Novartis files new Hepatitis B treatment in Europe
pharmafile | February 28, 2006 | News story | Sales and Marketing |
Novartis has filed its new hepatitis B treatment telbivudine in the European Union, and says it represents a potential new standard treatment for the condition.
Hepatitis B is the tenth leading cause of death in the world, killing around 1.2 million people every year from related chronic liver disease. The condition is also responsible for around 80% of primary liver cancer cases.
Novartis has developed the drug with its discoverers Idenix, and has tested the new drug head to head with the current standard treatment lamivudine, GSK's Zeffix.
Results from Novartis' GLOBE trials suggest patients treated with telbivudine achieved significantly greater viral suppression than those taking lamivudine.
The phase III study included 1,367 patients from 20 countries and is the largest registration trial of chronic hepatitis B patients ever conducted. Novartis also says GLOBE is the first global chronic hepatitis B registration trial to include patients from China, where the disease is highly prevalent.
"Despite recent advances in the treatment of chronic hepatitis B, there remains a need for new, safe and effective treatment options," said Dr Ching-Lung Lai, chief of gastroenterology and hepatology at the University of Hong Kong, and lead investigator of the GLOBE study.
The potent viral suppression achieved with telbivudine has the potential to reduce the serious complications associated with chronic hepatitis B and telbivudine's favourable safety and convenience profile in trials to date also may make it a promising treatment option for patients, including those requiring long-term therapy.
Idenix is also working with Novartis on another hepatitis B candidate valtorcitabine as part of a partnership originally formed in 2003.
If approved, telbivudine will be co-marketed by the companies in the US, France, Germany, Italy, Spain and the UK, with Novartis marketing the drug alone in the rest of the world.
Analysts forecast the drug could earn $150-250 million in peak sales but will have to compete with two major products, Bristol-Myers Squibb's Baraclude and Roche's Pegasys.
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Thursday , February 23, 2006
