Dalbavancin
Treatment for Skin and Structure InfectionVicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration
Once-Weekly Antibiotic Designed to Treat Growing Problem of Hospital Staph Infections
KING OF PRUSSIA, Pa., December 21, 2004 -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for dalbavancin, a novel antibiotic for the treatment of complicated skin and soft tissue infections (cSSTIs). Dalbavancin is a unique, once weekly IV lipoglycopeptide for the treatment of cSSTIs caused by Gram-positive bacteria, including the most difficult-to-treat strains of Staphylococcus-methicillin-resistant Staphylococcus aureus (MRSA).
"This is a major milestone for us as we move closer to bringing this promising antibiotic to the market," said George F. Horner III, President and CEO of Vicuron. "With the increase of infections caused by Gram-positive bacteria in the hospital, we believe dalbavancin will offer a potent alternative to older agents such as vancomycin. In addition, two doses of dalbavancin in complicated skin infections in place of other antibiotics requiring up to 28 doses, can potentially change the course of treatment for this serious disease."
The NDA includes results from more than 1,850 subjects and three Phase 3 trials which evaluated the safety and efficacy of dalbavancin in patients with SSTIs caused by Gram-positive bacteria. The Phase 3 clinical trials also met the primary and secondary endpoints of non-inferiority when compared to linezolid, cefazolin or vancomycin -- three commonly used standard-of-care agents for SSTIs. The vast majority of the patients treated in these studies had SSTIs caused by Staph aureus bacteria, with more than 400 patients infected with methicillin-resistant Staph aureus (MRSA), one of the most difficult-to-treat strains of bacteria.
"Given the promising benefits shown by this product, we believe dalbavancin represents an important achievement for both Vicuron and the hospital antibiotic category," added Mr. Horner.
About Dalbavancin
Dalbavancin, a novel second-generation lipoglycopeptide agent,
belongs to the same class as vancomycin, the most widely-used and
one of the few treatments available to patients infected with the
most difficult-to- treat strains of Staphylococcus (Staph.): MRSA
(methicillin-resistant Staphylococcus aureus) and MRSE
(methicillin-resistant Staphylococcus epidermidis). Dalbavancin has
been specifically designed as an improved alternative to
vancomycin. In vitro studies have shown that in addition to being
potent against clinically important Gram-positive bacteria, it is
bactericidal (i.e., kills bacteria rather than merely inhibiting
their growth). The potency, tissue penetration and half-life of
dalbavancin may allow for more flexible and convenient dosing
regimens than vancomycin. In preclinical and clinical studies to
date, dalbavancin appears to be one of the most potent antibiotics
in its class against MRSA and MRSE.
About Vicuron Pharmaceuticals
Vicuron Pharmaceuticals is a biopharmaceutical company focused on
discovering, developing, manufacturing and commercializing vital
medicine for seriously ill patients. The company has two New Drug
Applications pending with the U.S. Food and Drug Administration for
its lead products, dalbavancin, a novel intravenous antibiotic for
the treatment of serious Gram-positive infections, and
anidulafungin, a novel antifungal agent. Vicuron'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 Novartis and
Pfizer.
Related Articles:
Pfizer Receives Approvable Letter from FDA for Dalbavancin - December 21, 2007
Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office - June 2, 2005
Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application - May 11, 2005
Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections - February 24, 2005
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