28th Sep 2005 10:53
AstraZeneca PLC28 September 2005 Stock Exchange Announcement SEROQUEL ANDA AstraZeneca received a notice from Teva Pharmaceuticals USA on September 27,2005, that Teva has submitted an Abbreviated New Drug Application (ANDA) forquetiapine fumarate tablets (25mg base) containing a Paragraph IV Certification(alleging invalidity and non-infringement) with respect to AstraZeneca's USpatent number 4,879,288. AstraZeneca's US patent number 4,879,288 is listed inthe Orange Book in reference to Seroquel. AstraZeneca is evaluating Teva's notice, and the company continues to have fullconfidence in its intellectual property protecting Seroquel. AstraZeneca has 45 days within which to commence a patent infringement lawsuitagainst the filer of an ANDA that would automatically stay, or bar, the FDA fromapproving the ANDA for 30 months (or until an adverse court decision, whatevermay occur earlier). -Ends- September 28, 2005 Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel + 1 212 579 0506 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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