Healthcare Industry News: SPD476
News Release - March 3, 2006
Shire Sues Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc.BASINGSTOKE, England and PHILADELPHIA, March 3 (HSMN NewsFeed) -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that its subsidiary Shire Laboratories Inc. has filed a lawsuit in the US District Court for the Eastern District of Pennsylvania against Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. ('Teva') for infringement of Shire Laboratories' US Patent Nos. 6,322,819 ('the '819 Patent') and 6,605,300 ('the '300 Patent').
The lawsuit results from an Abbreviated New Drug Application filed by Teva for generic versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR®, pursuant to which Teva provided notice that it would seek to market its generic products before the expiration of the '819 and '300 Patents in 2018. The lawsuit alleges that all of Teva's generic strengths infringe the patents in suit. Pursuant to Hatch-Waxman legislation, there will be a 30-month stay with respect to Teva's proposed 25 mg dosage product.
ADDERALL XR is Shire's Attention Deficit Hyperactivity Disorder medicine.
Notes to editors
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire's therapeutic focus is on central nervous system (CNS), gastrointestinal (GI), human genetic therapies (HGT) and general products (GP). The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent that opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property 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 of 1995
Statements included herein that are not historical facts are forwarding-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialise, Shire plc's results could be materially affected. The risks and uncertainties include, but are not limited to; risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialisation; the impact of competitive products, including, but not limited to, the impact of those on Shire plc's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents, including but not limited to, legal challenges relating to Shire plc's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of DAYTRANA(TM) (MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), MESAVANCE(TM) (SPD476) (ulcerative colitis), ELAPRASE(TM) (idursulfase) (Hunter syndrome) and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire plc's ability to benefit from the acquisition of Transkaryotic Therapies Inc.; Shire plc's ability to secure new products for commercialisation and/or development; and other risks and uncertainties detailed from time to time in Shire plc's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the US Securities and Exchange Commission, including Shire Pharmaceuticals Group plc's Annual Report on Form 10-K for the year ended December 31, 2004.
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