INTUNIV(TM) - Shire Files Suit Against Actavis Elizabeth LLC and Actavis Inc.
The lawsuit results from an Abbreviated New Drug Application (ANDA) filedby Actavis for generic versions of 1 mg, 2 mg, 3 mg and 4 mg guanfacinehydrochloride extended release tablets, INTUNIV(TM), which seeks to marketsuch generic products before the expiration of the '290, '599, and '794patents. The regulatory exclusivity period for INTUNIV(TM) runs throughSeptember 2, 2012.
Notes to editors
Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit hyperactivitydisorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)diseases as well as opportunities in other therapeutic areas to the extentthey arise through acquisitions. Shire's in-licensing, merger and acquisitionefforts are focused on products in specialist markets with strongintellectual property protection and global rights. Shire believes that acarefully selected and balanced portfolio of products with strategicallyaligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:http://www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORMACT OF 1995
Statements included herein that are not historical facts areforward-looking statements. Such forward-looking statements involve a numberof risks and uncertainties and are subject to change at any time. In theevent such risks or uncertainties materialize, the Company's results could bematerially affected. The risks and uncertainties include, but are not limitedto, risks associated with: the inherent uncertainty of pharmaceuticalresearch, product development, manufacturing and commercialization including,but not limited to, the establishment in the market of VYVANSE(TM)(lisdexamfetamine dimesylate) (Attention Deficit Hyperactivity Disorder("ADHD")); the impact of competitive products, including, but not limited to,the impact of those on the Company's ADHD franchise; patents, including butnot limited to, legal challenges relating to the Company's ADHD franchise;government regulation and approval, including but not limited to the expectedproduct approval date of INTUNIV(TM) (guanfacine extended release) (ADHD);the Company's ability to secure new products for commercialization and/ordevelopment; the Company's proposed offer for Jerini AG, including but notlimited to, the Company's ability to successfully complete the offer andintegrate Jerini AG, as well as realize the anticipated benefits of theacquisition; and other risks and uncertainties detailed from time to time inthe Company's filings with the Securities and Exchange Commission, includingthe Company's Annual Report on Form 10-K for the year ended December 31, 2007.For further information please contact: Investor Relations: Clea Rosenfeld (Rest of the World) +44-1256-894-160 Eric Rojas (North America) +1-781-482-0999 Media: Jessica Mann (Rest of the World) +44-1256-894-280 Matthew Cabrey (North America) +1-484-595-8248
SOURCE Shire plc
You May Also Like