BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, May 18 /PRNewswire-FirstCall/ -- Shire plc announces that its subsidiary Shire Laboratories Inc. has filed a lawsuit in the U.S. District Court for the District of New Jersey against Corepharma LLC ("Corepharma") for infringement of Shire Laboratories' U.S. Patent Nos. 5,326,570 ("'570 Patent") and 5,912,013 ("'013 Patent").
The lawsuit results from an Abbreviated New Drug Application ("ANDA") filed by Corepharma for generic versions of Shire's 100 mg, 200 mg, and 300 mg CARBATROL(R) products, as to which Corepharma provided notice to Shire that it is seeking FDA approval to market its generic products prior to the expiration of the '570 and '013 Patents. Pursuant to Hatch-Waxman legislation, the lawsuit triggers a stay of FDA approval of up to 30 months from Corepharma's notice to allow the court to resolve the suit.
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 focuses its business on central nervous system, gastrointestinal, general products and human genetic therapies. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent 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 materialize, 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 commercialization; 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 SPD503 (ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476) (ulcerative colitis), ELAPRASE TM (I2S) (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 commercialization 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 plc's Annual Report on Form 10-K for the year ended December 31, 2005.