Shire Update on ProAmatine(R) (midodrine HCl)

By Shire Plc, PRNE
Sunday, September 12, 2010

FDA Posts Clarifying Statement on its Website

PHILADELPHIA, September 13, 2010 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that the United States Food and Drug
Administration today posted an update on its website related to ProAmatine
(known generically as midodrine), a medicine approved for the treatment of
symptomatic orthostatic hypotension. Notably, the FDA clarified that the
FDA's prior announcement related to midodrine "did not represent the actual
withdrawal of the medication from the market." Rather, the FDA stated that it
"represented a step in the regulatory process."

To view this FDA statement, visit:

"Shire is very pleased that FDA has stated that 'continued patient access
to midodrine is a key agency priority' and that the FDA has taken action
allowing midodrine to remain accessible to patients and their families who
rely on this medicine," said Jeffrey Jonas, M.D., Senior Vice President of
Research & Development for Shire. "We look forward to continuing our ongoing
discussions with FDA related to the efficacy of this medicine."

Important Safety Information

Warning: Because ProAmatine(R) can cause marked elevation of supine blood
pressure, it should be used in patients whose lives are considerably
impaired despite standard clinical care. The indication for use of
ProAmatine(R) in the treatment of symptomatic orthostatic hypotension is
based primarily on a change in a surrogate marker of effectiveness, an
increase in systolic blood pressure measured one minute after standing, a
surrogate marker considered likely to correspond to a clinical benefit. At
present, however, clinical benefits of ProAmatine(R), principally improved
ability to carry out activities of daily living, have not been verified.


ProAmatine(R) is contraindicated in patients with severe organic heart
disease, acute renal disease, urinary retention, pheochromocytoma or
thyrotoxicosis. ProAmatine(R) should not be used in patients with persistent
and excessive supine hypertension.

Please see Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit or call 1-800-FDA-1088.

For further information please contact:

Notes to editors


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:

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

    Investor         Eric Rojas (        +1-781-482-0999

    Media            Jessica Mann (       +44-(0)1256-894-280
                     Matthew Cabrey (   +1-484-595-8248

Investor Relations, Eric Rojas (erojas at, +1-781-482-0999;
Media, Jessica Mann (jmann at, +44-(0)1256-894-280;
Matthew Cabrey, (mcabrey at, +1-484-595-8248

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