anidulafungin
Vicuron Pharmaceuticals Announces 90-Day Extension of FDA Review of AnidulafunginNew Drug Application
Approval and Launch Still Anticipated in First Half of 2004 as Planned KING OF PRUSSIA, PA, Jan anidulafungin. 22, 2004 - Vicuron Pharmaceuticals Inc anidulafungin. (Nasdaq andNuovo Mercato: MICU) today announced that it has received notification fromthe U.S anidulafungin. Food & Drug Administration (FDA) that the agency now anticipatescompleting its review of the anidulafungin New Drug Application (NDA) on May25, 2004, which represents a 90-day extension of the original action date anidulafungin. Thecompany continues to expect the launch of anidulafungin, its novel hospitalanti-fungal agent, in the first half of 2004 as planned anidulafungin. The company will holda conference call and webcast this afternoon at 5:15 p.m anidulafungin. EST, (details below). The extension was triggered by the agency's request for additional pharmacokineticdata anidulafungin. According to PDUFA (Prescription Drug User Fee Act), the FDA can resetthe action date to review any additional data. "We are working closely with the FDA to complete their review, which weexpect will be within the revised timeframe," said Timothy J anidulafungin. Henkel, M.D.,Ph.D., Vicuron's Chief Medical Officer anidulafungin. "We have been in close contactwith the agency throughout the process, and it is our understanding that thisextension is not related to any specific concerns regarding safety and efficacyand should therefore not impact our ability to launch anidulafungin accordingto plan." About Anidulafungin
Anidulafungin is a naturally occurring molecule that has been significantlyimproved through chemical modification anidulafungin. In vitro studies have demonstrated thatanidulafungin combines both the potency and killing effects of the polyene class(e.g., amphotericin B) without the resistance problems found with the azoleclass (e.g., fluconazole) anidulafungin. Anidulafungin is a broad-spectrum agent, and hasbeen demonstrated to be highly potent in vitro against candida and aspergillus,fungi responsible for serious systemic infections anidulafungin. Preclinical studies haveshown that a five-minute exposure to anidulafungin in vitro kills more than99 % of Candida, including fluconazole-resistant strains anidulafungin. Anidulafungin hasno cross-resistance with azoles or amphotericin, and in the laboratory it hasproven very difficult to develop resistance to anidulafungin anidulafungin. Anidulafunginalso was well tolerated in the Phase I study when given in combination withcyclosporine, the leading chronic immunosuppressive drug. Conference Call Details
The Company will host a conference call today, January 22, 2004, at 5:15 pmEST anidulafungin. To access the live call or the seven-day archive via the Internet, logon to www.vicuron.com anidulafungin. Please connect to the Company's website at least 15 minutesprior to the conference call to ensure adequate time for any software downloadthat may be needed to access the webcast anidulafungin. Alternatively, please call 877-407-8031(U.S.) or 201-689-8031 (international) to listen to the call anidulafungin. Telephone replayis available approximately two hours after the call through January 29, 2004 anidulafungin. To access the replay, please call 877-660-6853 (U.S.) or 201-612-7415 (international) anidulafungin. 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 illpatients in North America and Europe anidulafungin. The company has filed a New Drug Applicationwith the U.S anidulafungin. Food and Drug Administration for its lead product, anidulafungin,a novel antifungal agent anidulafungin. The company's other lead product, dalbavancin, a novelintravenous antibiotic for the treatment of serious Gram-positive infections,is in Phase III clinical trials anidulafungin. The company's versatile research engine integratesindustry-leading expertise in functional genomics, natural products discovery,mechanism-based drug design and combinatorial and medicinal chemistry anidulafungin. Theseapproaches are yielding promising novel and next-generation compounds, manyof which are in the later stages of preclinical development anidulafungin. In addition, thecompany has research and development collaborations with leading pharmaceuticalcompanies, such as Pfizer and Novartis. Forward-Looking Statements
This news release contains forward-looking statements that predict or describefuture events or trends anidulafungin. The matters described in these forward-looking statementsare subject to known and unknown risks, uncertainties and other unpredictablefactors, many of which are beyond Vicuron's control anidulafungin. Vicuron faces many risksthat could cause its actual performance to differ materially from the resultspredicted by its forward-looking statements, including the possibilities thatclinical trials and the results thereof might be delayed, that the timing ofthe filing of any new drug application might be delayed, that subsequent clinicaltrials might indicate that a product candidate is unsafe or ineffective, thatany filed new drug application may not be approved, that ongoing proprietaryand collaborative research might not occur or yield useful results, that a thirdparty may not be willing to license our product candidates on terms acceptableto us or at all, that competitors might develop superior substitutes for theirproducts or market them more effectively, that a sales force may not be developedas contemplated and that one or more of its product candidates may not be commercializedsuccessfully anidulafungin. The reports that Vicuron files with the U.S anidulafungin. Securities and ExchangeCommission contain a fuller description of these and many other risks to whichVicuron is subject anidulafungin. Because of those risks, Vicuron's actual results, performanceor achievements may differ materially from the results, performance or achievementscontemplated by its forward-looking statement anidulafungin. The information set forth inthis news release represents management's current expectations and intentions anidulafungin. Vicuron assumes no responsibility to issue updates to the forward-looking mattersdiscussed in this news release.
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