Telbivudine - an oral, once-daily nucleoside analogue in development for the treatment of chronic hepatitis B (CHB) - provides both superior antiviral and clinical efficacy in Chinese patients with this disease after one year of use when compared with the commonly used treatment lamivudine, according to new clinical data submitted by Novartis.

The results from this phase III trial in China, a country estimated to have more than 120 million people infected with hepatitis B, were consistent with the findings from the GLOBE study. This study, the largest registration trial ever conducted for chronic hepatitis B, showed that telbivudine provided a rapid and profound viral suppression.

The new data were included in the recent regulatory submission of telbivudine to Chinese health authorities together with the one-year data from the GLOBE study. China is the latest in a series of filings for marketing approval of telbivudine following earlier submissions in the US and EU.

"Telbivudine displayed statistically superior efficacy compared to lamivudine on the key viral and clinical markers, including statistically superior viral suppression, a higher percentage of patients with normalization of liver enzymes and a higher proportion of patients with HBeAg loss at one year," said Dr. Jinlin Hou, Director and Professor of the Hepatology Unit and Department of Infectious Diseases at Nanfang Hospital, Southern Medical University, Guangzhou, China.

"This data suggests that telbivudine could become an important new first-line treatment option for the millions of Chinese patients suffering from this potentially life-threatening disease."

"In China alone, this devastating disease accounts for nearly 10 percent of all the chronic hepatitis B cases worldwide," Dr. James Shannon, Global Head of Development, Novartis Pharma AG said adding, "We are very pleased about these positive results and look forward to working with the Chinese authorities to make telbivudine available to patients as fast as possible. Despite advances in chronic hepatitis B treatment, a high unmet need remains for potent therapies. Novartis is committed to developing innovative and more effective therapies such as telbivudine to treat this disease."

This trial is an ongoing, randomized, double-blinded, double-dummy trial comparing two years of treatment with telbivudine or lamivudine in 332 Chinese adults with chronic hepatitis B. The majority of patients in this trial were HBeAg-positive (290).

The GLOBE study is an ongoing two-year phase III clinical trial comparing telbivudine with lamivudine in the treatment of 1,367 adults with chronic hepatitis B. The study is being conducted at 112 clinical centers in 20 countries worldwide, including France, Germany, Italy, Spain and the United Kingdom. GLOBE is also the first international hepatitis B study to include clinical sites and patients in China: in fact, more than 25 per cent of the patients enrolled in the GLOBE study (373 patients) were from China with another 25 per cent of Asian patients coming from other countries.

Idenix is developing its hepatitis B clinical product candidates, telbivudine and valtorcitabine, in collaboration with Novartis Pharma AG under a development and commercialization arrangement established in May 2003.

The collaboration arrangement further provides that Novartis Pharma AG and Idenix will co-promote telbivudine and valtorcitabine and other product candidates that Novartis Pharma AG has licensed, if successfully developed and approved for marketing, in the United States, France, Germany, Italy, Spain and the UK. Novartis Pharma AG holds the exclusive license to commercialize telbivudine and valtorcitabine in the rest of the world. The collaboration also provides Novartis Pharma AG with an exclusive option to license and collaborate with Idenix in the development and commercialization of other product candidates in Idenix's portfolio, including valopicitabine (NM283), a direct antiviral for the treatment of chronic hepatitis C.