UPDATE 2-Discovery Labs inches closer to lung drug approval

Wed May 19, 2010 10:49am EDT

* Says likely to receive feedback on new study in June

* On track to file complete response to FDA in Q1, 2011

* Shares up 7 pct (Recasts; updates share movement)

May 19 (Reuters) - Drug developer Discovery Laboratories Inc (DSCO.O) said it validated the design of its quality control and stability test, a key milestone in the company's bid to gain approval for its drug to treat respiratory illness in infants.

In April of last year, the U.S. Food and Drug Administration declined to approve the drug Surfaxin raising questions on certain aspects of a biological activity test (BAT) -- used to detect changes in product quality through its shelf-life.

To complete an FDA-mandated comprehensive preclinical program, Discovery will now have to prove BAT's ability to properly detect active Surfaxin when compared in side-by-side studies with the established preterm lamb model test.

Discovery said the FDA is likely to provide feedback on the company's study protocol in June 2010, and as such it remains on track to complete the preclinical program and submit its complete response in the first quarter of 2011.

Shares of the company were up 4 cents at $0.53 in Wednesday morning trade on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Don Sebastian, Anthony Kurian)

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.