PRNewswire-FirstCall (May 04, 07:34 AM) PRAGUE, Czech Republic, May 4 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today announced the presentation of Phase II data demonstrating superior efficacy of dalbavancin, the company's next-generation injectable glycopeptide antibiotic, compared to vancomycin, the current standard of care for the treatment of catheter-related bloodstream infections (CR-BSI). CR-BSIs are one of the most common hospital-acquired infections. These previously reported topline data were presented in full at the 14th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Prague, Czech Republic.
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 combination of dalbavancin's superior efficacy to a long-accepted standard of care for such a tough-to-treat infection combined with its optimized dosing suggest that it could be an important new option in the treatment of serious bacterial infections," said Timothy J. Henkel, M.D., Ph.D., Vicuron's chief medical officer. "We believe that dalbavancin's outstanding microbiological activity and unique dosing profile may translate into excellent clinical efficacy in these difficult-to-treat infections. Dalbavancin's potency and long half-life allow it to be administered just once per week as opposed to vancomycin, which typically involves multiple daily infusions."
CR-BSI Study Details and Results
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.
Additional Dalbavancin Data Highlights from ECCMID
-- In vitro data show dalbavancin has excellent activity against European
isolates of staphylococci and streptococci; and
-- In vitro data show dalbavancin has superior Gram-positive activity
against European isolates when compared to more than 20 other available
antibiotic agents, including several in its own class further
supporting some of the clinical findings reported at the meeting.
About Dalbavancin
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 Staphylococcus (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 bactericidal (i.e., kills bacteria rather than merely inhibiting their growth). 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.
About Vicuron
Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients in North America and major countries in Europe. The company has filed a New Drug Application with the U.S. Food and Drug Administration for its lead product, anidulafungin, a novel antifungal agent. The company's other lead product, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections, is in Phase III clinical trials. The company's versatile research engine integrates industry-leading expertise in functional genomics, natural products discovery, mechanism-based drug design and combinatorial and medicinal chemistry. These approaches are yielding promising novel and next-generation compounds, many of which are in the later stages of preclinical development. In addition, the company has research and development collaborations with leading pharmaceutical companies, such as Pfizer and Novartis.
Forward-Looking Statements
This news release contains forward-looking statements that predict or describe future events or trends. The matters described in these forward-looking statements are subject to known and unknown risks, uncertainties and other unpredictable factors, many of which are beyond Vicuron's control. Vicuron faces many risks that could cause its actual performance to differ materially from the results predicted by its forward-looking statements, including the possibilities that clinical trials and the results thereof might be delayed, that the timing of the filing of any new drug application might be delayed, that subsequent clinical trials might indicate that a product candidate is unsafe or ineffective, that any filed new drug application may not be approved, that ongoing proprietary and collaborative research might not occur or yield useful results, that a third party may not be willing to license our product candidates on terms acceptable to us or at all, that competitors might develop superior substitutes for their products or market them more effectively, that a sales force may not be developed as contemplated and that one or more of its product candidates may not be commercialized successfully. The reports that Vicuron files with the U.S. Securities and Exchange Commission contain a fuller description of these and many other risks to which Vicuron is subject. Because of those risks, Vicuron's actual results, performance or achievements may differ materially from the results, performance or achievements contemplated by its forward-looking statement. The information set forth in this news release represents management's current expectations and intentions. Vicuron assumes no responsibility to issue updates to the forward-looking matters discussed in this news release.
Vicuron Pharmaceuticals Inc.
CONTACT: Dov A. Goldstein, M.D. of Vicuron Pharmaceuticals Inc.,+1-610-205-2312, or dgoldstein@vicuron.com; or Hala Bashir of WeissComPartners, +1-212-204-2080, or Hala@weisscom.net, for Vicuron PharmaceuticalsInc.; or E. Blair Schoeb of Burns McClellan Inc., +1-212-213-0006, orbschoeb@burnsmc.com, for Vicuron Pharmaceuticals Inc.
Web site: http://www.vicuron.com/
