Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire LLC, has settled all pending litigation with Actavis, Inc., Actavis LLC, and Actavis Elizabeth LLC (collectively “Actavis”) and Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and ANDA, Inc. (collectively “Watson”) in connection with Actavis’ and Watson’s Abbreviated New Drug Applications (“ANDAs”) for generic versions of Shire’s INTUNIV® ( guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder.
The settlement provides Actavis with a license to make and market Actavis’ generic versions of INTUNIV in the United States on December 1, 2014, or earlier in certain limited circumstances. Such sales will require the payment of a royalty of 25% of gross profits to Shire during the 180 day period of Actavis’ exclusivity. The settlement also provides Watson with a license to make and market Watson’s generic versions of INTUNIV in the United States 181 days after Actavis’ launch of generic INTUNIV, or earlier in certain limited circumstances. To date, the US Food and Drug Administration has granted final approval only to Actavis’ ANDA for generic versions of INTUNIV.
These litigations were patent infringement lawsuits relating to U.S. patents 6,287,599 (“the ‘599 Patent”), 6,811,794 (“the ‘794 Patent”), 5,854,290 (which was subsequently dedicated to the public). As part of the settlement, Actavis and Watson have agreed to a consent judgment confirming that their proposed generic products infringe Shire’s ’599 and ’794 Patents and that those two patents are valid and enforceable with respect to those proposed generic products and any other generic version of INTUNIV.
The lawsuit against Actavis proceeded to trial in the District Court of Delaware in September 2012 wherein Teva Pharmaceuticals, USA, Inc. was also a defendant. The Delaware court has not issued a decision. The lawsuit against Watson is scheduled for trial to begin on February 10, 2014 wherein Impax Laboratories, Inc. is also a defendant.
The agreements, which are effective immediately, will be submitted to the US Federal Trade Commission and Department of Justice for review as required by law.
For further information please contact:
+1 781 482 0999
+44 1256 894157
Jessica Mann (Corporate)
+44 1256 894 280
Gwen Fisher (Specialty Pharma)
+1 484 595 9836
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Through our deep understanding of patients’ needs, we develop and provide healthcare in the areas of:
as well as other symptomatic conditions treated by specialist physicians.
We aspire to imagine and lead the future of healthcare, creating value for patients, physicians, policymakers, payors and our shareholders.
FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements. Forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
and other risks and uncertainties detailed from time to time in Shire’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
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