20th Jan 2006 09:35
Shire and Impax Settle All Pending Litigation Concerning ADDERALL XR‚®Enter into Agreements for Generic ADDERALL XR and Promotion of CARBATROL‚® inthe United StatesBasingstoke, UK and Philadelphia, PA - January 19, 2006 - Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) announces that it has settled all pending litigationwith Impax Laboratories, Inc. ("Impax") in connection with Impax's AbbreviatedNew Drug Application and its attempt to market generic versions of Shire'sADDERALL XR‚® (mixed amphetamine salts) for the treatment of Attention DeficitHyperactivity Disorder.The litigation involves patent infringement lawsuits covering Shire's U.S.patents Nos. 6,322,819 ("the `819 Patent"), 6,605,300 ("the `300 Patent") and6,913,768 (" the `768 Patent"). As part of the settlement, Impax has confirmedthat its proposed generic products infringe Shire's `819, `300 and `768 Patentsand that the three patents are valid and enforceable.Impax will be permitted to market generic versions of ADDERALL XR in the UnitedStates no later than January 1, 2010 and will pay Shire a royalty from thosesales. In certain situations, such as the launch of another generic version ofADDERALL XR, Impax may be permitted to enter the market as Shire's authorizedgeneric. No payments to Impax are involved in the settlement agreement.Shire and Impax have also entered into an agreement to promote Shire'sCARBATROL‚® (carbamazepine) for the treatment of epilepsy in the United States.Shire will pay Impax to promote CARBATROL to neurologists using a specialtyfield sales force of 66 representatives. Promotion will continue for threeyears beginning on or about July 2006. Impax will have incentives under a gainshare arrangement.Matthew Emmens, Shire Chief Executive Officer stated: "We are very pleased tohave resolved the lawsuits against Impax. The settlement terms are consistentwith our beliefs that Shire's patents are valid and enforceable. We lookforward to working together with Impax to resume promotion and growth ofCARBATROL."Shire confirms that discussions with Barr Laboratories, in connection withlawsuits pending against Barr in its attempts to market a generic ADDERALL XR,are continuing. The Court continued the final pretrial conference to March 10,2006. No trial date has been set.The agreements, which are effective immediately, will be submitted to theUnited States Federal Trade Commission for its review as required by law.For further information please contact:Investor Relations Clƒ©a Rosenfeld (Rest of the World) +44 1256 894 160 Brian Piper (North America) +1 484 595 8252 Media Jessica Mann (Rest of the World) +44 1256 894 280 Matthew Cabrey (North America) +1 484 595 8248 Notes to editorsSHIRE PLCShire's strategic goal is to become the leading specialty pharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on central nervous system (CNS), gastrointestinal (GI),general products (GP) and human genetic therapies (HGT) - all being areas inwhich Shire has a commercial presence. The structure is sufficiently flexibleto allow Shire to target new therapeutic areas to the extent opportunitiesarise through acquisitions. Shire believes that a carefully selected portfolioof products with a strategically aligned and relatively small-scale sales forcewill deliver strong results. Shire's focused strategy is to develop and marketproducts for specialty physicians. This approach aims to deliver increasedreturns and lower risks. Shire's in-licensing and merger and acquisitionefforts are focused on products in niche markets with strong intellectualproperty protection either in the US or Europe.For further information on Shire, please visit the Company's website: www.shire.com."SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995Statements included herein that are not historical facts are forwarding-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, Shire plc's results could be materially affected.The risks and uncertainties include, but are not limited to; risks associatedwith the inherent uncertainty of pharmaceutical research, product development,manufacturing and commercialization; the impact of competitive products,including, but not limited to, the impact of those on Shire plc's AttentionDeficit and Hyperactivity Disorder ("ADHD") franchise; patents, including butnot limited to, legal challenges relating to Shire plc's ADHD franchise;government regulation and approval, including but not limited to the expectedproduct approval dates of DAYTRANATM (MTS/METHYPATCH) (ADHD), SPD503 (ADHD),SPD465 (ADHD), MESAVANCETM (SPD476) (ulcerative colitis), ELAPRASETM(idursulfase) (Hunter syndrome) and NRP104 (ADHD), including its schedulingclassification by the Drug Enforcement Administration in the United States;Shire plc's ability to benefit from the acquisition of Transkaryotic TherapiesInc.; Shire plc's ability to secure new products for commercialization and/ordevelopment; and other risks and uncertainties detailed from time to time inShire plc's and its predecessor registrant Shire Pharmaceuticals Group plc'sfilings with the US Securities and Exchange Commission, including ShirePharmaceuticals Group plc's Annual Report on Form 10-K for the year endedDecember 31, 2004.Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom Tel +44 (0)1256 894000 Fax +44 (0)1256 894708 www.shire.com Press Release Registered in England 2883758 Registered Office as aboveENDSHIRE PLCRelated Shares:
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