Novo Nordisk refutes allegations on drug trials

BANGALORE: Novo Nordisk Pharma India (NNPI), the Indian subsidiary of Danish pharmaceutical major Novo Nordisk, has refuted allegations that the clinical trials of Ragaglitazar, an insulin sensitiser used in the treatment of diabetes type II, were conducted in an unethical manner.
The clinical trials of Ragaglitazar (NN622) were stopped on July 22, after urine bladder tumours were found in a number of rats treated with the drug.The compound was licensed from Dr Reddy’s Laboratories by Novo Nordisk.
At a press conference here on Wednesday, NNPI officials said trials involving rats have in the past shown tumours.
NNPI managing director Anil Kapur said the company considered it unethical to continue trials in humans until it could be documented that the mechanism by which these tumours develop is specific to rodents and not relevant to humans.
Kapur said Novo Nordisk has initiated a series of studies in animals to understand the reason for the tumours. “The primary theory is that the finding is specific to rodents,� he said.
“All patients were asked, through their investigators, to reassess their continued participation in clinical trials, which included the information about the tumours found in rats,� he added.
Anne Bording Jensen, project leader, NN622, informed the media from Copenhagen that Novo Nordisk had invested 0.5 billion Danish kroner on the Ragaglitazar research. The product was scheduled to hit the market in 2005-06.
Dr Reddy’s Laboratories said in a press statement said that Novo Nordisk had conducted long-term toxicology studies on the compound which were required prior to the commencement of trials in humans.
All genotoxic studies performed on NN622 had turned out to be negative, the statement said. “We believe that Novo Nordisk carried out the trials in the most responsible manner possible,� it added.
A total of 2,500 patients in 32 countries participated in the clinical trials. India was one of the countries that participated in the programme.