Nexium

AstraZeneca PLC
01 April 2005


                 FDA APPROVES INTRAVENOUS FORMULATION FOR NEXIUM(R)


AstraZeneca today announced that a new administration formulation for its
prescription proton pump inhibitor NEXIUM (R) (esomeprazole magnesium) has been
approved by the US Food and Drug Administration (FDA).  NEXIUM I.V. is now
approved as an intravenous infusion or injection for the short-term treatment
(up to 10 days) of gastroesophageal reflux disease (GERD) patients, with a
history of erosive esophagitis, who are unable to take capsules.


NEXIUM(R) I.V. (esomeprazole sodium) for injection is administered once daily as
either a 10 to 30 minute intravenous infusion or by intravenous injection (no
less than 3 minutes).  Treatment is given for up to 10 days and does not require
an in-line filter.


Hospitalised patients with GERD are often unable to take their oral medication.
The availability of NEXIUM in an intravenous formulation provides these patients
with an effective alternative route of administration that they can tolerate
easily.


The approval of NEXIUM I.V. was based, in part, on the findings of four
multi-centre, open-label, two-period crossover studies.  These studies compared
the pharmacodynamic efficacy of the intravenous formulation with NEXIUM
delayed-release capsules at corresponding doses of 20 mg and 40 mg in GERD
patients with or without a history of erosive esophagitis.  They demonstrated
that, after 10 days of once-daily administration, NEXIUM I.V. 20 mg and 40 mg
are similar in their ability to suppress acid to the corresponding oral dosage
form of NEXIUM.


There were no relevant changes in acid suppression when switching between
intravenous and oral dosage forms.


NEXIUM (delayed release capsules) is indicated for treating frequent, persistent
heartburn and other symptoms associated with acid reflux disease.  The drug was
recently approved for reducing the risk of gastric (stomach) ulcers developing
among at risk patients on continuous NSAID therapy. It also is approved for
healing erosive esophagitis.  Studies show that up to 94 percent of patients
were healed with NEXIUM.   Most erosions heal in 4 to 8 weeks.


NEXIUM I.V. formulation was first approved via the European Mutual Recognition
Process in August 2003 and launches in Europe are ongoing.   NEXIUM capsules
have been launched in 89 countries.  Worldwide NEXIUM sales totalled $3.9
billion in 2004, with US sales reaching $2.7 billion.


1 April 2005


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