Novartis Seeks Global Hepatitis B Drug Approval

Idenix Pharmaceuticals and Novartis have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) seeking marketing authorization for the 600 mg dose of telbivudine for treatment of chronic hepatitis B.

This is the second in a series of submissions to get marketing approvals for telbivudine, an orally active, once-daily nucleoside analogue. A New Drug Application (NDA) was recently submitted to the US FDA. Novartis also expects to submit applications for marketing authorization in key Asian markets during the first quarter of 2006.

Chronic hepatitis B is the most common serious liver infection in the world. It can cause liver failure, cirrhosis (scarring), liver cancer and death. It is caused by the hepatitis B virus (HBV), which infects the liver. HBV is 50 to 100 times more infectious than HIV. Chronic hepatitis B is the tenth leading cause of death worldwide and affects approximately 350 million people worldwide and is responsible for up to 80% of the world's cases of primary liver cancer. Each year, approximately 1.2 million people die worldwide from hepatitis B-related chronic liver disease.

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.

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.

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.

Source: Idenix Pharmaceuticals, Inc.