AstraZeneca PLC
11 February 2003
ASTRAZENECA SUBMITS IRESSA(TM) (gefitinib, ZD1839)
FOR APPROVAL IN EUROPE FOR
ADVANCED NON-SMALL CELL LUNG CANCER
AstraZeneca announced today the submission in Europe of a Marketing
Authorisation Application for IRESSA(TM) (gefitinib, ZD1839) for the treatment of
locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients
previously treated with platinum-based and docetaxel chemotherapy.
IRESSA is the first in a new class of anti-cancer drugs known as Epidermal
Growth Factor Receptor (EGFR) inhibitors and was approved by the Japanese
Ministry of Health, Labour and Welfare (MHLW) for the treatment of inoperable or
recurrent NSCLC in July 2002. Sales for IRESSA in 2002 totalled $67 million.
The submission for IRESSA in Europe is based on data from two Phase II trials,
IDEAL 1 and IDEAL 2 (IRESSA Dose Evaluation in Advance Lung Cancer). These data
confirmed that IRESSA 250mg per day monotherapy provides clinically-significant
anti-tumour activity in patients with previously treated advanced NSCLC. Results
also provided further confirmation of IRESSA's favourable safety profile, with
the majority of side effects (diarrhoea and skin rash) reported as mild and
reversible. Final results from these trials were presented internationally in
September, 2002.
In the year 2000, there were approximately 370,000 new cases of lung cancer in
Europe and more than 340,000 deaths from the disease. Only one in every 10
people with lung cancer is alive five years after diagnosis. The market for
NSCLC is valued at $1.6 billion, and is forecast to grow to $8 billion by 2011.
The IRESSA submission today follows the submission (4 February) of the European
Marketing Authorisation Application for the use of FASLODEXTM(TM) (fulvestrant)
in the treatment of advanced breast cancer in postmenopausal women whose disease
has progressed following prior endocrine therapy.
AstraZeneca continues its tradition of research excellence and innovation in
oncology that led to the development of its current anti-cancer therapies
including ARIMIDEX, CASODEX, FASLODEX, NOLVADEX, TOMUDEX and ZOLADEX, as well as
a range of novel targeted products such as anti-proliferatives,
anti-angiogenics, vascular targeting and anti-invasive agents. AstraZeneca is
also harnessing rational drug design technologies to develop new compounds that
offer advantages over current cytotoxic and hormonal treatment options. The
company has over 20 different anti-cancer projects in research and development.
AstraZeneca 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 top five pharmaceutical
companies in the world with healthcare sales of over $17.8 billion and leading
positions in sales of oncology, gastrointestinal, anaesthesia (including pain
management), cardiovascular, central nervous system (CNS) and respiratory
products.
IRESSA(TM), ARIMIDEX, CASODEX, FASLODEX, NOLVADEX, TOMUDEX and ZOLADEX are
trademarks of the AstraZeneca group of companies.
11 February 2003
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
Jonathan Hunt, Tel: +44 (0) 207 304 5087
- ENDS -
This information is provided by RNS
The company news service from the London Stock Exchange
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.