FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 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.
About Stribild
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, 2012.
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.
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. 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 athttp://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp
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.Patrick O’Brien, 650-522-1936 (Investors)Stephen
Head, +44 (208) 587-2359 (Media, Europe)Erin Rau, 650-522-5635
(Media, U.S.)
