Dalbavancin--the once-weekly skin antibiotic that Pfizer acquired as part of its 2005 $1.9 billion Vicuron Pharmaceuticals buyout--will not be going before the FDA anytime soon. Pfizer announced yesterday that it would withdraw approval requests and conduct another clinical trial on the medication before returning to FDA.
Pfizer is hoping the drug will treat antibiotic-resistant infections of the skin, such as those methicillin-resistant staphylococcus aureus (MRSA) and other tough-to-kill bugs cause. Although MRSA infection is on the rise, FDA feedback to Pfizer was discouraging enough that the company decided to head back to the clinical trial drawing board. The new study will take about 18 months to complete.
According to Mark Kunkel, the company's global medical therapeutic area leader for anti-infectives and HIV, the studies might not meet newer FDA statistical standards. Pfizer originally hoped for approval of the drug in 2005.
This is one in a series of late-stage drug mishaps for Pfizer, whose pipeline is looking increasingly thin.