Shire Reaches Agreement in Principle With U.S. Government
PHILADELPHIA, February 1, 2013 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), today announced that it has
reached an agreement in principle to resolve the previously
disclosed civil investigation into Shire's U.S. sales and marketing
practices relating to ADDERALL XR®, VYVANSE®
and DAYTRANA®[1].
The investigation was led by the U.S. Attorney's Office for the
Eastern District of Pennsylvania,
and Shire disclosed the investigation in 2009. The agreement
also addresses sales and marketing practices relating to
LIALDA® and PENTASA® pursuant to a subsequent
voluntary disclosure made by Shire.
Shire cooperated with the U.S. Government throughout the process
that led to this agreement in principle. Shire has recorded a
$57.5M charge in the fourth quarter
of 2012, comprised of the agreement in principle amount, interest
and costs.
The agreement in principle is subject to change until this
matter is finally resolved. Discussions between Shire and the
U.S. Government are ongoing to establish a final resolution to the
investigation.
Notes to editors
Shire enables people with
life-altering conditions to lead better lives.
Through our deep understanding of patients' needs, we develop
and provide healthcare in the areas of:
- Behavioral Health and Gastro Intestinal conditions
- Rare Diseases
- Regenerative Medicine
as well as other symptomatic conditions treated by specialist
physicians.
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1. DAYTRANA® is a trademark of Noven Pharmaceutical Inc.
We aspire to imagine and lead the future of healthcare, creating
value for patients, physicians, policymakers, payors and our
shareholders.
"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 Pharmaceuticals, Human Genetic Therapies and Regenerative
Medicine products, as well as the ability to secure 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
Sarah Elton-Farr seltonfarr@shire.com +44(0)1256-894157
Media
Jessica Mann (Corporate) jmann@shire.com +44(0)1256-894-280
SOURCE Shire plc
