Gilead Wins FDA Approval for Big Hepatitis C Drug

Gilead Sciences can now start going to work on commercializing the drug it paid $11 billion to get a couple years ago.

The Foster City, CA-based biotech company (NASDAQ: GILD) said today it has gotten FDA clearance to start selling sofusbuvir (Sovaldi) as a new treatment in the U.S. for people with chronic hepatitis C infections.

The drug, a nucleotide polymerase inhibitor, has long been anticipated as one of the next big things for hepatitis C, because of its ability to cure most patients and eliminate—in many cases—the need for a standard combo therapy called interferon alpha that causes flu-like symptoms. Those flu-like symptoms are a big reason why many people choose not to seek treatment today. About 4 million people in the U.S. are thought to have chronic hepatitis C, meaning this represents a massive market opportunity for Gilead.

The drug, taken as a once-daily pill, will cost about $28,000 for a 28-day wholesale supply, Gilead said. In clinical trials, combinations containing sofusbevir showed an ability to completely wipe out the hepatitis C virus in between 50-90 percent of patients after 12 weeks, the company said.

Gilead paid $11 billion to acquire this compound, and other antiviral drug candidates, from Pharmasset in 2011. Although Gilead has competition coming from AbbVie and Enanta Pharmaceuticals, among others, many analysts see it as having the inside track in this quest to wipe out a persistent viral scourge that, left untreated or inadequately treated, leads to cirrhosis and liver cancer.

Gilead, the world’s largest maker of HIV medicines, has seen its stock soar all year long in anticipation of the new hepatitis C opportunity, sending its market valuation beyond $110 billion. The stock continued to climb modestly in after-hours trading after the announcement, to $74.20.

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