Shire Receives INTUNIV Paragraph IV Notice Letter from Teva Pharmaceuticals
Dublin, Ireland - 16 March 2010 - Shire plc (LSE: SHP, NASDAQ; SHPGY),
announces that it has received a Paragraph IV Notice Letter from Teva
Pharmaceuticals USA, Inc. ("Teva") advising of the filing of an Abbreviated New
Drug Application ("ANDA") for a generic version of Shire''s 1 mg, 2mg, 3 mg, and
4mg guanfacine hydrochloride extended release tablets, INTUNIV™.
INTUNIV is protected by three FDA Orange Book listed patents: U.S. Patent No.
5,854,290, Use of Guanfacine in the Treatment of Behavioral Disorders; U.S.
Patent No. 6,287,599 ("the ''599 patent") and U.S. Patent No. 6,811,794 ("the
''794 patent") both titled Sustained Release Pharmaceutical Dosage Forms with
Minimized pH Dependent Dissolution Profiles. The three patents expire in 2015,
2020 and 2022, respectfully.
Shire is currently reviewing the details of Teva''s Paragraph IV Notice Letter
which was only directed to the ''599 and ''794 patents.
The Hatch-Waxman exclusivity period for INTUNIV runs until September 2, 2012
therefore, ANDAs for generic versions of INTUNIV cannot be approved prior to
the end of that exclusivity period.
Under the Hatch-Waxman Act, Shire has 45 days from the receipt of the Notice
Letter to determine if it will file a patent infringement suit. If Shire brings
suit pursuant to the Hatch Waxman regulations, a stay of approval of up to
30-months will be imposed by the FDA on Teva''s ANDA.
For further information please contact:
Investor Cléa 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 (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.
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
Press Release
www.shire.com
END
SHIRE PLC