11th Nov 2005 15:25
For immediate release ADDERALL XR‚®- Impax Files Suit against Shire for Invalidity and Non-infringement of U.S. Patent No. 6,913,768 Basingstoke, UK and Philadelphia, US - November 11, 2005 - ShirePharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces thatits subsidiary Shire Laboratories Inc. has been notified that ImpaxLaboratories, Inc. ("Impax") has filed a declaratory judgment complaint againstit in the District Court of Delaware. The lawsuit involves an ANDA (AbbreviatedNew Drug Application) filed by Impax seeking FDA approval to market and sellgeneric versions of Shire's 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALLXR‚® products. Impax alleges in its complaint that Shire's U.S. Patent No.6,913,768 ("the `768 Patent") is invalid and not infringed by Impax. The `768patent issued to Shire on July 5, 2005.On October 20, 2005, Shire previously announced that it had filed a lawsuit inthe U.S. District Court for the Southern District of New York against both BarrLaboratories, Inc. ("Barr") and Impax for infringement of the same `768 Patent.Shire also has separate pending patent litigations against Barr and Impaxregarding U.S. Patent Nos. 6,322,819 and 6,605,300, in New York and Delaware,respectively. ADDERALL XR‚® is Shire's leading Attention Deficit HyperactivityDisorder ("ADHD") medicine. -ends- 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 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 and marketing products in the areas ofcentral nervous system (CNS), gastrointestinal (GI), renal diseases and humangenetic therapies. Shire has operations in the world's key pharmaceuticalmarkets (US, Canada, UK, France, Italy, Spain and Germany) as well as aspecialist drug delivery unit in the US.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 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 Deficitand Hyperactivity Disorder (ADHD) franchise, patents, including, but notlimited to, legal challenges relating to Shire's ADHD franchise, governmentregulation and approval, including, but not limited to, the expected productapproval dates of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476(ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104(ADHD), including its scheduling classification by the Drug Enforcement Agencyin the United States, Shire's ability to benefit from its acquisition of TKT,Shire's ability to secure new products for commercialization and/or developmentand other risks and uncertainties detailed from time to time in Shire's filingswith the Securities and Exchange Commission, including its Annual Report onForm 10-K for the year to December 31, 2004.ADHD affects approximately 7.8 percent of all school-age children, about 4.4million U.S. children aged 4 to 17 years, according to the U.S. Centers forDisease Control and PreventionADHD is a neurological behavioral disorder that manifests as a persistentpattern of inattention and/or hyperactivity-impulsivity that is more frequentand severe than typically observed in individuals at a comparable age andmaturity level. Because everyone shows signs of these behaviors at times, thebehaviors must appear early in life (before age 7) and continue for at leastsix months, according to the ADHD diagnosis criteria as defined in the AmericanPsychiatric Association'sAlthough there is no cure for ADHD, physicians and advocates are finding waysto help people with the condition learn to adapt to their school, home, socialand work settings. ADHD usually can be successfully managed with a combinationof treatments, such as behavioral therapy, skill building and medication.Medication should be considered part of an overall multi-modal treatment planfor ADHD.For further information on ADHD please visitAbout ADDERALL XRAdderall XR was generally well tolerated in clinical studies. The most commonside effects in studies included:Adderall XR may not be right for everyone. Patients should speak with theirdoctor if they have a history of high blood pressure or any heart conditions,glaucoma, thyroid problems, emotional instability, mental illness, or a knownallergy to this type of medication. Abuse of amphetamines may lead todependence. Misuse of amphetamines may cause sudden death and seriouscardiovascular adverse events. These events have also been reported rarely withamphetamine use.If you are currently taking or have recently taken a type of antidepressantcalled a MAO inhibitor or have a pre-existing structural heart abnormality, youshould not take Adderall XR. There is a potential for worsening of motion orverbal tics and Tourette's syndrome. A patient should report any newpsychological symptoms to his or her physician.For further information on Shire, please visit the Company's website:###Thursday, Oct. 27, 2005, 4:30 to 6:30 p.m. CDTMLR Code: A707; Date of first use: 10/27/05 2Registered in England 2883758 Registered Office as aboveHampshire 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 Pharmaceuticals Group PLCRelated Shares:
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