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SciGen aims for a share of the multibillion hep B vaccine market

By Susan Gotensparre , 22-Jan-2007

Biopharmaceutical firm SciGen has invested $30m (€23.2m) in a hepatitis B vaccine manufacturing plant in Israel, expecting to capture up to 15 per cent of the global market during a three year period.

SciGen has announced the official opening of its $20m (€15.5m) vaccine manufacturing facility in Israel, supplying three million doses of the company's third generation hepatitis B vaccine, Sci-B-Vac. The company is boosting their vaccine manufacturing to be able to ensure supply to their European and Asian commercial partners. In addition, a further $10m (€7.7m) has been invested to expand the Israeli facilities.

The world market for hepatitis B is $1.2bn (€0.93bn) - Europe and the Asia Pacific region represent 40 per cent - but is expected to increase due to rising awareness of hepatitis B and increased public health expenditure, according to SciGen. The firm has high expectations of explosive annual sales figures from the third quarter of 2007, followed by an anticipated triple digit growth in 2008.

"We expect to capture 2 per cent of the world market in the first year going to 5 per cent in the second year and 15 per cent in the third,", Saul Mashaal, chairman and CEO, told In-PharmaTechnologist.com.

The Sci-B-Vac is a rapid-acting and highly immunogenic vaccine that will provide immunity from the first dose.

"Sci-B-Vac, is indeed a unique hepatitis B vaccine which has repeatedly been shown to be highly immunogenic and safe in neonates, babies and adults alike." said Professor Daniel Shouval, Hebrew University

"While conventional yeast derived vaccines contain only one of the three hepatitis B virus envelope proteins, Sci-B-Vac contains two additional proteins - namely pre-S1and pre-S2 which significantly enhance the immune response against potential encounter with the virus."

"The first generation was blood plasma vaccine, the second generation was the yeast derived vaccine containing only one of the three epitopes of the Hepatitis B virus. The third generation vaccine is a mammalian cell (CHO) derived vaccine and covers all three epitopes of the hepatitis B Vaccine virus, is highly immunogenic and has a faster onset of action," said Mashaal.

SciGen has three sites worldwide, out of which the contract manufacturing facility in India has a capacity of 15 million hepatitis B doses. To help fund these latest expansions, SciGen will use cash raised via loans from their major shareholder, Bioton.

According to the World Health Organisation, out of the 2 billion people infected with hepatitis B, about 350m remain chronically infected and become carriers of the disease.

Over 4m acute cases of HBV develop each year, about 25 per cent of which result in death due to chronic hepatitis B or related conditions, including cirrhosis and liver cancer.

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