Wednesday, February 11, 2015

Gilead expects big increase in Europeans treated with hep C drug

Gilead expects big increase in Europeans treated with hep C drug

Feb 10 (Reuters) - Gilead Sciences Inc said on Tuesday it expects the number of hepatitis C patients treated in Europe with its Sovaldi drug to increase dramatically this year, and that approvals for the newer combination pill, Harvoni, could come quickly.

The company, which has come under intense criticism in the United States for the high price of its treatments for the liver destroying virus, is negotiating price cuts in Europe in exchange for patient volume promises.

Unlike the United States, where it is left to insurers and pharmacy benefit managers to negotiate price cuts for expensive drugs, price controls on medicines have long been a reality in Europe.

Gilead President and Chief Operating Officer John Milligan said about 17,000 hepatitis C patients were treated in France last year under a temporary utilization program.

"This year they will increase that budget allotment fairly dramatically in return for some price/volume concessions. If they commit to certain volumes, we'll commit to certain price concessions," Milligan said at the Bio CEO&Investor conference in New York.

Similar arrangements have been made in Spain and in Italy, which has among the highest prevalence of hepatitis C in Europe, he said.

"Italy has committed to volumes this year that I believe are about three times the volume they have ever treated," Milligan said.

Sovaldi must be used with at least one other drug to produce cure rates well in excess of 90 percent.

The company's Harvoni drug, which combines Sovaldi with another Gilead anti-viral medicine into a one pill once a day treatment, won U.S. approval late last year. Gilead is currently in talks on gaining patient access to Harvoni in Europe, which could accelerate 2015 sales that many analysts expect to exceed $12 billion worldwide.

"Negotiations for approvals of Harvoni are going very, very fast," Milligan said. "Payers see the value of it and see that more patients can benefit than ever before. That means we can bring more patients onto Harvoni sooner than we anticipated."

Some investors have expressed concern that short duration treatments will ultimately limit hepatitis C drug sales, compared with Gilead's HIV drugs that patients may have to take for decades.

Milligan estimates it will take six years to exhaust the estimated 1.6 million patients already diagnosed in the United States alone.

"On top of that, about an equal number need to be diagnosed," he said. "So it plays out over a much longer period of time." (Reporting by Bill Berkrot. Editing by Andre Grenon)

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