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-- 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. and Strides
Arcolab Ltd. – to manufacture sofosbuvir and the investigational
single tablet regimen of ledipasvir/sofosbuvir for distribution in 91
The countries within the agreement account for more than 100 million
people living with hepatitis C, representing 54% of the total global
“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 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.
For a fact sheet on the agreement, visit www.gilead.com.
Gilead’s Approach to Treatment Access in
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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
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
June 30, 2014, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.
U.S. full prescribing information for Sovaldi is available at www.gilead.com.
Sovaldi is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company’s
website at www.Gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Investors:Patrick O’Brien, 650-522-1936Media:Nick