Targanta Files for FDA Approval of Anti-MRSA Drug

2/11/08

Shares of Targanta Therapeutics (NASDAQ: TARG) got a small boost today on the news that the Cambridge, MA-based firm has submitted an application to the FDA for approval of its antibiotic oritavancin for the treatment of complicated skin infections caused by the “superbug” MRSA and other gram-positive bacteria. The stock opened at $9.08, up from yesterday’s close of $8.83, and climbed as high as 9.40 before closing the day at $9.00.

The FDA submission incorporates data from more than 2,100 people in 19 clinical trials, according to the announcement, and includes Phase 3 data showing that the antibiotic is effective in just three to seven days. The submission marks an important step toward the company’s goal of winning approval for oritavancin, which was originally developed by Eli Lilly back in the 1990s, by year’s end. Targanta is pursuing additional indications for the drug, and is also developing antibiotics for treating bone infections.

Targanta has gotten a rather chilly reception from the market. The company debuted in October at $10 per share, well below its target price range of $12 to $14, and has spent most of the subsequent months hovering between $9 and $9.50. Should Targanta pull off the approval of oritavancin—which would compete with vancomycin and Lexington, MA-based Cubist Pharmaceuticals’ Cubicin in the increasingly hot market for treating MSRA and other complicated skin infections—the climate around the company could get decidedly warmer.

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