GlaxoSmithKline PLC
4 January 2001
GlaxoSmithKline's New
Triple Combination Therapy for HIV, Trizivir, Approved in the European Union.
GlaxoSmithKline plc announces that it has received approval from the European
Commission to market Trizivir, its new triple combination tablet, for the
treatment of HIV-infected adults, in all the 15 member states of the European
Union.
Trizivir is the first medicine to combine three anti-HIV therapies in one
tablet. Each tablet contains abacavir sulphate (300mg, Ziagen), lamivudine
(150mg, Epivir, 3TC) and zidovudine (300mg, Retrovir, ZDV). This fixed dose
combination replaces the three components used separately in similar dosages.
It is recommended that treatment is started with abacavir, lamivudine, and
zidovudine separately for the first 6-8 weeks. The choice of Trizivir should
be based not only on potential adherence criteria, but mainly on expected
efficacy and risk related to the three compounds. The three components of
Trizivir will continue to be available individually.
The benefits of Trizivir are related to its potent HIV activity in
antiretroviral naive patients and simplification of therapy so that only one
tablet twice daily is required, with no food or water restrictions. Hence the
simplified regimen of Trizivir may help to improve adherence to treatment, one
of the key challenges in managing the treatment of HIV infection.
The marketing application for Trizivir was submitted to the European Medicines
Evaluation Agency (EMEA) in December 1999 under the centralised procedure.
Trizivir is already approved in the US, Mexico, Switzerland, Chile, Ghana and
Malawi.
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.
Epivir, Retrovir, Ziagen and Trizivir are trademarks of the GlaxoSmithKline
Group of companies.
Ziagen was discovered and is being developed by GlaxoSmithKline. The rights to
related compounds and technology, including intermediates used in the
manufacture of abacavir, resulting from the research of Dr Robert Vince at
al., were licensed to Glaxo Wellcome by the University of Minnesota in 1992.
Epivir was discovered by BioChem Pharma of Laval, Quebec, Canada and licensed
to Glaxo Wellcome in 1990.
For further information, please contact:
Media enquiries: Martin Sutton (020) 8966 8000
Alan Chandler (020) 8975 2290
Philip Thomson (020) 8966 8000
European Analyst/Investor enquiries: Jennie Younger (020) 8966 8378
Duncan Learmouth (020) 8966 5961
Joan Toohill (020) 8966 8715
Anita Kidgell (020) 8966 8369
US Analyst/Investor enquiries: Frank Murdolo (212) 308 5185
Tom Curry (215) 751 5419
Jennie Younger (020) 8966 8378
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