Glenmark Pharmaceuticals is set to enter the final stage of clinical trials for its new drug, Revamilast, across several countries this year. It is meant for treatment of inflammatory disorders like asthma and rheumatoid arthritis. Glenmark may soon seek approval for Phase-III trials in the US, UK and India.
“Glenmark plans to file an IND (Investigational New Drug application) for Revamilast in the US in the third quarter of the current financial year. The company intends to initiate Phase-III trials for at least one indication by the end of FY13,” chairman and managing director Glenn Saldanha told Business Standard.
The current market for rheumatoid arthritis is estimated at around $26 billion and the asthma market at a little over $30 bn. Currently, Glenmark is conducting Phase-IIb trials for the drug in various countries. “These studies will determine the efficacy and safety of the molecule and provide dose range findings for Revamilast,” Saldanha said.
Phase-IIb is designed to study the efficacy of a drug in terms of how well it works at the prescribed dosages. The company had earlier said the clinical trials and the animal studies data for Revamilast were promising. According to a source, the company is expecting Phase-IIb data in rheumatoid arthritis by March next year, whereas clinical trial data for asthma is likely to come by the middle of 2013.
The molecule has successfully completed pre-clinical trials and Phase-I studies, mainly conducted in Britain.
Glenmark, traditionally seen as a research-based company, expects research and development expenses at six to seven per cent of sales for the current financial year. The R&D expenditure during 2011-12 was Rs 256 crore, of which it spent Rs 151 crore on innovation research and Rs 105 crore for generic research.
Shares of Glenmark ended on Thursday at Rs 356.30, marginally up 0.1 per cent from yesterday's close.
