PHILADELPHIA, October 13 Shire plc (LSE: SHP,NASDAQ: SHPGY), the global specialty biopharmaceutical company, announcesthat it has settled all pending litigation with Sandoz, Inc. ("Sandoz") inconnection with Sandoz's Abbreviated New Drug Application ("ANDA") and itsattempt to market generic versions of Shire's ADDERALL XR(R) (mixedamphetamine salts) for the treatment of Attention Deficit HyperactivityDisorder.
The settlement also provides Sandoz with a license to market it owngeneric versions of ADDERALL XR(R) in the United States beginning uponapproval of its own generic products by the FDA, and Sandoz will pay Shire aroyalty from those sales. To date, the US Food and Drug Administration hasnot approved any generic version of ADDERALL XR(R). No payments to Sandoz areinvolved in the settlement agreement. Impax Pharmaceuticals Inc. and BarrLaboratories Inc. remain the only authorized generic supplier of ADDERALL XR.
The litigation involves a patent infringement lawsuit covering Shire'sU.S. patents Nos. 6,322,819 ("the '819 Patent"), and 6,605,300 ("the '300Patent"). As part of the settlement, Sandoz has agreed to a consent judgmentconfirming that its proposed generic products infringe Shire's '819 and '300Patents and that the two patents are valid and enforceable.
Resolution of the case against Sandoz ends all litigation against genericANDA applicants over ADDERALL XR(R).
The agreements, which are effective immediately, have been submitted tothe US Federal Trade Commission for its review as required by law.
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: Investor Clea Rosenfeld (Rest of the World) +44-1256-894-160 Relations Eric Rojas (North America) +1-617-551-9715 Media Jessica Mann (Rest of the World) +44-1256-894-280 Matthew Cabrey (Specialty Pharma) +1-484-595-8248
SOURCE Shire Plc