Targanta Announces Posting of Briefing Documents for Review of FDA Anti-Infective Drugs Advisory Committee Meeting for Oritav...
November 17 2008 - 12:29PM
Business Wire
Targanta Therapeutics Corporation (Nasdaq: TARG) announced today
that the U.S. Food and Drug Administration (FDA) has posted on its
website briefing documents for the November 19, 2008 Anti-Infective
Drugs Advisory Committee (AIDAC) meeting. AIDAC will review
Targanta�s New Drug Application (NDA) for oritavancin for the
treatment of complicated skin and skin structure infection (cSSSI)
caused by gram-positive organisms, including methicillin-resistant
Staphylococcus aureus, or MRSA. Briefing documents from FDA and
Targanta can be found on FDA�s website at
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4394b2-00-Index-FDA.htm.
About Oritavancin Oritavancin is a novel semi-synthetic
lipoglycopeptide antibiotic candidate with potent bactericidal
(killing) activity against a broad spectrum of gram-positive
bacteria, including methicillin-resistant Staphylococcus aureus, or
MRSA. These types of resistant infections have created a market
that IMS Health estimated to be over one billion dollars in the
U.S. in 2007 and growing rapidly. In its intravenous (IV)
formulation, the product candidate has been tested in over 1,900
individuals and has completed two Phase 3 studies for the treatment
of complicated skin and skin structure infections (cSSSI) in which
the primary endpoints were met. The NDA dossier includes data from
more than 2,100 individuals and in vitro activity data on
oritavancin against more than 9,000 clinical bacterial isolates,
including a broad range of gram-positive strains resistant to
commonly used antibiotics such as oxacillin, methicillin,
vancomycin, daptomycin, and linezolid. FDA�s action date for the
oritavancin NDA is December 8, 2008. About Targanta Therapeutics
Targanta Therapeutics Corporation (Nasdaq: TARG) is a
biopharmaceutical company focused on developing and commercializing
innovative antibiotics to treat serious infections in the hospital
and other institutional settings. The Company�s pipeline includes
an intravenous version of oritavancin, a semi-synthetic
lipoglycopeptide antibiotic currently awaiting U.S. and EU
regulatory approval and a program to develop an oral version of
oritavancin for the possible treatment of Clostridium difficile
infection. The Company has operations in Cambridge, MA,
Indianapolis, IN, and Montreal, Qu�bec, Canada. For more
information on Targanta, visit www.targanta.com. Safe Harbor
Statement This press release contains �forward-looking statements�
that are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These are statements that
are predictive in nature, that depend upon or refer to future
events or conditions or that include words such as �potential,�
�may,� "will," "expects," "projects," "anticipates," "estimates,"
"believes," "intends," "plans," "should," "seeks," �hope� and
similar expressions. Forward-looking statements involve known and
unknown risks and uncertainties that may cause actual future
results to differ materially from those projected or contemplated
in the forward-looking statements. Forward-looking statements may
be significantly impacted by certain risks and uncertainties
described in Targanta�s filings with the Securities and Exchange
Commission. The risks and uncertainties referred to above include,
but are not limited to, delays in obtaining or a failure to obtain
regulatory approval for Targanta�s product candidates; unfavorable
clinical trial results; Targanta�s potential inability to initiate
and complete pre-clinical studies and clinical trials for its
product candidates; the possibility that results of pre-clinical
studies are not necessarily predictive of clinical trial results;
and those other risk factors that are described more fully in the
Company�s filings with the Securities and Exchange Commission.
Targanta does not undertake any obligation to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release.
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