FDA Approves Astrazeneca's Atacand(R) (Candesartan Cilexetil) For The Treatment Of Heart Failure

Atacand is first ARB to receive approval for reducing both CV mortality and hospitalizations for heart failure - AstraZeneca today announced that the US
Food and Drug Administration (FDA) has approved its angiotensin receptor blocker (ARB) ATACAND(r) (candesartan cilexetil) Tablets for the treatment of heart
failure (NYHA class II-IV and ejection fraction ? 40%) to reduce the risk of death from cardiovascular causes and reduce hospitalizations for heart failure.
ATACAND is the first ARB to receive an indication for reducing both cardiovascular mortality and hospitalizations for heart failure.


The approval was primarily based on results from Candesartan in Heart Failure Assessment of Reduction in Mortality and morbidity Alternative Trial (CHARM-
Alternative), which examined the effect of ATACAND (n= 1013) compared to placebo (n=1015) in 2028 heart failure patients who were intolerant to ACE
inhibitors, but were receiving other standard heart failure therapy. The trial demonstrated that in these CHF patients, the use of ATACAND resulted in a 23%
(p








IMPORTANT SAFETY INFORMATION


PREGNANCY WARNING: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury
and even death to the developing fetus. When pregnancy is detected, ATACAND should be discontinued as soon as possible.


In the CHARM program, hypotension was reported in 18.8% of patients on ATACAND vs. 9.8% of patients on placebo; the incidence of hypotension leading to drug
discontinuation in the candesartan-treated patients was 4.1% compared with 2.0% in placebo-treated patients. The incidence of abnormal renal function (e.g.,
creatinine increase) leading to drug discontinuation in patients treated with ATACAND was 6.3% vs. 2.9% in placebo-treated patients. Evaluation of patients
with heart failure should always include assessment of renal function and volume status. The incidence of hyperkalemia was 6.3% in patients receiving
ATACAND vs. 2.1% in those receiving placebo. The incidence of hyperkalemia leading to drug discontinuation in patients receiving ATACAND was 2.4% vs.0.6%
in the placebo-treated patients. During treatment with ATACAND in patients with heart failure, monitoring of blood pressure, serum creatinine, and serum
potassium is recommended during dose escalation and periodically thereafter.


The adverse event profile of ATACAND in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In
the CHARM program, comparing ATACAND in total daily doses up to 32 mg once daily (n=3803) with placebo (n=3796), 21% of patients receiving ATACAND
discontinued for adverse events vs. 16.1% of placebo patients. For full Prescribing Information for ATACAND, including boxed WARNING, call 1-800-236-9933 or
visit atacand-us.



About Chronic Heart Failure


Heart failure, also called chronic heart failure or CHF, is a condition in which the heart is unable to pump blood adequately to the rest of the body. When
the heart is not pumping as it should, less oxygen and nutrients are carried through the body, and some of the wastes may not be removed from the body. This
can result in fatigue, shortness of breath, and fluid buildup in the lungs, liver, or ankles. It is a serious, progressive, debilitating condition and
frequently leads to a fatal outcome. Many heart failure patients have impaired left ventricular systolic function and this is the population that has been
studied in most previous heart failure trials. In these patients, the heart's ability to function as a pump is compromised, as evidenced by a reduced
ejection fraction, which is the percentage of blood ejected by the heart with each contraction. The normal heart ejects more than 50% of the blood in the
left ventricle with each beat. Common causes of heart failure include coronary artery disease, heart attacks (or myocardial infarction), high blood pressure
(or hypertension), and heart disease of unknown origin (or cardiomyopathy).


The American Heart Association estimates that nearly 5 million Americans are currently living with heart failure, and more than half a million new cases are
diagnosed each year.



About AstraZeneca


AstraZeneca (NYSE: AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over
$21.4 billion and leading positions in sales of cardiovascular, gastrointestinal, respiratory, oncology, and neuroscience products. In the United States,
AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as
well as the FTSE4Good Index.



For more information about AstraZeneca, please visit astrazeneca-us



This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts
involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that
could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/
Form 20-F for 2004.


View drug information on Atacand.