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HYDERABAD, Feb. 6

THURSDAY was a day of mixed fortunes, some good and some bad, for the basic drug research activities of Dr Reddy's Laboratories Ltd, the NYSE-listed pharmaceutical major.

Novo Nordisk, which had earlier temporarily suspended clinical trials on Dr Reddy's anti-diabetic molecule, DRF-2725 (Ragaglitazar), has now decided to completely terminate further clinical trials on the molecule. Dr Reddy's had out-licensed the compound to Novo Nordisk in August 1998.

The positive development was that Novo Nordisk has decided to take up another promising molecule, an insulin sensitiser, DRF-2593 from Dr Reddy's for further development.

Having found tumours in one mouse and several rats in long-term animal studies, Novo Nordisk had suspended phase-III clinical trials of Ragaglitazar (DRF-2725) during July last year, while announcing that it would take a final decision after performing renewed assessment of the compound.

In a press release here on Thursday, Dr Reddy's said Novo Nordisk has now decided not to pursue further development of DRF-2725. "The decision has been taken after Novo Nordisk performed a renewed benefit/risk assessment of the compound, including analysis of both the clinical phase-III data and the tumour findings in the long-term animal studies."

According to Dr Reddy's, Novo Nordisk has completed analysis of phase-II data on the insulin sensitiser, DRF-2593. "Based on the good clinical efficacy and safety profile obtained in these studies, Novo Nordisk has decided to progress the development of Balaglitazone."

While DRF-2593 is a potent insulin sensitiser that acts as a partial PPAR (peroxisome proliferator-activated receptor) gamma agonist, DRF-2725 is an insulin sensitiser that acts as a dual PPAR alpha and gamma agonist.

At the time of suspending the clinical trials on DRF-2725, Novo Nordisk expressed doubts whether further clinical trials involving DRF-2725 would be initiated at all in case of relevance of tumours development in mice and rats to human beings. Stating that the mechanism was not yet known for such a development of tumours, Novo Nordisk said the new clinical trials might be delayed by close to two years provided the mechanism of tumours was of no human relevance. However, Dr Reddy's Thursday release did not give any details on the issue whether Novo Nordisk has found the relevance of tumours development to human beings or not.

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