Targanta Announces Posting of Briefing Documents for Review of FDA Anti-Infective Drugs Advisory Committee Meeting for Oritavancin.
CAMBRIDGE, Mass. -- Targanta Therapeutics Corporation (Nasdaq: TARG TARG Tatra Area Research Group
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TARG Target Alternative Relevant Groups ) announced today that the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) 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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for oritavancin for the treatment of complicated skin and skin structure infection (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline, , or MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. .
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.
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal bactericidal /bac·te·ri·ci·dal/ (bak-ter?i-si´d'l) destructive to bacteria.
An agent that destroys bacteria (e.g. (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 in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.
In an artificial environment outside a living organism. 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 oxacillin /ox·a·cil·lin/ (ok?sah-sil´in) a semisynthetic penicillinase-resistant penicillin used as the sodium salt in infections due to penicillin-resistant, gram-positive organisms. , 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 Clostridium difficile A common cause of bacterial colitis; it is the causative agent in 99% of pseudomembranous colitis, and 20-30% of antibiotic-associated diarrhea infection. The Company has operations in Cambridge, MA, Indianapolis, IN, and Montreal, Quebec, Canada. For more information on Targanta, visit www.targanta.com.
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This press release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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.