PHILADELPHIA, October 13 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, announces that it has settled all pending litigation with Sandoz, Inc. ("Sandoz") in connection with Sandoz's Abbreviated New Drug Application ("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR(R) (mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder.
The settlement also provides Sandoz with a license to market it own generic versions of ADDERALL XR(R) in the United States beginning upon approval of its own generic products by the FDA, and Sandoz will pay Shire a royalty from those sales. To date, the US Food and Drug Administration has not approved any generic version of ADDERALL XR(R). No payments to Sandoz are involved in the settlement agreement. Impax Pharmaceuticals Inc. and Barr Laboratories Inc. remain the only authorized generic supplier of ADDERALL XR.
The litigation involves a patent infringement lawsuit covering Shire's U.S. patents Nos. 6,322,819 ("the '819 Patent"), and 6,605,300 ("the '300 Patent"). As part of the settlement, Sandoz has agreed to a consent judgment confirming that its proposed generic products infringe Shire's '819 and '300 Patents and that the two patents are valid and enforceable.
Resolution of the case against Sandoz ends all litigation against generic ANDA applicants over ADDERALL XR(R).
The agreements, which are effective immediately, have been submitted to the US Federal Trade Commission for its review as required by law.
Notes to editors
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned 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 REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.
SOURCE Shire Plc
CONTACT: 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 (Specialty Pharma), +1-484-595-8248