Idenix Pharmaceuticals and Novartis Pharma AG announced that the phase III GLOBE registration trial for the experimental hepatitis B drug telbivudine successfully reached its primary efficacy endpoint of therapeutic response at one year in chronic hepatitis B patients. Idenix and Novartis are co-developing telbivudine.

The endpoint, designed to assess if telbivudine was at least as effective as lamivudine (Epivir-HBV), evaluated the combination of viral suppression (HBV DNA suppression below 100,000 copies/mL) coupled with either improved liver function (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg).

The largest hepatitis B registration trial to date, GLOBE has enrolled more than 1,350 patients in over 130 medical centers worldwide. The ongoing trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in patients with HBeAg-positive and HBeAg-negative compensated chronic hepatitis B for two years of treatment in two daily treatment regimens: telbivudine 600 mg or lamivudine 100 mg.

The one-year analysis of this trial will be the primary data used for preparing the marketing registration applications for submission to the U.S. Food and Drug Administration (FDA. Idenix and Novartis plan to file with the FDA  by the end of 2005 for marketing approval of telbivudine for the treatment of chronic hepatitis B. Worldwide marketing filings, including the filing that will be submitted to the European Medicines Agency (EMEA), are expected in the first quarter of 2006.

The World Health Organization (WHO) has estimated that approximately 350 million people, or 5% of the world's population, are chronically infected with hepatitis B virus (HBV). Chronic Hepatitis B can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. The WHO estimates that annually over 50 million people worldwide become infected with HBV and that more than one million individuals die annually from HBV-related chronic liver disease.

Current treatment options for chronic hepatitis B are often associated with limited efficacy, poor tolerability or resistance concerns, and new therapeutic options are needed to respond to the significant unmet need in treating this debilitating condition.

"We are very pleased that telbivudine met the primary endpoint in the phase III GLOBE study and may provide an important new therapeutic option for patients with chronic hepatitis B," commented Nathaniel Brown, M.D., executive vice president of clinical development and chief medical officer of Idenix. "Bringing our first clinical candidate through this stage of development is a major milestone for Idenix, particularly given the large international scope of the GLOBE study."

The companies anticipate that complete data from the GLOBE study will be submitted for presentation to the American Association for the Study of Liver Diseases (AASLD) meeting in San Francisco, California, November 11-15, 2005.

More about Telbivudine

Telbivudine is a specific and selective, oral, once-daily nucleoside that is unique in its preferential inhibition of 2nd strand HBV DNA synthesis. This distinct mechanism of action may be responsible for the rapid and profound viral suppression associated with telbivudine treatment.

The GLOBE study results continue to support a favorable overall safety profile for telbivudine with no substantial safety issues being identified to date through the combined two years of treatment in the phase IIb clinical trial and in the phase III clinical program to date. The most frequently reported adverse events, regardless of attributability to study treatment, were upper respiratory infection and fatigue, which were similar for telbivudine (14% and 12 %, respectively) and lamivudine (13% and 10% respectively).

An additional phase III trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in HBeAg-positive and HBeAg-negative patients with decompensated chronic hepatitis B. This ongoing trial has enrolled 87 patients to date.

The Idenix/Novartis Collaboration

Idenix is developing its experimental 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 and Idenix will co- promote in the United States, France, Germany, Italy, Spain and the UK those product candidates Novartis has licensed, including telbivudine and valtorcitabine, that are approved for marketing. Novartis holds the exclusive license to telbivudine and valtorcitabine in the rest of the world.

The collaboration also provides Novartis 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 hepatitis C product candidate.

About Idenix

Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts. The company also has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.

08-01-05

Source
PR Newswire-FirstCall. Telbivudine Achieves Primary Endpoint in Phase III GLOBE Trial, Largest Ever Registration Trial in Hepatitis B. July 28, 2005.