GlaxoSmithKline PLC
23 January 2003
Issued - 23 January 2003, London, United Kingdom
GlaxoSmithKline Receives Positive Opinion from European Committee for
Proprietary Medicinal Products for Seretide(TM) for the Treatment of COPD
GlaxoSmithKline plc (LSE and NYSE: GSK), announced today that they have received
a positive opinion from the European Committee for Proprietary Medicinal
Products (CPMP) for Seretide(TM) (Seretide Diskus 500/50) as a new treatment for
Chronic Obstructive Pulmonary Disease (COPD). This means that European Marketing
Authorization should be granted within the next few months followed by launches
across Europe in the first half of 2003.
"Today's decision by the CPMP represents a milestone in the treatment of COPD -
Seretide is an effective and convenient medicine for the treatment of COPD and
offers real hope to those physicians and patients fighting this deadly disease",
said Andrew Witty, President, Pharmaceuticals, Europe at GSK.
The approval is important for Europe where COPD is currently the fifth largest
killer (1) and affects an estimated 340 million COPD patients worldwide (2).
Seretide is the first inhaled steroid/long acting beta2 agonist combination
product to receive a positive European regulatory opinion for the treatment of
COPD a multi-component disease.
S M Bicknell
Company Secretary
23 January 2003
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer.
Note that Seretide is marketed as VianiTM in Germany.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities Litigation Reform
Act of 1995, GlaxoSmithKline cautions investors that any forward-looking
statements or projections made by GSK, including those made in this news
release, are subject to risks and uncertainties that may cause actual results to
differ materially from those projected. Factors that may affect the company's
operations are discussed in the section "Cautionary factors that may affect
future results" in GSK's results announcement for the year ended 31 December
2001, filed with the U.S. Securities and Exchange Commission.
References:
1. Murray CJL, Lopez AD. Eds. The Global Burden of Disease: a comprehensive
assessment of mortality and disability from diseases, injuries, and risk factors
in 1990 and projected to 2002. Cambridge; Harvard University Press; 1996.
2. The World Health Report 1998. Life in the 21st Century. A vision for all.
World Health Organisation, Geneva, 1998.
Enquiries:
UK Media enquiries: Martin Sutton (020) 8047 5502
Siobhan Lavelle (020) 8047 5502
US Media enquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Patricia Seif (215) 751 7709
European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540
Philip Thomson (020) 8047 5543
Anita Kidgell (020) 8047 5542
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
This information is provided by RNS
The company news service from the London Stock Exchange
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