NEW YORK (AP) — Shares of Pharmasset Inc. climbed Tuesday after the company said it is starting late-stage clinical trials of an experimental hepatitis C drug.
THE SPARK: The Princeton, N.J., company, is planning a 12-week study that treats hepatitis C with a combination of its experimental drug called PSI-7977 and ribavirin. Both drugs are given orally, and the regimen does not include the intravenous drug interferon. The company said it will enroll 500 patients with all types of hepatitis C. Some will get PSI-7977 and ribavirin, and the others will get the standard treatment for hepatitis C, a combination of ribavirin pills and intravenous interferon.
Pharmasset expects to start enrolling patients before the end of 2011. The company said it will start two other late-stage trials in 2012 and hopes to file for marketing approval of PSI-7977 in the U.S. and European Union in the second half of 2013.
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THE BIG PICTURE: Pharmasset's regimen could become a preferred option for hepatitis C if studies show it works as well as drug cocktails containing interferon. Dosing the drug would be more convenient and it could have fewer side effects because it does not include interferon.
In early 2012, Pharmasset will start a trial involving 225 patients who have type 2 or 3 hepatitis C and who cannot safely take interferon. In the middle of the year, it will start a third trial on patients with any genotype who cannot take interferon.
Hepatitis C is a viral infection that often has no symptoms but which can lead to life-threatening liver damage.
THE ANALYSIS: Citi Investment Research analyst Yaron Werber said patients who have cirrhosis of the liver or are on antidepressant medications can't take interferon, and some others cannot tolerate the side effects of the drug. He said an interferon-free regimen would simplify treatment for hepatitis C because it would be less expensive and patients would require less monitoring.
SHARE ACTION: Pharmasset stock rose $7.04, or 10 percent, to $77.44 in afternoon trading. In the past year, Pharmasset shares have more than tripled in value. The stock is up 30 percent since June 8, when the company said it was expanding a study of PSI-7977, seen as a strong indication that the drug is working.
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