The Mumbai based USV Ltd has launched its sevelamer product, Sevagel 400 mg and 800 mg tablets, a polymer developed through novel process to treat toxic excess of phosphate in the body caused by chronic renal failure, in Indian market.
The company developed the polymer through a novel process in collaboration with Council of Scientific and Industrial Research (CSIR). The research and development process went as long as three years to develop, as sevelamer is a complex polymer to be prepared with precise cross linking of polymers and phosphate-binding capacity, according to Prashant Tewari, managing director, USV Ltd.
The company, which has commenced marketing of the product through in-house marketing facilities, is also in talks with some Indian firms to expand marketing programmes. The product is expected to explore the market potential of Rs 3 to 5 crore in India and will be marketed in US and Europe in a later stage. Meanwhile, the US-based Genzyme Corporation has its patent for sevelamer valid till 2014.
Sevagel is also manufactured using special excipients, as the calcium content in ordinary excipients may increase the risk in renal disease patients. The company is also developing two compounds from sevelamer for diabetes, dyslipidemia and end stage renal disease.
"The sevelamer product comes as the first one in the segment from USV, whereas, we are also developing cole sevelamer and sevelamer carbonate further in the line. While cole sevelamer will address dyslipidemia and diabetes patients, the sevelamer carbonate is developed to treat end stage renal disease," said Tewari. He added that the company will launch the cole sevelamer product in India within next two years, even as the timeframe for launching sevelamer carbonate is not fixed yet.
The company has acquired the US and Indian patent of the novel process for producing sevelamer from CSIR last year through a one time payment. As per the agreement with CSIR, USV had the first right to license the know-how and acquire the patent rights. USV had approached CSIR's constituent lab in Pune, the National Chemical Laboratory (NCL), in the middle of 2003 to develop the innovative process to manufacture the polymer. However, the company refused to comment on the amount involved in the deal.
The company, which is focusing into branded generic, biotherapeutics and peptide business, enjoys strong leadership position in the anti-diabetic and cardio-vascular segments in India. Based on its marketing strength, USV has entered into a number of in-licensing deals with foreign based pharmaceutical companies.