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Abstract:
Vicuron Pharmaceuticals (formerly Versicor Inc.) is developing anidulafungin [LY 303366, ECB, V-echinocandin, VEC, VER-02, VER 002], a lipopeptide echinocandin B derivative, for IV treatment of mycoses. Anidulafungin acts against fungal infection by inhibiting beta-1,3-glucan synthase, an enzyme essential for cell wall formation. Anidulafungin was originally developed for oral use by Eli Lilly and was undergoing phase II clinical trials in the UK and the US for the treatment of Candida, Aspergillus and Pneumocystis carinii infections. However, Eli Lilly discontinued development of the oral formulation due to poor oral bioavailability. In May 1999, Versicor obtained exclusive worldwide commercialisation rights to anidulafungin with responsibility for its development and clinical registration. Under the terms of the agreement, Eli Lilly received a signing fee, and will receive milestone payments upon future development of anidulafungin and royalties on future sales. Eli Lilly also retains an option for the development of an oral formulation of the compound. On 3 March 2003, Versicor Inc. of Fremont (California, USA) and Biosearch Italia SpA of Milan (Italy) announced the completion of a merger agreement, whereby Biosearch was merged with and into Versicor in a stock-for-stock exchange valued at US dollars 260.7 million. The combined company temporarily kept the name Versicor until the new name, Vicuron Pharmaceuticals, was announced on 26 March 2003. In January 2003, Versicor announced that positive results from a phase II trial for anidulafungin IV treatment involving 120 patients in the US with invasive candidiasis/candidaemia, have led to another double-blind, randomised phase III trial being conducted in the US, Canada and Europe for this indication. This additional phase III trial will enrol approximately 300 patients to investigate the efficacy of IV anidulafungin (200 mg loading dose followed by 100 mg maintenance dose) versus IV fluconazole for 10 to 42 days. Vicuron Pharmaceuticals also plans to seek approval for invasive candidiasis/candidaemia in Europe and Canada in the second half of 2003.