Targanta Therapeutics Corp (MM) (NASDAQ:TARG)
Historical Stock Chart
From Jul 2019 to Jul 2024
![Click Here for more Targanta Therapeutics Corp (MM) Charts. Click Here for more Targanta Therapeutics Corp (MM) Charts.](/p.php?pid=staticchart&s=N%5ETARG&p=8&t=15)
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.