Regulatory Approval

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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