September 15, 2014
Gilead Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries
-- Indian companies granted license to produce generic sofosbuvir and investigational single tablet regimen of ledipasvir/sofosbuvir for treatment of chronic hepatitis C --
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
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
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.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility that licensees will not be able to produce and distribute
generic versions of Gilead medicines, that licensing terms will be
modified or that ledipasvir/sofosbuvir does not receive regulatory
approval. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended
U.S. full prescribing information for Sovaldi is available at www.gilead.com.
Sovaldi is a registered trademark of
For more information on
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Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Nick Francis, 650-522-5674