25th Apr 2013 14:26
SHIRE PLC - Shire Settles INTUNIV Litigation with Actavis and WatsonSHIRE PLC - Shire Settles INTUNIV Litigation with Actavis and Watson
PR Newswire
London, April 25
Shire Settles All Pending Litigation with Actavis and Watson concerning INTUNIV ®
Philadelphia, PA, United States - April 25, 2013 - Shire plc (LSE: SHP, NASDAQ:SHPG), announces that its subsidiary, Shire LLC, has settled all pendinglitigation 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' andWatson's Abbreviated New Drug Applications ("ANDAs") for generic versions ofShire's INTUNIV® ( guanfacine hydrochloride) for the treatment of AttentionDeficit 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, orearlier in certain limited circumstances. Such sales will require the paymentof a royalty of 25% of gross profits to Shire during the 180 day period ofActavis' exclusivity. The settlement also provides Watson with a license tomake and market Watson's generic versions of INTUNIV in the United States 181days after Actavis' launch of generic INTUNIV, or earlier in certain limitedcircumstances. To date, the US Food and Drug Administration has granted finalapproval only to Actavis' ANDA for generic versions of INTUNIV.
These litigations were patent infringement lawsuits relating to U.S. patents6,287,599 ("the `599 Patent"), 6,811,794 ("the `794 Patent"), 5,854,290 (whichwas subsequently dedicated to the public). As part of the settlement, Actavisand Watson have agreed to a consent judgment confirming that their proposedgeneric products infringe Shire's '599 and '794 Patents and that those twopatents are valid and enforceable with respect to those proposed genericproducts and any other generic version of INTUNIV.
The lawsuit against Actavis proceeded to trial in the District Court ofDelaware in September 2012 wherein Teva Pharmaceuticals, USA, Inc. was also adefendant. The Delaware court has not issued a decision. The lawsuit againstWatson is scheduled for trial to begin on February 10, 2014 wherein ImpaxLaboratories, Inc. is also a defendant.
The agreements, which are effective immediately, will be submitted to the USFederal Trade Commission and Department of Justice for review as required bylaw.
For further information please contact:
Investor Relations Eric Rojas [email protected] +1 781 482 0999 Sarah Elton-Farr [email protected] +44 1256 894157 Media Jessica Mann (Corporate) [email protected] +44 1256 894 280Gwen Fisher (Specialty Pharma) [email protected] +1 484 595 9836
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Through our deep understanding of patients' needs, we develop and providehealthcare in the areas of:
* Behavioral Health and Gastro Intestinal conditions * Rare Diseases * Regenerative Medicineas well as other symptomatic conditions treated by specialist physicians.
We aspire to imagine and lead the future of healthcare, creating value forpatients, physicians, policymakers, payors and our shareholders.
www.shire.com
FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATESECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts areforward-looking statements. Forward-looking statements involve a number ofrisks and uncertainties and are subject to change at any time. In the eventsuch risks or uncertainties materialize, Shire's results could be materiallyadversely affected. The risks and uncertainties include, but are not limitedto, 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 filingswith the U.S. Securities and Exchange Commission, including its most recentAnnual Report on Form 10-K.
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