Dalbavancin new drug application dalbavancin
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Vicuron Pharmaceuticals Submits New Drug
Application for Dalbavancin to U.S. Food and Drug
Once-Weekly Antibiotic Designed to Treat Growing Problem of Hospital Staph Infections
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
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
Recent Drug Searches 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
"Given the promising benefits shown by this product, we believe dalbavancin represents an important achievement
for both Vicuron and the hospital antibiotic category,"
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.
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