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Dr Reddy's diabetes drug to enter phase-III trials soon

C.R. Sukumar

Hyderabad , March16

BALAGLITAZONE, the diabetes molecule of Dr Reddy's Labs is slated to enter the phase-III trials (human trials) soon. The company had out-licensed this compound to the global drug major Novo Nordisk in March 1997.

The development is being considered significant for Dr Reddy's, which suffered a setback recently in its legal battle with Pfizer on amlodipine maleate in the US market.

According to sources in the pharmaceutical industry, certain toxicology studies are currently being taken up on Balaglitazone for the late phase-II trials and the drug might enter the phase-III trials shortly.

Balaglitazone is a potent insulin sensitiser, which increases glucose uptake in peripheral tissue. At present, Novo Nordisk is of the view that the new chemical entity is expected to have at least as good an efficacy profile as the currently marketed thiazolidinediones and an attractive safety profile.

Confirming that Novo Nordisk has completed analysis of phase-II data on the insulin sensitiser - DRF-2593, the Dr Reddy's spokesperson told Business Line that based on the good clinical efficacy and safety profile obtained in these studies, Novo Nordisk has already decided to progress the development of Balaglitazone.

"We do expect milestone payments from Novo Nordisk as the molecule progresses through the clinical trials. We were informed by Novo Nordisk that the late phase-II trials on Balaglitazone were currently being taken up and the compound would soon enter phase-III trials," the Dr Reddy's spokesperson said, while declining to throw light on the size of milestone payments expected.

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