PHASE III RESULTS LESINURAD COMBINATION THERAPY

ASTRAZENECA ANNOUNCES TOP-LINE RESULTS FROM THE PHASE III PROGRAMME OF LESINURAD
IN COMBINATION WITH XANTHINE OXIDASE INHIBITORS IN GOUT PATIENTS

AstraZeneca today announced positive top-line results from CLEAR1, CLEAR2 and
CRYSTAL, the pivotal Phase III clinical trials investigating the potential of
lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a
combination therapy for the treatment of patients with symptomatic gout.
Lesinurad is an investigational agent that inhibits the URAT1 transporter,
increasing uric acid excretion and thereby lowering serum uric acid (sUA).

CLEAR1 and CLEAR2 studied lesinurad (200mg and 400mg once daily) in combination
with the xanthine oxidase (XO) inhibitor allopurinol, in symptomatic gout
patients not achieving target sUA levels on their current allopurinol dose.
CRYSTAL studied lesinurad (200mg and 400mg once daily) in combination with the
XO inhibitor febuxostat (80mg once daily) in gout patients with tophi (visible
nodules of uric acid crystals that are deposited in joints and skin).

In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination
with allopurinol met the primary endpoint, with a statistically significant
higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month
6 compared to allopurinol alone (p<0.0001).

In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the
primary endpoint, with a statistically significant higher proportion of patients
reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat
alone (p<0.0001). Although lesinurad 200mg did not achieve statistical
significance at month 6 (p=0.13), this dose in combination with febuxostat, was
superior to placebo plus febuxostat at all other time points (measured at months
1 to 5, 8, 10 and 12; nominal p<0.05).

The three most commonly reported adverse events across the CLEAR1 and CLEAR2
trials for patients receiving lesinurad in combination with allopurinol were
upper respiratory tract infection, nasopharyngitis and back pain. In CRYSTAL,
the three most commonly reported adverse events for patients receiving lesinurad
in combination with febuxostat were nasopharyngitis, arthralgia and upper
respiratory tract infection.

The incidence of renal-related adverse events (including serious events) and
incidence of kidney stones with lesinurad 200mg plus XO inhibitor was comparable
to placebo plus XO inhibitor. The incidence of renal-related adverse events and
kidney stones was higher with lesinurad 400mg plus XO inhibitor. A full
assessment of the safety and tolerability findings of all three studies is
ongoing.

“Gout is a serious, chronic and debilitating inflammatory disease. There is a
significant unmet need, with 40 to 70 percent of gout patients not reaching
target levels of serum uric acid with the current standard of care,” said Briggs
Morrison, Executive Vice President, Global Medicines Development and Chief
Medical Officer. “We are encouraged by our initial review of the top-line
results from the CLEAR1, CLEAR2 and CRYSTAL studies which provide important new
information on the efficacy and safety of lesinurad in combination with
febuxostat and allopurinol. These data indicate that combination therapy with
lesinurad may be a potential treatment option for gout patients.”

CLEAR1, CLEAR2 and CRYSTAL were conducted by Ardea Biosciences, a wholly-owned
subsidiary of AstraZeneca. Results from these Phase III clinical trials will be
submitted to a scientific meeting later in 2014. The company is proceeding with
preparation of regulatory submissions for lesinurad (200mg) combination therapy.

About the Design of the Studies

CLEAR1 and CLEAR2 (Combining Lesinurad with Allopurinol in Inadequate
Responders) were 12-month (US and global, respectively) multicenter, randomised,
placebo-controlled studies (n=603 and n=610, respectively) comparing the
efficacy and safety of lesinurad (200mg and 400mg once daily) when added to the
patient’s current stable medically-appropriate dose of allopurinol (at least
300mg daily, and at least 200mg daily for those with moderate renal impairment)
compared to placebo plus allopurinol. Patients entering CLEAR1 and CLEAR2 had
multiple sUA levels above target and had also reported at least two gout flares
in the 12 months prior to randomisation.

CRYSTAL (Combination Treatment Study in Subjects with Tophaceous Gout with
Lesinurad and Febuxostat) was a 12-month global multicenter, randomised, placebo
-controlled study (n=324) comparing the efficacy and safety of lesinurad (200mg
and 400mg once daily) in combination with febuxostat (80mg) compared to
febuxostat (80mg) plus placebo in gout patients with tophi and sUA levels above
target. In the CRYSTAL study all patients were started on febuxostat three weeks
prior to the initiation of the randomised study medication (with either placebo
or lesinurad).

Patients who completed the randomised pivotal Phase III clinical studies had the
option to enroll in two on-going open-label, uncontrolled extension studies to
continue to evaluate the safety and efficacy of combination therapy with
lesinurad 200mg and 400mg with XO inhibitors.

About Gout

Gout is a serious, chronic and debilitating inflammatory arthritis. There were
15.3 million diagnosed cases of chronic gout in major markets in 2013 and this
is forecast to grow to 17.7 million by 2021. Gout is caused by a metabolic
disorder, hyperuricemia (elevated sUA) which leads to the deposition of crystals
in musculoskeletal structures including joints, in the kidneys, and in other
tissues.

The goal of all urate lowering treatments is to reduce sUA levels to the
recommended targets. International treatment guidelines from the American
College of Rheumatology, European League Against Rheumatism and the British
Society for Rheumatology recommend achieving an sUA target at a minimum of < 6
mg/dL in all gout patients and often to < 5 mg/dL in gout patients with greater
disease severity and urate burden, such as those with tophi.

About Ardea Biosciences

Ardea Biosciences, Inc. was acquired by AstraZeneca in June 2012. It is located
in San Diego, California and is a wholly owned subsidiary of AstraZeneca PLC.
Ardea is developing a portfolio of molecules for the treatment of gout,
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

Esra Erkal-Paler                          +44 20 7604 8030 (UK/Global)

Vanessa Rhodes                         +44 20 7604 8037 (UK/Global)

Ayesha Bharmal                          +44 20 7604 8034 (UK/Global)

Michele Meixell                           +1 302 885 2677 (US)

Jacob Lund                                 +46 8 553 260 20 (Sweden)

Investor Enquiries

Karl Hård                                     +44 20 7604 8123 mob: +44 7789
654364

Anthony Brown                           +44 20 7604 8067   mob: +44 7585 404943

Jens Lindberg                             +44 20 7604 8414   mob: +44 7557
319729

Eugenia Litz                               +44 20 7604 8233     mob: +44 788 473
5627

13 August 2014

-ENDS-