Vicuron Pharmaceuticals' Phase II Results Show Superiority of Once-Weekly Dalbavancin vs. Vancomycin for Bloodstream Infections

KING OF PRUSSIA, Pa. -- Vicuron Pharmaceuticals Inc. today announced results of a Phase II clinical trial demonstrating that dalbavancin, the company's next generation injectable glycopeptide antibiotic, showed superior efficacy to vancomycin, the current standard of care for the treatment of gram-positive catheter-related bloodstream infections (CR-BSI). CR-BSIs are one of the most common hospital-acquired infections.

Dalbavancin administered once weekly for the treatment of CR-BSI was superior to vancomycin given twice daily at the study's primary endpoint, the combined clinical and microbiological response. This is the first time any gram-positive injectable antibiotic has been shown to be superior to vancomycin in a head-to-head comparison for these types of infections.

"These results support our belief that dalbavancin's outstanding microbiological activity and unique dosing profile would translate into excellent clinical efficacy in these difficult-to-treat infections," said Timothy J. Henkel, MD, PhD, Vicuron's chief medical officer. "These data are consistent with and, in many ways, surpass the favorable Phase II results we reported last year with dalbavancin in skin and soft tissue infections."

Two pivotal Phase III clinical trials of once-weekly dalbavancin for the treatment of skin and soft tissue infections (SSTIs) are ongoing. Vicuron expects to file a New Drug Application with the U.S. Food and Drug Administration by the end of 2004.

The randomized, comparative, open-label Phase II clinical trial enrolled 67 adults suffering from CR-BSI due to a suspected or identified Gram-positive organism at clinical sites in North America. The patients were either administered two doses of dalbavancin one week apart or vancomycin twice daily for 14 days. The primary endpoint was based on a composite of clinical and microbiological responses measured approximately 21 days after the end of treatment. To qualify as a success in the overall group, a patient had to have both a clinical and a microbiological success. The following results were observed:

* The primary endpoint showed there was an overall response rate of 87

percent in patients who received once-weekly dalbavancin (20/23)

compared to 50 percent in those treated twice daily with vancomycin

(14/28).

* Results of each of the clinical and microbiological responses were

similar to the overall response rate.

* Dalbavancin was well-tolerated with similar numbers of patients in the

dalbavancin and vancomycin groups experiencing adverse events.

"Because dalbavancin's once weekly dosing regimen offers a significant advantage over currently marketed gram-positive antibiotics, it has the potential to become a top-selling hospital product," said George F. Horner, III, Vicuron's president and chief executive officer. "With anidulafungin FDA approval and launch expected in the first half of this year and our NDA filing for dalbavancin targeted for the second half, this promises to be a very eventful and outstanding year for Vicuron."

Dalbavancin, a novel next-generation glycopeptide agent, belongs to the same class as vancomycin, the most widely-used and one of the few treatments available to patients infected with the most difficult-to-treat strains of Staph: MRSA (methicillin-resistant Staphylococcus aureus) and MRSE (methicillin-resistant Staphylococcus epidermidis). Dalbavancin has been specifically designed as an improved alternative to vancomycin. In vitro studies have shown that in addition to being potent against clinically important gram-positive bacteria, it is also bactericidal. The potency, tissue penetration and long half-life of dalbavancin may allow for more flexible and convenient dosing regimens than vancomycin. Dalbavancin may also help reduce the length of hospital stays by decreasing the need for intravenous lines that increase the risk of local and bloodstream infection. In preclinical and clinical studies to date, dalbavancin appears to be one of the most potent antibiotics in its class against MRSA and MRSE and has not shown significant dose-limiting side effects. Currently, once-weekly administration of dalbavancin is being studied in multiple Phase III clinical trials of complicated and uncomplicated skin and soft tissue infections.

Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients in North America and Europe.

Source: Vicuron Pharmaceuticals Inc.