Country's second largest drug maker Dr Reddy's Laboratories has said it is working on six new drugs in different areas, including metabolic disorders and cardiovascular diseases, psoriasis and migraine.
According to a filing with US Securities Exchange Commission, the drug maker
said as of March 31, 2013, DRL had 21 active products in the proprietary products pipeline, of which six are in clinical development stage.
"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. We have built a pipeline of assets that we expect to produce a steady stream of investigational new drugs in the coming years," DRL said.
"As of March 31, 2013, we had 21 active products in our proprietary products pipeline, of which 6 were in clinical development stage," the company stated.
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/cardiovascular disorders is in phase-II while the remaining five drugs are in clinical stage, it said.
In FY13, Dr Reddy's invested approximately Rs. 767 crore in R&D activities, which accounted for 6.6% of consolidated revenues, against Rs. 591 crore in FY12.
This represents a growth of 30 per cent over the previous year, and is mainly attributable to increasing spends on complex molecules and a greater focus on biosimilars and proprietary research, GV Prasad, chairman and CEO DRL, 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 US FDA 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.
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