Gilead Sciences Inc. is moving its experimental drug combination against hepatitis C into a late-stage trial after it cured 95 percent of patients who used the medicine for eight weeks.
The virus was undetectable in the blood of 19 of 20 patients who hadn’t received prior therapy eight weeks after finishing treatment with Gilead’s sofosbuvir and ledipasvir, the Foster City, California-based company said today in a statement. The length of the treatment is important because previously, the company had been focusing on 12-week course, said Mark Schoenebaum, a New York-based analyst at International Strategy & Investment Group LLC.
Gilead is competing with drugmakers including AbbVie Inc. and Bristol-Myers Squibb Co. in the quest for hepatitis C regimens that don’t involve injections of interferon, which can cause flu-like symptoms and depression. Hepatitis C affects about 150 million people worldwide and the market for new pills is estimated at $20 billion.
“Treatment for only 8 weeks with Gilead’s regimen is possible. This is new!” Schoenebaum wrote today in a note. “This data greatly strengthens Gilead’s position in the hepatitis C market with an all oral once daily pill.”
In March, Schoenebaum estimated Gilead’s sales from its hepatitis C treatments may reach $6.5 billion in the U.S. alone in 2014 or 2015 after it wins regulatory clearance.
Gilead said it is moving the drugs into a third of three stages of clinical trials typically required for U.S. regulatory approval.
The interim results released today from a mid-stage study called Lonestar show Gilead’s combination works well without ribavirin, an antiviral that is paired with interferon for as long as a year as part of the current standard treatment. It also gives the company “a clear advantage versus potential competitors like AbbVie and Bristol-Myers,” Bret Holley, an analyst with Guggenheim Partners, wrote in a research note.
Gilead gained 4.1 percent to $52.18 at the close in New York. The shares have doubled in the past 12 months.