Lialda(R) - Shire Files Suit Against Cadila Healthcare Limited, Doing Business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc.
The lawsuit was filed as a result of an Abbreviated New Drug Application(ANDA) filed by Zydus seeking FDA approval to market and sell genericversions of Lialda(R) (mesalamine) prior to the expiration of the '720 patent.
Under the Hatch-Waxman Act, because Shire filed its patent infringementlawsuit within 45 days of receiving the Paragraph IV notification letter fromZydus, the FDA must refrain from approving Zydus' ANDA for 30 months, oruntil a district court decision finding that the patent is invalid or notinfringed, whichever occurs earlier. The stay on generic approval will expirein November 2012 unless terminated earlier.
Notes to editors
Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit hyperactivitydisorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)diseases as well as opportunities in other therapeutic areas to the extentthey arise through acquisitions. Shire's in-licensing, merger and acquisitionefforts are focused on products in specialist markets with strongintellectual property protection and global rights. Shire believes that acarefully selected and balanced portfolio of products with strategicallyaligned 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 REFORMACT OF 1995
Statements included herein that are not historical facts areforward-looking statements. Such forward-looking statements involve a numberof risks and uncertainties and are subject to change at any time. In theevent such risks or uncertainties materialize, the Company's results could bematerially adversely affected. The risks and uncertainties include, but arenot limited to, risks associated with: the inherent uncertainty of research,development, approval, reimbursement, manufacturing and commercialization ofthe Company's Specialty Pharmaceutical and Human Genetic Therapies products,as well as the ability to secure and integrate new products forcommercialization and/or development; government regulation of the Company'sproducts; the Company's ability to manufacture its products in sufficientquantities to meet demand; the impact of competitive therapies on theCompany's products; the Company's ability to register, maintain and enforcepatents and other intellectual property rights relating to its products; theCompany's ability to obtain and maintain government and other third-partyreimbursement for its products; and other risks and uncertainties detailedfrom time to time in the Company's filings with the Securities and ExchangeCommission.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
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