Tremelimumab granted Orphan Drug Designation

Tremelimumab granted Orphan Drug Designation by US FDA for treatment of
malignant mesothelioma

AstraZeneca today announced that the US Food and Drug Administration has granted
Orphan Drug Designation for the anti-CTLA-4 monoclonal antibody, tremelimumab,
for the treatment of malignant mesothelioma.

Mesothelioma is a rare, aggressive cancer that most often affects the lining of
the lungs and abdomen. Available treatments for mesothelioma are very limited,
particularly for patients with advanced disease.

"There is a significant need for new treatment options for patients with
mesothelioma because fewer than five percent of patients currently survive
beyond five years, even when they receive timely diagnosis and care. Our aim is
to rapidly advance the development of tremelimumab as a potential new treatment
option for these patients," said Robert Iannone, Senior Vice President, Head of
Immuno-oncology, Global Medicines Development at AstraZeneca.

The Orphan Drug Designation programme provides orphan status to drugs and
biologics, which are defined as those intended for the safe and effective
treatment, diagnosis or prevention of rare diseases or disorders that affect
fewer than 200,000 people in the US1.

Tremelimumab is part of the broad pipeline of immuno-oncology assets being
developed by AstraZeneca and its biologics research and development arm,
MedImmune, which are designed to harness the body's own immune system to fight
cancer. It is a fully human monoclonal antibody, which stimulates the immune
system to destroy cancer cells through binding to the protein CTLA-4, expressed
on the surface of activated T-lymphocytes.

In addition to being investigated as a monotherapy treatment for patients with
mesothelioma, tremelimumab is currently being studied in combination with
AstraZeneca's anti PD-L1 investigational immunotherapy, MEDI4736, in tumour
types including non-small cell lung cancer and head and neck cancer. It is also
being studied in combination with Iressa (gefitinib) in EGFR mutated non-small
cell lung cancer and with MEDI6469 (a murine OX40 agonist) in solid tumours.

1US Food and Drug Administration. Developing Products for Rare Diseases &
Conditions
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/defau
l 
t.htm Accessed on 31 March 2015

About AstraZeneca in Oncology

Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It
will be potentially transformational for the company's future, becoming the
sixth growth platform. Our vision is to help patients by redefining the cancer
treatment paradigm and one-day eliminate cancer as cause of death. By 2020, we
are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease
areas - ovarian, lung, breast, and haematological cancers. These are being
targeted through four key platforms - immuno-oncology, the genetic drivers of
cancer and resistance, DNA damage repair and antibody drug conjugates.

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

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15 April 2015

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