Shantha Biotechnics Pvt Ltd plans to become the first Indian biopharma firm to tap the US market in 2005 by launching its Hepatitis-B vaccine 'Shanvac B' and AlphaFeto Protein test kit in that country.
The company also expects to more than double its turnover to Rs 75 crore (Rs 750 million) during the current financial year from Rs 34 crore (Rs 340 million) in 2003-04 due to a Rs 26 crore (Rs 260 million) order from UNICEF and government orders from Iran and Egypt.
K Varaprasad Reddy, managing director, said the company had recently tied up with the US-based Spectrum Pharmaceuticals, which would take care of all regulatory, marketing and distribution related issues for certain products of the company for the generic biologicals market in the US.
Spectrum is an oncology-focussed company which is developing two major anti-cancer drugs straplatin and elsamitrucin.
The US company has also filed ANDAs (abbreviated new drug applications) for the generic drugs like ciprofloxacin, carboplatin and fluconazole.
To start with, Shantha Biotechnics is targeting its recombinant Hepatitis-B vaccine, 'Shanvac B,' and AlphaFeto Protein test kit for the US market.
A very important test during pregnancy, AlphaFeto Protein test checks for the possibility of Spina bifida, a condition in which there is a problem in the normal development of the spine and brain (neural tube).
Using the AlphaFeto-protein test along with two other enzymes/hormones tests will also helps find whether babies are affected with Down's Syndrome.
"The US Food and Drug Administration (US FDA) is likely to release regulatory guidance for regulatory framework for approval of generic biologicals during this year itself, and Shantha Biotechnics expects to enter the market in 12 to 18 months depending upon the regulatory framework," he said.
He said the company's products would be far cheaper than those available in the US and help the company gain a strong foothold in the US.
Reddy said that his company had also tied up with Chiba University of Japan for conducting phase 1A clinical trials on Shanvac-B and erythropoetins.
Erythropoetins are used to treat anaemia associated due to kidney or drug related causes. It increases and maintains the red blood cell levels so that blood transfusions are not needed.
The company also expects its joint venture partner Biocon to launch human insulin in the latter-half of the current financial year. Shantha has developed the product and provided the know-how to Biocon. The insulin market is said to be around Rs 300 crore (Rs 3 billion) in India.
Reddy said that Shantha Biotechnics has also entered into a tie-up with Biovac in South Africa to launch Shanferon, India's first recombinant DNA-based human interferon alpha 2b from the company. It is used for patients with acute myocardial infarction.
Speaking of the thrust placed on research and development (R&D), Reddy said that the company had spent around 25 per cent of its total turnover on R&D.
"Our R&D team is working on new generation biologicals and the current work is on in several lines of research independently and in collaboration with leading organisations in India and abroad," he said.
The independent as well as collaborative projects are targeted at innovative biopharmaceuticals like vaccines against Hepatitis-C virus, Hepatitis-E virus, Human Immuno deficiency virus and tuberculosis.
Research is also under progress on therapeutic anti-bodies and diagnostic kits for Kala Azar, acute lymphoblastic leukemia and other diseases.Reddy said that the Rs 40-crore (Rs 400 million) new plant to produce a vaccine for DPT (diphtheria, pertussis and tetanus) is fast nearing completion and would be inaugurated in July.