Trizivir Approved in the European Union
BioChem Pharma Inc. (NASDAQ: BCHE; TSE: BCH) announced today that its partner, GlaxoSmithKline plc, has received approval from the European Commission to market Trizivir, the 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 naïve 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.
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 et al., were licensed to Glaxo Wellcome by the University of Minnesota in 1992.
Under agreement, BioChem Pharma receives royalties from GlaxoSmithKline on sales of its discovery lamivudine for use in treatment of both HIV/AIDS (3TC/Epivir/Combivir/Trizivir) and HBV (Zefix/Zeffix/Epivir-HBV/Heptovir/Heptodin). GlaxoSmithKline has the right to develop, manufacture and sell lamivudine worldwide, except in Canada, where BioChem Pharma and GlaxoSmithKline have formed a commercialization partnership.
BioChem Pharma is an innovative and fast-growing biopharmaceutical company focused on infectious diseases and cancer.
Heptodin, Zefix, Zeffix, Epivir-HBV, Heptovir, 3TC, Epivir, Retrovir, Ziagen, Combivir, and Trizivir are trademarks of the GlaxoSmithKline group of companies.
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