European CHMP Adopts Positive Opinion for Stribild®, a Once-Daily, Integrase
Inhibitor-Based, Single Tablet Regimen for the Treatment of HIV-1 Infection
FOSTER CITY, Calif. -- March 22, 2013
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for
Medicinal Products for Human Use (CHMP), the scientific committee of the
European Medicines Agency (EMA), has adopted a positive opinion on the
company’s Marketing Authorisation Application (MAA) for the once-daily, single
tablet regimen Stribild^® for the treatment of HIV-1 infection in adult
patients who are antiretroviral-naïve or are infected with HIV-1 without known
mutations associated with resistance to any of the three antiretroviral agents
in Stribild. Stribild combines elvitegravir, an integrase inhibitor, and
cobicistat, a pharmacoenhancing agent, with Truvada^® (emtricitabine and
tenofovir disoproxil (as fumarate)). The CHMP’s positive recommendation will
be reviewed by the European Commission, which has the authority to approve
medicines for use in the 27 countries of the European Union (EU).
“With its potency, tolerability and convenient once-daily dosing, we believe
Stribild has the potential to be an important treatment option for patients
new to therapy or with no known resistance to any of the three components of
the product,” said John C. Martin, PhD, Chairman and Chief Executive Officer,
Gilead Sciences. “We are pleased with today’s positive opinion from the CHMP,
and anticipate receiving a final decision from the European Commission on our
application for Stribild in the coming months.”
The regulatory filing for Stribild is supported by 48-week data from two Phase
3 double-blind, active-controlled, randomized studies in which Stribild met
its primary objective of non-inferiority compared to Atripla^® (efavirenz 600
mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 300 mg) (Study 102)
and to a regimen containing ritonavir-boosted atazanavir plus Truvada (Study
103). In November 2012, data from Studies 102 and 103 were presented at the
11th International Congress on Drug Therapy in HIV Infection in Glasgow,
United Kingdom. These data demonstrated that Stribild maintained high
antiviral efficacy through 96 weeks of treatment. In all studies, Stribild was
well tolerated and most adverse events were mild to moderate. The most common
adverse events observed were nausea, diarrhea, upper respiratory tract
infection and headache.
Stribild has received marketing approval in the United States, Canada, South
Korea and Australia. To increase access to Stribild in the developing world,
Gilead has granted its Indian manufacturing partners and the Medicines Patent
Pool the right to develop and distribute generic versions of Stribild in 100
developing countries. These agreements include a complete technology transfer
from Gilead of the manufacturing process for the single tablet regimen.
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) 300 mg.
Elvitegravir is a member of the integrase inhibitor class of antiretroviral
compounds. Integrase inhibitors block the ability of HIV 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.
Gilead submitted a New Drug Application (NDA) to U.S. Food and Drug
Administration (FDA) for elvitegravir as a standalone agent on June 27, 2012,
and the agency has set a target action date under the Prescription Drug User
Fee Act (PDUFA) of April 27, 2013. A Marketing Authorisation Application (MAA)
for elvitegravir in the EU was validated for review by the EMA on June 18,
Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of
cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.
Unlike ritonavir, cobicistat acts only as a pharmacoenhancing or “boosting”
agent and has no antiviral activity. Gilead submitted an NDA to FDA for
cobicistat as a standalone agent on June 28, 2012, and a PDUFA date of April
28, 2013 has been set. An MAA for cobicistat in the EU was validated for
review by EMA on May 22, 2012.
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 Pacific.
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. These risks include the uncertainty
related to the timing of the European Commission’s decision and whether the
European Commission will approve Stribild. In addition, any marketing approval
provided by the European Commission or other regulatory authorities, if
granted, may have significant limitations on its use. Further, the U.S. Food
and Drug Administration and European Commission may not approve pending
marketing applications for elvitegravir or cobicistat as standalone agents.
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 Annual Report on Form 10-K
for the year ended December 31, 2012, 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 and Truvada are available at
Stribild and Truvada are registered trademarks of Gilead Sciences, Inc.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences,
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
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Stephen Head, +44 (208) 587-2359 (Media, Europe)
Erin Rau, 650-522-5635 (Media, U.S.)
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