Targanta Completes Enrollment in Phase 2 Oritavancin Infrequent Dosing Study

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Tue May 20, 2008 7:58am EDT

SIMPLIFI Examining Single- and Infrequent-Dosing Regimens in cSSSI
CAMBRIDGE, Mass.--(Business Wire)--
Targanta Therapeutics Corporation (Nasdaq: TARG) today announced
that enrollment has been completed in its Phase 2 trial investigating
the safety and efficacy of oritavancin at Single or Infrequent Doses
for the Treatment of Complicated Skin and Skin Structure Infections
(cSSSI), or SIMPLIFI. Oritavancin is Targanta's lead antibiotic
candidate targeting gram-positive infections.

   Mark Leuchtenberger, President and Chief Executive Officer of
Targanta, commented on the event: "We are very pleased to have
completed enrollment in SIMPLIFI on schedule and are looking forward
to locking the database and analyzing the results over the next few
months. We are optimistic that we will have data ready to submit to
one of the major infectious disease meetings this fall and will be
using these data to determine whether to pursue Phase 3 registration
trials for infrequent dosing of oritavancin in the treatment of
cSSSI."

   "As discussed previously," Mr. Leuchtenberger continued, "we
believe that, if demonstrated effective in pivotal, controlled trials
and subsequently approved by regulatory authorities, a less frequent
dosing regimen for oritavancin could be a major advantage to the
infectious disease community by providing flexible patient treatment
options and could also confer pharmacoeconomic benefits through
shorter hospital stays and reduced use of hospital resources."

   Targanta submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) in February 2008 seeking to
commercialize oritavancin for the treatment of cSSSI; the FDA has
accepted the NDA submission for standard review, establishing an
action date of December 8, 2008.

   About SIMPLIFI

   This Phase 2 study is an international, multi-center, randomized,
double-blind, controlled study in patients with cSSSI presumed or
proven to be caused by gram-positive pathogen(s). The study consisted
of three treatment arms in which patients received either:

   --  200 mg oritavancin delivered by intravenous (IV)
        administration daily for a minimum of 3 days and up to a
        maximum of 7 days (the dosing regimen used in the larger of
        the two completed Phase 3 studies of oritavancin in cSSSI and
        currently under review by U.S. regulatory authorities);

   --  A single dose of 1200 mg oritavancin IV; or

   --  A single dose of 800 mg oritavancin IV, with a further dose of
        400 mg IV on Day 5, if needed.

   As its primary endpoint, SIMPLIFI is measuring clinical response
(either cure or improvement versus failure) in clinically evaluable
patients. As a secondary endpoint, this study is examining safety data
in all intent-to-treat patients. Over 300 patients were enrolled in
the study.

   About Oritavancin

   Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic
candidate with potent bactericidal (killing) activity against a broad
spectrum of gram-positive bacteria. In its intravenous (IV)
formulation, the product candidate has been tested in over 2,100
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. Targanta submitted a New Drug Application
to the U.S. Food and Drug Administration in February 2008 seeking to
commercialize IV oritavancin for the treatment of cSSSI and believes
oritavancin's properties may give it distinct advantages in the
treatment of serious gram-positive skin infections, if approved.
Targanta is also developing an oral version of oritavancin for
possible treatment of Clostridium difficile-related conditions.

   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. regulatory approval, a program to
develop an oral version of oritavancin and a number of antibacterial
agents in pre-clinical development. The Company has operations in
Cambridge, MA, Indianapolis, IN, and Montreal, Quebec, 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 "may," "will," "expects,"
"projects," "anticipates," "estimates," "believes," "intends,"
"plans," "should," "seeks," and similar expressions. Such statements
include, the availability of the results of the SIMPLIFI trial for
submission to an infectious disease meeting in the fall of 2008; the
pursuit of Phase 3 registration trials for infrequent dosing of
oritavancin in the treatment of cSSSI; and the provision of flexible
treatment options and the achievement of pharmacoeconomic benefits
from shorter hospital stays and reduced use of hospital resources
resulting from a less frequent dosing regimen for oritavancin.
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, risks
related to delays in obtaining or a failure to obtain regulatory
approval for Targanta's product candidates; failure of any approved
product to achieve significant commercial acceptance in the medical
community or receive reimbursement by third-party payors; unfavorable
clinical trial results; competition from other pharmaceutical or
biotechnology companies; and those other risks 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.

Targanta Therapeutics Corporation
George Eldridge (investors), 617-577-9020 x212
Chief Financial Officer
or
Russo Partners LLC
Tony Russo (media), 212-845-4251
Chairman & CEO

Copyright Business Wire 2008
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