PHILADELPHIA, Pennsylvania, August 17, 2010 Shire plc (LSE: SHP, NASDAQ: SHPGY) acquired ProAmatine as a part of theacquisition of Roberts Pharma in 1999 and Shire conducted and completed thepost marketing trials that the FDA required. The FDA, however, viewed thesetrials as inconclusive and required that additional trials be conducted forProAmatine to maintain its marketing authorization. As a result, Shireelected to withdraw the product effective September 30, 2010 and notified theFDA in November 2009 and healthcare professionals earlier this year of thisdecision. Shire's withdrawal of the NDA was not related to any concernsregarding the safety of ProAmatine.
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 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: Media Matthew Cabrey ([email protected]
) +1-610-613-2790 Ben Atwell ([email protected]
SOURCE Shire plc