Gilead Sciences, Inc. Says Indian Firms May Sell Generics of Hep C Drug Sovaldi
September 15, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Gilead Sciences, Inc. announced it was entering into non-exclusive licensing agreements with seven generic pharmaceutical manufacturers in India to make and sell its hepatitis C drug Sovaldi (sofusbuvir).
The drug has generated some controversy because of its price, which runs to about $1,000 per day, or about $84,000 for a 12-week course of treatment.
The deal announced today received instant criticism. Rohit Malpani of Doctors Without Borders, told The New York Times, “Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 percent of people with Hepatitis C live today.”
The Indian companies granted approval are Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd., and Strides Arcolab Ltd.
The agreements allow the generic companies to manufacture sofosbuvir and an investigational single tablet regimen of ledipasvir/sofusbuvir for commercialization in 91 developing countries.
The Indian companies, as part of the licensing deals, receive complete technology transfer, which will allow them to scale up production in a very short period of time. The companies also can set their own prices and pay a royalty to Gilead.
Gilead said it will launch its own brand of Sovaldi in India at a price of around $300 per month. Sovaldi’s projected sales for 2014, the first full year on the market, is expected to surpass $11 billion. The pricing concerns have even been the focus of World Health Organization (WHO) criticism, that reported it wanted a “concerted effort” to decrease the costs of new hepatitis drugs.
In March, Gilead offered to sell the drug in Egypt at a 99 percent discount compared to the U.S. price. Egypt has the highest rate of hepatitis C infection in the world.
This underlines a disparity, in which U.S. concerns focus on costs, where the majority of pharmaceutical revenues are generated, and in middle-income and lower-income countries where access to medications is of greater concern.
Further complicating the world market for the drug is the nature of drug patents from country to country. Gilead holds the patent for Solvaldi in the U.S. and in many other markets, but does not currently own it in India, although it has applied for it.
There is opposition to the Indian patent by the Indian Pharmaceutical Alliance (IPA), global patient access group I-Mak and an Indian generic manufacturer.
IPA secretary general D.G. Shah said, “We have opposed the Gilead patent for the new Hepatitis drug in India as it is violative of Section 3(d) of the country’s patent act.” Section 3(d) of that act denies patent protections for drugs that are modifications of previously known medications, or are less inventive in nature.