Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for marketing approval of the single-tablet
regimen of Truvada® (emtricitabine and tenofovir disoproxil
fumarate) and Tibotec Pharmaceuticals’ investigational
non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine
hydrochloride) for HIV-1 infection in adults. If approved, this
would be the second product that contains a complete HIV treatment
regimen in a single once-daily tablet.
“Combination antiretroviral therapy has dramatically advanced
the field of HIV medicine, but the need remains for new
single-tablet regimens that are effective, safe and well
tolerated,” said John C. Martin, PhD, Chairman and Chief Executive
Officer, Gilead Sciences. “Gilead is committed to helping advance
HIV treatment by pursuing both scientific research and innovative
partnerships that will deliver more options to the healthcare
community. We are pleased to work with Tibotec to bring this
potentially important new therapy to people living with HIV.”
On July 23, 2010, Tibotec submitted an NDA for U.S. marketing
approval of TMC278 for once-daily use with other antiretroviral
agents. That NDA is supported by 48-week data from two Phase III
double-blind, randomized studies (ECHO and THRIVE) that evaluated
the safety and efficacy of TMC278 in treatment-naive HIV-1 infected
adults, the majority of whom received TMC278 in combination with
Truvada. The Gilead NDA for Truvada/TMC278 is supported by a
bioequivalence study conducted by Gilead demonstrating that the
formulation of the single-tablet regimen achieved the same levels
of medication in the blood as the component products dosed
simultaneously as individual pills.
On September 3, 2010, the European marketing applications for
TMC278 and for the Truvada/TMC278 single-tablet regimen were filed
simultaneously by Tibotec and Gilead, respectively.
Gilead entered into a license and collaboration agreement with
Tibotec for the development and commercialization of the
single-tablet regimen in July 2009. Subject to regulatory approval,
Gilead will assume the lead role in the manufacturing,
registration, distribution and commercialization of the
single-tablet regimen worldwide, excluding the developing world and
Japan. Tibotec will be responsible for the commercialization of
TMC278 as a stand-alone product and will hold rights to co-promote
the single-tablet regimen in these territories. The companies are
currently working on an agreement to make the combination product
available in the developing world.
Truvada/TMC278 is an investigational product and its safety and
efficacy have not yet been established.
Important Product Safety Information
About Truvada
Truvada is a fixed-dose combination tablet containing 200 mg of
emtricitabine (Emtriva®) and 300 mg of tenofovir disoproxil
fumarate (Viread®). In the United States, Truvada is indicated in
combination with other antiretroviral agents (such as
non-nucleoside reverse transcriptase inhibitors or protease
inhibitors) for the treatment of HIV-1 infection in adults.
Lactic acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with the use of
nucleoside analogues alone or in combination with other
antiretrovirals including Viread (tenofovir disoproxil fumarate), a
component of Truvada. Truvada is not approved for the
treatment of chronic hepatitis B virus (HBV) infection and its
safety and efficacy has not been established in patients
co-infected with HBV and HIV-1. Severe acute exacerbations
of hepatitis B have been reported in patients co-infected with
HIV-1 and HBV who have discontinued Truvada. Hepatic function
should be monitored closely with both clinical and laboratory
follow-up for at least several months in patients who are
co-infected with HBV and HIV-1 and discontinue Truvada. If
appropriate, initiation of anti-hepatitis B treatment may be
warranted.
It is important for patients to be aware that anti-HIV medicines
including Truvada do not cure HIV infection or AIDS and do not
reduce the risk of transmitting HIV to others.
Emtricitabine and tenofovir are principally eliminated by the
kidneys. Renal impairment, including cases of acute renal failure
and Fanconi syndrome (renal tubular injury with severe
hypophosphatemia), has been reported in association with the use of
Viread. It is recommended that creatinine clearance be calculated
in all patients prior to initiating therapy with Truvada and as
clinically appropriate during therapy. Routine monitoring of
calculated creatinine clearance and serum phosphorous should be
performed in patients at risk for renal impairment including
patients who have previously experienced renal events while
receiving Hepsera® (adefovir dipivoxil).
