Gilead-Medivir Hepatitis C Drug Clears Virus in Patients

Gilead-Medivir Hepatitis C Drug Clears Virus in Patients

By Ryan Flinn & Shannon Pettypiece

An automated machine works on purification of a potential hepatitis C virus drug candidate at the Gilead Sciences Inc. lab in Foster City,

California. Photographer: David Paul Morris/Bloomberg

An experimental drug combination from Gilead Sciences Inc. (GILD), Medivir AB (MVIRB) and Johnson & Johnson (JNJ) eradicated the virus that causes hepatitis C in patients with the liver disease in a study.

The trial’s 80 patients, who had tried and failed other medications, took a two-drug mixture of Medivir’s simeprevir and Gilead’s sofosbuvir, according to research presented at the Conference on Retroviruses and Opportunistic Infections today in Atlanta. The patients took the combination for 12 or 24 weeks, with and without the antiviral ribavirin, researchers said.

“We went for the most difficult to cure, with the idea if we could show good efficacy there, it could be assumed the regimen could be efficacious in other patient populations,” Gaston Picchio, hepatitis disease area leader for J&J’s Janssen unit, said in a telephone interview. Medivir, based in Huddinge, Sweden, is working with J&J to develop simeprevir.

The interim results showed that among the 10 patients who had been off the treatment for 12 weeks, all of them still had their virus suppressed.

Gilead, Medivir and J&J are competing with Abbott Laboratories (ABT), Bristol-Myers Squibb Co. (BMY), Merck & Co. (MRK) and Vertex Pharmaceuticals Inc. (VRTX) to develop a new generation of oral hepatitis C treatments. The goal is to eliminate the standard therapy that requires ribavirin and an injection of interferon, an immune-boosting protein that can cause flu-like side effects for as long as 48 weeks.
Fewer Effects

Hepatitis C affects about 150 million people worldwide, according to the World Health Organization. The new drug regimens in testing are designed to be taken as pills, with shorter treatment durations and fewer side effects.

“Sofosbuvir continues to look like a backbone treatment,” said Brian Skorney, an analyst with Robert W. Baird & Co in a note to clients. “These results support our belief that sofosbuvir’s profile allows it to be combined with virtually any active HCV agent and eliminate the need for interferon and ribavirin.”

Gilead rose 1 percent to $43.87 at the close of trading in New York. The shares of the Foster City, California-based company had gained 87 percent in the past 12 months. Medivir climbed 3.8 percent to 90 kronor.

Gilead Therapy

While Gilead is unlikely to pursue a partnership with Medivir and J&J since the company is developing a combination of its own therapies, doctors may prescribe the pair reported in the study off-label, Brian Abrahams, an analyst with Wells Fargo Securities in New York, said in a note today.

“Of course, this would depend on pricing of the two components and payer acceptability, though with elimination of interferon and possibly ribavirin costs and side effects and substantial sustained virologic responses we believe the would likely be amenable,” Abrahams wrote.

Vertex is also testing an experimental drug, VX-135, with Medivir’s Simeprevir, and today’s clinical trial results could make that combination more likely, if no safety issues emerge, Abrahams said.

To contact the reporters on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net; Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

http://globalregulatoryscience.com/2013/03/27/gilead-medivir-hepatitis-c-drug-clears-virus-in-patients/

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