Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent
January 26 2015 - 1:00AM
Business Wire
–Sofosbuvir/GS-5816 Single Tablet Regimen
May Provide Important New Option for Patients in Developing
Countries –
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the
company has expanded its hepatitis C generic licensing agreements
to include the investigational NS5A inhibitor GS-5816, which is
being evaluated in Phase 3 clinical studies as part of a single
tablet regimen that combines the compound and sofosbuvir for the
treatment of all six genotypes of hepatitis C. The expanded
agreements will allow Gilead’s India-based partners to manufacture
GS-5816 and the single tablet regimen of sofosbuvir/GS-5816, once
approved, for distribution in 91 developing countries, which
together account for 54 percent of the total worldwide population
of individuals infected with the hepatitis C virus (HCV).
If approved by regulatory authorities, the sofosbuvir/GS-5816
regimen would become the first pan-genotypic, all-oral single
tablet regimen for HCV. A pan-genotypic therapeutic option is
particularly important for developing countries, where genotype
testing is often unreliable or not readily available.
“Today’s announcement marks an important milestone in Gilead’s
effort to make effective hepatitis C treatment accessible to as
many patients, in as many places, as quickly as possible,” said
Gregg H. Alton, Executive Vice President, Corporate and Medical
Affairs, Gilead Sciences. “Developing countries are home to a
diverse mix of hepatitis C genotypes, and the development of a
medicine that has the potential to cure any patient, regardless of
genotype, could help accelerate access to treatment.”
Professor Abhijit Chowdhury, Head of Hepatology, Institute of
Post Graduate Medical Education and Research, Kolkata, commented:
“Pan-genotypic hepatitis C treatments have the potential to
radically change the treatment landscape in developing countries,
removing the need for patients to undergo burdensome laboratory
tests. Even if testing facilities are available, their cost is a
barrier to treatment access, so a regimen that can be used for any
genotype is going to be a real attribute in tackling this disease
on a global level.”
The amended agreements expand on Gilead’s existing generic
licensing partnerships for hepatitis C, announced in September
2014, under which partners may produce sofosbuvir and the single
tablet regimen of ledipasvir/sofosbuvir. Eight Indian-based generic
manufacturers now hold licenses to manufacture Gilead’s HCV
medicines – Biocon Ltd., Cadila Healthcare Ltd., Cipla Ltd., Hetero
Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd.,
Sequent Scientific Ltd. and Strides Arcolab Ltd.
Sofosbuvir recently received regulatory approval in India
(January 2015), and regulatory submissions have been completed in
additional countries, including Pakistan, Thailand, Brazil, Uganda,
South Africa and Nigeria.
About GS-5816
The single tablet regimen of sofosbuvir/GS-5816 is an
investigational agent and its safety and efficacy have not been
established. Phase 3 studies evaluating the combination of GS-5816
and sofosbuvir are currently underway, with data anticipated in the
second half of 2015.
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 10 years, where seven million patients are 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. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
Forward-Looking
Statement
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 of unfavorable clinical results on the
single tablet regimen of sofosbuvir/GS-5816. Further,
sofosbuvir/GS-5816 may not receive marketing approval by regulatory
authorities. As a result, the generic licensing partners may not be
able to produce and distribute generic versions of
sofosbuvir/GS-5816. 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 September 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.
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.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936
(Investors)Nick Francis, 650-522-5674 (Media)
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