Novartis said this morning it has got a green light from Swiss regulators for Sebivo, a new orally-active drug for hepatitis B.
Sebivo (telbivudine) has been tipped as a fairly big seller for Novartis, as clinical trials have suggested it is more effective than the current standard treatment, GlaxoSmithKline's Zeffix (lamivudine), in tackling chronic hepatitis B infections. Analysts have suggested Novartis' drug could achieve annual sales of around $400 million or more at peak.
In the pivotal GLOBE clinical trial, Novartis' drug was found to be better than lamivudine at reducing hepatitis B virus DNA, a marker for the presence of the virus in the blood. After a year's treatment HBV was undetectable in 60% of telbivudine patients, compared to 40% of the lamivudine group. Two-year data are due to be presented next month.
Chronic hepatitis B, the world's most common serious liver infection, is a potentially fatal disease which is thought to affect over 350 million people worldwide.
Telbivudine was originally developed by US company Idenix, and Novartis licensed rights to the product in 2003 in a $225 million deal. Novartis is also working with Idenix on another hepatitis B product candidate, valtorcitabine, which is in Phase II testing.
The two companies extended their agreement earlier this year to extend the license to valtorcitabine to include the treatment of chronic hepatitis C, and are also co-developing another oral drug valopicitabine, for this indication.