AZ LICENSES ZURAMPIC TO GRÜNENTHAL GMBH

ASTRAZENECA LICENSES ZURAMPIC TO
GRÜNENTHAL GMBH IN EUROPE AND LATIN AMERICA

Agreement includes rights to the fixed-dose combination of lesinurad and
allopurinol in gout





AstraZeneca today announced that it has entered into a licensing agreement with
Grünenthal GmbH for the exclusive rights to Zurampic (lesinurad) in Europe and
Latin America. Zurampic was approved by the European Medicines Agency (EMA) in
February 2016 (https://www.astrazeneca.com/media-centre/press
-releases/2015/ZURAMPIC-lesinurad-approved-by-US-FDA-for-patients-with-gout
-22122015.html), in combination with a xanthine oxidase inhibitor (XOI), for the
adjunctive treatment of hyperuricemia (excess of uric acid in the blood) in
adult patients with uncontrolled gout.



Grünenthal will acquire the exclusive rights to Zurampic in all 28 European
Union member states, Switzerland, Iceland, Norway and Lichtenstein, and in all
Latin-American countries including Mexico, the Dominican Republic and Cuba. In
addition, Grünenthal will also obtain the exclusive rights to the fixed-dose
combination of lesinurad and allopurinol in these markets. This combination is
currently in clinical trials.



Under the terms or the agreement, Grünenthal will submit the fixed-dose
combination programme for regulatory review and will pay AstraZeneca up to $230
million in sales and other related milestones over the lifetime of the contract.
Grünenthal will also pay tiered, low double-digit royalties on annual Product
Sales. AstraZeneca will initially manufacture and supply Zurampic to Grünenthal
and will undertake the European post-approval commitment on Grünenthal's behalf.
From 1 October 2021, Grünenthal has the option to take over manufacturing of
Zurampic.

Luke Miels, Executive Vice President, Global Product and Portfolio Strategy,
AstraZeneca, said: "Grünenthal has an established presence across European and
Latin American markets and extensive expertise in inflammatory diseases. This
agreement allows us to further focus our resources on our strategic priorities."

Prof. Dr. Eric-Paul Pâques, CEO, Grünenthal, said: "We are highly committed to
the research, development and commercialisation of innovative therapies that
bring true benefits to patients. Zurampic is a strong addition to our existing
portfolio of innovative therapies in the areas of inflammatory diseases and
chronic pain. We will thus use our capabilities to provide patients in our
markets with this innovative new medicine to better control their condition."

Gout is a serious, chronic, progressive and potentially debilitating form of
inflammatory arthritis that affects more than 7.8 million people in the major
European and Latin American markets1.

Financial considerations

Revenue from the licensing agreement will provide AstraZeneca with future
recurring Externalisation Revenue from expected milestone payments and tiered,
low double-digit percent royalty payments on Product Sales. The agreement does
not impact AstraZeneca¹s financial guidance for 2016.

1 Markets include France, Germany, Italy, Spain, United Kingdom, Brazil, Mexico,
Colombia, and Argentina. Source: Decision Resources Group, Community Oriented
Programme for Control of Rheumatic Diseases.



About Zurampic

Zurampic (lesinurad) is the first in a new class of medicines called Selective
Uric Acid Reabsorption Inhibitors (SURI) that work selectively to complement
xanthine oxidase inhibitors (XOIs) in the treatment of hyperuricemia associated
with uncontrolled gout. Zurampic is not recommended for the treatment of
asymptomatic hyperuricemia and should not be used as monotherapy. XOIs reduce
the production of uric acid; Zurampic increases the excretion of uric acid.
Together, the combination of Zurampic and an XOI provides a dual mechanism of
action that both decreases production and increases excretion of uric acid,
thereby lowering serum uric acid (sUA) levels in patients who have not achieved
target serum acid levels with XOI treatment alone. Zurampic selectively inhibits
the function of transporter proteins urate transporter (URAT1) and organic anion
transporter 4 (OAT4), involved in uric acid reabsorption in the kidney. In
people, Zurampic does not inhibit OAT1 and OAT3, which are drug transporters in
the kidney associated with drug-drug interactions. The efficacy of Zurampic was
established in three Phase III clinical trials that evaluated a once daily dose
of Zurampic in combination with the XOI allopurinol or febuxostat compared to
XOI alone.

In April 2016, AstraZeneca entered into a licensing
agreement (https://www.astrazeneca.com/media-centre/press
-releases/2016/astrazeneca-enters-into-us-licensing-agreement-with-ironwood
-pharmaceuticals-for-lesinurad-26042016.html) with Ironwood Pharmaceuticals for
the exclusive US rights to Zurampic and the fixed-dose combination of lesinurad
and allopurinol.

About Grünenthal

The Grünenthal Group is an independent, family-owned, international research
-based pharmaceutical company headquartered in Aachen, Germany. We are an
entrepreneurial specialist delivering true benefits to patients. By sustainably
investing in research and development above the industrial average, we are
committing to innovation in order to treat unmet medical needs and bring value
adding products to markets. Grünenthal is a fully integrated research &
development company with a long track record of bringing innovative pain
treatments and state-of-the-art technologies to patients. Altogether, the
Grünenthal Group is present in 32 countries with affiliates in Europe, Latin
America and the US. Grünenthal products are sold in more than 155 countries and
approx. 5,300 employees work for the Grünenthal Group worldwide. In 2015,
Grünenthal achieved revenues of €1.2 bn. More information: www.grunenthal.com.



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 diseases in three main therapy areas -
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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





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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal





2 June 2016



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