Gilead Signs Deal for Generic Sovaldi in India

A generic version of Gilead Science’s hepatitis C drug Sovaldi will be produced in India and sold there and other poorer countries at what is likely to be a fraction of what it costs in the United States.

Gilead announced recently that it has signed non-exclusive licensing agreements with seven generic pharmaceutical manufacturers in India that allows the California-based company to expand the reach of its hepatitis C drug in developing countries. Sovaldi, known generically as sofosbuvir, is a ground-breaking drug approved within the last year by the FDA and European Commission that quickly grabbed attention for its high cure rate -- up to 90% in clinical trials -- as well as its high price in the US.

The price tag for Sovaldi in the US runs about $1000 a pill for a daily dose, adding up to $84,000 for a standard 12-week course of treatment or more if interferon and ribavirin are included. Gilead has countered complaints of price-gauging from US law makers, medical groups, and insurance companies by arguing that Sovaldi is worth the cost because it offers a cure for the disease.

The deal with Gilead gives the Indian companies rights to manufacture sofosbuvir and an investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries, according to a statement released by Gilead. The companies were identified as Candila Healthcare Ltd, Cipla Ltd., Hetero Labs Ltd., Mylan LaboratoriesLtd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd., and Strides Arcolab Ltd.

The cheaper generic version of the drug to be made in India is likely to cost just a fraction of what is charged in the US, however a particular price was not indicated in the Sep. 15 Gilead statement. Press reports in February when negotiations were announced but not yet finalized quoted Gilead estimates at about $2000 per treatment course.

The generic drug companies set their own prices and will pay a 7% royalty to Gilead to support overall developing, world product registration, education, training, and safety monitoring. Gilead will provide technology of the manufacturing process to facilitate a fast scale up of production, the statement said.

The hepatitis C virus is a bloodborne virus that if left untreated can attack the liver and lead to cirrhosis, liver cancer or the need for a liver transplant. About 15 million people worldwide are believed to have the virus, which often goes undetected for many years.

“Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible,” Gregg H. Alton, Gilead’sexecutive vice president of corporate and medical affairs said in the statement. “In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries.”

To further access to treatment in developing countries Gilead uses tiered pricing, voluntary generic licensing, product registration, and medical education, and it negotiates with national governments, and partners with business and non-profit groups, according to the statement. The company said it has had success with this approach with its HIV humanitarian program in the past 10 years.