Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R)
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
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