Dr Reddy's hopes to launch balaglitazone in US, Europe in two years

Dr Reddy's Laboratories Ltd hopes to launch its oral anti-diabetic drug balaglitazone(DRF2593-307), currently under phase III trial, within the next two years, targeting the patients in the US and Europe.

The phase III trials started in Europe in July with a target of 50,000 subjects and the drug would be launched as soon as possible, said Dr Raj Kumar, president of R&D and Commercialisation. The Indian company has tied up with Rheoscience for this insulin sensitizer that acts as a partial PPAR (peroxisome proliferator-activated receptor) gamma agonist.

Balaglitazone, fully developed from ground zero by Reddy's, is a second generation of PPAR gamma agonist with only partial agonistic properties, which in clinical phase II studies have shown to have glucose lowering capabilities and to be body-weight neutral. In preclinical experiments, balaglitazone has been shown to cause less fluid retention than full PPAR gamma agonists.

Dr Raj Kumar, while briefing on R&D programmes to the visiting mediamen, said the company was open to all options including developing NCEs at its own and going with partners to further improve the already discovered molecules.

"Our focus area will be metabolic disorders and thrust is being given to NCE discoveries by the company in the coming times,'' Dr Raj Kumar said. The pipeline molecules include therapeutic areas of metabolic, cancer and cardiovascular disorders.

DRL 16536 (AMPL Activator) is in the pre-clinical stage while DRF10945, another PPAR in the metabolic area, is in the second phase of trials. RUS 3108, targeting cardiovascular disorders as perlecan inducer is in the phase I stage of trials while DRF 1042 in the therapeutic area of cancer is in the pre-clinical stage.

Balaglitazone is being developed under a co-development agreement between the company and Rheoscience. Rheoscience will retain the marketing rights to European Union and China and the company will retain the marketing rights in the territories of United States and rest of the world. Rheoscience shall obtain all necessary regulatory approvals on behalf of the company in the United States.