Idenix, Novartis seek European approval of telbivudine to treat chronic hepatitis B

By Lisa Kerner

Erie, Pa., Feb. 7 - Idenix Pharmaceuticals, Inc. and Novartis AG announced the submission of a Marketing Authorization Application to the European Medicines Agency (EMEA) seeking marketing authorization for the 600 mg dose of telbivudine for the treatment of chronic hepatitis B.

A New Drug Application for telbivudine was recently submitted to the Food and Drug Administration, and Novartis plans to submit similar applications in key Asian markets early this year, according to a company news release.

"This MAA submission with the EMEA is another significant step in the development of telbivudine, a drug with the potential to improve the management of chronic hepatitis B, a disease with potentially fatal consequences that affects millions of people around the globe," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix, in the release.

The marketing application is based primarily on one-year data from an ongoing two-year, phase 3 clinical trial comparing telbivudine with lamivudine in the treatment of 1,367 adults with chronic hepatitis B.

The study, known as Globe, is the largest registration trial for a chronic hepatitis B treatment and includes 112 clinical centers in 20 countries.

Chronic hepatitis B can cause liver failure, cirrhosis, liver cancer and death. Each year about 1.2 million people die worldwide from hepatitis B-related chronic liver disease.

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.

Idenix, a Cambridge, Mass.-based biopharmaceutical company, develops drugs for the treatment of human viral and other infectious diseases.

Novartis is a Basel, Switzerland, pharmaceutical company that offers medicines to protect health, cure disease and improve well-being.

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