Gilead Sciences has agreed to let seven Indian generic drugmakers sell its chronic hepatitis C medicines - including the $1,000 per pill Sovaldi (sofosbuvir) - in 91 developing countries, in a bid to help get more patients access to treatment.
The non-exclusive licenses will allow the companies - Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab - to manufacture both Sovaldi and the investigational single tablet regimen ledipasvir/sofosbuvir for distribution in the agreed territories.
Under the deal, the firms can set prices for their own versions of these drugs, and Gilead stands to receive sales-based royalties, which, it says, will support product registrations, medical education and training, safety monitoring and other essential business activities.
Gilead notes that the countries included within the agreement account for more than 100 million people living with hepatitis C, representing 54% of the total global infected population. However, pressure group Médecins Sans Frontières argues that the move doesn’t go far enough.
Most of the countries expected to be included in the license agreements are low-income economies, many of which may not have had patent protection on these new drugs in the first place, it says, arguing that Gilead’s licensing terms “fall far short of ensuring widespread affordable access to these new drugs in middle-income countries”, where prices are expected to be substantially higher.
“The deal excludes many middle-income countries considered by industry to be profitable emerging markets, even though people living with chronic Hepatitis C in these countries often come from poor and marginalised communities with little ability to pay for expensive medicines,” adds Rohit Malpani, Director of Policy and Analysis, MSF, Access Campaign.
Gilead’s pricing for Sovaldi means that a 12-week course comes in at $84,000 in high-income countries, and it reportedly plans to launch its own version in India for around $900 per course, which will likely set a benchmark for the rest of the industry, Bhavesh Shah, director of international marketing at Hetero Laboratories, told The Wall Street Journal.
But a study by researchers at Liverpool University has found that treatment could cost as low as $101, achievable with large scale generic production, MSF says, which could significantly expand the drug’s reach.