Targanta Announces Review of Oritavancin at FDA Anti-Infective Drugs Advisory Committee Meeting
October 14 2008 - 3:12PM
Business Wire
Targanta Therapeutics Corporation (Nasdaq: TARG) announced today
that the U.S. Food and Drug Administration's (FDA) Anti-Infective
Drugs Advisory Committee will review the Company�s New Drug
Application (NDA) for oritavancin on November 19, 2008. Targanta
submitted the NDA in February to obtain approval 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. The
submission includes data from 19 clinical trials, including two
pivotal Phase 3 clinical trials that examined the safety and
efficacy of intravenous oritavancin for the treatment of cSSSI,
both of which met their primary endpoints. The NDA dossier also
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. The FDA�s action
date for the oritavancin NDA is December 8, 2008. The
Anti-Infective Drugs Advisory Committee plans to meet on November
18, 2008 to discuss justification of the non-inferiority margin for
cSSSI. Targanta, as well as other companies, has been asked to
present before the panel on this topic. About Oritavancin
Oritavancin is a novel, semi-synthetic lipoglycopeptide antibiotic
candidate with potent bactericidal (killing) activity against a
broad spectrum of gram-positive bacteria. These types of
gram-positive antibiotic-resistant infections have created a market
that IMS Health estimated to be more than $1 billion in the U.S. in
2007 and growing rapidly. MRSA infections have become an
increasingly serious problem both in the hospital and in the
community. According to the Centers for Disease Control and
Prevention, there are over 126,000 hospitalized persons infected
with MRSA annually. More than $2.5 billion in healthcare costs can
be attributed to MRSA infections.1 About Targanta Therapeutics
Targanta Therapeutics Corporation 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. The Company has operations in
Cambridge, MA; Indianapolis IN; and Montreal, Quebec, Canada. For
more information about Targanta, visit www.targanta.com. 1
CreditSuisse, Hospital-Associated Infections, pg. 18, January 18,
2008. 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. Such statements
include the approval of oritavancin for the treatment of cSSSI
caused by gram-positive organisms. 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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