Biocon completes Phase IV studies of INSUGEM™

Biocon Ltd has announced that Clinigene International Pvt Ltd, a wholly owned subsidiary of the Company recently concluded a landmark Postmarketing Results of INSUGEM™ Evaluation (PRIDE) Study.

The PRIDE Study is India's largest documented safety study conducted on Insulin vials in recent years involving 507 doctors and 6164 patients covering the length and breadth of the country. This is the biggest PMS* study for Insulin conducted in India. The number of patients involved were in excess of the regulatory requirement of 500 patients as stipulated by the Drug Controller General of India (DGCI). Clinigene, India’s first CAP (College of American Pathologists) accredited lab analyzed targeted patient records and prepared the report of the study.

Dr Arvind Attignal, Chief Operating Officer, Clinigene said, "This study involved the three formulations of INSUGEM™ i.e. INSUGEM™ R, N & 30/70 covering subjects with all types of Diabetes mellitus and those requiring insulin. The response of the subject in terms of glycemic control was monitored by routine tests such as Fasting and Post Prandial blood sugar and HbA1c estimation. Overall, treatment with INSUGEM™ was administered to 334 patients (5.5%) with Type I diabetes mellitus, whereas 5555 patients (92.6%) receiving formulations were diagnosed with Type II diabetes mellitus".

Mr Rakesh Bamzai, President- Marketing, of the Company said, "Results of this study reaffirm the benefits of using INSUGEM™. It is indeed an honour that we have been able to indigenously develop a quality biotechnology product that is at par with the best global brands. INSUGEM™ is a true proponent of India’s biotechnology capabilities."

Findings:

- PRIDE STUDY involved 507 Investigators (doctors) and 6164 patients across India.

- 99% of the Investigators (doctors) opined that safety with INSUGEM™ was at par with the leading marketed brands of insulin in the country.

- Clinical response to INSUGEM™ was excellent in 99% of patients in terms of safety.

- INSUGEM™ in routine clinical practice has not shown any untoward, unanticipated adverse effects qualitatively and quantitatively compared to other Insulin preparations.

- The efficacy of INSUGEM™ in treating Diabetes mellitus is as expected by the investigators.

*Postmarketing Surveillance Studies (PMS) also called 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.

Source : Equity Bulls

Keywords