Novartis' antiviral drug telbivudine is more effective than GlaxoSmithKline's lamivudine in treating patients with chronic hepatitis B, according to the GLOBE trial.
The GLOBE study, presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in San Francisco, found that telbivudine (LDT600) was better than lamivudine on a range of clinical outcomes. Novartis' drug was better at reducing hepatitis B virus DNA, a marker for the presence of the virus in the blood, and after a year's treatment HBV was undetectable in the blood of 60% of telbivudine patients, compared to 40% of the lamivudine group.
Meanwhile, the main measure of efficacy in the study - a combination of viral levels and other factors such as liver disease markets, was also better with telbivudine, although the study was only designed to demonstrate non-inferiority to GSK's drug.
Novartis said it would include the data in its regulatory filings for the drug, which are scheduled to take place in the first quarter of 2006. GLOBE will also continue to generate data out to two years.
The market for hepatitis B virus treatments is remarkably underserved, considering there are 400 million chronically infected HBV patients around the world and 2 billion people are exposed to the virus. Despite the huge patient numbers involved, even the top products such as Zeffix achieve modest sales, and investment in new treatments has been limited. GSK's drug brought in $179 million in the first nine months of this year, while its main rival, Gilead Sciences' Hepsera (adefovir dipivoxil), made $135 million.
A recent report by consultancy firm Datamonitor predicted that the world market for HBV treatments will grow to $1 billion in 2009, with telbivudine and two other drugs in the same nucleoside analogue class - Bristol-Myers Squibb's Baraclude (entacavir) and Gilead's clevudine - expected to contribute to the growth. Also adding to the market development will by Roche's Pegasys (peginterferon alfa-2a), although this injectable drug is unlikely to topple the orally active nucleoside analogues as the first-choice treatment for HBV.
Telbivudine is one of two new treatments for hepatitis that Novartis is developing alongside US company Idenix Pharmaceuticals. Phase II data on the other compound, valopicitabine (NM283), in hepatitis C were also presented at the AASLD meeting and will be published on Pharma Times Newsonline tomorrow.