AstraZeneca PLC
21 February 2001
ASTRAZENECA PLC
FDA APPROVES ASTRAZENECA'S NEXIUM WITH COMPREHENSIVE SET OF INDICATIONS
London - AstraZeneca confirms it will launch Nexium during March in the US,
following its approval by the US Food and Drug Administration (FDA) and the
announcement of the catalogue price to wholesalers.
Tom McKillop, Chief Executive of AstraZeneca said, 'We are delighted to
receive FDA approval for all indications sought for Nexium. The US label
compares favourably with both the US Prilosec label and with those received so
far in Europe for Nexium which has had launches among the best in the
pharmaceutical industry's history. Nexium will be available on prescription
in the US in March.
'We are very well prepared to launch Nexium in the US and with this label we
are confident of retaining our global leadership of the gastro-intestinal
market'.
The FDA has approved Nexium with a comprehensive set of indications as
follows:
- Heartburn and other symptoms associated with gastro-esophageal reflux
disease (GERD).
- The healing and symptom resolution of erosive esophagitis, a potentially
serious condition associated with GERD.
- The maintenance of both healing and symptom resolution of esophagitis.
- The eradication of Helicobacter pylori infection in patients with duodenal
ulcer disease in 10 days, in combination with certain antibiotics.
The label confirms that Nexium 40mg demonstrates higher healing rates in
erosive esophagitis than Prilosec 20mg (the approved dose for this
indication). In three studies, Nexium 40mg consistently demonstrated higher
healing rates than Prilosec 20mg and two of these studies were statistically
significant. Healing rates achieved for Nexium 20mg were between those
achieved with Nexium 40mg and Prilosec 20mg.
Sustained resolution of heartburn was achieved in 5 days for Nexium 40mg; 7-8
days for Nexium 20mg against 7-9 days for Prilosec 20mg. After four weeks of
40mg Nexium treatment, a higher percentage of patients achieved sustained
resolution of heartburn than with Prilosec 20mg.
In clinical trials, the safety profile of Nexium was similar to that of
Prilosec. The most frequently occurring side effects were headache, diarrhoea
and abdominal pain.
The catalogue price to wholesalers has been set at $3.33 for either a Nexium
20mg or Nexium 40mg capsule. The catalogue price to wholesalers of Prilosec
20mg is $3.45.
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of ethical (prescription)
pharmaceuticals and the supply of healthcare services. It is one of the top
five pharmaceutical companies in the world with healthcare sales of $15.8
billion and leading positions in cardiovascular, gastrointestinal, oncology,
anaesthesia including pain management, central nervous system (CNS) and
respiratory products.
The US Nexium label is available on the US AstraZeneca website -
www.astrazeneca-us.com.
AstraZeneca PLC will be conducting a conference call for analysts and the
media at 0900 hrs GMT (Europe and US lines available) and 1630 hrs GMT (Europe
and US lines available) on Wednesday, 21 February, as follows:
09.00 GMT / 04.00 EST
Analysts (UK) 0800 027 0199 / 0800 027 1111
Analysts (rest of Europe) +44 (0) 8700 559 377 / +44 (0) 8700 559 381
Analysts (US) +1 212 346 6435 / 800 340 5810
Media + 44 (0) 8700 559 363 / 0800 027 2020
16.30 GMT / 11.30 EST
Analysts (UK) 0800 027 0199 / 0800 027 1111
Analysts (rest of Europe) +44 (0) 8700 559 377 / +44 (0) 8700 559 381
Analysts (US) + 1 415 908 6221 / 800 416 4516
Media + 44 (0) 8700 559 363 / 0800 027 2020
The Conference Call will be replayed until 28 February 2001 on the following
numbers :
UK Replay access : +44 (0) 141 566 8866 or 0800 027 0225
Client Identity Number : 507 Passcode : 130 Hash
US Replay access : 1 858 812 6440 or 800 633 8284
Passcode : 18064389 Hash
This press release contains forward-looking statements with respect to the
business of AstraZeneca. By their nature, forward-looking statements 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 the risks and uncertainties please see the Company's Annual
Report/Form 20-F for 1999.
21 February 2001
Further enquiries to:
Media Relations:
Steve Brown: Tel +44 (0) 20 7304 5033
Lucy Williams: Tel +44 (0) 20 7304 5034
Investor Relations:
Michael Olsson: Tel +44 (0) 20 7304 5087
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