Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections
February 24 2005 - 1:00AM
PR Newswire (US)
Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA
by FDA in Complicated Skin and Soft Tissue Infections Also Receives
Acceptance to File Notification KING OF PRUSSIA, Penn., Feb. 24
/PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq:
MICU; Nuovo Mercato) announced today that the company has received
the acceptance to file notification and been granted Priority
Review status by the U.S. Food and Drug Administration (FDA) for
the New Drug Application (NDA) for its investigational agent
dalbavancin, a novel once-weekly antibiotic for the treatment of
complicated skin and soft tissue infections (cSSTIs) including the
most difficult to treat strain of staphylococcus,
methicillin-resistant staphylococcus aureus (MRSA). The FDA grants
Priority designation to products which, if approved, would be a
significant improvement in the treatment of a disease. "We are very
pleased with this regulatory development which we believe further
demonstrates the serious underserved medical need that dalbavancin
has the potential to address," said George F. Horner III, President
and CEO of Vicuron. "We expect to commercialize dalbavancin by the
first quarter of 2006 pending FDA approval." Dalbavancin is a novel
second-generation lipoglycopeptide agent that belongs to the same
class as vancomycin. Vancomycin is one of the few treatments
available to hospital patients infected with difficult-to-treat
strains of Staphylococcus bacteria, or Staph known as MRSA
(methicillin-resistant Staphylococcus aureus) and MRSE
(methicillin-resistant Staphylococcus epidermidis). Dalbavancin has
been specifically designed as an improved alternative to
vancomycin. The NDA, which was submitted in December of last year,
includes results from more than 1,850 subjects and three Phase 3
trials that evaluated the safety and efficacy of dalbavancin in
patients with SSTIs caused by Gram-positive bacteria. The Phase 3
clinical trials each met the primary and secondary endpoints of
non-inferiority when compared to linezolid, cefazolin or
vancomycin, three currently used agents for SSTIs. The most common
pathogen isolated in these studies was S. aureus, with more than
400 patients infected with MRSA. In vitro studies have shown that
in addition to being potent against clinically important
Gram-positive bacteria, dalbavancin 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
convenient dosing regimens than vancomycin. In preclinical studies,
dalbavancin appears to be one of the most potent antibiotics
against MRSA, including multiply drug-resistant S. aureus and
certain other Gram-positive bacteria. 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 collaborations with leading
pharmaceutical companies, such as Novartis and Pfizer.
Forward-Looking Statements This news release contains
forward-looking statements that predict or describe future events
or trends. The matters described in these forward- looking
statements are subject to known and unknown risks, uncertainties
and other unpredictable factors, many of which are beyond Vicuron's
control. Vicuron faces many risks that could cause its actual
performance to differ materially from the results predicted by its
forward-looking statements, including the possibilities that
clinical trials and the results thereof might be delayed or
unsuccessful, that the timing of the filing of any new drug
application or any amendment to a new drug application might be
delayed, that clinical trials might indicate that a product
candidate is unsafe or ineffective, that the FDA might require
additional information to be submitted and additional actions to be
taken before it will make any decision, that any filed new drug
application may not be approved by the FDA, that ongoing
proprietary and collaborative research might not occur or yield
useful results, that the pipeline may not yield a new clinical
candidate or a commercial product, that a third party may not be
willing to license product candidates on terms acceptable to it or
at all, that competitors might develop superior substitutes for
Vicuron's products or market these competitive products more
effectively, that a sales force may not be developed as
contemplated and that one or more of Vicuron's product candidates
may not be commercialized successfully. The reports that Vicuron
files with the U.S. Securities and Exchange Commission contain a
fuller description of these and many other risks to which Vicuron
is subject. Because of those risks, Vicuron's actual results,
performance or achievements may differ materially from the results,
performance or achievements contemplated by its forward- looking
statements. The information set forth in this news release
represents management's current expectations and intentions.
Vicuron assumes no responsibility to issue updates to the
forward-looking matters discussed in this news release. DATASOURCE:
Vicuron Pharmaceuticals Inc. CONTACT: Dov A. Goldstein, M.D., of
Vicuron Pharmaceuticals Inc., +1-610-205-2312, or ; or E. Blair
Schoeb of WeissComm Partners, +1-212-923-6737, or , or Aline
Schimmel of Burns McClellan Inc., +1-212-213-0006, or , both for
Vicuron Pharmaceuticals Inc. Web site: http://www.vicuron.com/
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