AstraZeneca PLC
5 July 2002
ASTRAZENECA SECURES FIRST MARKET APPROVAL
FOR IRESSA(TM) IN JAPAN
AstraZeneca announced today that 'Iressa' (ZD1839) 250 mg once daily has
received approval for the treatment of inoperable or recurrent non-small cell
lung cancer (NSCLC) from the Japanese Ministry of Health, Labour and Welfare
(MHLW), making Japan the first country worldwide to licence the drug. 'Iressa'
is the first in a new class of anti-cancer drugs, known as Epidermal Growth
Factor Receptor (EGFR) inhibitors, to become commercially available.
The Japanese regulatory authorities have recently re-engineered the new drug
application review procedure, which historically has been seen as somewhat
slower than other regulatory bodies worldwide. The 'Iressa' review, which is
the fastest on record (besides that for an AIDS treatment), is among the first
to benefit from the new system. 'Iressa' will be the first drug in the world to
be simultaneously developed in Japan, the United States and Europe, and launched
in Japan first. AstraZeneca is the second fastest-growing major pharmaceutical
company and ranks first in the oncology market in Japan, the world's second
largest pharmaceutical market.
NSCLC killed close to a million people worldwide in 2000 alone. Each year in
Japan, there are 50,000 patients with NSCLC, of which 43,000 will die. The
Japanese MHLW is forecasting an 80 per cent increase in the incidence of lung
cancer in Japan over the next 15 years. The worldwide market for lung cancer is
currently worth approximately
$1.6 billion, the majority of which is accounted for by NSCLC, and is scheduled
to grow to $8 billion by 2011.
AstraZeneca anticipates full reimbursement for 'Iressa' by the end of the third
quarter. Product launch is expected in the second half of this year in the
United States, while regulatory reviews in Switzerland and Australia are
currently underway.
The first approval of 'Iressa' is based on data from two pivotal phase II
trials, IDEAL 1 and 2. Results from these studies confirm 'Iressa' as an
effective treatment for many patients with inoperable or recurrent advanced
NSCLC, with an acceptable tolerability profile with the majority of side effects
(diarrhoea and skin rash) reported as mild and reversible. 'Iressa' is
administered as a once daily, oral tablet.
'Iressa' is leading a new class of anti-cancer drugs known as epidermal growth
factor receptor (EGFR) inhibitors. This targeted mode of action is different
from cytotoxic chemotherapies and 'Iressa' is not causally associated with the
same types of side effects such as alopecia, neutropenia or other haematological
toxicity. Within the cell, 'Iressa' targets and blocks signalling pathways that
are implicated in the growth and survival of cancer cells. These pathways appear
to play a major role in the growth of many solid tumours; therefore, Iressa may
have therapeutic potential in a broad range of common cancers.
'Iressa' is a trademark of the AstraZeneca group of companies.
Date: July 5, 2002
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
- Ends -
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