Hyderabad-based pharma major Dr Reddy?s is ?fine tuning? its much touted combination drug for cardiovascular diseases ?Poly pill? and plans to carry out phase III human trials in Australia and New Zealand. The company has already applied for regulatory approvals in the two countries.
?Depending on the regulatory approvals from authorities in the two countries, the company expects to initiate the trials by the end of this year,? vice chairman and chief executive officer at Dr Reddy?s Laboratories GV Prasad said. According to the clinical evidence available currently, the market potential for the product should be in the range of $4-5 billion annually.
The company had earlier slipped on the timelines and the trials ran into some delays for regulatory clearance to commence the global trials.
Dr Reddy?s would recruit around 1,000 people at high risk. Patients initially would be given the lowest-dose version of the drug but would later be upgraded to the medium or high dose if their blood-pressure and cholesterol goals are not met. If successful, a full-scale trial is planned in over 5,000 people.
Regarding the global experience of similar pills, industry leader health science at Ernst & Young Utkarsh Palnitkar said: ?It is about 5 years since the ?poly pill? made its appearance and that period is relatively less to draw conclusions on the success or other wise.?