2004 and now five years later, the developer continues to face difficulties gaining regulatory approval.

The FDA has issued three approvable letters so far, each time requesting more information. The latest setback came in late April when the agency asked for more information on the drug's biological activity test. Discovery's stock plunged more than 60 percent on the news. In follow-up meetings in June, the FDA told the developer it had set new standards to determine whether surfaxin was comparable to commercial drug product. Discovery said it did not have the data to meet those standards, ending the chance of an approval in 2009 as the company and stakeholders had hoped. Discovery's stock closed at $0.50 on Thursday.

- read the Discovery Labs release