Dr Reddy's working on six new drugs
They will address metabolic disorders, cardiovascular problems and psoriasis among others Dr Reddy had...
They will address metabolic disorders, cardiovascular problems and psoriasis among others Dr Reddy had spent close to Rs 767 crore in research & development activities last fiscal, nearly 30 per cent more than Rs 591 crore it had invested in this area during FY-12. This spurt is mainly attributable to increasing spends on complex molecules and a greater focus on biosimilars and proprietary research Hyderabad: City-based pharma major Dr Reddy's Laboratories is developing six new drugs that address different diseases including metabolic disorders, cardiovascular problems and psoriasis, beside migraine. In a filing to the US Securities Exchange Commission, the drug major said these six drugs reached clinical development stage as on March 31, 2013, from as many as 21 active products that were in the pipeline. "Since repositioning our research activities in the years ended March 31, 2009 and 2010, our proprietary products segment has focused its efforts towards developing drugs to meet key unmet clinical needs," Dr Reddy's said in the filing. The statement further said: "We have built a pipeline of assets that we expect to produce a steady stream of investigational new drugs in the coming years. As of March 31, 2013, we had 21 active products in our proprietary products pipeline, of which 6 were in clinical development stage". The drugs which are currently in clinical development stage are targeted in the areas of cardiovascular disorders, psoriasis, pain, anti-infective atopic dermatitis, psoriasis and migraine. The new drug research on metabolic disorders and cardiovascular disorders is in phase-II while the remaining five drugs are in clinical stage, it added. Dr Reddy had spent close to Rs 767 crore in research & development activities last fiscal, nearly 30 per cent more than Rs 591 crore it had spent in this area during FY-12. This spurt is mainly attributable to increasing spends on complex molecules and a greater focus on biosimilars and proprietary research, GV Prasad, the company's Chairman, said in the latest annual report. The clinical trial process can take five to 10 years or more to complete, and there can be no assurance that the data collected will be in compliance with good clinical practice regulations, will demonstrate that the product is safe or effective, or, in the case of a biologic product, pure and potent, or will provide sufficient data to support US Food and Drug Administration approval of the product, DRL said in the SEC filing. The Indian drug maker also said the USFDA may place clinical trials on hold at any point in this process if, among other reasons, it concludes that clinical subjects are being exposed to an unacceptable health risk.
16 Sep 2019 3:51 AM GMT