Shantha Biotechnics is progressing with its plans to introduce DTP+ Hep B+ Hib pentavalent vaccine by the end of 2006. The company is also in the process of developing a series of new vaccines.
The market size for this combination vaccine in India is estimated to the tune of Rs 20-25 crore, and the global market size close to US $ 50 million. The vaccines through UNICEF are likely to reach about 60 countries and the company will market the product in another 15 countries.
Dr KI Varaprasad Reddy, managing director of Shantha Biotechnics, told Pharmabiz that the company is expecting to achieve WHO pre-qualification to supply tetravalent vaccines by July 2006 and is hoping to get the same for pentavalent vaccine by mid-2007.
Shantha is also filing an IND for monoclonal antibodies in the US by August 2006. By early 2007, the company will initiate trials on monoclonal antibodies and is working on four monoclonal antibodies mainly focusing on cancer and genetic disorders. Most of these would be ready by 2007.
Shantha is also planning to develop a single dose Hepatitis B vaccine, which will not only reduce the pain but also ensure that the subjects do not miss the doses, as it happens with the currently available vaccines. It may take another 2-3 years to launch this vaccine, Reddy informed.
Shantha is working on typhoid conjugate, pneumococcal, cellular pertusis and serum free vaccines for DPT. Rotavirus vaccine will also be an important part of the company's portfolio, which is likely to take four years for development. The company is also to develop a cholera vaccine either based on indigenously developed technology or an acquired technology, he informed.
The company is carrying out animal toxicity studies on tissue plasminogen activator (tPA) and the product would be developed by the end of 2006. It is developing cholera and typhoid vaccines in collaboration with International Vaccine Institute (IVI) of Korea and rotavirus vaccine in collaboration with NIH. The company is also planning to develop JE vaccine, vaccine for varicella-zoster and heat stable vaccines.
The company has tied up with Cambridge Biostability, which is a University spin-off company. The company hopes to be in a position to launch heat stable vaccines in another 2-3 years.
The company also has inked a pact with Polytherics Ltd., a University of London spin-off company for technology transfer, last year, which will enable Shantha to license Polytherase, a novel Pegylation Technology to make an affordable PEG interferon product for the treatment of Hepatitis C. The technology will be transferred to Shantha.
The company is also expanding its current facilities at Hyderabad by adding three new blocks including facilities for mammalian cell culture, viral vaccines and warehouses to stock vaccines. The new blocks will be operational by October 2006.
The company, on an expansion plan, is scouting for about 80 acres of land near Hyderabad, exclusively for contract manufacturing for international markets. If AP Government speeds up work on the proposed special economic zone for biotechnology industry in an estimated area of 414 acres near Hyderabad, Shantha is open to acquire land in it, he said.
He added, The company's exports have accounted to 87 per cent of the total revenues for the financial year 2005-06. The company has achieved a turnover of over Rs 90 crore during the financial year. Research and development investment in the previous financial year has been up to 25 per cent. It is expecting to clock Rs 300-crore turnover in next three years.