December 29, 2014
Gilead Announces Amended Agreements With Janssen to Develop and Commercialize Tenofovir Alafenamide-Based Single Tablet Regimens for HIV Treatment
TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead’s Viread® (tenofovir disoproxil fumarate), as well as an improved renal and bone safety profile.
“We believe that TAF’s efficacy and safety advantages may make it a
strong backbone of new fixed-dose combinations and single tablet
Gilead and Janssen also have amended a licensing agreement for the development and commercialization of a once-daily single tablet regimen for HIV containing Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir. Under the amended agreement, Janssen will be responsible for further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide.
Separate to the Janssen agreements, Gilead is advancing its own
TAF-based single tablet regimen containing elvitegravir, cobicistat,
emtricitabine and TAF. The company announced on
TAF and TAF-based regimens are investigational products in
About Gilead Sciences
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 risks
related to whether ongoing clinical trials of TAF-based combinations
will be successful and Gilead’s ability to coformulate new single tablet
regimens containing TAF, emtricitabine and rilpivirine, and TAF,
emtricitabine, cobicistat and darunavir. In addition, Gilead and Janssen
may make a strategic decision to discontinue development of the TAF
combination products if, for example, the market for the products fails
to materialize as expected. As a result, the agreements may terminate.
Further, regulatory authorities may not approve TAF-based regimens, and
marketing approvals, if granted, may have significant limitations on
their use. As a result, TAF combination products 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
U.S. full prescribing information for Complera and Viread is available at www.gilead.com.
Complera, Eviplera and Viread are registered trademarks of
For more information on
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Ryan McKeel, 650-377-3548 (Media)