Shire plc - Statement re ProAmatine
By Shire Plc, PRNEMonday, August 16, 2010
PHILADELPHIA, Pennsylvania, August 17, 2010 - Shire plc (LSE: SHP, NASDAQ: SHPGY) acquired ProAmatine as a part of the
acquisition of Roberts Pharma in 1999 and Shire conducted and completed the
post marketing trials that the FDA required. The FDA, however, viewed these
trials as inconclusive and required that additional trials be conducted for
ProAmatine to maintain its marketing authorization. As a result, Shire
elected to withdraw the product effective September 30, 2010 and notified the
FDA in November 2009 and healthcare professionals earlier this year of this
decision. Shire's withdrawal of the NDA was not related to any concerns
regarding the safety of ProAmatine.
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.
For further information please contact: Media Matthew Cabrey (mcabrey@shire.com) +1-610-613-2790 Ben Atwell (Ben.Atwell@fd.com) +44-020-7269-7242
For further information please contact: Media, Matthew Cabrey (mcabrey at shire.com), +1-610-613-2790; Ben Atwell (Ben.Atwell at fd.com), +44-020-7269-7242
Tags: August 17, Pennsylvania, Philadelphia, Shire Plc