Dosing interval adjustment and close monitoring of renal
function are recommended in all patients with creatinine clearance
30-49 ml/min. Truvada should be avoided with concurrent or recent
use of a nephrotoxic agent. Truvada should not be administered with
Hepsera.
Truvada should not be coadministered with Emtriva, Viread,
Atripla® (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir
disoproxil fumarate 300 mg) or lamivudine-containing products,
including Combivir® (lamivudine/zidovudine), Epivir® or Epivir-HBV®
(lamivudine), Epzicom® (abacavir sulfate/lamivudine) or Trizivir®
(abacavir sulfate/lamivudine/zidovudine). In treatment-experienced
patients, the use of Truvada should be guided by laboratory testing
and treatment history.
Decreases in bone mineral density (BMD) at the lumbar spine and
hip have been seen with the use of Viread. The effect on long-term
bone health and future fracture risk is unknown. BMD monitoring
should be considered in patients with a history of pathologic
fractures or who are at risk for osteopenia. Cases of osteomalacia
(associated with proximal renal tubulopathy and which may
contribute to fractures) have been reported in association with the
use of Viread.
Redistribution/accumulation of body fat has been observed in
patients taking antiretroviral medicines. Immune Reconstitution
Syndrome has been reported in patients treated with combination
therapy, including Viread and Emtriva, and may necessitate further
evaluation and treatment. Early virologic failure has been reported
in HIV-infected patients on regimens containing only three
nucleoside reverse transcriptase inhibitors. Patients on a therapy
utilizing a triple nucleoside-only regimen should be carefully
monitored and considered for treatment modification.
Coadministration of Truvada and didanosine should be undertaken
with caution. Patients should be monitored closely for
didanosine-associated adverse events and didanosine should be
discontinued if these occur. Dose reduction of didanosine should be
considered, if warranted. Patients on atazanavir and
lopinavir/ritonavir plus Truvada should be monitored for
Truvada-associated adverse events and Truvada should be
discontinued if these occur. When co-administered with Truvada, it
is recommended that atazanavir be boosted with ritonavir 100 mg.
Atazanavir without ritonavir should not be co-administered with
Truvada.
The most common adverse reactions (incidence greater-than or
equal to 10 percent) are diarrhea, nausea, fatigue, headache,
dizziness, depression, insomnia, abnormal dreams and rash.
The parent compound of Viread was discovered through a
collaborative research effort between Dr. Antonin Holy, Institute
for Organic Chemistry and Biochemistry, Academy of Sciences of the
Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega
Institute for Medical Research, Katholic University in Leuven,
Belgium. The inventors of Viread have agreed to waive their right
to a royalty on sales of Viread and Truvada in the Gilead Access
Program countries to ensure that the product can be offered at a
no-profit price in parts of the world where the HIV/AIDS epidemic
has hit the hardest.
For complete prescribing information for Truvada, visit
www.Truvada.com.
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 America, Europe and Australia.
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 risks related to Gilead’s ability to successfully
commercialize the single-tablet regimen of Truvada/TMC278. For
example, the FDA, European Medicines Agency or other regulatory
agencies may not approve TMC278 or the single-tablet regimen of
Truvada/TMC278 for the treatment of HIV-1 infection in adults, and
any marketing approval, if granted, may have significant
limitations on its use. Further, Gilead and Tibotec may make a
strategic decision to discontinue development of the combination
product if, for example, the market for the product fails to
materialize as expected. 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, 2010, 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 Truvada
is available at www.Truvada.com.
U.S. full prescribing information for Atripla
is available at www.Atripla.com.
U.S. full prescribing information for Viread is
available at www.Viread.com.
U.S. full prescribing information for Emtriva
is available at www.GileadHIV.com.
U.S. full prescribing information for Hepsera
is available at www.Hepsera.com.
Truvada, Viread, Emtriva and Hepsera are
registered trademarks of Gilead Sciences, Inc.
Atripla is a registered trademark of
Bristol-Myers Squibb & Gilead Sciences, LLC.
For more information on Gilead Sciences, please
visit the company's website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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