The Company is developing its lead antibiotic, oritavancin, in an intravenous (IV) formulation for the treatment of serious gram-positive bacterial infections, including complicated skin and skin structure infections, or cSSSI, and bacteremia, a blood stream infection. 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; In December 2008, FDA issued a Complete Response Letter to Targanta. In the Letter, FDA indicated that they will require Targanta to perform an additional clinical study to demonstrate efficacy and safety of oritavancin for the treatment of cSSSI in order to gain approval. Additionally, 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 targeting Clostridium difficile-associated diseases.
The Company has operations in Cambridge, MA, Indianapolis, IN, and Montreal, Québec, Canada.
Discussion of the FDA's Decision on Oritavancin for the Treatment of cSSSI To access the webcast of Targanta's presentation click HERE.
Discussion of FDA Advisory Committee's Opinion on Oritavancin for the Treatment of cSSSI To access the webcast of Targanta's presentation click HERE.
Rodman & Renshaw Annual Global Investment Conference To access the webcast of Targanta's presentation at the Conference on November 11, 2008 click HERE.
Lazard Capital Markets 5th Annual Healthcare Conference
To access the webcast of Targanta's presentation at the Conference on November 18, 2008 click HERE.
Please click HERE to download the corporate Fact Sheet.
Analyst Coverage:
Credit Suisse
Michael Aberman, M.D.
212-325-3487
Cowen and Company
Ian Sanderson
617-946-3922
Merriman Curhan Ford & Co.
Edward H. Nash
646-292-1450
Lazard Capital Markets
Joel Sendek
212-632-1926
Leerink Swann
Howard Liang
617-918-4857
| Latest News February 25, 2009 THE MEDICINES COMPANY ANNOUNCES COMPLETION OF TENDER OFFER FOR SHARES OF TARGANTA THERAPEUTICS February 20, 2009 TARGANTA ENTERS INTO MEMORANDUM OF UNDERSTANDING TO RESOLVE SHAREHOLDER LAWSUIT |
| More News >> |
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