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The ruling granted-in-part and denied-in-part the requests from Shire.Shire had requested the FDA to issue formal guidance, consistent with theFDA's advice to Shire, requiring that bioequivalence to Pentasa be shown byboth rigorous dissolution testing and studies with clinical endpoints. TheFDA response to the Shire's Citizen's Petition granted the request withregard to the dissolution testing and denied the request with respect to thestudies with clinical endpoints. The FDA response further imposed arequirement for pharmacokinetic data to establish bioequivalence.
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A copy of the FDA's ruling can be found in the Investors section of theCompany's website: http://www.shire.com.
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 Eric Rojas (North America) +1-781-482-0999 Relations Media Jessica Mann (Rest of the World) +44-1256-894-280 Matthew Cabrey +1-484-595-8248 (North America, Specialty Pharma)
SOURCE Shire plc
