PHILADELPHIA, April 25, 2013 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its
subsidiary, Shire LLC, has settled all pending litigation with
Actavis, Inc., Actavis LLC, and Actavis Elizabeth LLC (collectively
"Actavis") and Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and ANDA, Inc.
(collectively "Watson") in
connection with Actavis' and Watson's Abbreviated New Drug Applications
("ANDAs") for generic versions of Shire's INTUNIV® (
guanfacine hydrochloride) for the treatment of Attention Deficit
Hyperactivity Disorder.
The settlement provides Actavis with a license to make and
market Actavis' generic versions of INTUNIV in the United States on December 1, 2014, or earlier in certain limited
circumstances. Such sales will require the payment of a
royalty of 25% of gross profits to Shire during the 180 day period
of Actavis' exclusivity. The settlement also provides
Watson with a license to make and
market Watson's generic versions
of INTUNIV in the United States
181 days after Actavis' launch of generic INTUNIV, or earlier in
certain limited circumstances. To date, the US Food and Drug
Administration has granted final approval only to Actavis' ANDA for
generic versions of INTUNIV.
These litigations were patent infringement lawsuits relating to
U.S. patents 6,287,599 ("the '599 Patent"), 6,811,794 ("the '794
Patent"), 5,854,290 (which was subsequently dedicated to the
public). As part of the settlement, Actavis and Watson have agreed to a consent judgment
confirming that their proposed generic products infringe Shire's
'599 and '794 Patents and that those two patents are valid and
enforceable with respect to those proposed generic products and any
other generic version of INTUNIV.
The lawsuit against Actavis proceeded to trial in the District
Court of Delaware in September 2012 wherein Teva Pharmaceuticals,
USA, Inc. was also a defendant.
The Delaware court has not issued a decision. The
lawsuit against Watson is
scheduled for trial to begin on February 10,
2014 wherein Impax Laboratories, Inc. is also a
defendant.
The agreements, which are effective immediately, will be
submitted to the US Federal Trade Commission and Department of
Justice for review as required by law.
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.
We aspire to imagine and lead the future of healthcare, creating
value for patients, physicians, policymakers, payors and our
shareholders.
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 (Corporate)
jmann@shire.com
+44-1256-894-280
Gwen Fisher (Specialty Pharma)
gfisher@shire.com
+1-484-595-9836
