FDAnews
www.fdanews.com/articles/70792-bms-hepatitis-b-treatment-baraclude-wins-fda-approval

BMS' Hepatitis B Treatment Baraclude Wins FDA Approval

April 6, 2005

Bristol-Myers Squibb (BMS) has received FDA clearance to market Baraclude, a new drug intended to treat hepatitis B.

The FDA approval for Baraclude (entecavir) tablets and oral solution covers treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease. BMS said the drug would be available in the U.S. as early as April 8.

BMS didn't project sales figures for Baraclude, but financial analysts said the drug has the potential to generate roughly $300 million in annual revenues for the company. Banc of America Securities estimated Baraclude revenues could reach approximately $32 million in 2005, $80 million in 2006 and $290 million by 2009.