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FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 28, 2013--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European
Commission has granted marketing authorization for Stribild®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir
disoproxil (as fumarate) 245 mg), a single tablet regimen for the
treatment of HIV-1 infection in adults who are antiretroviral
treatment-naïve or are infected with HIV-1 without known mutations
associated with resistance to any of the three antiretroviral agents in
Stribild. This approval allows for the marketing of Stribild in all 27
countries of the European Union.
“Single tablet regimens make it easier for HIV patients to take their
treatment consistently every day, which may improve their health
outcomes,” said Jürgen Rockstroh, MD, Professor of Medicine, University
of Bonn, Germany and a lead investigator for one of the Stribild pivotal
studies. “Stribild is a highly effective and well tolerated HIV
treatment regimen, and is an important addition to the growing arsenal
of simplified therapies in Europe.”
This approval is supported by 48-week data from two pivotal Phase 3
studies in which Stribild met its primary objective of non-inferiority
compared to Atripla® (efavirenz 600 mg/emtricitabine 200
mg/tenofovir disoproxil (as fumarate) 245 mg) (Study 102) and to a
regimen containing ritonavir-boosted atazanavir plus Truvada®
(emtricitabine/tenofovir disoproxil (as fumarate)) (Study 103).
“We look forward to making Stribild available to HIV-treating physicians
and their patients throughout the European Union as quickly as
possible,” said John C. Martin, PhD, Chairman and Chief Executive
Officer, Gilead Sciences.
Stribild is also approved in the United States, Canada, Australia, South
Korea, Japan and Turkey.
Stribild is the third single tablet HIV regimen developed by Gilead to
become available in Europe. The first, Atripla, was approved in the
European Union in 2007 and is marketed by Gilead in partnership with
Bristol-Myers Squibb and Merck & Co. The second, Eviplera®▼ (emtricitabine/rilpivirine/tenofovir
disoproxil (as fumarate) 245 mg)), is marketed by Gilead and Janssen R&D
Ireland and received European marketing authorization in November 2011.
Stribild contains four Gilead compounds in a complete once-daily, single
tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine
200 mg; and tenofovir disoproxil (as fumarate) 245 mg.
Elvitegravir is a member of the integrase inhibitor class of
antiretroviral compounds. Integrase inhibitors interfere with HIV
replication by blocking the ability of the virus to integrate into the
genetic material of human cells. Elvitegravir was licensed by Gilead
from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s
agreement with JT, Gilead has exclusive rights to develop and
commercialize elvitegravir in all countries of the world, excluding
Japan, where JT retains rights.
Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of
cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.
Marketing applications for elvitegravir and cobicistat as standalone
agents are currently under review in the European Union. In the United
States, on April 29, 2013, Gilead announced it had received Complete
Response Letters from the U.S. Food and Drug Administration (FDA) on its
New Drug Applications for elvitegravir and cobicistat as standalone
agents. The company is working to address the questions raised in FDA’s
letters as quickly as possible.
Elvitegravir and cobicistat as standalone agents are investigational
products and their safety and efficacy have not yet been established.
EU Important Product Information About Stribild
Lactic acidosis, usually associated with hepatic steatosis, has been
reported with the use of nucleoside analogues. Lactic acidosis has a
high mortality and patients at increased risk should be followed closely.
Stribild should not be taken with any of the following due to the
potential for serious and/or life-threatening events or loss of
virologic response and possible resistance to Stribild:
As a fixed combination, Stribild should not be administered
concomitantly with other medicinal products containing tenofovir
disoproxil (as fumarate), lamivudine or adefovir dipivoxil used for the
treatment of hepatitis B virus infection.
Emtricitabine and tenofovir are primarily excreted by the kidneys by a
combination of glomerular filtration and active tubular secretion. Renal
failure, renal impairment, elevated creatinine, hypophosphataemia and
proximal tubulopathy (including Fanconi syndrome) have been reported
with the use of tenofovir disoproxil (as fumarate).
Patients who have previously discontinued treatment with tenofovir
disoproxil (as fumarate) due to renal toxicity should not be treated
Patients should have creatinine clearance calculated and urine glucose
and urine protein determined prior to initiating Stribild therapy.
Stribild should not be initiated in patients with creatinine clearance
below 70 mL/min. It is recommended that Stribild is not initiated in
patients with creatinine clearance < 90 mL/min unless, after review of
the available treatment options, it is considered that Stribild is the
preferred treatment for the individual patient.
Creatinine clearance, serum phosphate, urine glucose and urine protein
should be monitored every four weeks during the first year and then
every three months. More frequent monitoring of renal function should be
considered in patients at risk for renal impairment.
Cobicistat inhibits the tubular secretion of creatinine and may cause
modest increases in serum creatinine and modest declines in creatinine
clearance. Patients who experience a confirmed increase in serum
creatinine of greater than 26.5 μmol/L (0.3 mg/dL) from baseline should
be closely monitored for renal safety.
Renal function should be re-evaluated within one week if serum phosphate
is < 0.48 mmol/L (1.5 mg/dL) or creatinine clearance decreases to < 70
mL/min during Stribild therapy.
If creatinine clearance is confirmed as < 50 mL/min or serum phosphate
decreases to < 0.32 mmol/L (1.0 mg/dL) then Stribild should be
There are currently inadequate data to determine whether
co-administration of tenofovir disoproxil (as fumarate) and cobicistat
is associated with a greater risk of renal adverse reactions compared
with regimens that include tenofovir disoproxil (as fumarate) without
Stribild should be avoided with concurrent or recent use of a
nephrotoxic medicinal product due to the increased risk of renal adverse
reactions (with the tenofovir disoproxil (as fumarate) component of
Bone abnormalities (infrequently leading to fractures) may be associated
with proximal renal tubulopathy and appropriate consultation should be
obtained if suspected.
Stribild has not been studied in patients with severe hepatic impairment
(CPT Score C).
Discontinuation of Stribild therapy in patients co-infected with HIV and
hepatitis B virus (HBV) may be associated with severe acute
exacerbations of hepatitis. Patients co-infected with HIV and HBV who
discontinue Stribild should be closely monitored with both clinical and
laboratory follow-up for at least several months after stopping
treatment. If appropriate, initiation of hepatitis B therapy may be
warranted. In patients with advanced liver disease or cirrhosis,
treatment discontinuation is not recommended since post treatment
exacerbation of hepatitis may lead to hepatic decompensation.
Immune Reactivation Syndrome has been reported in patients treated with
combination therapy, including the components of Stribild.
Combination therapy has been associated with the redistribution of body
fat (lipodystrophy) in HIV patients. The long-term consequences of these
events are currently unknown.
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 Asia
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
risk that physicians in Europe may not see advantages of Stribild over
other HIV therapies and may therefore be reluctant to prescribe the
product. In addition, pending marketing applications for elvitegravir
and cobicistat as standalone agents in the United States and Europe may
not be approved or approvals may be delayed, including due to Gilead’s
inability to address the questions raised in FDA’s complete response
letters. Further, any marketing approvals, if granted, may have
significant limitations on their use. 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 March 31, 2013, 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.
EU Summary of Product Characteristics for Atripla, Eviplera, Stribild
and Truvada are available athttp://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp
Eviplera, Stribild and Truvada 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,
follow Gilead on Twitter(@GileadSciences) or call Gilead
Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Investors:Patrick O’Brien,
650-522-1936orMedia:Stephen Head, +44 (208)
587-2359 (Europe)Erin Rau, 650-522-5635 (U.S.)www.gilead.com