Theravance Inc. (THRX:US)’s Vibativ, approved to combat complex skin infections, may carry a higher risk for patients with kidney problems or diabetes if it’s given added clearance for hospital-acquired pneumonia, U.S. regulators said.
One study of the antibiotic showed a “substantially higher risk for death” for those patients compared with an older antibiotic vancomycin, while another trial showed no difference, Food and Drug Administration staff said in a report today. An advisory panel will meet on the drug in two days. Vibativ is South San Francisco, California-based Theravance’s only marketed product in the U.S.
There are 300,000 cases of hospital-acquired pneumonia annually and the illness can lengthen hospital stays by as many as nine days, according to the Cleveland Clinic. Hospitalized patients are exposed to organisms that non-hospitalized patients aren’t and often are less able to fight infection.
Theravance rose 1.7 percent to $21.64 at the close in New York. The company has gained 8.1 percent in the past 12 months.
Theravance hasn’t released the date by which the FDA may decide whether to clear a wider use of Vibativ, first approved for infections including MRSA in September 2009. The company would like to reach a resolution in the first half of next year, Chief Executive Officer Rick Winningham said in a telephone interview.
The FDA rejected Vibativ, also known as telavancin, to treat hospital-acquired pneumonia in November 2009. The company won’t likely pursue the wider use again if it isn’t approved this time, Winningham said.
“We probably would not make a new investment,” he said.
The FDA released draft guidelines in 2010 that changed the criteria for clinical trials for antibiotic development for hospital-acquired pneumonia to measuring deaths instead of whether the drug cured patients. While Theravance didn’t redo its studies on Vibativ, the company reviewed the trials and collected mortality data to supplement their 2009 submission, Winningham said.
The FDA wouldn’t pool the mortality data because patients in one study had more risk factors for mortality, including kidney problems and diabetes, than patients in the other, the agency staff said. In one study, 26 percent of patients on Vibativ died compared to 20 percent on vancomycin, while 22 percent of patients on Vibativ died in the other study compared to 24 percent on vancomycin.
Vancomycin was approved in the 1960s, he said, and Pfizer Inc. (PFE:US)’s Zyvox to treat hospital-acquired pneumonia was cleared in 2000, according to the FDA’s website. Vancomycin has been used for so long, people are becoming immune, Winningham said.
While the company awaits the Vibativ decision, the respiratory projects being pursued with GlaxoSmithKline Plc (GSK) “really comprise all the value in the market with Theravance,” Winningham said.
He expects an advisory panel to meet in the first half of next year on one of the products, proposed to be called Breo, to treat chronic obstructive pulmonary disorder. The FDA is set to decide whether to approve the drug by May 12.
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