TARG Targanta Therapeutics Corp (MM)

Targanta Therapeutics Corporation (Nasdaq: TARG) today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorization Application (MAA) for oritavancin, Targanta�s novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. Targanta is seeking approval of intravenous oritavancin in the European Union for the treatment of complicated skin and soft tissue infections (cSSTI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Targanta announced the submission of its MAA for oritavancin to EMEA on June 9, 2008. �With the acceptance for review of our United States regulatory filing for oritavancin earlier this year, closely followed by this EMEA acceptance for review, we are proud to have achieved these planned operational milestones and we are now in the position of planning for the commercial launch of oritavancin in the U.S. and European markets," said Mark Leuchtenberger, President and CEO of Targanta. �If regulatory discussions progress as anticipated and approval is received, we expect to launch oritavancin in the U.S. in the first half of 2009. Given the standard regulatory review times in the EU, we hope to receive approval for oritavancin in late 2009.� Mona Haynes, Targanta�s Chief Commercial Officer, commented further on the need for new agents in the EU: �As in the U.S., serious gram-positive infections are increasing and provide challenges to healthcare professionals. We are excited at the possibility of bringing clinicians another option to use in patients with these difficult-to-treat infections.� The oritavancin MAA includes data from 19 clinical trials, including two pivotal Phase 3 clinical trials examining the safety and efficacy of intravenous oritavancin in the treatment of cSSTI (known in the U.S. as complicated skin and skin structure infections, or cSSSI), both of which met their primary endpoints. The MAA 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. 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 2,400 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 (NDA) to the U.S. Food and Drug Administration (FDA) in February 2008 seeking to commercialize oritavancin for the treatment of cSSSI; the FDA accepted the NDA submission for standard review, establishing an action date of December 8, 2008. Targanta�s Marketing Authorization Application (MAA) for oritavancin was accepted for review by the European Medicines Agency (EMEA) in June 2008. 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. and EU 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, 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 �may,� "will," "expects," "projects," "anticipates," "estimates," "believes," "intends," "plans," "should," "seeks," and similar expressions. Such statements include the regulatory approvals of oritavancin for the treatment of cSSTI/cSSSI, the expected launch of oritavancin in the U.S. in the first half of 2009, the possibility of oritavancin being another option for clinicians to use in patients with difficult-to-treat infections, and the development of an oral version of 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.