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INTUNIV is protected by three FDA Orange Book listed patents: U.S. PatentNo. 5,854,290, Use of Guanfacine in the Treatment of Behavioral Disorders;U.S. Patent No. 6,287,599 ("the '599 patent") and U.S. Patent No. 6,811,794("the '794 patent") both titled Sustained Release Pharmaceutical Dosage Formswith Minimized pH Dependent Dissolution Profiles. The three patents expire in2015, 2020 and 2022, respectfully.
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Shire is currently reviewing the details of Teva's Paragraph IV NoticeLetter which was only directed to the '599 and '794 patents.
The Hatch-Waxman exclusivity period for INTUNIV runs until September 2,2012 therefore, ANDAs for generic versions of INTUNIV cannot be approvedprior to the end of that exclusivity period.
Under the Hatch-Waxman Act, Shire has 45 days from the receipt of theNotice Letter to determine if it will file a patent infringement suit. IfShire brings suit pursuant to the Hatch Waxman regulations, a stay ofapproval of up to 30-months will be imposed by the FDA on Teva's ANDA.
Notes to editors
SHIRE PLC
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 adversely affected. The risks and uncertainties include, but arenot limited to, risks associated with: the inherent uncertainty of research,development, approval, reimbursement, manufacturing and commercialization ofthe Company's Specialty Pharmaceutical and Human Genetic Therapies products,as well as the ability to secure and integrate new products forcommercialization and/or development; government regulation of the Company'sproducts; the Company's ability to manufacture its products in sufficientquantities to meet demand; the impact of competitive therapies on theCompany's products; the Company's ability to register, maintain and enforcepatents and other intellectual property rights relating to its products; theCompany's ability to obtain and maintain government and other third-partyreimbursement for its products; and other risks and uncertainties detailedfrom time to time in the Company's filings with the Securities and ExchangeCommission.For further information please contact: Investor Relations Clea Rosenfeld (Rest of the World), +44-1256-894-160; Eric Rojas (North America), +1-617-551-9715. Media Jessica Mann (Rest of the World), +44-1256-894-280; Matthew Cabrey (North America, Specialty Pharma), +1-484-595-8248.
SOURCE Shire Pharmaceutical
