Navigation Links
INTUNIV(TM) - Shire Files Suit Against Anchen Pharmaceuticals, Inc. and Anchen, Inc.
Date:6/3/2010

DUBLIN and PHILADELPHIA, June 3, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Delaware against Anchen Pharmaceuticals, Inc. and Anchen, Inc. (collectively "Anchen") for the infringement of U.S. Patent Nos. 5,854,290 (the '290 patent), 6,287,599 (the '599 patent), and 6,811,794 (the '794 patent).

The lawsuit results from an Abbreviated New Drug Application (ANDA) filed by Anchen for generic versions of 1 mg, 2 mg, 3 mg and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV(TM), which seeks to market such generic products before the expiration of the '290, '599, and '794 patents. The regulatory exclusivity period for INTUNIV(TM) runs through September 2, 2012.

Notes to Editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such 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, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

    For further information please contact:

    Investor Relations
    Clea Rosenfeld (Rest of the World)
    +44-1256-894-160

    Eric Rojas (North America)
    +1-781-482-0999


    Media

    Jessica Mann (Rest of the World)
    +44-1256-894-280

    Matthew Cabrey (North America, Specialty Pharma)
    +1-484-595-8248


'/>"/>
SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. INTUNIV(TM) - Shire Files Suit Against Actavis Elizabeth LLC and Actavis Inc.
2. Shire Receives 2010 Corporate Award From the National Organization for Rare Disorders (NORD) for the Development of VPRIV (velaglucerase alfa for Injection)
3. Shires Replenished Portfolio Drives Excellent Quarterly Performance
4. Shire Receives INTUNIV (TM) Paragraph IV Notice Letter From Teva Pharmaceuticals
5. Shire Supports Rare Disease Day 2010
6. Shire Announces FDA Approval of VPRIV(TM) (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease
7. Shire Provides Update on Biologics License Application (BLA) Filing for REPLAGAL(R) (agalsidase alfa) With the U.S. Food and Drug Administration (FDA)
8. Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease
9. New Shire Board Member
10. Shire Secures European Wide Label Extension for FOSRENOL(R) in Chronic Kidney Disease
11. New CapSure™ Cleanroom Wiper from Berkshire Corporation Captures and Retains 42 Times More Contaminant Particles
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016 A person commits a crime, ... scene to track the criminal down. An outbreak ... and Drug Administration (FDA) uses DNA evidence to track down ... Sound far-fetched? It,s not. The FDA has increasingly used ... investigations of foodborne illnesses. Put as simply as possible, whole ...
(Date:6/23/2016)... 23, 2016   EpiBiome , a precision microbiome ... in debt financing from Silicon Valley Bank (SVB). The ... to advance its drug development efforts, as well as ... "SVB has been an incredible strategic partner to ... traditional bank would provide," said Dr. Aeron Tynes ...
(Date:6/23/2016)... , June 23, 2016  Blueprint Bio, a ... discoveries to the medical community, has closed its Series ... Matthew Nunez . "We have received a ... the capital we need to meet our current goals," ... provide us the runway to complete validation on the ...
(Date:6/23/2016)... Windsor, Connecticut (PRWEB) , ... June 23, 2016 ... ... will introduce a new line of intelligent tools designed, tuned and optimized exclusively ... place September 12–17 in Chicago. The result of a collaboration among several companies ...
Breaking Biology Technology:
(Date:6/15/2016)... York , June 15, 2016 ... new market report titled "Gesture Recognition Market by Application ... Forecast, 2016 - 2024". According to the report, the  ... 11.60 billion in 2015 and is estimated to ... USD 48.56 billion by 2024.  Increasing ...
(Date:6/2/2016)... -- The Department of Transport Management (DOTM) of ... US Dollar project, for the , Supply and ... and IT Infrastructure , to Decatur ... of Identity Management Solutions. Numerous renowned international vendors participated in ... was selected for the most compliant and innovative solution. ...
(Date:5/20/2016)... 2016  VoiceIt is excited to announce its ... By working together, VoiceIt and VoicePass will ... VoicePass take slightly different approaches to voice biometrics, ... and usability. ... partnership. "This marketing and technology partnership ...
Breaking Biology News(10 mins):