Study results on Novartis/Idenix drug Telbivudine shows significant suppression of hepatitis B virus

By E. Janene Geiss

Philadelphia, Nov. 14 - Novartis Pharmaceuticals Corp. and Idenix Pharmaceuticals Inc. said Monday that results from an ongoing Globe study demonstrate the investigational drug Telbivudine provides significantly greater response on all evaluated virologic markers compared to Lamivudine after one year in both HbeAG-positive and HbeAg-negative patients with chronic hepatitis B.

Patients treated with Telbivudine achieved significantly greater viral suppression than patients treated with Lamivudine. Patients treated with Lamivudine also experienced significantly higher rates of non-detectable viral levels, according to a company news release.

The Globe study, a phase 3 clinical trial, includes 1,367 patients from 20 countries and is the largest registration trial of chronic hepatitis B patients ever conducted, officials said. And the study is the first to include patients from China, officials said, where the disease is highly prevalent.

Idenix is developing its hepatitis B clinical product candidates Telbivudine and Valtorcitabine in collaboration with Novartis under a development and commercialization arrangement established in May 2003.

"The potent viral suppression achieved with Telbivudine has the potential to reduce the serious complications associated with chronic hepatitis B and Telbivudine's favorable safety and convenience profile in trials to date also may make it a promising treatment option for patients, including those requiring long-term therapy," Dr. Ching-Lung Lai, professor of Medicine and chief of the Gastroenterology and Hepatology Division at the University of Hong Kong and lead investigator of the Globe study, said in the release.

The data was presented Monday at the annual meeting of the American Association for the Study of Liver Diseases.

Cambridge, Mass.-based Idenix is a biopharmaceutical company focused on drug discovery for viral and infectious diseases.

Novartis of East Hanover, N.J., discovers, develops, manufactures and markets prescription drugs.

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