SHIRE PLC: Shire Settles INTUNIV Litigation with Actavis and Watson

SHIRE PLC: Shire Settles INTUNIV Litigation with Actavis and Watson
Shire Settles All Pending Litigation with Actavis and Watson concerning INTUNIV 
® 
Philadelphia, PA, United States - April 25, 2013 - 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: 
Investor Relations                                                              
                                                                           
Eric Rojas                              erojas@shire.com     +1 781 482 0999    
                                                                           
Sarah Elton-Farr                        seltonfarr@shire.com +44 1256 894157    
                                                                           
Media                                                                           
                                                                           
Jessica Mann (Corporate)                jmann@shire.com      +44 1256 894 280   
                                                                           
Gwen Fisher (Specialty Pharma)          gfisher@shire.com    +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: 
* Behavioral Health and Gastro Intestinal conditions 


      * Rare Diseases
      * Regenerative Medicine
    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.

www.shire.com

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:

  * Shire's products may not be a commercial success;
      * revenues from ADDERALL XR are subject to generic erosion;
      * the failure to obtain and maintain reimbursement, or an adequate level of
    reimbursement, by third-party payors in a timely manner for Shire's
    products may impact future revenues and earnings;
      * Shire relies on a single source for manufacture of certain of its products
    and a disruption to the supply chain for those products may result in Shire
    being unable to continue marketing or developing a product or may result in
    Shire being unable to do so on a commercially viable basis;
      * Shire uses third party manufacturers to manufacture many of its products
    and is reliant upon third party contractors for certain goods and services,
    and any inability of these third party manufacturers to manufacture
    products, or any failure of these third party contractors to provide these
    goods and services, in each case in accordance with its respective
    contractual obligations, could adversely affect Shire's ability to manage
    its manufacturing processes or to operate its business;
      * the development, approval and manufacturing of Shire's products is subject
    to extensive oversight by various regulatory agencies and regulatory
    approvals or interventions associated with changes to manufacturing sites,
    ingredients or manufacturing processes could lead to significant delays,
    increase in operating costs, lost product sales, an interruption of
    research activities or the delay of new product launches;
      * the actions of certain customers could affect Shire 's ability to sell or
    market products profitably and fluctuations in buying or distribution
    patterns by such customers could adversely impact Shire's revenues,
    financial conditions or results of operations;
      * investigations or enforcement action by regulatory authorities or law
    enforcement agencies relating to Shire's activities in the highly regulated
    markets in which it operates may result in the distraction of senior
    management, significant legal costs and the payment of substantial
    compensation or fines;
      * adverse outcomes in legal matters and other disputes, including Shire's
    ability to obtain, maintain, enforce and defend patents and other
    intellectual property rights required for its business, could have a
    material adverse effect on Shire's revenues, financial condition or results
    of operations;


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. 
                                                          
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX 
Press Release                                      
                                              
www.shire.com                                      
END 
-0- Apr/25/2013 13:26 GMT
 
 
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