1st Nov 2007 07:02
AstraZeneca PLC01 November 2007 CRESTOR(TM) ANDA On 30th October 2007, AstraZeneca received a notice-letter from CobaltPharmaceuticals, Inc. ("Cobalt") notifying AstraZeneca Pharmaceuticals LP,AstraZeneca AB, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaishathat Cobalt had submitted an Abbreviated New Drug Application (ANDA) to the USFood and Drug Administration for approval to market generic rosuvastatin calciumtablets. Cobalt's notice-letter advised that it intended to market genericversions of CrestorTM tablets in 5, 10, 20, and 40 mg strengths before theexpiration of US Patents Nos. RE37,314E (the '314 patent) and 6,316,460B1 (the '460 patent). Cobalt's notice-letter states that its ANDA contained a ParagraphIV certification alleging that the claims of the '314 and '460 patents are notinfringed, invalid or unenforceable. Cobalt's notice-letter also states that itsANDA contains a certification under section 505(j)(2)(A)(viii) of the FDCAalleging that its labelling will not include medical uses claimed in US Patent6,858,618 (the '618 patent). The '314 patent expires in January 2016, the '460 patent expires in August 2020,and the '618 patent expires in December 2021. AstraZeneca is evaluating Cobalt's allegations and certifications. AstraZenecahas full confidence in its intellectual property portfolio protecting CrestorTM. 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, whichevermay occur earlier). 1st November 2007 Media Enquiries:Steve Brown, +44 207 304 5033 (24 hours)Edel McCaffrey, +44 207 304 5034 (24 hours) Investor Enquiries:Jonathan Hunt, +44 207 304 5087Ed Seage, +1 302 886 4065Karl Hard, +44 207 304 5322Jorgen Winroth, +1 212 579 0506Mina Blair, +44 20 7304 5084Peter Vozzo, (MedImmune) +1 301 398 4358 -Ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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