6th Apr 2006 15:59
CARBATROL‚® - Paragraph IV Notice Letter from Corepharma LLC Philadelphia, PA, US and Basingstoke, UK - April 06, 2006 -- Shire plc (LSE:SHP, NASDAQ: SHPGY, TSX: SHQ) announces that it has received a Paragraph IVnotice letter from Corepharma LLC advising of the filing of an Abbreviated NewDrug Application (ANDA) for its carbamazepine extended release products,generic versions of Shire's Carbatrol. The notice letter is directed to 100 mg,200 mg and 300 mg strength products. Shire is currently reviewing the detailsof Corepharma's Paragraph IV notice letter.Shire has previously announced that it received a notice letter from NostrumPharmaceuticals, Inc. regarding its ANDA for a 300 mg strength genericCARBATROL product. Shire has filed a lawsuit against Nostrum regarding thisnotice letter and the litigation is pending in the District of New Jersey.CARBATROL is an important product for the treatment of epilepsy and trigeminalneuralgia, and is protected by two patents, U.S. Patent No. 5,326,570 and U.S.Patent No. 5,912,013.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, gastrointestinal, generalproducts and human genetic therapies - all being areas in which Shire has acommercial presence. The structure is sufficiently flexible to allow Shire totarget new therapeutic areas to the extent opportunities arise throughacquisitions. Shire believes that a carefully selected portfolio of productswith strategically aligned and relatively small-scale sales forces will deliverstrong results. Shire's strategy is to develop and market products forspecialty physicians. Shire's in-licensing and merger and acquisition effortsare focused on products in niche markets with strong intellectual propertyprotection 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 risksor uncertainties materialize, Shire plc's results could be materiallyaffected. The risks and uncertainties include, but are not limited to: risksassociated with the inherent uncertainty of pharmaceutical research, productdevelopment, manufacturing and commercialization; the impact of competitiveproducts, including, but not limited to, the impact of those on Shire plc'sAttention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents,including but not limited to, legal challenges relating to Shire plc's ADHDfranchise; government regulation and approval, including but not limited to theexpected product approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE¢â€ž¢(SPD476) (ulcerative colitis), ELAPRASE¢â€ž¢ (I2S) (Hunter syndrome) and NRP104(ADHD), including its scheduling classification by the Drug EnforcementAdministration in the United States; Shire plc's ability to benefit from theacquisition of Transkaryotic Therapies Inc.; Shire plc's ability to secure newproducts for commercialization and/or development; and other risks anduncertainties detailed from time to time in Shire plc's and its predecessorregistrant Shire Pharmaceuticals Group plc's filings with the US Securities andExchange Commission, including Shire plc's Annual Report on Form 10-K for theyear ended December 31, 2005. # # # 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 ENDSHIRE PLCRelated Shares:
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