September 24, 2018
Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C
-- List Price of Authorized Generics to Reflect Discounts in the
System Today --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2018--
Gilead Sciences, Inc. (NASDAQ: GILD) announced today plans to launch
authorized generic versions of Epclusa® (sofosbuvir
400mg/velpatasvir 100mg) and Harvoni® (ledipasvir
90mg/sofosbuvir 400mg), Gilead’s leading treatments for chronic
hepatitis C virus (HCV), in the United States, through a newly created
subsidiary, Asegua Therapeutics LLC. The authorized generics will launch
at a list price of $24,000 for the most common course of therapy and
will be available in January 2019.
Since the launch of Gilead’s first HCV medication in 2013, the average
price paid for each bottle of medicine in the United States has
decreased by more than 60 percent off of the public list prices, across
health insurers and government payers. Due to the complexity and
structure of the U.S. healthcare system, however, these discounts
provided by Gilead may not always translate into lower costs for
patients. Further, existing contracts, together with laws associated
with government pricing policies, make it challenging to quickly lower a
product’s list price once it is on the market.
The authorized generics are priced to more closely reflect the discounts
that health insurers and government payers receive today. Insurers will
have the choice of offering either the authorized generics or the
branded medications for both Epclusa and Harvoni. In the Medicare Part D
setting, the authorized generics could save patients up to $2,500 in
out-of-pocket costs per course of therapy. The authorized generics will
also offer substantial savings to state managed Medicaid plans that do
not currently benefit from negotiated rebates and that represent a
significant number of people in need, potentially opening up access to
our medications to beneficiaries who were previously denied coverage.
“Launching these authorized generics is the best solution available to
us today to quickly introduce a lower-priced alternative to our HCV
medications without significant disruption to the healthcare system and
our business,” said John F. Milligan, PhD, President and Chief Executive
Officer, Gilead Sciences. “This launch also will hopefully help increase
transparency by more closely aligning our medications’ list prices with
their cost. Our ultimate goal is to lower the list price of Epclusa – a
medication we believe is of great importance given its clinical profile
across genotypes – and Harvoni. We are committed to working with all of
our partners in the healthcare system to help enable list price
reductions of our HCV medications and find better solutions to reduce
patients’ out-of-pocket costs.”
Beyond the company’s efforts to reduce patient costs, Gilead is
continuing to pursue innovative collaborations and long-term financing
models, such as a potential subscription model, that could not only
expand access, but aim to eliminate HCV in the United States and around
About Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care
for people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters in
Foster City, California.
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 that 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, 2018, 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.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792