Mumbai-based USV Ltd will be setting up a facility for the manufacture of recombinant products at an estimated cost of Rs 75 crore at Roha in Maharashtra, according to its managing director, Prashant Tiwari. The project will be financed by the internal accruals of the company.
Recombinant products like human insulin analogues, growth hormones and CVS products will be manufactured in the facility. The initial capacity targeted for the commercial production is between 1,000 -10,000 litres.
USV has already achieved pilot scale efficiency in the development of these recombinant products. "Our next step will be to achieve critical efficiency and consistency in the efficacy of our products. After getting the necessary approvals, we are expecting to start clinical trials by the end of this year and commercial production by 2005 end," said Tiwari.
Insulin analogues are molecules whose structure has been altered in order to improve its pharmacokinetic and pharmacodynamic properties compared with regular human insulin, whilst preserving its biological effects and safety profile. These analogues provide a relatively constant basal insulin supply with no pronounced peak. Long acting insulin analogues cause less hypoglycaemia, especially nocturnal hypoglycaemia in comparison to regular human insulin. Eli Lilly's Humalog, Aventis' Lantus and Novo Nordisk's Detemir are some of the well known analogue insulin brands.
The company already markets human insulin manufactured by M.J. Biopharm in the country. USV is in talks for technical tie-ups from biotech companies abroad.
USV Ltd is a major player in diabetes and cardiology segments. It markets about 32 brands in these segments that contribute to 52 per cent of its turnover. USV crossed a turnover of Rs. 400 crore for the year ended March 2003 and is growing at a rate of 20 per cent. The company has an intellectual capital of 24 PhDs, 55 MScs and 11 MPharmas at its R&D centre in Govandi, Mumbai.
In order to increase the range of services for diabetic care USV entered into an agreement with B Braun - a $ 2.3 billion German healthcare company - for marketing of blood glucose monitoring system known as Quicktest - U.