Shantha set to launch 2 vaccines by March 2005

Company expects Unicef to be major buyer for its DPT, Hepatitis B combo vaccine

City-based Shantha Biotechnics Private Limited is gearing up to launch two vaccines before March 2005, one of which is expected to find a major buyer in Unicef.

This apart, the company is also working on a drug -- GCSF, which will help improve the immunity factor of the body.

Speaking to Business Standard, Shantha Biotechnics managing director K Varaprasad Reddy said that the company would launch the DPT vaccine and the DPT and Hepatitis B combination vaccine before March 2005.

"Apart from these two vaccines, we will also be ready to launch our erythroprotein drug for kidneys apart from our streptokinase drug for heart attacks. We expect the Unicef to be a major buyer for our DPT and Hepatitis B combination vaccine when it is ready. At present, Glaxo Smithkline (GSK) is the only company in the world that is manufacturing this vaccine, but they are not able to meet existing demand," Reddy pointed out.

GSK is selling the combination vaccine at a price of about $1.8 per dose. "Shantha can definitely be more competitive in pricing than that because our manufacturing costs are lower," Reddy said.

The company expects its drug to get its final approvals from the Union government by December this year for the combination vaccine.

After this, it expects to take another nine months to be pre-qualified by the WHO to supply the DPT and Hepatitis B combination vaccine. "We should definitely be able to supply by the start of 2006," Reddy said.

The company is also working to launch a GCSF (granulocyte stimulating factor) drug before the end of the next calendar year. The GCSF drug improves the immunity factor in the body and can be, according to Reddy, be even part of the AIDS cocktails.

The AIDS cocktail as the name suggests is a combination of powerful drugs that offers symptomatic relief from the fatal virus.

The US Food and Drug Administration had in August this year approved two combination pills by GlaxoSmithKline and Gilead Sciences this week that simplify this treatment. Each pill lets a patient take two AIDS-fighting drugs in a once-a-day tablet.

Shantha is also slated to raise close to $30 million from a strategic investor to further phase 1 trials for its four monoclonal molecules for cancer treatment. Shantha will be offering the strategic investor close to 25 per cent stake in its US-subsidiary Shantha West Inc, which is based out of San Diego.

"The four molecules have the potential to be worth $1 billion each, but it would take us at least another three years to come out with the product, if everything goes right," Reddy said.

Shantha has transferred the four molecules to its US subsidiary, where it has a 51 per cent stake. "Ghassal Shekhar, an NRI investor holds 40 per cent, while another 9 per cent is held by two other investors," Reddy pointed out.

The four molecules are, according to Reddy, unique because of the fact that the molecules would target only affected cells and the treatment would be targeted and specific.

"We would need lots of money to do phase I and phase II trials. At present, we are trying to do phase I (a) trials in Japan," he said.

The company's four monoclonal cancer molecules target cancers of the breast, lung, pancreas and colon. This apart the company is also working on a HPV (human pappyloma virus) vaccine. "Merck is the only company which has this and it targets cervical cancer," Reddy pointed out.

For the first six months of the current fiscal, Shantha has posted a turnover of Rs 29 crore, as compared to last year's turnover of Rs 34 crore. The company according to Reddy was all set to record a turnover of about Rs 60 crore this year.