Gilead to license generic version of hepatitis C drug Sovaldi

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Gilead Sciences has reached a deal with several generic drugmakers to produce cheaper versions of its popular, expensive hepatitis C drug Sovaldi for use in developing countries.

Gilead said Monday that the India-based drugmakers will make a generic version of Sovaldi, also known as sofosbuvir, and another investigational drug for distribution in 91 countries.

Sovaldi hit the U.S. market late last year, and Gilead has taken criticism over the $1,000-per-pill price attached to the drug, which has been hailed as a breakthrough treatment. A full course of treatment can cost $84,000.

Hepatitis C is a liver-destroying virus carried by an estimated 3 million to 4 million Americans. Until late last year, the standard treatments required taking up to 12 pills a day, alongside antiviral drug injections that can cause flu-like symptoms. That approach cured only about 75 percent of patients.

U.S. regulators approved Sovaldi last December, and it was quickly embraced by physicians based on its once-a-day pill regimen and increased effectiveness, curing between 80 percent and 90 percent of patients.

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The drug is expected to generate several billion dollars in sales this year alone for Foster City, California-based Gilead. The drugmaker has said that Sovaldi’s costs for payers will be recouped over the long term as fewer patients suffer liver failure and transplant complications. It also has said it offers financial assistance to patients who cannot afford the drug and related insurance costs.

Even so, Congressional leaders have criticized the drug’s pricing, and some state-based Medicaid plans are scaling back access to the treatment.

Gilead Sciences Inc. did not detail the price on the generic version of Sovaldi to be sold in developing markets.

The Indian companies, which include Ranbaxy Laboratories Ltd. and Mylan Laboratories Ltd., will pay sales royalties to Gilead. They will receive a technology transfer that helps them start production quickly.

Gilead’s agreement also covers another treatment, a single tablet combination of sofosbuvir and another antiviral drug, ledipasvir. Regulators in both the United States and Europe are currently reviewing that combination.


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