PHILADELPHIA, May 31, 2013 /PRNewswire/ --
Shire LLC has settled its litigation against Teva
Pharmaceuticals USA Inc. ("Teva")
in connection with Teva's Abbreviated New Drug Application ("ANDA")
for a generic version of Shire's INTUNIV (guanfacince) Extended
Release Tablets for the treatment of Attention Deficit
Hyperactivity Disorder.
The settlement provides Teva with a license to market in
the United States either its own
generic versions of INTUNIV or authorized generic versions of
INTUNIV supplied by Shire. The license takes effect after the
expiration of the 180 day exclusivity period granted to Actavis, as
the first ANDA filer. Actavis is licensed by Shire to market
generic product beginning on December 1,
2014.
The litigation involves a patent infringement lawsuit relating
to U.S. patents 6,287,599 ("the '599 Patent"), and 6,811,794 ("the
'794 Patent"). A bench trial against Actavis and Teva was
held in September 2012. As
Shire has previously settled with Actavis, and has now settled with
Teva, the court will not be issuing a decision on the trial.
As part of the settlement, Teva has confirmed that its
proposed generic products infringe Shire's '599 and '794 Patents
and that the two patents are valid and enforceable with respect to
those proposed generic products.
The agreements, which are effective immediately, have been
submitted to the US Federal Trade Commission for its review as
required by law.
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
SOURCE Shire plc