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

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'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:


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:
(Date:6/27/2016)... 2016 /PRNewswire/ - BIOREM Inc. (TSX-V: BRM) ("Biorem" or "the ... major shareholders, Clean Technology Fund I, LP and Clean ... based venture capital funds which together hold approximately ... fully diluted, as converted basis), that they have entered ... equity holdings in Biorem to TUS Holdings Co. Ltd. ...
(Date:6/27/2016)... ... 27, 2016 , ... Newly created 4Sight Medical Solutions ... the healthcare market. The company's primary focus is on new product introductions, to ... that are necessary to help companies efficiently bring their products to market. , ...
(Date:6/24/2016)... , June 24, 2016  Regular discussions on a ... take place between the two entities said Poloz. ... Ottawa , he pointed to the country,s ... the federal government. ... said, "Both institutions have common economic goals, why not sit ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... the release of its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” ... and retention in this eBook by providing practical tips, tools, and strategies for ...
Breaking Biology Technology:
(Date:4/13/2016)... 13, 2016  IMPOWER physicians supporting Medicaid patients in ... new clinical standard in telehealth thanks to a new ... higi platform, IMPOWER patients can routinely track key health ... mass index, and, when they opt in, share them ... to a local retail location at no cost. By ...
(Date:3/31/2016)...  Genomics firm Nabsys has completed a financial  restructuring ... , M.D., who returned to the company in October ... team, including Chief Technology Officer, John Oliver , ... and Vice President of Software and Informatics, Michael ... Dr. Bready served as CEO of Nabsys from 2005-2014 ...
(Date:3/23/2016)... WAKEFIELD, Massachusetts , March 23, 2016 ... kombiniert im Interesse erhöhter Sicherheit Gesichts- und ... Xura, Inc. (NASDAQ: MESG ... heute bekannt, dass das Unternehmen mit SpeechPro ... insbesondere aus der Finanzdienstleistungsbranche, wird die Möglichkeit ...
Breaking Biology News(10 mins):