Navigation Links
Lialda(R) - Shire Files Suit Against Cadila Healthcare Limited, Doing Business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc.
Date:7/8/2010

DUBLIN and PHILADELPHIA, July 8, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiaries Shire Development Inc. and Shire Pharmaceutical Development Inc. have filed a lawsuit in the U.S. District Court for the District of Delaware against Cadila Healthcare Limited, doing business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc. (collectively "Zydus") for the infringement of U.S. Patent No. 6,773,720 (the '720 patent).

The lawsuit was filed as a result of an Abbreviated New Drug Application (ANDA) filed by Zydus seeking FDA approval to market and sell generic versions of Lialda(R) (mesalamine) prior to the expiration of the '720 patent.

Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving the Paragraph IV notification letter from Zydus, the FDA must refrain from approving Zydus' ANDA for 30 months, or until a district court decision finding that the patent is invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire in November 2012 unless terminated earlier.

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         Clea Rosenfeld (Rest of the World)   +44(0)1256-894-160
    Relations        Eric Rojas (North America)           +1-781-482-0999

    Media            Jessica Mann (Rest of the World)     +44(0)1256-894-280
                     Matthew Cabrey (North America,       +1-484-595-8248
                     Specialty Pharma)


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

Related biology technology :

1. Shire Receives CHMP Positive Opinion for VPRIV(TM) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease in the European Union
2. Shire plc Appoints Two New Board Directors
3. INTUNIV(TM) - Shire Files Suit Against Anchen Pharmaceuticals, Inc. and Anchen, Inc.
4. Shire Receives 2010 Corporate Award From the National Organization for Rare Disorders (NORD) for the Development of VPRIV (velaglucerase alfa for Injection)
5. INTUNIV(TM) - Shire Files Suit Against Actavis Elizabeth LLC and Actavis Inc.
6. Shires Replenished Portfolio Drives Excellent Quarterly Performance
7. Shire Receives INTUNIV (TM) Paragraph IV Notice Letter From Teva Pharmaceuticals
8. Shire Supports Rare Disease Day 2010
9. Shire Announces FDA Approval of VPRIV(TM) (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease
10. Shire Provides Update on Biologics License Application (BLA) Filing for REPLAGAL(R) (agalsidase alfa) With the U.S. Food and Drug Administration (FDA)
11. Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... is exhibiting at the Pennsylvania Convention Center and will showcase its product’s latest ... ClinCapture will also be presenting a scientific poster on Disrupting Clinical Trials in ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... line of intelligent tools designed, tuned and optimized exclusively for Okuma CNC machining ... Chicago. The result of a collaboration among several companies with expertise in toolholding, ...
(Date:6/23/2016)... 23, 2016 ReportsnReports.com adds ... to its pharmaceuticals section with historic and forecast ... much more. Complete report on the ... profiling 15 companies and supported with 261 tables ... . The Global Cell Culture ...
(Date:6/22/2016)... Research and Markets has announced the addition of the "Biomarkers: ... The global biomarkers market has grown ... market is expected to grow at a five-year compound annual growth ... billion in 2015 to $96.6 billion in 2020. ... 2020) are discussed. As well, new products approved in 2013 and ...
Breaking Biology Technology:
(Date:5/9/2016)... UAE, May 9, 2016 Elevay ... comes to expanding freedom for high net worth professionals ... in today,s globally connected world, there is still no ... could ever duplicate sealing your deal with a firm ... passports by taking advantage of citizenship via investment programs ...
(Date:4/26/2016)... April 27, 2016 Research ... Multi-modal Biometrics Market 2016-2020"  report to their offering.  ... The analysts forecast the global multimodal ... 15.49% during the period 2016-2020.  Multimodal ... sectors such as the healthcare, BFSI, transportation, automotive, ...
(Date:4/13/2016)... -- IMPOWER physicians supporting Medicaid patients in Central ... in telehealth thanks to a new partnership with higi. ... patients can routinely track key health measurements, such as ... when they opt in, share them with IMPOWER clinicians ... retail location at no cost. By leveraging this data, ...
Breaking Biology News(10 mins):