Biocon completes phase-IV trials for insulin drug

Financial Express | 27th Dec 2006

Biotech firm Biocon Ltd on Tuesday said it had completed the phase-IV clinical trials for its insulin drug, Insugen. In a communique to the Bombay Stock Exchange, the company said its wholly owned subsidiary, Clinigene International Pvt Ltd concluded the post-marketing surveillance study (PMS) on insulin vials, which involved 507 doctors and 6,164 patients form across the country.

"This is the biggest PMS for Insulin conducted in India. The number of patients involved were in excess of the regulatory requirements of 500 patients as stipulated by the drug controller general of India (DGCI)." it said. About 99% of the investigators (doctors) opined that safety with Insugen was at par with the leading marketed brands of insulin in the country and clinical response to the drug was excellent in around 99% of patients in terms of safety, it said.

The company said compared with other insulin preparations, Insugen has not shown any untoward, unanticipated adverse effects qualitatively and quantitatively in routine clinical practice.

PMS or phase IV studies are done as part of regulatory requirement, to know primarily the safety of the drug in addition to the efficacy of the drug.

Phase-IV studies the usage of drug by large populations and in natural settings unlike phase-III, where the drug is tested in a controlled environment.
 

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