Targanta Announces Launch of Oral Oritavancin Development Program against C. Difficile Bacterial Infection
C. difficile are anaerobic, gram-positive, spore-forming bacteria that are a major cause of morbidity in the hospitalized elderly. C. difficile infection is associated with many conditions, the most significant of which are uncomplicated diarrhea and pseudomembranous colitis, or severe infection of the colon. Often, after normal gut flora are eradicated by the use of antibiotics, it is postulated that C. difficile spores refractory to current antimicrobial therapies persist, causing recurrent infections.
Nosocomial diarrhea is estimated to cost the U.S. healthcare system over $1.1 billion annually, primarily as a result of increased hospital stays. Currently only oral vancomycin is approved in the U.S. for the treatment of CDAD; the antibiotic metronidazole is also commonly used to treat the disease. Despite these therapeutic options, up to 20% of patients treated experience relapse or recurrent infections.
Data were presented over the weekend at ECCMID comparing the efficacy of oritavancin and vancomycin in the treatment of C. difficile infection in a human gut model. Consistent with results from two previously conducted studies presented last fall, researchers found that, while both oritavancin and vancomycin were effective in treating clindamycin-induced C. difficile infection in the model, only oritavancin appeared active against the spore forms of the bacteria, suggesting that oritavancin may prevent recurrence of disease.
In its IV formulation, oritavancin is currently awaiting U.S. regulatory approval for the treatment of complicated skin and skin structure infections, or cSSSI, caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, or MRSA. Targanta expects to begin Phase 1 testing of oral oritavancin in early 2009.
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 IV oritavancin for the treatment of cSSSI and believes oritavancin's properties may give it distinct advantages in the treatment of patients with 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," "hope" and similar expressions. Such statements include, the development of an oral formulation of oritavancin for the treatment of C. difficile, the receipt of U.S. regulatory approval for IV oritavancin, and the commencement of Phase 1 testing of oral oritavancin in early 2009. 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 Targanta's dependence on the success of oritavancin; 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; failure to maintain and protect Targanta's intellectual property assets and to avoid infringing the intellectual property rights of others; competition from other pharmaceutical or biotechnology companies; 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 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
Russo Partners LLC
Tony Russo (media), 212-845-4251
Chairman & CEO
Posted: April 2008