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Idenix and Novartis Seek European Approval of Telbivudine for the Treatment of Patients With Chronic Hepatitis B

CAMBRIDGE, MA -- February 7, 2006 -- Idenix Pharmaceuticals, Inc. and Novartis announced today the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) seeking marketing authorization for the 600 mg dose of telbivudine for the treatment of chronic hepatitis B. This MAA is the second in a series of submissions aimed at obtaining marketing approvals for telbivudine, an orally active, once-daily nucleoside analogue. A New Drug Application (NDA) was recently submitted with the United States Food and Drug Administration (FDA). Novartis expects to submit applications for marketing authorization in key Asian markets during the first quarter of 2006.

"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. "The submission of the MAA in Europe and the NDA in the U.S. within a month of each other demonstrates the strength of our ongoing collaboration with Novartis."

The MAA submission is based primarily on one-year data from the GLOBE study, the largest registration trial for a chronic hepatitis B treatment. The GLOBE study is an ongoing, two-year, phase 3 clinical trial comparing telbivudine with a standard therapy, lamivudine, in the treatment of 1,367 adults with chronic hepatitis B from 112 clinical centers in 20 countries worldwide including (in Europe) the Czech Republic, France, Germany, Greece, Italy, Poland, Spain, Turkey, and the United Kingdom. GLOBE is the first international hepatitis B study to include clinical sites and patients in mainland China.

Chronic hepatitis B is the most common serious liver infection in the world. It can cause liver failure, cirrhosis (scarring), liver cancer and death.1 It is caused by the hepatitis B virus (HBV), which infects the liver.¹ HBV is 50 to 100 times more infectious than HIV (the virus that causes AIDS).² Chronic hepatitis B is the tenth leading cause of death worldwide.³ It affects approximately 350 million people worldwide and is responsible for up to 80 percent of the world's cases of primary liver cancer.⁴ Each year approximately 1.2 million people die worldwide from hepatitis B-related chronic liver disease.³ In Europe there are considerable regional differences in the prevalence of chronic hepatitis B, ranging from below 0.1% in Northwestern Europe to up to 8% in Eastern and Southern Europe.⁵

Despite the availability of treatments for chronic hepatitis B, significant unmet needs still exist, including the need for improved response rates, better-long-term efficacy, reduced rates of drug resistance, improved safety and tolerability, and more convenient dosing regimens.

REFERENCES:
1. Centers for Disease Control and Prevention. Hepatitis B Frequently Asked Questions. Available at: www.cdc.gov/ncidod/diseases/hepatitis/b/faqb.htm Accessed 12/8/05
2. World Health Organization. Hepatitis B Fact Sheet Number 204 Available at www.who.int/mediacentre/factsheets/fs204/en/print.html Accessed 12/8/05
3. Lavanchy D. J Viral Hepat. 2004 Mar 11 (2): 97-107
4. World Health Organization. Expanded programme on immunization hepatitis B vaccine – making global progress. Available at www.childrensvaccine.org/files/WHO_hep_B_update.pdf Accessed 12/8/05
5. Robert Koch Institut. Epidemiologisches Bulletin. 18. November 2005 / Nr. 46


SOURCE: Idenix Pharmaceuticals

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