Targanta Therapeutics Corporation (Nasdaq: TARG) announced today that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for its lead candidate, oritavancin, a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. The MAA seeks approval of oritavancin for the treatment of complicated skin and soft tissue infections (cSSTI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
As in TargantaÂ™s United States regulatory filing, the oritavancin MAA includes data from 19 clinical trials, including two pivotal Phase 3 clinical trials examining the safety and efficacy of 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.
Following our submission for U.S. approval of oritavancin in February, we are very pleased to have achieved yet another projected and significant milestone for Targanta with this European submission, said Mark Leuchtenberger, President and Chief Executive Officer of Targanta. Data from the European Antimicrobial Resistance Surveillance System (EARSS) indicate that the prevalence of MRSA, while different across countries, has been rising across Europe over the past decade. As such, we look forward to working with the EMEA to make oritavancin available throughout the European Union for the treatment of cSSTI in a timely manner.
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 (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 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 CompanyÂ™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, QuÂ©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 approval of oritavancin for the treatment of cSSTI/cSSSI, the available of oritavancin throughout the European Union, 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 TargantaÂ™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 TargantaÂ™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 CompanyÂ™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
Susan Hager, 617-577-9020 x217
Vice President, Investor Relations and
Russo Partners LLC
Tony Russo, 212-845-4251
Chairman & CEO