Claris Lifesciences Ltd, the Ahmedabad-based Rs 100-crore pharmaceutical formulations company, has announced in Hyderabad the national launch of its new product, brand named Limus, an immuno-suppressive agent for use in kidney transplantation. The product was launched at the 14th Annual Conference of the Indian Society of Organ Transplantation (ISOT), which was held from August 8 to 10. The company claims that the drug will effectively reduce acute rejection rate and increase graft and patient survival rate. The product is an improvement over the current immuno-suppressive agent used in areas of organ transplantation.
Launching Limus (Sirolimus oral solution), Pankaj Singh, Claris Business Head, said the product was the result of more than 20 years of research. It gained approval from US FDA in 1999 and the product was being launched in the market after extensive research at Claris Research Foundation. The drug demonstrated safety and efficacy in large clinical studies in kidney transplantation.
According to Singh, the new drug possessed a pharmacokinetic and drug interaction profile similar to that of its earlier product cyclosporine, but maintained a unique mechanism of action and adverse effect profile. He said cyclosporine had side-effects like nephrotoxicity, while multi-centre clinical trials of Sirolimus proved that it could reduce rejection rate, increase graft and the patient survival rate.
The new drug was so sensitive to heat, Claris had designed a special 'kool kit' to control temperature. The drug would be available at select medical outlets, which had the required storage infrastructure.
Claris, which manufactures and markets a range of specialty products for the treatment of renal failure, had entered the transplant therapy segment by introducing Perfusol and Renograf. According to Singh, Claris was the first Indian company to introduce alcohol-based cyclosporine under the brand name Cyrin for kidney transplant therapy. He said the company would not withdraw cyclosporine from the market after the launch of Sirolimus. In fact, a combination of cyclosporine and Sirolimus proved more effective in kidney transplant patients. Against an average monthly expenditure of Rs 4,000-6,000, in the case of cyclosporine, the combination therapy would cost between Rs 5,000 and Rs 7,000, he said.