EraxisTreatment for Candidemia
Vicuron Pharmaceuticals Provides Update on Anidulafungin Regulatory Paths
KING OF PRUSSIA, Pa., September 21, 2004 -- 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:
- 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.
- 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."
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.
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.
Posted: September 2004
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- Vicuron Pharmaceuticals Files New Drug Application (NDA) for Anidulafungin for Treatment of Invasive Candidiasis/Candidemia - August 18, 2005
- Vicuron Pharmaceuticals Files Amendment to Anidulafungin New Drug Application (NDA) for Treatment of Esophageal Candidiasis - May 31, 2005
- Vicuron Pharmaceuticals Receives Approvable Letter from FDA for Anidulafungin for the Treatment of Esophageal Candidiasis Requesting Additional Data - May 24, 2004
- Vicuron Pharmaceuticals Announces 90-Day Extension of FDA Review of Anidulafungin New Drug Application - January 22, 2004