Glaxo plc has begun Phase III trials in Europe and the Far East oflamivudine for the treatment of the hepatitis B virus, BioChemPharma Inc. said Thursday.BioChem Pharma, of Laval, Quebec, invented the antiviral agent andlicensed worldwide rights, excluding North America, to Glaxo ofLondon. In North America, lamivudine will be produced by a jointventure of the companies, and sold in Canada by the joint venture andthe U.S. by Glaxo. BioChem will receive undisclosed royalties, thecompany's president and CEO, Francesco Bellini, told BioWorld.Lamivudine is a different formulation of the HIV drug 3TC, whichalso is in Phase III and being developed by BioChem Pharma andGlaxo. Wellcome plc has an option to gain marketing rights to 3TC.The London firm is expected to decide on exercising its option by theend of the year, after trial results are produced.Bellini said the drug is more active against hepatitis than it is againstHIV, allowing for a lower dose and once-a-day oral delivery, ratherthan twice a day. Bellini said 100 mg per day is the dose for hepatitisB that showed strong activity and no side effects.Phase II tests of lamivudine showed it had an inhibitory effect on viralreplication at all doses tested as evidenced by a reduction in serumHBV DNA.Bellini said Phase III trials of lamivudine are expected to begin inCanada, the U.S. and China later this year, and in Japan in early 1995.The drug has either completed or nearly completed Phase II testing atcenters throughout the world, and results are expected to be presentedat the American Association for the Study of Liver DiseasesConference in Chicago in November, Bellini said.BioChem Pharma stock closed at $9 Thursday, up 50 cents. _ JimShrine
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