Novartis: hepatitis B pill better than standard drug
UPDATE 1-Novartis: hepatitis B pill better than standard drug
Mon Nov 14, 2005 02:07 AM ET
(Adds detail of competitors, company comments, share price)
By Tom Armitage
ZURICH, Nov 14 (Reuters) - A new treatment for hepatitis B developed by U.S. drugmaker Idenix Pharmaceuticals Inc (IDIX.O: Quote, Profile, Research) and Switzerland's Novartis AG (NOVN.VX: Quote, Profile, Research) (NVS.N: Quote, Profile, Research) works better than a current standard treatment, data showed on Monday.
Novartis said in a statement that patients in a one-year Phase III trial saw a greater reduction of the hepatitis B virus in their bloodstreams when treated with telbivudine, compared with those treated on the current standard drug, lamivudine.
Lamivudine is sold as Epivir-HBV by Britain's GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) .
Telbivudine was developed by Idenix, in which Novartis has a 54-percent stake, and forms part of what Novartis hopes will be a lucrative push into virology.
"We are committed to achieving leadership in this growing area and marketplace," William Hinshaw, head of the firm's infectious diseases business, told Reuters.
The results of the trial, the largest of its kind and conducted in more than 1,350 hepatitis B patients, were presented at the American Association for the Study of Liver Diseases in San Francisco.
The data showed that the new drug produces significantly faster and more profound viral suppression compared to lamivudine after one year of treatment, Novartis said.
REGULATORY FILINGS
Idenix and Novartis expect to file the drug for regulatory approval in the United States by the end of 2005 and in Europe by the end of the first quarter of 2006.
Bristol-Myers Squibb (BSY.N: Quote, Profile, Research) sells Baraclude for hepatitis B, which U.S. health experts have said is more potent than either lamivudine, telbivudine or a drug made by Gilead Sciences Inc. (GILD.O: Quote, Profile, Research) called Hepsera.
All four drugs are nucleoside analogues, which disrupt the enzyme that reproduces the hepatitis B virus.
Novartis said chronic hepatitis B is the tenth leading cause of death worldwide, with more than 350 million people infected. It is also the second leading cause of cancer after smoking.
Sales potential for hepatitis B drugs is limited, however, because the disease is concentrated in parts of Africa and Southeast Asia, where patients are often unable to afford drugs.
Novartis also has the right to license in other drugs developed by Idenix, including an experimental hepatitis C pill called NM283 which has shown promise in a 12-week mid-stage clinical trial when combined with standard interferon drugs.
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