15th Aug 2006 07:00
Shire and Barr Settle All Pending Litigation Concerning ADDERALL XR‚®and enter into Development and License AgreementBasingstoke, UK and Philadelphia, US - August 14, 2006 - Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) announces that it has settled all pending litigationwith Barr Laboratories, Inc. ("Barr"), a subsidiary of Barr Pharmaceuticals,Inc. (NYSE: BRL) in connection with Barr's Abbreviated New Drug Application("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR(extended-release mixed amphetamine salts) for the treatment of AttentionDeficit Hyperactivity Disorder ("ADHD").Barr will not be permitted to market a generic version of ADDERALL XR in theUnited States until April 1, 2009, except for certain limited circumstances,such as the launch of another party's generic version of ADDERALL XR. Asannounced earlier this year, Shire's settlement with Impax Laboratories allowsImpax to market a generic version of ADDERALL XR 181 days following Barr'slaunch. No payments to Barr are involved in the settlement agreement.The litigations, all pending in the United States District Court for theSouthern District of New York, are directed to Barr's infringement of Shire'sU.S. Patent Nos. 6,322,819 ("the `819 Patent"), 6,605,300 ("the `300 Patent")and 6,913,768 ("the `768 Patent") and Barr's desire to market generic versionsof ADDERALL XR prior to the expiration of Shire's patents. As part of thesettlement, Barr entered into consent judgments and agreed to permanentinjunctions confirming the validity and enforceability of Shire's `819, `300and `768 Patents. Barr has also admitted that any generic product made underits ANDA would infringe the `768 patent.Shire and Duramed Pharmaceuticals, Inc. ("Duramed"), a subsidiary of BarrPharmaceuticals, Inc., have also entered into an agreement related to Duramed'stransvaginal ring technology that will be applied to at least five women'shealth products, as well as a license to Duramed's currently marketed oralcontraceptive, Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg). Under this agreement, Shirewill make an initial payment of $25 million to Duramed for previously incurredproduct development expenses, and will reimburse Duramed for developmentexpenses incurred going forward up to a maximum of $140 million over eightyears. Shire will have the exclusive rights to market these products in thefive major European markets of the UK, Germany, France, Italy and Spain andother areas, excluding North America and to the subsequent sales they willgenerate on a royalty-free basis.Duramed has also agreed to purchase Shire's ADDERALL‚® (immediate-release mixedamphetamine sales) product for $63 million. This transaction is subject toreporting under the United States Hart-Scott-Rodino Act.Matthew Emmens, Shire Chief Executive Officer stated: "We are very pleased tohave reached this settlement on terms that are consistent with our beliefs thatShire's patents are valid and enforceable and infringed by would-be genericcompetitors. We are also excited about the opportunity of a new development andlicensing agreement in the specialty area of women's health, particularly inEurope."The agreements will be submitted to the United States Federal Trade Commissionas required by law and become effective upon the Courts' signing of consentjudgments for all of the litigations.Live conference call & webcastThe details of the live conference call are as follows:Date Tuesday August 15, 2006Time 1230 BST / 0730 EDTUK dial in 0800 953 0934US / Canada dial in 1866 224 2843International dial in +44 (0) 1452 569 102Password/Conf ID 4583928Live Webcast: link will be available for two weeks on www.shire.comReplay:A replay of the call will be available for two weeks on www.shire.com, in theinvestor relations section.For further information please contact:Investor Relations Clƒ©a Rosenfeld (Rest of the World) +44 1256 894 160Brian Piper (North America) +1 484 595 8252Media Jessica Mann (Rest of the World) +44 1256 894 280Matthew Cabrey (North America) +1 484 595 8248Notes 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 attention deficit and hyperactivity disorder (ADHD),human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. Thestructure is sufficiently flexible to allow Shire to target new therapeuticareas to the extent opportunities arise through acquisitions. Shire believesthat a carefully selected portfolio of products with a strategically alignedand relatively small-scale sales force will deliver strong results.Shire's focused strategy is to develop and market products for specialtyphysicians. Shire's in-licensing, merger and acquisition efforts are focused onproducts in niche markets with strong intellectual property protection eitherin 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 forward-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's results could be materially affected. Therisks and uncertainties include, but are not limited to, risks associated with: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's Attention Deficitand Hyperactivity Disorder (ADHD) franchise; patents, including but not limitedto, legal challenges relating to Shire's ADHD franchise; government regulationand approval, including but not limited to the expected product approval datesof SPD503 (ADHD), SPD465 (ADHD), MESAVANCE TM (ulcerative colitis) and NRP104(ADHD), including its scheduling classification by the Drug EnforcementAdministration in the United States; Shire's ability to benefit from theacquisition of Transkaryotic Therapies Inc.; Shire's ability to secure newproducts for commercialization and/or development; and other risks anduncertainties detailed from time to time in Shire's and its predecessorregistrant Shire Pharmaceuticals Group plc's filings with the Securities andExchange Commission, including its Annual Report on Form 10-K for the yearended December 31, 2005 and its most recent Quarterly Report filed on Form 10-Qfor the financial period ended on March 31, 2006. 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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