Sebivo(R) (telbivudine), a new treatment for patients with chronic hepatitis B shown to deliver more rapid and profound viral suppression than lamivudine, has received approval in Switzerland.

This important approval provides access to an innovative new therapy for Swiss patients but also supports expanded regulatory submissions. More than 100 countries worldwide look to the approval of a medicine in the company's home country to serve as a reference for local regulatory reviews.

A single pill taken orally once daily with or without food, Sebivo has been shown to effectively suppress replication of the hepatitis B virus[1].

Approximately 350 million people worldwide are living with chronic hepatitis B[2], a virus that affects the liver and is estimated to be 50 to 100 times more infectious than human immunodeficiency virus (HIV)[2]. Hepatitis B virus can cause chronic lifelong infection, which can lead to several liver conditions - including cirrhosis (scarring), cancer or organ failure - and death[3] . Hepatitis B is the second most common cause of cancer after smoking, with 1.2 million people estimated to die annually from hepatitis B-related chronic liver disease[4].

"We are committed to helping physicians offer better care for patients with chronic hepatitis B, and the approval of Sebivo in Switzerland is a significant step toward achieving this goal," said Giacomo di Nepi, Head of the Infectious Diseases, Transplantation and Immunology Business Unit at Novartis Pharma AG. "This approval not only makes Sebivo available in Switzerland but also supports approvals in many countries that first require Swiss approval."

Applications for approval were filed with the US Food and Drug Administration (FDA) in late 2005 as well as with the European Medicines Agency (EMEA) and the Chinese health authority in the first quarter of 2006. A different trademark for telbivudine in the US is currently under discussion.

About the GLOBE study

The approval of Sebivo is based primarily on one-year data from the GLOBE study, the largest worldwide registration trial ever conducted in patients with chronic hepatitis B. This two-year Phase III clinical trial compared Sebivo with lamivudine in the treatment of 1,367 adults with chronic hepatitis B at 112 clinical centers in 20 countries[1].

Results from GLOBE indicate that Sebivo produces significantly greater viral suppression on a number of virologic markers compared to lamivudine after one year in both chronic hepatitis B e-antigen (HBeAg) positive and negative patients. Two-year data from the GLOBE study is planned to be presented at the American Association for the Study of Liver Disease meeting in Boston on October 30.

"The goal of managing chronic hepatitis B is to prevent long-term complications such as liver damage or liver cancer, which is possible through rapid, profound and sustained suppression of the hepatitis B virus," said Professor Rafael Esteban, Head of Internal Medicine and Chief of the Liver Unit at the Hospital Universitario Vall d'Hebron in Barcelona, Spain. "Telbivudine's demonstrated ability to drive down virus levels in the first six months of treatment, along with its favorable safety and convenience profile in clinical trials to date, make it a promising treatment option for patients."

The primary efficacy endpoint of the GLOBE study was therapeutic response at one year, a composite endpoint coupling viral suppression (serum HBV DNA suppression below 100,000 copies/mL) with either improved liver disease markers (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg). In HBeAg-positive patients, therapeutic response was significantly higher among patients treated with Sebivo compared to those treated with lamivudine (75 vs. 67 percent respectively, p