Mumbai: Drugmaker Glenmark Pharmaceuticals Ltd, after posting a net loss in the quarter ended 31 March, is counting on drugs that are entering the last stage of global human trials to revive its fortunes and bolster investor confidence.
Glenmark last week said its investigational drug for type 2 diabetes, Melogliptin, has successfully completed phase 2b clinical trials, which are conducted to assess the drug’s efficacy at prescribed doses.
After this stage, the drug will move to the last stage of human testing, generally called phase III globally, by the end of this year.
Phase III studies are multi-location drug testing on large patient groups, involving a sample size of 300-3,000 or more, and are structured to be the definitive assessment of how effective the drug is compared with existing treatments.
Melogliptin is one of eight new drug leads in Glenmark’s discovery pipeline.
“With the phase II study (involving around 500 patients) being successful, we take a step closer towards our objective of becoming the first India company to have a truly global innovative drug for the world,” Glenn Saldanha, managing director and chief executive officer, said in a statement.
Glenmark is expected to start the final phase by the end of 2009. As these studies involve a large patient population size and are expensive, Glenmark is likely to license a global pharmaceutical company to develop and market the drug for a price.
The company also has three other drugs that may be licensed out, as they too are nearing advanced trial stages.
Saldanha, in an earlier interview to Mint, had said that the company is aggressive on the research front with at least four new drug candidates in advanced stages of development.
“We are talking to potential global partners to license out these molecules which are in the advanced stages, and one such deal would help gaining back the investor confidence in the company,” he had said.
The company, whose shares fell at least 60% in the 11 months to June, posted a net loss of Rs120 crore for the three months to 31 March, due largely to one-time charges.
Glenmark’s shares closed 0.96% up at Rs232.40 on Friday on the Bombay Stock Exchange. The benchmark index Sensex closed 2.92% up at 14,764.64. The stock traded at a high of Rs696.50 on 28 July.
On a consolidated basis, Glenmark posted sales of Rs491 crore during the January-March quarter, 14% lower than the Rs571 crore in the corresponding quarter the previous year. For the fiscal year ended 31 March, the company posted a net profit of Rs193.4 crore on total sales of Rs2,121.5 crore.
While the generics, or off- patent, drug business of Glenmark has been growing, it had to write off in the March quarter at least Rs130 crore on account of stock withdrawals following delayed US market approvals, and Rs117 crore for price erosion of distributor stock after the expiry of US market exclusivity of its anti-epilepsy drug oxcarbazapine.