PHILADELPHIA, May 9, 2013 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its
subsidiary, Shire Development LLC, has prevailed in its litigation
against Watson Pharmaceuticals Inc., Watson Laboratories,
Inc.-Florida, Watson Pharma, Inc.
and Watson Laboratories, Inc. (collectively "Watson", now "Actavis") in connection with
their Abbreviated New Drug Application ("ANDA") for a generic
version of Shire's LIALDA® (mesalamine) delayed release
tablets for the induction of remission in adults with active, mild
to moderate ulcerative colitis and for the maintenance of remission
of ulcerative colitis.
Following a five day bench trial in the Southern District of
Florida, Judge Middlebrooks issued
a ruling upholding the validity of the patent covering LIALDA, US
Patent No. 6,773,720 (the "'720 patent), and holding that the
proposed ANDA formulation infringes the claims of that patent.
Accordingly, Judge Middlebrooks confirmed that Shire is
entitled to an injunction, which he will issue separately, which
prohibits the FDA from approving the ANDA formulation until the
expiration of the '720 patent.
"Shire is very pleased that the court has ruled in our favor.
We rely on our patents to be able to continue to invest in
therapies that bring value to our patients and their caregivers.
This ruling supports the innovative therapies that we develop
in order to improve the lives of ulcerative colitis patients,"
stated Roger Adsett, head of Shire's
GI Business Unit.
Shire's LIALDA remains the only once-daily mesalamine product
indicated for both the induction of remission of mild to moderate
ulcerative colitis and for the maintenance of remission of
ulcerative colitis. No ANDA's have been approved for generic
versions of LIALDA.
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead
better lives.
Our strategy is to focus on developing and marketing innovative
specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases,
Gastrointestinal, Internal Medicine and Regenerative Medicine and
we are developing treatments for symptomatic conditions treated by
specialist physicians in other targeted therapeutic areas.
http://www.shire.com
FORWARD - LOOKING STATEMENTS - "SAFE
HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included in this announcement that are not historical
facts are forward-looking statements. 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, Shire's results could be materially adversely
affected. The risks and uncertainties include, but are not limited
to, that:
- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion;
- the failure to obtain and maintain reimbursement, or an
adequate level of reimbursement, by third-party payors in a timely
manner for Shire's products may impact future revenues and
earnings;
- Shire relies on a single source for manufacture of certain of
its products and a disruption to the supply chain for those
products may result in Shire being unable to continue marketing or
developing a product or may result in Shire being unable to do so
on a commercially viable basis;
- Shire uses third party manufacturers to manufacture many of its
products and is reliant upon third party contractors for certain
goods and services, and any inability of these third party
manufacturers to manufacture products, or any failure of these
third party contractors to provide these goods and services, in
each case in accordance with its respective contractual
obligations, could adversely affect Shire's ability to manage its
manufacturing processes or to operate its business;
- the development, approval and manufacturing of Shire's products
is subject to extensive oversight by various regulatory agencies
and regulatory approvals or interventions associated with changes
to manufacturing sites, ingredients or manufacturing processes
could lead to significant delays, increase in operating costs, lost
product sales, an interruption of research activities or the delay
of new product launches;
- the actions of certain customers could affect Shire 's ability
to sell or market products profitably and fluctuations in buying or
distribution patterns by such customers could adversely impact
Shire's revenues, financial conditions or results of
operations;
- investigations or enforcement action by regulatory authorities
or law enforcement agencies relating to Shire's activities in the
highly regulated markets in which it operates may result in the
distraction of senior management, significant legal costs and the
payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including
Shire's ability to obtain, maintain, enforce and defend patents and
other intellectual property rights required for its business, could
have a material adverse effect on Shire's revenues, financial
condition or results of operations; and other risks and
uncertainties detailed from time to time in Shire's filings with
the U.S. Securities and Exchange Commission, including its most
recent Annual Report on Form 10-K.
For further information please contact:
Investor Relations
Eric Rojas
erojas@shire.com
+1-781-482-0999
Sarah Elton-Farr
seltonfarr@shire.com
+44-1256-894157
Media
Jessica Mann
jmann@shire.com
+44-1256-894-280
Gwen Fisher
gfisher@shire.com
+1-484-595-9836