Gilead Sciences Announces Notification of ANDA Filing for
Atripla(R) FOSTER CITY, Calif., Apr 06, 2009 (BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a
Paragraph IV Certification Notice Letter advising that Teva
Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to
the U.S. Food and Drug Administration (FDA) requesting permission to
manufacture and market a generic version of Atripla(R)
(efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300
mg). Atripla is currently sold in the United States through a joint
venture between Bristol-Myers Squibb and Gilead.
In the Notice Letter, Teva alleges that two of the patents associated
with emtricitabine - U.S. Patent Numbers 6,642,245 and 6,703,396 - owned
by Emory University and licensed exclusively to Gilead Sciences are
invalid, unenforceable and/or will not be infringed by Teva's
manufacture, use or sale of the product described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the
date of receipt to commence a patent infringement lawsuit against Teva.
Such a lawsuit would restrict the FDA from approving Teva's ANDA for up
to 30 months or until a district court decision that is adverse to
Gilead, whichever occurs first. Atripla is currently protected by 15
patents, which are listed in the FDA's Approved Drugs Products List and
all 15 patents would need to be invalidated or expired before a generic
version of Atripla could be marketed.
In November 2008, Teva challenged the validity of these same two
emtricitabine patents - U.S. Patent Numbers 6,642,245 and 6,703,396 -
with an ANDA filing for Truvada(R) (emtricitabine and tenofovir
disoproxil fumarate). Gilead subsequently filed a patent infringement
lawsuit in U.S. District Court in New York against Teva Pharmaceuticals
USA, Inc. and Teva Pharmaceutical Industries, Ltd. in December. The
lawsuit is ongoing.
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
uncertainty related to whether Gilead will file a patent infringement
lawsuit against Teva and whether such a lawsuit or the lawsuit that is
currently pending related to Teva's ANDA filing for Truvada would be
successful. 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, 2008 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.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead
Sciences, LLC.
Truvada is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead, please call the Gilead Public Affairs
Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com
SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O'Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)
Return to Press Releases |
