Gilead Sciences Announces Notification of ANDA Filing for Truvada
Gilead Sciences Announces Notification of ANDA Filing for Truvada
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 Truvada ® (emtricitabine and tenofovir disoproxil fumarate).
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. Truvada is currently protected by 10 patents, which are listed in the FDA’s Approved Drugs Products List, and all 10 patents would need to be invalidated or expired before a generic version of Truvada could be marketed.
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 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, 2007 and its Quarterly Report on Form 10-Q for the first, second and third quarters of 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.
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
Contact:
Gilead Sciences, Inc.
Patrick O'Brien, Investors, 650-522-1936
Cara
Miller, Media, 650-522-1616
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