Gilead inks licensing pacts for Hep C drug with Ranbaxy, Cipla, Mylan, four Indian firms

In what could be seen as a major shift in marketing & pricing strategy for patented products in developing markets, the US-based drug innovator Gilead Sciences Inc has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies - Cadila Healthcare Ltd, Cipla Ltd, Hetero Labs Ltd, Mylan Laboratories Ltd, Ranbaxy Laboratories Ltd, Sequent Scientific Ltd and Strides Arcolab Ltd – to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.
 
The countries within the agreement account for more than 100 million people living with hepatitis C, representing 54% of the total global infected population.
 
“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. 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,” commented Gregg H Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences.
 
Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
 
Sofosbuvir was approved under the trade name Sovaldi by the US Food and Drug Administration (USFDA) in December 2013 and by the European Commission in January 2014. The FDA and the European Medicines Agency are currently reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir; it is an investigational agent and its safety and efficacy have not been established.
 
The deal is expected to bring down price of Sofosbuvir tablet in the developing markets. While a 12-week treatment course with Sovaldi costs $84,000 in the US, the cost of treatment is likely to be in the range of $300-$1,000 in the developing countries.