ledipasvir/sofosbuvir - Gilead Signs generic licensing agreement for hepatitis C drug

Gilead Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries

Date(s): 15-Sep-2014 6:30 AM

-- Indian companies granted license to produce generic sofosbuvir and investigational single tablet regimen of ledipasvir/sofosbuvir for treatment of chronic hepatitis C --

NEW DELHI--(BUSINESS WIRE)--Sep. 15, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company 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. andStrides 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 U.S. Food and Drug Administration(FDA) in December 2013 and by the European Commission in January 2014. The FDA and theEuropean 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.

For a fact sheet on the agreement, visit www.gilead.com.

Gilead's Approach to Treatment Access in Developing Countries
Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means. In developing countries, Gilead's treatment access strategies include tiered pricing, voluntary generic licensing (often in advance of U.S./EU regulatory approval), negotiation with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organizations. This approach has been successfully applied to Gilead's humanitarian program in HIV over the past ten years, with six million patients now receiving Gilead-based HIV medicines in developing countries.