REHOVOT, Israel Israeli drug company SciVac is seeking U.S. approval for a widely used hepatitis B vaccine as part of a push for increased global sales of a product which it says could stem global growth in the disease.
Some 1.2 million people die each year from HBV, 100 times more than HIV, while as many as 400 million people are carriers.
SciVac - 45 percent owned by Opko Health, which is controlled by Teva Pharmaceutical Industries Chairman Phillip Frost - has applied to the U.S. Food and Drug Administration for distribution of its vaccine to dialysis and HIV sufferers in the United States.
It is about to embark on a clinical trial in the United States that will take a year and a half. Should it get FDA approval, SciVac will then seek similar confirmation in Europe.
SciVac's Sci-B-Vac, already given to the majority of Israeli children just after birth, comprises all three native proteins of the virus, compared with just one protein in an older vaccine from GlaxoSmithKline's called Engerix-B and cheaper copycats from China.
Dosage of Sci-B-Vac is just a quarter that of Engerix.
SciVac also says 10 percent of newborn babies and 25 percent of adults over 40 do not respond to the older products.
"It (Sci-B-Vac) looks the same as the virus itself. The immune system cannot ignore it, so it gives full protection," Michal Ben-Attar, chief executive of SciVac, told Reuters, adding that Sci-B-Vac is virtually 100 percent effective against HBV in newborns.
SciVac has distributed more than a half-million doses of its vaccine since 2009. It is also registered for use in India, Hong Kong, Vietnam, the Philippines and some African countries.
Ben-Attar said SciVac is on the verge of signing a distribution agreement for the product in India. Although HBV is most prevalent in developing countries, Ben-Attar said it is tough to sell in such markets because they prefer cheaper alternatives.
She said Sci-B-Vac is being sold at prices that are competitive with Engerix despite it being expensive to produce.
SciVac had revenue of $10 million in 2012 and Ben-Attar said it will break even by the end of 2013 before moving into the black in 2014.
The CEO expects the company to seek a public share offering - possibly on Nasdaq - after breaking even, at which point it could be valued at between $600 million and $1 billion.
(Editing by David Holmes)
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