EraxisTreatment for Candidemia
Vicuron Pharmaceuticals Announces 90-Day Extension of FDA Review of Anidulafungin New Drug Application
Approval and Launch Still Anticipated in First Half of 2004 as Planned
KING OF PRUSSIA, PA, Jan. 22, 2004 - Vicuron Pharmaceuticals Inc. (Nasdaq and Nuovo Mercato: MICU) today announced that it has received notification from the U.S. Food & Drug Administration (FDA) that the agency now anticipates completing its review of the anidulafungin New Drug Application (NDA) on May 25, 2004, which represents a 90-day extension of the original action date. The company continues to expect the launch of anidulafungin, its novel hospital anti-fungal agent, in the first half of 2004 as planned. The company will hold a conference call and webcast this afternoon at 5:15 p.m. EST, (details below).
The extension was triggered by the agency's request for additional pharmacokinetic data. According to PDUFA (Prescription Drug User Fee Act), the FDA can reset the action date to review any additional data.
"We are working closely with the FDA to complete their review, which we expect will be within the revised timeframe," said Timothy J. Henkel, M.D., Ph.D., Vicuron's Chief Medical Officer. "We have been in close contact with the agency throughout the process, and it is our understanding that this extension is not related to any specific concerns regarding safety and efficacy and should therefore not impact our ability to launch anidulafungin according to plan."
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 candida and aspergillus, fungi responsible for serious systemic infections. Preclinical studies have shown that a five-minute exposure to anidulafungin in vitro kills more than 99 % 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 the Phase I study when given in combination with cyclosporine, the leading chronic immunosuppressive drug.
Conference Call Details The Company will host a conference call today, January 22, 2004, at 5:15 pm EST. To access the live call or the seven-day archive via the Internet, log on to www.vicuron.com. Please connect to the Company'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 877-407-8031 (U.S.) or 201-689-8031 (international) to listen to the call. Telephone replay is available approximately two hours after the call through January 29, 2004. To access the replay, please call 877-660-6853 (U.S.) or 201-612-7415 (international). The account number is 1628 and the conference ID number is 91477.
About Vicuron Pharmaceuticals Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients in North America and 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.
Posted: January 2004
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