Vicuron Pharmaceuticals Inc. has received the acceptance to file notification and been granted Priority Review status by the US FDA for the New Drug Application (NDA) for its investigational agent dalbavancin, a novel once-weekly antibiotic for the treatment of complicated skin and soft tissue infections (cSSTIs) including the most difficult to treat strain of staphylococcus, methicillin-resistant staphylococcus aureus (MRSA).

Dalbavancin is a novel second-generation lipoglycopeptide agent that belongs to the same class as vancomycin. Vancomycin is one of the few treatments available to hospital patients infected with difficult-to-treat strains of Staphylococcus bacteria, or Staph known as MRSA (methicillin-resistant Staphylococcus aureus) and MRSE (methicillin-resistant Staphylococcus epidermidis). Dalbavancin has been specifically designed as an improved alternative to vancomycin.

"We are very pleased with this regulatory development which we believe further demonstrates the serious underserved medical need that dalbavancin has the potential to address," George F. Horner III, president and CEO of Vicuron said adding, "We expect to commercialize dalbavancin by the first quarter of 2006 pending FDA approval."

The NDA, which was submitted in December of last year, includes results from more than 1,850 subjects and three Phase 3 trials that evaluated the safety and efficacy of dalbavancin in patients with SSTIs caused by Gram-positive bacteria. The Phase 3 clinical trials each met the primary and secondary endpoints of non-inferiority when compared to linezolid, cefazolin or vancomycin, three currently used agents for SSTIs. The most common pathogen isolated in these studies was S. aureus, with more than 400 patients infected with MRSA.