Thursday, November 20, 2008

FDA rejects efficacy of Targanta’s antibiotic

By Mass High Tech Staff

The committee that advises the U.S. Food and Drug Administration on antibiotics approval has doubts about the efficacy of a new drug from local biotech company Targanta Therapeutics Corp.

Cambridge-based Targanta (Nasdaq: TARG) specializes in making antibiotics to treat infections incurred in hospitals and other institutions. The drug in question is oritavancin, which is designed to heal complicated skin and skin structure infections (cSSSI). These infections are caused by gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).

On Wednesday, the FDA Anti-Infective Drugs Advisory Committee voted several times on the issue of whether the clinical studies on oritavancin proved it was effective as an antibiotic. On the third and final vote, the committee voted 10-to-eight that the trial data hadn’t demonstrated the safety and effectiveness of the drug.

In a press release, Targanta noted that the committee’s recommendations aren’t binding. Nevertheless the FDA will use its guidance when it reviews the New Drug Application (NDA) Targanta submitted for oritavancin in February 2008. The target Prescription Drug User Fee Act (PDUFA) date for oritavancin is Dec. 8, 2008.

The company was disappointed by the committee’s recommendations, noted Targanta president and CEO Mark Leuchtenberger, in a statement. Nevertheless, the company stood by its claims that oritavancin’s safety profile to-date and “unique pharmacokinetic profile” were proof of its efficacy. The company planned to continue its discussion with the FDA, he stated.

On Nov. 12, Targanta reported a net loss of $12.7 million for the third quarter. It reported a 2007 net loss of $63.4 million, with no revenue.