Gilead Sciences 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 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.

Sofosbuvir was approved under the trade name Sovaldi by the US Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014. It is Gilead’s top-selling drug with first half 2014 revenues of $5.754 billion.The FDA and the European Medicines Agency are currently reviewing the company's applications for a single tablet regimen of ledipasvir/sofosbuvir.

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. 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.

“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,” said Gregg H. Alton, executive vice president, corporate and medical affairs of Gilead Sciences in a press release. “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.”

Source: Gilead Sciences