INTUNIV - Shire Files Suit Against Impax and Watson
DUBLIN and
PHILADELPHIA, December 3, 2010/PRNewswire-FirstCall/ -- Shire plc
(LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical
company, announces that its subsidiary Shire LLC has filed a
lawsuit in the U.S. District Court for the Northern District of
California against Impax Laboratories, Inc. ("Impax") and Watson
Pharmaceuticals, Inc., Watson Laboratories, Inc.-Florida, Watson
Pharma, Inc and ANDA, Inc. (collectively "Watson") for the
infringement of U.S. Patent Nos. 5,854,290 (the '290 patent),
6,287,599 (the '599 patent), and 6,811,794 (the '794 patent).
The lawsuit results
from Abbreviated New Drug Applications (ANDAs) filed by Impax and
Watson for generic versions of 4 mg guanfacine hydrochloride
extended release tablets, INTUNIV(TM), which seek to market such
generic products before the expiration of the '290, '599, and '794
patents. The regulatory exclusivity period for INTUNIV(TM) runs
through September 2, 2012.
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 Relations Eric Rojas (erojas@shire.com) +1-781-482-0999
Media Jessica Mann (jmann@shire.com) +44-1256-894-280
Matthew Cabrey (mcabrey@shire.com) +1-484-595-8248
Source: Shire plc
Investor, Eric Rojas
(erojas@shire.com), +1-781-482-0999, Relations, Media, Jessica
Mann, (jmann@shire.com), +44-1256-894-280, Matthew Cabrey
(mcabrey@shire.com) +1-484-595-8248
Posted: December 2010
