AstraZeneca Submits New Drug Applications for ZACTIMA(TM) in Second-Line Advanced...

AstraZeneca Submits New Drug Applications for ZACTIMA(TM) in Second-Line
Advanced Non-Small Cell Lung Cancer

WILMINGTON, Del., July 30 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN)
today announced the company has submitted a New Drug Application to the U.S.
Food and Drug Administration (FDA) and a Marketing Authorisation Application
(MAA) to the European Medicines Agency (EMEA) for an investigational drug,
vandetanib 100 mg for use in combination with chemotherapy for the treatment
of advanced non-small cell lung cancer in patients previously treated with one
prior anti-cancer therapy. The U.S. and European submissions are supported by
data from Phase III clinical studies evaluating the safety and efficacy of
vandetanib 100 mg in combination with chemotherapy. Pending approval, the
treatment will be marketed as ZACTIMA(TM).

Evaluation of vandetanib is ongoing, as monotherapy or in combination with
other anti-cancer therapies in a range of tumour types, including thyroid
cancer. Results from the ZEPHYR (300mg monotherapy study in EGFR failures in
advanced NSCLC, Phase III) and ZETA (300 mg monotherapy in advanced medullary
thyroid cancer, Phase III) studies will be presented in the first half of
2010.

Howard Hutchinson, MD, Chief Medical Officer at AstraZeneca said, "Lung cancer
is an area of high unmet need and these submissions are an important step
toward potentially broadening the treatment options available for patients."

About Vandetanib
Vandetanib has a unique profile that fights cancer through two clinically
proven mechanisms -- by blocking the development of tumour blood supply
(anti-angiogenesis or anti-VEGFR), and by blocking the growth and survival of
the tumour itself (anti-EGFR). Vandetanib also inhibits RET-tyrosine kinase
activity, an important growth driver in certain types of thyroid cancer.

About Vandetanib Phase III Studies
ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer)
is a Phase III randomised, double-blind, placebo-controlled study evaluating
the combination of vandetanib 100mg once daily plus docetaxel versus docetaxel
alone in patients with locally advanced or metastatic NSCLC, treated with one
prior anti-cancer therapy. It enrolled 1391 patients at 250 centres
throughout Europe, North America, South America and Asia Pacific.

ZEAL (ZACTIMA Efficacy with Alimta in Lung cancer) is a randomised,
double-blind, placebo-controlled Phase III study evaluating the combination of
vandetanib 100mg with pemetrexed versus pemetrexed alone in patients with
locally advanced or metastatic NSCLC, treated with one prior anti-cancer
therapy. It enrolled 534 patients at 160 centres across 23 countries.

ZEST (ZACTIMA Efficacy Study versus Tarceva) is a Phase III randomised,
double-blind, multi-centre study to assess the efficacy of vandetanib 300mg
versus erlotinib in patients with locally advanced or metastatic NSCLC after
failure of at least one prior anti-cancer therapy. It enrolled 1240 patients
at 171 centres across 22 countries.

ZEPHYR (ZACTIMA Efficacy trial for NSCLC Patients with HistorY of EGFR-TKI and
chemo-Resistance) is a Phase III, randomised, double-blind, parallel-group,
multi-centre study evaluating the efficacy of ZACTIMA 300mg plus best
supportive care versus best supportive care in patients with locally advanced
or metastatic (stage IIIB-IV) NSCLC after prior therapy with an EGFR
inhibitor. The study is running in approximately 170 centres across 23
countries.

ZETA (Zactima Efficacy in Thyroid Cancer Assessment) is a phase III,
randomized, double-blind, placebo-controlled, multi-centre study, evaluating
once-daily ZACTIMA 300mg as a monotherapy in advanced medullary thyroid
cancer.

About lung cancer
-- Over 1.35 million new cases of lung cancer are diagnosed every year
and
nearly 1.2 million people die as a result of this devastating disease
--
more than breast, colon and prostate cancer combined(i).
-- Non-small cell lung cancer accounts for around 85% of all lung
cancers(ii).

-- If lung cancer is detected at early stages, before it has spread to
other organs or lymph nodes, around half of patients can survive for
five years or more. However, few lung cancers are found at this early
stage and it is normally diagnosed at the advanced stage, when five
year
survival falls to approximately 15%(iii).

About AstraZeneca
AstraZeneca is engaged in the research, development, manufacturing and
marketing of meaningful prescription medicines and in the supply of healthcare
services. AstraZeneca is one of the world's leading pharmaceutical companies
with global healthcare sales of $ 31.6 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infectious disease medicines. In the United States, AstraZeneca is a $13.5
billion dollar healthcare business.

For more information about AstraZeneca in the US, please visit:
www.astrazeneca-us.com.

(i) Ferlay, J. et al. GLOBOCAN 2002: Cancer Incidence, Mortality and
Prevalence Worldwide. IARC CancerBase No. 5. version 2.0. Lyon: IARC Press,
2004.

(ii) Ginsberg RJ. et al. Cancer: Principles and Practices of Oncology. 5(th)
ed; 858-911. 1997. 6(th) ed. 925-983. 2001.

(iii) Bepler G. Lung cancer epidemiology and genetics. J Thorac Imaging 1999;
14(4):228-234.

SOURCE AstraZeneca

Emily Denney of AstraZeneca, +1-302-885-3451