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Hepatitis B treatment Baraclude approved in Europe

Published on 30/06/06 at 11:23am

A new hepatitis B treatment Baraclude has been approved in Europe and could eventually become a first-line choice thanks to its efficacy, safety and convenience to patients.

Bristol-Myers Squibb's Baraclude (entecavir) has been given marketing approval in the EU and is set for launch in the first European markets in autumn, when it will start to challenge existing treatments such as GSK's Zeffix.

Hepatitis B is the 10th 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.

Currently there is no cure for hepatitis, and all existing treatments work by suppressing the replication of the virus within the body. Patients taking Zeffix (lamivudine) eventually develop resistance to the drug, but Baraclude's main advantage is that this effect is seen much later.

Analysts Datamonitor say the drug's greater potency and superior resistance profile will help it gradually overtake Zeffix as the first-line choice, and it could hit peak annual sales of $300 million, depending on the drug's pricing in key markets.

"Chronic hepatitis B is a burden to millions of people in our region and we believe Baraclude represents an innovative treatment option," said Beatrice Cazala, president, Europe, Middle East and Africa for Bristol-Myers Squibb. "We are focused on finding ways to extend and enhance the lives of chronically-infected hepatitis B patients across the entire region, including Western Europe, but also in other countries with high prevalence such as Turkey, Russia and Greece."

Another newer drug already on the market is Roche's Pegasys, a pegylated version of the older interferon drugs which are used to treat hepatitis B and hepatitis C, usually in combination with another drug ribavirin.

Pegasys is rapidly gaining a market share with sales rising 17% in 2005 to 1.4 billion Swiss francs and will present the main competition for Baraclude.

A further expected entrant to the market, Novartis' telbivudine, was filed in Europe in March and analysts forecast it could earn $150-250 million in peak sales, but will face stiff competition from Baraclude and Pegasys.


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