TIDMSHP
FDA Determines VYVANSE® was Properly Granted Five-Year Market Exclusivity
DUBLIN, IRELAND - October 26, 2009 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the
global specialty biopharmaceutical company, announces that the Food and Drug
Administration (FDA), following a thorough administrative review of governing
statutory and regulatory standards and public comments, has affirmed its prior
decision to grant five-year New Chemical Entity (NCE) exclusivity to
lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the
treatment of attention-deficit hyperactivity disorder under the name VYVANSE®.
The five-year exclusivity period for VYVANSE expires on February 23, 2012.
VYVANSE is covered by United States patents which remain in effect until June
29, 2023.
On February 23, 2007, after reviewing the requisite clinical studies submitted
on behalf of VYVANSE, the FDA determined that VYVANSE qualified as a NCE and
was entitled to five-year market exclusivity. The FDA therefore appropriately
refused to file the Abbreviated New Drug Application submitted by Actavis
Elizabeth, LLC (Actavis) for generic lisdexamfetamine dimesylate in January
2009. On February 24, 2009, Actavis sued the FDA in the District Court of the
District of Columbia challenging the NCE decision. On April 13, 2009, the FDA
opened a public docket to consider Actavis's challenge to the FDA's regulations
governing NCE exclusivity and the corresponding award of exclusivity to
VYVANSE. The court case was stayed pending the outcome of this FDA review.
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) +1 484 595 8248
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 Web site: http://
www.shire.com.
THE "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.
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Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
Press Release
www.shire.com
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