Pharmasset off after stopping clevudine trials
Pharmasset Inc. (NASDAQ:VRUS) fell $0.92 (10%) to $8.33 on Monday after ending two Phase III trials of clevudine to treat HBV infection following serious adverse events among those using the drug in South Korea, where it is marketed as Levovir. Pharmasset said the reports of myopathy, or muscle weakness associated with creatine kinase elevations, are more serious than the small number of mild to moderate myopathy cases reported in the double-blind QUASH studies; however, the Korean patients have had longer exposures to the agent than those in the QUASH trials. Given the number and severity of cases seen in Korea, the company said it was best to stop the trials.
The company has rights to clevudine in the Americas, Europe and several other territories from Bukwang Pharmaceutical Co. Ltd. (Seoul, South Korea), which markets the oral pyrimidine nucleoside analog in Korea. Pharmasset said Bukwang has not given any indication about its plans for the product. ...