SHIRE PLC: Shire Wins Patent Trial Against Watson concerning LIALDA

SHIRE PLC: Shire Wins Patent Trial Against Watson concerning LIALDA
Shire Wins Patent Trial Against Watson concerning LIALDA® 
Philadelphia, PA - May 9, 2013 - Shire plc (LSE: SHP, NASDAQ: SHPG), announces
that its subsidiary, Shire Development LLC, has prevailed in its litigation
against Watson Pharmaceuticals Inc., Watson Laboratories, Inc.-Florida, Watson
Pharma, Inc. and Watson Laboratories, Inc. (collectively "Watson", now
"Actavis") in connection with their Abbreviated New Drug Application ("ANDA")
for a generic version of Shire's LIALDA® (mesalamine) delayed release tablets
for the induction of remission in adults with active, mild to moderate
ulcerative colitis and for the maintenance of remission of ulcerative colitis. 
Following a five day bench trial in the Southern District of Florida, Judge
Middlebrooks issued a ruling upholding the validity of the patent covering
LIALDA, US Patent No. 6,773,720 (the "'720 patent), and holding that the
proposed ANDA formulation infringes the claims of that patent. Accordingly,
Judge Middlebrooks confirmed that Shire is entitled to an injunction, which he
will issue separately, which prohibits the FDA from approving the ANDA
formulation until the expiration of the `720 patent. 
"Shire is very pleased that the court has ruled in our favor. We rely on our
patents to be able to continue to invest in therapies that bring value to our
patients and their caregivers. This ruling supports the innovative therapies
that we develop in order to improve the lives of ulcerative colitis patients."
stated Roger Adsett, head of Shire's GI Business Unit. 
Shire's LIALDA remains the only once-daily mesalamine product indicated for
both the induction of remission of mild to moderate ulcerative colitis and for
the maintenance of remission of ulcerative colitis. No ANDA's have been
approved for generic versions of LIALDA. 
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                            jmann@shire.com      +44 1256 894 280   
                                                                           
Gwen Fisher                             gfisher@shire.com    +1 484 595 9836    
NOTES TO EDITORS 
Shire enables people with life-altering conditions to lead better lives. 
Our strategy is to focus on developing and marketing innovative specialty
medicines to meet significant unmet patient needs. 
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal,
Internal Medicine and Regenerative Medicine and we are developing treatments
for symptomatic conditions treated by specialist physicians in other targeted
therapeutic areas. 
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- May/09/2013 15:58 GMT
 
 
Press spacebar to pause and continue. Press esc to stop.