Selumetinib granted Orphan Drug Designation by FDA

SELUMETINIB granted Orphan Drug Designation by US FDA for treatment of UVEAL
MELANOMA

AstraZeneca today announced that the US Food and Drug Administration has granted
Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of
uveal melanoma.

Uveal melanoma is a rare disease in which cancer cells form in the tissues of
the eye. It is the most common primary intraocular malignancy in adults and
comprises 5% of all melanomas1,2.

"Uveal melanoma is a rare and devastating disease for which there are currently
no effective treatment options once it spreads beyond the tissues of the eye.
Selumetinib could potentially become the first effective treatment for these
patients. The Orphan Drug Designation is an important regulatory advancement as
we further our development plans for selumetinib in uveal melanoma," said
Antoine Yver, Head of 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 US3.

Selumetinib, originally licensed from Array BioPharma Inc., inhibits the MEK
pathway in cancer cells to prevent the tumour from growing. Data from a phase
III study evaluating selumetinib in combination with chemotherapy in patients
with first-line metastatic uveal melanoma is expected to be available later this
year. In addition to uveal melanoma, selumetinib is being investigated in Phase
III studies in KRAS mutation positive lung cancer and thyroid cancer and in
Phase II in children with neurofibromatosis Type 1.

Initial data from a combination study of selumetinib with other AstraZeneca
pipeline molecules including AZD9291 (T790M-directed EGFR inhibitor) and
MEDI4736 (anti-PD-L1) in non-small cell lung cancer will be presented at the
American Society of Clinical Oncology (ASCO) annual meeting 2015.

1Egan KM, et al. Surv Ophthalmol 1988; 32: 239-51

2.Ramaiya KJ, Harbour JW. Expert Rev Ophthalmol 2007; 2: 939-46

3US 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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17 April 2015

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