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www.fdanews.com/articles/88717-scigen-wins-indian-approval-for-hepaptitis-b-vaccine

SCIGEN WINS INDIAN APPROVAL FOR HEPAPTITIS B VACCINE

November 13, 2006

SciGen, a Singapore-based biopharmaceutical company, has received marketing approval in India for its third-generation hepatitis B vaccine, Sci-B-Vac. Commercialization of the vaccine will begin as soon as the manufacturing facility in Rehovot, Israel, is commissioned, which is expected to happen in the second quarter of 2007.

It is estimated that at least 45 million people in India were infected with hepatitis B in 2005, according to the company. Shreya Life Sciences, one of the top 20 pharmaceutical companies in India, will distribute the vaccine.

Sci-B-Vac is a third-generation recombinant vaccine produced in mammalian cell culture that contains all three regions (epitope) of the hepatitis B virus surface antigen and elicits a faster immune response than other hepatitis B vaccines presently available, according to SciGen. The vaccine has been proven safe and effective after clinical trials in more than 5,000 men, women and children in the Asia-Pacific region, Europe and Israel.