Nov 18, 2014, 10:52am PST
John Martin of Gilead
Tony Avelar
John Martin of Gilead
Ron LeutyReporter-
San Francisco Business Times
Gilead Sciences Inc.'s next-generation hepatitis C drug won European approval Tuesday, opening the door for the drug to be sold in 28 countries.
Pricing of Harvoni, which has raised eyebrows at $95,000 in the United States, is a little more complex since the Foster City-based company (NASDAQ: GILD) must negotiate with individual countries.
Still, Wall Street viewed the approval by the European Commission positively, pushing the stock nearly 3 percent higher to $103.33 per share in mid-day trading, compared to Monday's close. The stock had fallen more than 10 percent this month, through Monday, due to concerns about insurers paying the hefty price.
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Harvoni — the first once-daily tablet targeting chronic hepatitis C — was approved last month by the Food and Drug Administration. It combines the drug ledipasvir with Sovaldi, Gilead's first-generation hepatitis C drug that was approved in the United States in December 2013 and in Europe in January 2014.
Gilead Chairman and CEO John Martin and other company executives have argued that three to four months of Harvoni and Sovaldi are valuable because they steer hepatitis C patients away from 48 weeks of injections of interferon and ribavirin, two drugs whose side effects are blamed for patients discontinuing therapy.
Chronic hepatitis C can lead to liver cancer and transplants, and Gilead officials have said that the high, short-term prices of Harvoni and Sovaldi in the United States are less than the longer-term prices of liver cancer drugs and transplantation.
European approval of Harvoni in hepatitis C patients with genotype 1 — the most prevalent form of the disease in Europe — and genotype 4 comes a week after Gilead said Harvoni had cure rates of 96 percent to 97 percent in a study of patients who had cirrhosis and hadn't benefitted from previous treatments.
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