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Novo Nordisk halts trials on Dr Reddy's diabetes drug

Our Bureau

Hyderabad , Oct. 27

NOVO Nordisk has decided to terminate further clinical development of Balaglitazone, a promising candidate for type-2 diabetes from Dr Reddy's Laboratories .

The decision comes as yet another setback to the drug discovery pursuit of Dr Reddy's Laboratories, the Hyderabad-based pharmaceutical major listed on the New York Stock Exchange (NYSE).

According to a press release from Dr Reddy's on Wednesday, Novo Nordisk announced that it is halting further clinical development of its partial PPAR (Peroxisome Proliferator Activated Receptor) gamma agonist Balaglitazone (DRF 2593) as the preclinical results did not suggest a sufficient competitive advantage over similar marketed products within this therapeutic category.

Dr Reddy's had licensed this molecule to Novo Nordisk in 1997.

Commenting on the development, the Chief Scientific Officer of Dr Reddy's Labs, Dr Uday Saxena, said, "We are disappointed that the development of Balaglitazone had to be discontinued by Novo Nordisk. However, Dr Reddy's remains committed to the research and development of new medicines to address unmet medical needs in the areas of diabetes and metabolic disorders."

Earlier during July 2002, Novo Nordisk had temporarily suspended the clinical development of its dual-acting insulin sensitiser - Ragaglitazar (DRF 2725 outlicensed from Dr Reddy's) following findings of carcinogenicity studies that revealed tumours in rats and mice. Subsequently, after performing a renewed benefit/risk assessment of the compound, including analysis of both the clinical Phase-3 data and the tumour findings in the long-term animal studies, Novo Nordisk had decided not to pursue further development of Ragaglitazar.

In lieu of Ragaglitazar, Novo Nordisk had taken up trials on insulin sensitiser Balaglitazone (DRF2593; NN 2344). During February last year, Dr Reddy's had announced that Novo Nordisk had completed analysis of Phase-2 data on Balaglitazone. Based on the good clinical efficacy and safety profile obtained in these studies, Novo Nordisk decided to progress the development of Balaglitazone.

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