ADLS gains after FDA posts briefing documents

Advanced Life Sciences Holdings Inc. (OTCBB:ADLS) gained $0.42 (42%) to $1.41 on Friday after FDA posted briefing documents ahead of Tuesday's Anti-Infective Drugs Advisory Committee meeting to discuss an NDA for Restanza cethromycin to treat mild to moderate community-acquired pneumonia (CAP). The panel will be asked whether the data demonstrate safety and efficacy, and whether additional studies are needed. The clinical development program for the oral ketolide antibiotic included two global Phase III studies with a primary endpoint of clinical cure that demonstrated noninferiority (NI) to Biaxin clarithromycin from Abbott Laboratories (NYSE:ABT). Biaxin is the standard of care in CAP (See BioCentury, Oct. 13, 2008).

Both Phase III trials for Restanza used a 10% margin to show noninferiority to Biaxin -- in line with the NI margin recommended in draft guidance on CAP issued by FDA in March (See BioCentury Extra, Thursday, March 19, 2009). ...