Gilead Aims to License Hepatitis C Drug to 3-4 Indian Firms

Reuters Health Information

Gilead Aims to License Hepatitis C Drug to 3-4 Indian Firms

By Ben Hirschler
April 09, 2014

(Reuters) - Gilead Sciences aims to license its new hepatitis C drug Sovaldi to three or four Indian generic manufacturers to allow sales of the medicine at lower prices in some 60 developing nations.

Clifford Samuel, head of access operations and emerging markets at the U.S. drugmaker, told Reuters he expected to have deals in place shortly with the Indian firms, which would be able to produce the drug in high volumes and at low margins.

Gilead is under pressure to address the high cost of its breakthrough pill, which is the first of a new wave of drugs that have been shown to raise cure rates and cut treatment duration without the side effects of current injections.

"We're in the midst of discussions right now. We're nailing down the geographical scope, and we should have these licenses in place and ready to go in short order," Samuel said on a visit to London for an international liver conference.

He said Gilead was looking to strike deals with firms that had proven experience in producing generic versions of its HIV/AIDS drugs, such as the Indian division of Mylan.

The Foster City, California-based company has been operating a similar voluntary licensing program for many years for low-cost HIV drugs, which covers 112 countries.

Under the hepatitis C plan, Indian-made generics would be available in most of sub-Saharan Africa, selected Asian countries including India, Pakistan and Myanmar, and some smaller developing nations.

Gilead is also working to establish "tiered pricing" for Sovaldi in other low- and middle-income countries, Samuel said.

The company struck the first such tiered pricing deal last month in Egypt, where it has agreed to supply the government at just over 1 percent of the U.S. price, or $300 for a 28-day bottle against $28,000.

For India, the company is currently discussing a price of $2,000 based on 24 weeks of treatment, although no final deal has been reached, Samuel added.

Egypt has the world's highest prevalence of the liver-destroying hepatitis C virus, which is spread through blood, making it an obvious first market for more affordable, tiered pricing.

"We're targeting key, high-prevalence countries like India, Pakistan and Egypt. We are sitting down with them and looking at differential pricing," Samuel said.

Gilead's tiered pricing will not apply, however, to some large middle-income countries with significant hepatitis C populations such as Ukraine and China, which are viewed as commercial market opportunities.

In the United States, Sovaldi's price tag of $84,000 for a 12-week course of treatment has been described by one health provider as "outrageous", while U.S. lawmakers have written to the firm demanding an explanation of the price.