ASTRAZENECA PLC ANNOUNCES MARKETING AUTHORISATION APPLICATION FOR GOUT TREATMENT LESINURAD ACCEPTED BY EUROPEAN MEDICINES AGENCY


AstraZeneca today announced the European Medicines Agency has accepted the
Marketing Authorisation Application (MAA) for lesinurad 200mg tablets. Lesinurad
is a selective uric acid reabsorption inhibitor (SURI) developed for the chronic
treatment of hyperuricaemia in combination with xanthine oxidase (XO) inhibitors
allopurinol or febuxostat in gout patients when additional therapy is warranted.

The MAA filing was based on data from the CLEAR1, CLEAR2 and CRYSTAL pivotal
Phase III combination therapy studies. CLEAR1 and CLEAR2 were 12-month,
multicentre, randomised, placebo-controlled studies that evaluated the efficacy
and safety of a once daily dose of lesinurad in combination with allopurinol
versus allopurinol alone, in symptomatic gout patients not achieving target
serum uric acid (sUA) levels on their current allopurinol therapy. CRYSTAL was a
12-month, multicentre, randomised, placebo-controlled study that evaluated the
efficacy and safety of a once daily dose of lesinurad in combination with
febuxostat compared to febuxostat alone in gout patients with tophi (deposits of
uric acid crystals in joints and skin).

Between 40 to 80% of patients do not achieve recommended sUA goals with the
current standard of care of an XO inhibitor alone. XO inhibitors including
allopurinol and febuxostat reduce the production of uric acid. Lesinurad works
by inhibiting the uric acid transporter URAT1 in the kidney, thereby increasing
uric acid excretion resulting in lower sUA.Combination therapy with lesinurad
and an XO inhibitor provides a dual mechanism approach targeting both excretion
and production of uric acid which effectively lowers sUA and enables
significantly more patients to achieve and maintain target treatment goals to
control their disease.

The CLEAR1, CLEAR2 and CRYSTAL studies were conducted by Ardea Biosciences, a
member of the AstraZeneca Group.

About Lesinurad
Lesinurad is a selective uric acid reabsorption inhibitor (SURI) that inhibits
the URAT1 transporter and is being studied as an investigational agent for the
treatment of gout. URAT1 is responsible for the majority of the reabsorption of
filtered uric acid from the renal tubular lumen. By inhibiting URAT1, lesinurad
increases uric acid excretion and thereby lowers sUA. Lesinurad also inhibits
OAT4, a uric acid transporter involved in diuretic-induced hyperuricaemia.

About Gout

Gout is a serious, chronic and debilitating form of inflammatory arthritis.
There are more than 15.8 million diagnosed cases of gout in major markets. Gout
is caused by a metabolic disorder, hyperuricaemia (elevated sUA), which leads to
the deposition of crystals in musculoskeletal structures including joints, in
the kidneys, and in other tissues.

About Ardea Biosciences

Ardea Biosciences, Inc. was acquired by AstraZeneca in June 2012. It is located
in San Diego, California and is a member of the AstraZeneca Group. Ardea is
leading the development of AstraZeneca's gout portfolio, including lesinurad and
RDEA3170.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com

CONTACTS

Media Enquiries
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Investor Enquiries
Thomas Kudsk Larsen  +44 20 7604 8199 mob: +44 7818 524185
Karl Hård            +44 20 7604 8123 mob: +44 7789 654364
Eugenia Litz         +44 20 7604 8233 mob: +44 7884 735627
Craig Marks          +44 20 7604 8591 mob: +44 7881 615764
Christer Gruvris     +44 20 7604 8126 mob: +44 7827 836825

22 January 2015

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