Crestor ANDAs

AstraZeneca PLC
12 December 2007


           AstraZeneca Files Patent Infringement Actions in Response
                              to Crestor(TM)  ANDAs


AstraZeneca today announced that it has filed patent infringement actions in
United States District Court, District of Delaware, against seven generic drug
manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs)
for Crestor(TM)


On 1st November 2007, AstraZeneca announced its receipt of a notice-letter from
Cobalt Pharmaceuticals, Inc., notifying AstraZeneca that Cobalt had submitted an
ANDA to the U.S. Food and Drug Administration (FDA). Cobalt's ANDA sought
approval to market generic versions of Crestor(TM)tablets prior to the
expiration of patents covering Crestor(TM)tablets. Cobalt's ANDA contained a
Paragraph IV certification alleging that the U.S. patents owned or licensed by
AstraZeneca, and listed in the FDA's Orange Book referencing CrestorTM, were not
infringed or that the patents were otherwise invalid or unenforceable.


Since receiving Cobalt's notice-letter, AstraZeneca has received similar
Paragraph IV Certification notice-letters from eight additional generic drug
manufacturers. AstraZeneca received notice letters from (1) Teva
Pharmaceuticals, USA (Teva) on October 31, 2007; (2) Aurobindo Pharma Limited
(Aurobindo) on November 5, 2007; (3) Apotex, Inc. (Apotex) on November 6, 2007
and December 5, 2007; (4) Par Pharmaceutical (Par) on November 6, 2007; (5)
Sandoz Inc. (Sandoz) on November 12, 2007; (6) Mylan Pharmaceuticals Inc.
(Mylan) on November 15, 2007; (7) Glenmark Pharmaceuticals, Inc. USA (Glenmark)
on November 15, 2007; and (8) Sun Pharmaceutical Industries Ltd. (Sun) on
November 19, 2007.


Each of the eight additional generic drug companies has notified AstraZeneca
that it has submitted an ANDA to the FDA seeking approval to market generic
versions of Crestor(TM)tablets before the expiration of the U.S. Patents owned or
licensed by AstraZeneca.  Each notice-letter contained a Paragraph IV
certification notice alleging that one or more of the three Orange Book listed
US patents referencing Crestor in the FDA's Orange Book was not infringed or
otherwise invalid or unenforceable.


Based on these various ANDA filings and Paragraph IV certifications, on 11th
December 2007 AstraZeneca filed individual patent infringement actions in United
States District Court, District of Delaware, against Aurobindo, Apotex, Cobalt,
Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314 (the 
'314 patent).  AstraZeneca licenses the '314 patent from Shionogi & Co. Ltd.


Summary details of each notice-letter are as follows:


Aurobindo stated that its ANDA includes a 'Paragraph IV' certification, alleging
that the claims of U.S. Patent Nos. 6,316,460 B1 (the '460 patent), 6,858,618
(the '618 patent), and the '314 patent are invalid, unenforceable, and/or not
infringed.


Teva stated that its Paragraph IV certification alleges that the '460 patent and
the '618 patent are invalid, unenforceable, and/or not infringed. AstraZeneca
did not file patent infringement actions against Teva based on the '314 patent.
Teva did not notify AstraZeneca that they intended to market generic
rosuvastatin calcium tablets prior to the expiration of the '314 patent, which
covers the active ingredient and expires in 2016.


Apotex stated that its Paragraph IV certifications alleges that the '460 patent
and the '314 patent are invalid, unenforceable, and/or not infringed.


Par stated that its Paragraph IV certification alleges that the '460 patent and
the '314 patent are invalid, unenforceable, and/or not infringed.


Sandoz stated that its Paragraph IV certification alleges that the '460 patent,
the '618 patent, and the '314 patent are invalid, unenforceable, and/or not
infringed.


Mylan stated that its Paragraph IV certification alleges that the '460 patent
and the '314 patent are invalid, unenforceable, and/or not infringed.


Glenmark stated that its Paragraph IV certification alleges that the '460 patent
is invalid, unenforceable, and/or not infringed. AstraZeneca did not file patent
infringement actions against Glenmark based on the '314 patent. Glenmark  did
not notify AstraZeneca that they intended to market generic rosuvastatin calcium
tablets prior to the expiration of the '314 patent, which covers the active
ingredient and expires in 2016.


Sun stated that its Paragraph IV certification alleges that the '460 patent, the
'618 patent, and the '314 patent are invalid, unenforceable, and/or not
infringed.


12th December 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]

Peter Vozzo, (MedImmune)       [phone]


- Ends -


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