Vicuron Pharmaceuticals Provides Update on Anidulafungin Regulatory Paths Conference Call Scheduled Today at 8:30 a.m. EDT KING OF PRUSSIA, Pa., Sept. 21 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today provided an update on the status of its New Drug Application (NDA) for anidulafungin, its novel antifungal agent. In May of this year, Vicuron received an approvable letter from the U.S. Food and Drug Administration (FDA) for anidulafungin. Based upon Vicuron's discussions with the agency and the approvable letter, Vicuron plans to pursue the following two paths to approval: 1. For the potential treatment of esophageal candidiasis: The initial NDA has been kept open and Vicuron will file an amendment to that NDA for this indication. The amendment will provide supplemental clinical data for anidulafungin largely at the 100 mg dose from studies with enrollment already completed. The amendment is currently anticipated to be submitted in the second quarter of 2005. Under this timeline, the fourth quarter of 2005 is the earliest anidulafungin could be approved for this indication. 2. For the potential treatment of invasive candidiasis/candidemia: Vicuron will file a new NDA for this indication using integrated clinical data, including data from the recently-completed pivotal Phase 3 trial, the results of which are expected to be released in the first half of 2005. Vicuron plans to submit this NDA in the third quarter of 2005 and expects a standard review period. "We now believe that we have defined paths to approval for anidulafungin in two indications," said George F. Horner, III, President and Chief Executive Officer of Vicuron. "We will continue to work closely with the agency on both of these programs." About Anidulafungin Anidulafungin is a naturally occurring molecule that has been significantly improved through chemical modification. In vitro studies have demonstrated that anidulafungin combines both the potency and killing effects of the polyene class (e.g. amphotericin B) without the resistance problems found with the azole class (e.g., fluconazole). Anidulafungin is a broad- spectrum agent, and has been demonstrated to be highly potent in vitro against the fungi responsible for several serious fungal infections. Preclinical studies have shown that five-minute exposure to anidulafungin in vitro kills more than 99 percent of Candida, including fluconazole-resistant strains. Anidulafungin has no cross-resistance with azoles or amphotericin, and in the laboratory it has proven very difficult to develop resistance to anidulafungin. Anidulafungin also was well tolerated in a Phase 1 study when given in combination with cyclosporine, a leading chronic immunosuppressive drug. Conference Call Information Vicuron will host a conference call today at 8:30 a.m. (Eastern Time). To access the live call or the 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 1-800-822-4794 (U.S.) or 1-913-981-4912 (international) to listen to the call. Telephone replay is available from approximately one hour after the call through September 28, 2004. To access the replay, please call 1-888-203-1112 (U.S.) or 1-719-457-0820 (international). The replay access code is 853414. About Vicuron Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients. In May 2004, Vicuron received an approvable letter from the FDA for its lead product anidulafungin for the treatment of esophageal candidiasis. The company's other lead product, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections, has completed Phase 3 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, or unsuccessful, that the timing of the filing of any new drug application or any amendment to a new drug application might be delayed, that clinical trials might indicate that a product candidate is unsafe or ineffective, that the FDA might require additional information to be submitted and additional actions to be taken before it will make any decision, 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 Vicuron's products or market these competitive products more effectively, that a sales force may not be developed as contemplated and that one or more of Vicuron's 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 ; or Hala Bashir of WeissComm Partners, +1-212-204-2080, or , or Aline Schimmel of Burns McClellan Inc., +1-212-213-0006, or , both for Vicuron Pharmaceuticals Inc. Web site: http://www.vicuron.com/

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