.
Lialda# - Shire Files Suit against Cadila Healthcare Limited, doing business as
Zydus Cadila and Zydus Pharmaceuticals (USA), Inc.
Dublin, Ireland and Philadelphia, US - July 8, 2010 - Shire plc (LSE: SHP,
NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that
its subsidiaries Shire Development Inc. and Shire Pharmaceutical Development
Inc. have filed a lawsuit in the U.S. District Court for the District of
Delaware against Cadila Healthcare Limited, doing business as Zydus Cadila and
Zydus Pharmaceuticals (USA), Inc. (collectively "Zydus") for the infringement
of U.S. Patent No. 6,773,720 (the '720 patent).
The lawsuit was filed as a result of an Abbreviated New Drug Application (ANDA)
filed by Zydus seeking FDA approval to market and sell generic versions of
Lialda# (mesalamine) prior to the expiration of the '720 patent.
Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit
within 45 days of receiving the Paragraph IV notification letter from Zydus,
the FDA must refrain from approving Zydus' ANDA for 30 months, or until a
district court decision finding that the patent is invalid or not infringed,
whichever occurs earlier. The stay on generic approval will expire in November
2012 unless terminated earlier.
For further information please contact:
Investor Cléa Rosenfeld (Rest of the World) +44 1256 894 160
Relations
Eric Rojas (North America) +1 781 482 0999
Media Jessica Mann (Rest of the World) +44 1256 894 280
Matthew Cabrey (North America, Specialty +1 484 595 8248
Pharma)
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:
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.
2
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
Press Release
www.shire.com
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