Crestor ANDA

AstraZeneca PLC
01 November 2007



                                 CRESTOR(TM) ANDA



On 30th October 2007, AstraZeneca received a notice-letter from Cobalt
Pharmaceuticals, Inc. ('Cobalt') notifying AstraZeneca Pharmaceuticals LP,
AstraZeneca AB, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha
that Cobalt had submitted an Abbreviated New Drug Application (ANDA) to the US
Food and Drug Administration for approval to market generic rosuvastatin calcium
tablets. Cobalt's notice-letter advised that it intended to market generic
versions of CrestorTM tablets in 5, 10, 20, and 40 mg strengths before the
expiration 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 Paragraph
IV certification alleging that the claims of the '314 and '460 patents are not
infringed, invalid or unenforceable. Cobalt's notice-letter also states that its
ANDA contains a certification under section 505(j)(2)(A)(viii) of the FDCA
alleging that its labelling will not include medical uses claimed in US Patent
6,858,618 (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. AstraZeneca
has full confidence in its intellectual property portfolio protecting CrestorTM.


AstraZeneca has 45 days within which to commence a patent infringement lawsuit
against the filer of an ANDA that would automatically stay, or bar, the FDA from
approving the ANDA for 30 months (or until an adverse court decision, whichever
may occur earlier).


1st November 2007


Media Enquiries:
Steve Brown,  [phone]  (24 hours)
Edel McCaffrey,  [phone]  (24 hours)


Investor Enquiries:
Jonathan Hunt,  [phone]
Ed Seage,  [phone]
Karl Hard,  [phone]
Jorgen Winroth,  [phone]
Mina Blair,  [phone]
Peter Vozzo, (MedImmune)  [phone]


-Ends-




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