Dr Reddy's Laboratories Ltd., which formed a novel integrated drug development company 'Perlecan Pharma Private Limited and transferred four of its most promising molecules to the new venture, is currently working on about ten promising drug leads, according to senior R&D experts with Dr. Reddy’s Labs.
As part of the formation of Perlecan Pharma, Dr. Reddy’s will transfer the rights and titles including the development and commercialization rights of four of its NCE’s—DRF 10945, RUS 3108, DRF 11605 and DRF 16536.
The Phase I development of DRF 10945 (a non-fibrate PPAR alpha agonist) for the treatment of dyslipidemia has been completed in Canada and the drug will enter into Phase II trials within two weeks. RUS 3108 (perlecan inducer), a drug candidate for the treatment of atherosclerosis is undergoing Phase I trials in Europe. Toxicology studies of DRF 11605, a drug candidate for the treatment of obesity and Type II diabetes are progressing. Late stage pre-clinical studies are on in the case of DRF 16536, an AMPK modulator for the treatment of dyslipidemia related to metabolic disorders.
According to N R Srinivas, Executive Vice President, Drug Development, Dr. Reddy’s Lab, Phase I& II studies are being carried out for DRF 1042 (oral topoisomerase inhibitor), a drug candidate for the treatment of specific cancer tumors. Phase II trials are being held for diastereomeric mixture and Phase I trials are being done for single isomer. It is found to have properties similar to topotecan for ovarian cancer and Irinotican for colon cancer. The drug is being validated in 60 to 80 patients in some of the South Indian cities like Hyderabad, Bangalore and in Delhi, Jaipur etc. It is likely to enter into the Phase III stage in another 12 to 15 months, said Srinivas.
He said another promising molecule pursued by Dr. Reddy’s is to develop an antibacterial compound (DRF 13792 – oxazolidinone analogue) a drug candidate for the treatment of resistance developed in the case certain anti-bacterials and gram positive pathogens. The drug is under late stage pre-clinical evaluation and will move to Phase III within one year. Further, DRL is working on a few promising drug leads in the area of cardiovascular, metabolic and anti-inflammatory segments, added Srinivas.
Sources also said the company would further pursue its Balalitazone (DRF 2593), oral insulin for the treatment of patients with Type II diabetes. DRL is in talks with a company to partner to work on the drug, likely to enter into Phase III trails by next year.
According to G V Prasad, Vice Chairman and CEO, Dr. Reddy’s, the company would continue to invest in R&D the same way (in and around 14% of turnover in 2004-05) as it was doing in the recent past, despite the formation of Perlecan Pharma.