UPDATE 2-U.S. FDA OKs Salix drug for liver failure disorder
Wed Mar 24, 2010 7:04pm EDT
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Salix Pharmaceuticals Ltd
SLXP.O
$33.52
-0.01-0.03%
2:00pm CDT
* Drug to be launched by end of May
* Shares rise nearly 7 percent (Adds background)
LOS ANGELES, March 24 (Reuters) - U.S. regulators on Wednesday approved the use of Salix Pharmaceuticals Ltd's (SLXP.O) Xifaxan antibiotic as a treatment for reducing the risk of a debilitating liver disorder in adults.
The company's shares rose about 7 percent.
The Food and Drug Administration approved the drug for reducing the risk of recurrent hepatic encephalopathy, a disorder caused by chronic liver failure that can cause confusion, memory problems or coma.
About 50,000 people in the United States are hospitalized each year for the condition, where a poorly functioning liver allows bacteria-produced poisons such as ammonia to accumulate in the gut and affect the nervous system. It strikes up to 45 percent of people with cirrhosis.
Salix said there are an estimated 200,000 patients in the United States who suffer from episodic overt HE.
Piper Jaffray has estimated annual sales of Xifaxan for treating recurrent HE at $400 million to $500 million.
Xifaxan, known generically as rifaximin, is already approved by the FDA for so-called travelers' diarrhea caused by certain strains of E. coli bacteria. Sales of the drug last year totaled $118 million.
The company expects 550 mg tablets of the drug to be available by the end of May.
A pivotal trial of Xifaxan, published in the latest issue of the New England Journal of Medicine, showed that it cut the risk of recurrent hepatic encephalopathy by 58 percent. The article also said the drug reduced the risk of hospitalization.
The U.S. Food and Drug Administration previously granted orphan status to Xifaxan for treating HE. The designation comes with a seven-year marketing exclusivity period.
Other antibiotics used to treat HE are not recommended for prolonged treatment -- even though they can also reduce the number of ammonia-producing bacteria in the gut -- because of possible side effects. Xifaxan tends to stay in the intestine and not be absorbed by the body.
Salix shares, which closed at $33.52 on Nasdaq, were higher at $35.76 in after hours trading. (Reporting by Deena Beasley; editing by Andre Grenon, Gary Hill)
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