Olaparib receives positive CHMP opinion

LYNPARZA™ (olaparib) RECEIVES POSITIVE CHMP OPINION in the EU for the
MAINTENANCE treatment of BRCA-mutated Platinum sensitive relapsed ovarian CANCER

AstraZeneca today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion
recommending the marketing authorisation of Lynparza™ (olaparib) as monotherapy
for the maintenance treatment of adult patients with platinum sensitive relapsed
BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian,
fallopian tube or primary peritoneal cancer who are in response (complete or
partial) to platinum-based chemotherapy. Olaparib is a poly ADP-ribose
polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies
to preferentially kill cancer cells.

Briggs Morrison, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "We are delighted that the CHMP has
recommended Lynparza as a first-in-class treatment option for women with BRCA
-mutated ovarian cancer and we look forward to the European Commission's
decision once it completes its review. We are committed to investigating the
full potential of olaparib and have a number of studies underway in multiple
tumour types including breast and gastric cancer."

The positive CHMP opinion was based on the results from Study 191, a Phase II
clinical trial that evaluated the efficacy and safety of olaparib compared to
placebo in platinum sensitive relapsed high grade serous ovarian cancer
patients. The study showed that olaparib maintenance therapy significantly
prolonged progression free survival (PFS) compared with placebo in patients with
BRCA-mutated ovarian cancer- median PFS 11.2 months vs. 4.3 months (PFS HR=0.18;
95% CI 0.10-0.31; p<0.0001). The most common adverse events associated with
olaparib monotherapy to date were generally mild to moderate and included
nausea, vomiting, fatigue and anaemia.

Harpal Kumar, Chief Executive, Cancer Research UK, said: "We're delighted that
olaparib has received a positive opinion from the CHMP, particularly given the
early role Cancer Research UK scientists played in discovering and developing
PARP inhibitors as a new generation of drugs that exploit the weaknesses cancer
cells have in repairing damaged DNA. If approved, olaparib could offer new hope
to women with advanced ovarian cancer and this illustrates how our partnerships
with AstraZeneca are helping us to accelerate our efforts to beat cancer through
new treatments for patients."

The CHMP's positive opinion on olaparib will now be reviewed by the European
Commission, which has the authority to approve medicines for the European Union.
The final decision will be applicable to all 28 European Union member countries
plus Iceland, Norway and Liechtenstein. If approved, Lynparza will be the first
PARP inhibitor available in these markets for the treatment of platinum
sensitive relapsed BRCA-mutated high grade serous ovarian cancer.

1 Ledermann J, et al. Olaparib maintenance therapy in patients with platinum
-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis
of outcomes by BRCA status in a randomised Phase II trial. The Lancet Oncology
2014. http://dx.doi.org/10.1016/S1470-2045(14)70228-1

About ovarian cancer

In Europe, ovarian cancer is the fifth most commonly diagnosed cancer in women
and the sixth leading cause of cancer death among women, mainly because it is
often diagnosed late and has an extremely poor prognosis. Women with BRCA1 or
BRCA2 mutations have an increased risk of developing ovarian cancer; the
lifetime risk for ovarian cancer is up to 40% in individuals who harbour these
mutations.

About olaparib

Olaparib is an innovative, investigational, potential first-in-class oral poly
ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathways
deficiencies to selectively induce cancer cell death.  This mode of action gives
olaparib the potential for activity in a range of tumour types with DNA repair
deficiencies.

Study 19, a randomised, double-blinded Phase II clinical trial of 265 patients,
evaluated the efficacy and safety of olaparib compared to placebo in PSR high
grade serous ovarian cancer patients.

Olaparib is currently being investigated in Phase III trials for the treatment
of BRCAm ovarian cancer patients who are in complete or partial response
following platinum-based chemotherapy in the relapsed and first-line settings
and is one of a number of compounds being investigated by AstraZeneca for
ovarian cancer. Phase III studies in gastric cancer and adjuvant and metastatic
BRCAm breast cancers are also underway.

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)

Jacob Lund                                  +46 8 553 260 20 (Sweden)

Investor Enquiries

Thomas Kudsk Larsen               +44 20 7604 8199     mob: +44 7818 524185


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

Jens Lindberg                                                               mob:
+44 7557 319729

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

Eugenia Litz                                +44 20 7604 8233    mob: +44 7884
735627

24 October 2014

-ENDS-