Vicuron Pharmaceuticals Announces Positive Pivotal Phase III Results for Dalbavancin in Skin and Soft Tissue Infections Company Plans to Submit NDA Later This Year as Planned KING OF PRUSSIA, Pa., Aug. 12 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today announced results from pivotal Phase III clinical trials comprising more than 1,500 patients evaluating once-weekly dalbavancin in skin and soft tissue infections (SSTIs) caused by Gram-positive bacteria. All three studies met the primary endpoint of non-inferiority in evaluable patients' clinical response at two weeks following therapy when compared to linezolid, cefazolin or vancomycin, the three most widely administered standard-of-care agents for SSTIs. All studies also met the secondary endpoint of non-inferiority in clinical response for the intent-to-treat (ITT) patient population. Dalbavancin was also shown to be well tolerated. "Based on this compelling data, we plan to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) later this year," said George F. Horner III, Vicuron's president and chief executive officer. "We look forward to working through the FDA to move this important new antibiotic toward the market." The vast majority of the patients treated in these studies had SSTIs caused by Staphylococcus (Staph) aureus bacteria, with more than 400 patients infected with methicillin-resistant Staphylococcus aureus (MRSA), one of the most difficult-to-treat strains of bacteria. SSTIs are some of the most common infections seen in the clinic and hospital. Postoperative surgical site infections are one of the major sources of these infections. "The consistent response versus standard of care we observed with dalbavancin across all three studies is extremely encouraging," said Timothy J. Henkel, MD, PhD, chief medical officer of Vicuron. "Dalbavancin has the potential to become an important new agent in the physician's armamentarium to treat serious skin and soft tissue infections caused by a broad spectrum of Gram-positive bacteria." Phase III Study Design and Results -- Complicated SSTIs: Randomized, controlled, double-blind study of 854 patients versus linezolid. The primary endpoint was clinical response at the follow-up visit in the evaluable patient population. Evaluable patients taking dalbavancin demonstrated an 88.9 percent response versus 91.2 percent for linezolid patients (95 percent confidence interval -7.3, 2.9). In the ITT group, dalbavancin patients showed a 76.5 percent response versus 82.7 for linezolid (95 percent confidence interval -12.0, -0.3). Dalbavancin was well tolerated in the study. -- Uncomplicated SSTIs: Randomized, controlled, double-blind study of 565 patients versus intravenous cefazolin followed by oral cephalexin. The primary endpoint was clinical response at the follow-up visit in the evaluable patient population. Evaluable patients taking dalbavancin demonstrated an 89.1 percent response versus 89.1 percent for cefazolin (95 percent confidence interval -6.8, 6.8). In the ITT group, dalbavancin patients showed a 76.0 percent response versus a 75.8 percent response for cefazolin (95 percent confidence interval -7.7, 8.2). Dalbavancin was well tolerated in the study. -- SSTIs caused by MRSA: Randomized, controlled, open-label study of 156 patients versus vancomycin in SSTIs suspected or confirmed to be caused by methicillin-resistant Staphylococcus aureus (MRSA). The primary endpoint was clinical response at the follow-up visit in the evaluable patient population. Evaluable patients taking dalbavancin demonstrated an 89.9 percent response versus 86.7 percent for vancomycin (95 percent confidence interval -13.0, 19.4). In the ITT group, dalbavancin patients showed an 86.0 percent response versus 65.3 percent for vancomycin (95 percent confidence interval 4.3, 37.0). Dalbavancin was well tolerated in the study. This study is not pivotal, but will be part of the NDA submission. 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. Conference Call Information Vicuron will host a conference call today, August 12 at 10:00 a.m. Eastern Daylight Time. To access the live call or the 14-day archive via the Internet, log on to http://www.vicuron.com/. Please connect to Vicuron's website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (800) 811-0667 (U.S. or Canada) or (913) 981-4901 (international) to listen to the call. Telephone replay will be available beginning approximately one hour after the call through September 12, 2004. To access the replay, please call (888) 203-1112 (U.S. or Canada) or (719) 457-0820 (international). The conference ID number is 964098. 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. In May 2004, Vicuron received an approvable letter from the FDA for its lead product anidulafungin for the treatment of esophageal candidiasis. A Phase III study of anidulafungin in invasive candidiasis is ongoing. 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 by the FDA, 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. DATASOURCE: Vicuron Pharmaceuticals, Inc. CONTACT: Dov A. Goldstein, M.D. of Vicuron Pharmaceuticals Inc., +1-610-205-2312, ; or Hala Mirza of WeissCom Partners, +1-212-204-2080, or , for Vicuron Pharmaceuticals Inc.; or Aline Schimmel of Burns McClellan, +1-212-213-0006, or , for Vicuron Pharmaceuticals Inc. Web site: http://www.vicuron.com/

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