Shire and Sandoz Settle all Pending Litigation Concerning Adderall XR
Settlement Ends all Litigation With Generics Over ADDERALL XR(R)
PHILADELPHIA, October 13/PRNewswire-FirstCall/ -- Shire plc
(LSE: SHP, NASDAQ: SHPGY), 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 PLC
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.
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
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
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