Shire Reaches Agreement in Principle With U.S. Government
PHILADELPHIA, February 1, 2013
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 ^® .
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
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
as well as other symptomatic conditions treated by specialist physicians.
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
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:
Eric Rojas firstname.lastname@example.org +1-781-482-0999
Sarah Elton-Farr email@example.com +44(0)1256-894157
Jessica Mann (Corporate) firstname.lastname@example.org +44(0)1256-894-280
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