Shire and Impax Settle Litigation Concerning Supply of Adderall XR Authorized Generic
Geschrieben am 08-02-2013 |
Philadelphia (ots/PRNewswire) -
Shire plc , announces that its subsidiary, Shire LLC, has settled
all pending litigation with Impax Laboratories, Inc. ("Impax") over
Shire's supply of an authorized generic version of Adderall XR. Shire
has been supplying Impax with authorized generic Adderall XR since
October 2009 pursuant to a supply agreement between the parties.
In November 2010, Impax filed suit claiming that Shire was in
breach of its supply obligations, and Shire brought a counterclaim
against Impax relating to its ordering practices under the agreement.
Under the terms of the settlement, both Impax's claim and Shire's
counterclaim will be dismissed, and the parties have entered into an
amended supply agreement which will govern the supply of authorized
generic Adderall XR from Shire to Impax until the end of the supply
term on September 30, 2014. Also as part of the settlement, Shire
will make a one-time cash payment to Impax of $48.0 million, which
has been recorded as a liability at December 31, 2012. In accordance
with US GAAP, as this represents a payment to a customer, the amount
has been recorded in the Income Statement as a reduction in reported
ADDERALL XR product sales and royalties in 2012. The reduction to
revenues for the fourth quarter of 2012 was $8.0 million, with the
balance having been recorded in earlier periods. The above mentioned
charges will not change Shire's updated financial guidance for 2012
and 2013, as provided on January 8, 2013.
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
ots Originaltext: Shire Pharmaceuticals Group Plc
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