Novartis has unveiled new clinical data showing that telbivudine, its an oral, once-daily nucleoside drug for chronic hepatitis B, is more effective in treating Chinese patients with the disease compared to lamivudine, the most commonly used oral drug for hep B.
The results from this Phase III trial are significant because China is estimated to have more than 120 million people infected with hep B. Novartis has filed a marketing application for telbivudine on the back of the data, as well as the results of the GLOBE study, carried out in Europe and other world markets.
China is the latest in a series of filings for marketing approval of telbivudine, following earlier submissions in the USA and European Union.
Market analyst firm Decision Resources believes that telbivudine is one of a handful of products expected to drive growth in the market for antiviral hepatitis B drugs, from around $1 billion at present to $3 billion by 2012. And analysts have suggested Novartis' drug could achieve annual sales of around $400 million or more at peak.
Novartis is working together with Idenix on various hepatitis product candidates, including telbivudine and valtorcitabine for hepatitis B, and the Swiss firm has an option on Idenix' valopicitabine, a potential drug for hep C. Last year it signed a $570 million deal with Anadys Pharmaceuticals for ANA975, another hep C candidate.