Gilead Announces New License Agreement With the Medicines Patent Pool for Access to Bictegravir
October 04 2017 - 3:01AM
Business Wire
– Agreements with the Medicines Patent Pool
and Four Manufacturers Provide Licenses for Generic Production of
Bictegravir, an Investigational Agent for the Treatment of HIV
–
Gilead Sciences, Inc. (NASDAQ:GILD) announced today a new
licensing agreement with the Medicines Patent Pool (MPP), a United
Nations-backed public health organization, to expand access to
bictegravir (BIC) upon regulatory approval in the United States.
BIC is a novel investigational integrase strand transfer inhibitor
for use in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults. Through this agreement, MPP
can sub-license rights to BIC to generic drug companies in India,
China and South Africa to manufacture therapies containing BIC for
distribution in 116 low- and middle-income countries.
Gilead has also expanded its licensing agreements with Sun
Pharmaceutical Industries Limited, Strides Shasun Limited, Mylan
Laboratories Limited and SeQuent Scientific Limited to include BIC,
and products incorporating the compound, for distribution in 116
developing countries.
Under these voluntary licensing agreements, the manufacturers
may produce BIC as a single agent or in fixed-dose combinations
with other HIV medicines. BIC is the fifth HIV agent to be licensed
in Gilead’s agreements with the MPP and generic manufacturers.
Gilead and the MPP recently expanded the geographic scope of the
licensing agreements for Gilead’s other HIV therapies to include
Malaysia, Philippines, Ukraine and Belarus.
“These agreements allow for our licensees to provide generic
versions of our latest therapies to people living with HIV in the
developing world,” said Gregg H. Alton, Executive Vice President
for Corporate and Medical Affairs at Gilead Sciences. “Today, more
than 10 million people in resource-limited countries are on
Gilead-based HIV therapies, which would not be possible without
these strong alliances.”
Voluntary licensing agreements are a key component of Gilead's
efforts to increase access to the company's therapies in the
developing world. Competition among manufacturers has reduced the
lowest price of a Gilead HIV generic therapy by 80 percent since
2006, to as low as $3.50 per patient per month. Ninety-nine percent
of people taking Gilead’s HIV therapies in developing countries
receive generic medicine.
Gilead has filed a New Drug Application to the U.S. Food and
Drug Administration for an investigational, once-daily single
tablet regimen containing BIC (50mg) and emtricitabine/tenofovir
alafenamide (200mg/25mg) (BIC/FTC/TAF). In the European Union, the
company’s Marketing Authorization Application for BIC/FTC/TAF has
been fully validated and is now under evaluation by the European
Medicines Agency.
BIC in combination with FTC/TAF as a single tablet regimen is an
investigational treatment that has not been determined to be safe
or efficacious and is not approved anywhere globally.
Gilead’s licensing agreements are available at
www.gilead.com/responsibility, and the full MPP licensing agreement
is available at www.medicinespatentpool.org.
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.
For nearly 30 years, Gilead has been a leading innovator in the
field of HIV, driving advances in treatment, prevention, testing
and linkage to care, and cure research. Today, it’s estimated that
more than 10 million people living with HIV globally receive
antiretroviral therapy provided by Gilead or one of the company’s
manufacturing partners.
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 that regulatory authorities may not
approve BIC/FTC/TAF in the currently anticipated timelines, and
marketing approvals, if granted, may have significant limitations
on their use. As a result, BIC/FTC/TAF may never be successfully
commercialized. 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, 2017, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171004005434/en/
Gilead Sciences, Inc.InvestorsSung Lee,
650-524-7792orMediaMichele Rest, 650-577-6935
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Apr 2023 to Apr 2024