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2015-10-23

AstraZeneca: FDA Advisory Committee recommends the approval of lesinurad for gout patients

AstraZeneca today announced that the US Food and Drug Administration's
(FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend
the approval of lesinurad 200mg tablets for the treatment of
hyperuricemia associated with gout, in combination with a xanthine
oxidase inhibitor (XOI). The AAC reviewed safety and efficacy data
from the pivotal Phase III combination therapy programme trials,
representing the largest clinical trial data set of gout patients
treated with combination urate lowering therapy.

The FDA is not bound by the Advisory Committee's recommendation but
takes its advice into consideration when reviewing the application
for a potential medicine. The Prescription Drug User Fee Act (PDUFA)
target goal date for lesinurad is 29 December 2015.

If approved, lesinurad will be the first selective uric acid
reabsorption inhibitor, or SURI, in the US. It inhibits the urate
transporter, URAT1, which is responsible for the majority of the
renal reabsorption of uric acid.

Sean Bohen, Executive Vice President of Global Medicines Development
and Chief Medical Officer, AstraZeneca, said: "The Committee's
positive recommendation for lesinurad is an encouraging step for
patients suffering from the debilitating effects of gout. We look
forward to the outcome of the FDA's review and the opportunity to
provide a new treatment option that, when combined with a xanthine
oxidase inhibitor, addresses both the under-excretion and
over-production of uric acid, the underlying causes of gout."

Gout is a serious and debilitating form of inflammatory arthritis
caused by hyperuricemia (elevated serum uric acid (sUA)). Gout
affects millions of Americans, many of whom do not reach recommended
sUA treatment goals on the current standard of care (XOIs), which
decrease production of uric acid. For those inadequately controlled
patients, the addition of a urate lowering therapy to increase
excretion of uric acid, may help them achieve treatment goals.

Lesinurad is also under regulatory review in the European Union and
other territories.

- ENDS -

NOTES TO EDITORS

About Lesinurad

If approved, lesinurad will be the first selective uric acid
reabsorption inhibitor, or SURI, in the US. It inhibits the urate
transporter, URAT1, which is responsible for the majority of the
renal reabsorption of uric acid. By inhibiting URAT1, lesinurad
increases uric acid excretion and thereby lowers serum uric acid
(sUA). Lesinurad also inhibits organic anion transporter (OAT4) a
uric acid transporter involved in diuretic-induced hyperuricemia. In
addition, in patients, lesinurad does not inhibit OAT1 and OAT3,
which are drug transporters in the kidney associated with drug-drug
interactions.

If approved, lesinurad in combination with an XOI would provide a dual
mechanism of action to increase excretion and decrease production of
uric acid enabling more patients with inadequately controlled gout to
achieve target treatment goals.

About Hyperuricemia and Gout

Gout is a serious, chronic, progressive, and debilitating form of
inflammatory arthritis. Currently, there are more than 8.3 million
patients suffering from gout in the US. The underlying cause of gout
is hyperuricemia (elevated serum uric acid (sUA)), which leads to the
deposition of crystals primarily in the joints and in other tissues.
This can result in recurrent attacks of inflammatory arthritis and,
if left uncontrolled, could lead to chronic, progressive arthritis,
and tophus (visible deposits of urate crystals) formation.

The goal of sUA lowering treatment is to reduce sUA levels to the
target level of <6.0mg/dL (360 µmol/L) as recommended by both the
American College of Rheumatology (ACR) and the European League
Against Rheumatism (EULAR). To improve signs and symptoms such as
tophaceous gout, the ACR guidelines state that achieving and
maintaining sUA levels <5.0mg/dL (300 µmol/L) may be required.

Among patients treated in clinical trials, less than 50% of patients
on allopurinol 300mg reached sUA target levels <6.0mg/dL (360
µmol/L). This suggests approximately two million gout patients in the
US on urate lowering therapy remain inadequately controlled. For
patients who cannot reach target on an XOI alone, the current ACR
guidelines recommend adding an agent that increases uric acid
excretion.

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. RDEA3170 is a
potent selective uric acid reabsorption inhibitor, also intended for
use as a combination urate lowering therapy with xanthine oxidase
inhibitors. RDEA3170 is our lead investigational urate lowering
therapy (ULT) in Asia and is currently entering a Phase IIb trial in
the US.

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 UK/Global +44 20 7604 8030
Vanessa Rhodes UK/Global +44 20 7604 8037
Ayesha Bharmal UK/Global +44 20 7604 8034
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries irteam@astrazeneca.com
UK
Thomas Kudsk Larsen Oncology +44 20 7604 8199 +44 7818 524185
Eugenia Litz RIA +44 20 7604 8233 +44 7884 735627
Nick Stone CVMD +44 20 7604 8236 +44 7717 618834
Craig Marks Finance +44 20 7604 8591 +44 7881 615764
Christer Gruvris +44 20 7604 8126 +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 301 398 5118 +1 240 543 7970
Mitch Chan Oncology +1 301 398 1849 +1 240 477 3771
Dial / Toll-Free +1 301 398 3251 +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD -
Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

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Författare WKR

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