April 29, 2013
Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 29, 2013--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company
has received Complete Response Letters from the U.S. Food and Drug
Administration (FDA) for its New Drug Applications (NDAs) for
elvitegravir and cobicistat for use as part of HIV treatment regimens.
In its communications, FDA states that it cannot approve the
applications in their current forms. The letters state that during
recent inspections, deficiencies in documentation and validation of
certain quality testing procedures and methods were observed. Gilead is
working with FDA to address the questions raised in the Complete
Response Letters and move the applications forward.
Elvitegravir and cobicistat are also components of Gilead’s once-daily
single tablet HIV-1 regimen Stribild® (elvitegravir 150
mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate
300 mg), which was approved by FDA in August 2012 for treatment-naïve
adults. This regulatory action does not affect the marketing
authorization or continued use of Stribild.
Gilead submitted its NDAs for elvitegravir and cobicistat in June 2012.
Marketing applications are also pending in Europe.
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.
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.
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 we may be unable to remedy the deficiencies cited by the FDA in the
Complete Response Letters on a timely basis and that our inability to
address those deficiencies could adversely impact currently marketed
products and products in development. There is also the risk that health
authorities in other countries where applications are pending will
undertake similar additional reviews which could delay the approval of
such products in those countries. 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.
U.S. full prescribing information for Stribild is available at www.gilead.com.
Stribild is a registered trademark of Gilead Sciences, Inc.
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)
Rau, 650-522-5635 (Media)