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Idenix and Novartis Announce New Drug Application Submitted to the U.S. Food and Drug Administration for Telbivudine for The Treatment of Chronic Hepatitis B

http://ir.idenix.com/phoenix.zhtml?c=131556&p=irol-newsArticle&ID=799680&highlight

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- Submission Based on Positive Data from GLOBE Study -

CAMBRIDGE, Mass., Jan. 3 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) and Novartis Pharmaceuticals Corporation (NYSE: NVS) announced today that a New Drug Application (NDA) was submitted to the United States Food and Drug Administration (FDA) seeking marketing approval for the 600 mg dose of telbivudine for the treatment of chronic hepatitis B. This NDA is the first marketing approval submission for telbivudine, an oral, once-daily nucleoside analog. Additional applications for marketing authorization in the European Union (EU) and key Asian markets are expected to be submitted by Novartis Pharma AG (an affiliate of Novartis Pharmaceuticals Corporation) in 1Q2006.

"Idenix is pleased to be submitting its first NDA for an agent that has the potential to provide a new treatment option for the millions of chronic hepatitis B patients around the world," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix. "The submission of this application in just 7 years from discovery of the use of telbivudine for the treatment of hepatitis B highlights the expertise and execution capabilities of our team and the impact of our alliance with Novartis. This marks a significant step in our company's growth and in the pursuit of our goal of building a leading antiviral franchise."

The NDA submission is primarily based on one-year data from the GLOBE study, the largest registration trial for a chronic hepatitis B treatment and the first global trial to include clinical sites and patients in mainland China. The GLOBE study is an ongoing two-year phase III clinical trial comparing telbivudine with a standard therapy, lamivudine, in 1,367 adults with chronic hepatitis B from 112 clinical centers in 20 countries worldwide.

The Centers for Disease Control and Prevention (CDC) estimates that 1.25 million Americans are chronically infected with hepatitis B(1), the most common serious liver infection in the world that can cause liver failure, cirrhosis (scarring), liver cancer and death.

Chronic hepatitis B is caused by the hepatitis B virus (HBV), which infects the liver.(2) HBV is 50-to-100 times more infectious than HIV (the virus that causes AIDS).(3) Chronic hepatitis B is the tenth leading cause of death worldwide.(4) It affects approximately 350 million people worldwide and is responsible for up to 80 percent of the world's primary liver cancer.(5) Each year approximately 1.2 million people die worldwide from hepatitis B-related chronic liver disease.(4)

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/Novartis Collaboration

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.

About Idenix

Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development 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 and it 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.
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