14th Jan 2005 07:01
ADDERALL XR‚® - Paragraph IV Notices Update Basingstoke, UK and Philadelphia, US - 14 January 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) remains committed to protectingthe patents which it has relating to ADDERALL XR‚®, its product for treatment ofAttention Deficit Hyperactivity Disorder (ADHD).Shire has previously announced a pending suit against Impax Laboratories, Inc.based on Impax's Paragraph IV notice letter for a 30 mg generic version ofADDERALL XR‚®. Shire has now filed a second complaint based on an additionalParagraph IV notice letter from Impax advising of the filing of an AbbreviatedNew Drug Application (ANDA) for a generic version of the 5 mg, 10 mg, 15 mg, 20mg and 25 mg strengths of Shire's mixed amphetamine product ADDERALL XR‚®.Also, as previously announced, Shire has received Paragraph IV notice lettersadvising of the filing of ANDAs for generic versions of all strengths ofADDERALL XR‚® from Barr Laboratories Inc. and from Colony Pharmaceuticals Inc.Shire has filed lawsuits against Barr, the first company to send a noticeletter, and has chosen not to sue Colony.Barr, Impax and Colony may not launch a generic version of ADDERALL XR‚® beforereceiving final approval of their respective ANDAs from the US Food and DrugAdministration (FDA). Should Barr receive a tentative approval from the FDA, itcannot lawfully launch its generic version before the earlier of the expirationof the currently pending 30-month stays or a district court decision in itsfavor. Neither Impax nor Colony will be able to lawfully launch a genericversion of ADDERALL XR‚® without the necessary final approval from the FDA andthe expiration of the "first to file's" exclusivity rights. The FDA may grant180 days of generic market exclusivity to the "first to file".The Barr court case is scheduled to go to trial in January 2006. In the Barrcase, the 30 month stay for the `819 patent began in January 2003 and withrespect to the `300 patent it began in August 2003.The Impax case has an October 2005 trial date. The Impax 30 month stay for the30 mg product began in November 2003 and for the new strengths of 5 mg, 10 mg,15 mg, 20 mg and 25 mg in December 2004.ADDERALL XR‚® is an important product in Shire's portfolio of treatments forADHD and is protected by two patents which expire in 2018: Shire Laboratories'U.S. patent No. 6,322,819 ("819" Patent) and U.S. patent No. 6,605,300 ("300"Patent). -ends- For further information please contact:Investor Relations Clƒ©a Rosenfeld (UK and Europe) +44 1256 894 160 Brian Piper (US and Canada) +1 484 595 8252 Media Jessica Mann (UK and Europe) +44 1256 894 280 Matthew Cabrey (US) +1 484 595 8248 Notes to editorsShire Pharmaceuticals Group plcShire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceuticalcompany with a strategic focus on meeting the needs of the specialist physicianand currently focuses on developing projects and marketing products in theareas of central nervous system (CNS), gastrointestinal (GI), and renaldiseases. Shire has operations in the world's key pharmaceutical markets (US,Canada, UK, France, Italy, Spain and Germany) as well as a specialist drugdelivery unit in the US.For further information on Shire, please visit the Company's website: www.shire.comTHE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACTOF 1995Statements 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 withthe 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 Deficit& 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 METHYPATCH‚® (methylphenidate), Shire's ability to secure new products fordevelopment, including, but not limited to, the execution of a bindingagreement with New River Pharmaceuticals Inc, the implementation of the currentreorganization and other risks and uncertainties detailed from time to time inShire's filings, including its Annual Report on Form 10-K for the year endedDecember 31, 2003, with the Securities and Exchange Commission.212ENDRelated Shares:
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