FDA Issues Complete Response Letter for Oritavancin
December 08 2008 - 10:52PM
Business Wire
Targanta Therapeutics Corporation (Nasdaq: TARG) announced today
that it has received a Complete Response Letter from the U.S. Food
and Drug Administration (FDA) regarding its New Drug Application
(NDA) for oritavancin for the treatment of complicated skin and
skin structure infections (cSSSI). The FDA indicated in its letter
that they cannot approve the application for oritavancin in its
current form and will require Targanta to perform an additional
well-controlled clinical study to demonstrate efficacy and safety
in order to gain approval. The FDA requested that a sufficient
number of patients with methicillin-resistant Staphylococcus aureus
(MRSA) as the cause of cSSSI be enrolled in the study to
demonstrate the effectiveness of oritavancin in this subset of
patients. The FDA further suggested that the clinical study
evaluate the effect of oritavancin on macrophage function and
monitor for the potential for subsequent infections that could
possibly be related to macrophage dysfunction due to the long
terminal half-life of oritavancin. The FDA also requested that the
clinical study collect additional information on phlebitis rates.
In its letter to Targanta, the FDA stated the Company�s NDA did not
demonstrate the safety and efficacy of oritavancin for treatment of
cSSSI. The FDA reasoned that ARRI, the second and larger of two
Phase 3 clinical studies which met a 10% non-inferiority margin,
provided evidence of activity of oritavancin but did not provide
substantial evidence alone or in combination with ARRD, the smaller
of two Phase 3 clinical studies, to support the efficacy and safety
of oritavancin. Regarding ARRD, the FDA determined that the study
did not provide sufficient evidence of activity because the 95%
confidence interval between oritavancin and vancomycin was not less
than 10%. FDA also mentioned that, in ARRI, oritavancin did not
appear to perform well in patients with MRSA and, in ARRD, the
number of patients with MRSA was insufficient to address the
performance of the drug candidate in treating these patients. The
FDA mentioned several safety findings from the two pivotal studies
for cSSSI including the higher rate of study discontinuations for
lack of efficacy among oritavancin-treated patients, the greater
number of oritavancin-treated patients who died or had a serious
adverse event of sepsis, septic shock and related events, and more
oritavancin-treated patients who experienced adverse events of
osteomyelitis and other sepsis. Oritavancin is a novel,
semi-synthetic lipoglycopeptide antibiotic candidate with potent
bactericidal (killing) activity against a broad spectrum of
gram-positive bacteria. The oritavancin NDA submission included
data from 19 clinical trials, including two pivotal Phase 3
clinical trials examining the safety and efficacy of oritavancin in
the treatment of cSSSI, both of which met their primary endpoints.
The NDA dossier also included 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.
CONFERENCE CALL & WEBCAST INFORMATION Targanta will host a
conference call and live audio webcast to discuss the complete
response letter for oritavancin. WHEN: December 9, 2008 at 8:30
a.m. ET LIVE DOMESTIC & CANADA CALL-IN: 877-407-9210LIVE
INTERNATIONAL CALL-IN: 201-689-8049 24-HOUR REPLAY DOMESTIC &
CANADA: 1-877-660-685324-HOUR REPLAY INTERNATIONAL:
1-201-612-7415REPLAY PASSCODES (BOTH REQUIRED FOR PLAYBACK):ACCOUNT
#: 286, CONFERENCE ID #: 305896 The call will also be webcast live,
listen only, via the internet at: www.targanta.com.Replay will be
available on Targanta�s website for 30 days. 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 EU regulatory
approval, and a program to develop an oral version of oritavancin
for the possible treatment of Clostridium difficile-related
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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