Eraxis
anidulafungin
Treatment for CandidemiaVicuron Pharmaceuticals Receives Approvable Letter from FDA for Anidulafungin for the Treatment of Esophageal Candidiasis Requesting Additional Data
KING OF PRUSSIA, Penn., May 24, 2004 -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA). However, the letter indicated that the company's NDA submission for anidulafungin does not currently support a labeling claim for the initial treatment of esophageal candidiasis.
In the letter, the FDA indicated that Vicuron could potentially achieve approval for anidulafungin upon the completion of Vicuron's ongoing Phase III clinical trial for the treatment of invasive candidiasis/candidemia or the completion of further clinical work in patients with candidal disease refractory to other treatments.
"We intend to meet with the FDA to discuss all of our options with respect to the approval of anidulafungin as soon as possible, and intend to complete the Phase III trial in invasive candidiasis/candidemia by the end of this year," said George F. Horner III, President and CEO of Vicuron. "We also will take appropriate management action to reduce the expenses of the company in light of this delay."
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 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 I
study when given in combination with cyclosporine, a leading
chronic immunosuppressive drug.
About Vicuron
Vicuron Pharmaceuticals is a biopharmaceutical company focused on
discovering, developing, manufacturing and commercializing vital
medicine for seriously ill patients in North America and major
countries in Europe. The company received an approvable letter for
its lead product anidulafungin in May 2004. 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.
For further information, please visit www.vicuron.com
Related Articles:
Eraxis - Pfizer Inc - Treatment for Candidemia - February 17, 2006
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 Provides Update on Anidulafungin Regulatory Paths - September 21, 2004
Vicuron Pharmaceuticals Announces 90-Day Extension of FDA Review of Anidulafungin New Drug Application - January 22, 2004
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