Vicuron Pharmaceuticals Inc. has filed a New Drug Application (NDA) with the US FDA for anidulafungin for the treatment of invasive candidiasis/candidemia, the most common hospital-acquired fungal infection. The NDA includes clinical data from a previously announced Phase 3 trial demonstrating superiority of anidulafungin versus fluconazole in invasive candidiasis/candidemia.
"We are pleased to have filed this NDA in the third quarter as planned," said George F. Horner, III, Vicuron's President and Chief Executive Officer.
Anidulafungin is a product candidate made through chemical modification of a naturally occurring molecule. 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 per cent of candida, including fluconazole-resistant strains.
The company has three NDAs submitted to the US Food and Drug Administration for its two lead products, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections, and anidulafungin, a novel antifungal agent.
The company recently announced that it was being acquired by Pfizer at a price of $29.10 per share in cash, for an aggregate equity purchase price of approximately $1.9 billion. Completion of this transaction is subject to regulatory approval, Vicuron shareholder's approval and other customary closing conditions, according to a company release.