Gilead’s Single Pill Hepatitis C Study Targets 2014 Approval
Gilead Sciences Inc. (GILD) said it plans to start a combination study of two drugs in a single pill to treat hepatitis C by the end of the year, putting it on track to request U.S. regulatory approval for the medicine in 2014.
Gilead, which spent $10.8 billion to acquire one of the medicines, GS-7977, plans to combine it with another, GS-5855, in a trial of 800 patients starting in the fourth-quarter, said Norbert Bischofberger, chief medical officer of the Foster City, California-based company, in a conference call yesterday. If the combination is effective, the company could apply for regulatory approval in the middle of 2014, Bischofberger said.
Gilead is among several drugmakers racing to develop new hepatitis C treatments that act more quickly with fewer side effects than the current standard of care. The goal is to provide doctors and patients with simpler, more effective treatments, Bischofberger said.
The company aims for a therapy that “will clearly be a one pill, once daily, maybe a 12 week course,” for patients with all different types of hepatitis C, Bischofberger said. “That’s our goal. We are very close.”
Conventional therapy combines ribavirin with interferon, an injected immune-boosting protein that can cause flu-like side effects, for as long as 48 weeks.
Gilead is competing with Abbott Laboratories, Bristol-Myers Squibb Co., Johnson & Johnson, Merck & Co. and Vertex Pharmaceuticals Inc. (VRTX) to develop a new generation of hepatitis C treatments. Rising deaths among baby boomers from hepatitis C prompted U.S. health officials to declare in May that the entire age group is at risk and should be tested for the disease.
Another study of GS-7977, given with ribavirin, found nine of nine patients who were previously untreated had a sustained response to the drug, with no signs of virus in their bodies after finishing the therapy. A second study, however, found just 53 percent of patients had a similar benefit, a difference the company is still trying to figure out, Bischofberger said.
Gilead, the world’s biggest maker of AIDS drugs, yesterday reported net income fell 4.6 percent in the second quarter to $711.6 million, or 91 cents a share, from $746 million, or 93 cents, a year earlier. Earnings, excluding one-time items, of 99 cents a share beat the 95 cents a share average of 25 analyst estimates compiled by Bloomberg. Revenue jumped 13 percent to $2.41 billion, the company said in a statement yesterday.
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