India-based Dr Reddy's Laboratories has joined forces with the University of Auckland in New Zealand to start clinical trials of the polypill, the first to contain four compounds in one tablet.
Combining four heart disease medications in one pill will improve patient compliance and cut the cost of treatment, and this dual benefit prompted the researchers to collaborate on the project.
Developing the drug candidate proved a challenge because the formulation technology is complex, as the active ingredients are reactive with each other and need to be stabilised, while the bioavailability is highly variable.
"The formulation is one of the more complex formulations that Dr Reddy's has undertaken, " said Raghu Cidambi, a technical adviser to Dr. Reddy's.
The polypill comes in two versions and in multiple dose formats. The medications that make up the pill are aspirin (75 mg), simvastatin (10, 20 and 40 mg), and two antihypertensives at different strengths.
Polypill is advantageous because it is a cheaper option than prescribing separate medicines, easier to take, and more effective in prevention of heart diseases, claims Dr Reddy's.
"Research shows that people with chronic diseases like heart disease only take half of their medications. They forget, or they feel well so think they don't need to take their pills," said Professor Anthony Rodgers, University of Auckland.
New Zealand's Health Research Council has invested NZ$350,00 (€182,000) to maintain the trial co-ordination, will Dr Reddy's Laboratories are due to invest NZ$7.5 million to offer supplies for worldwide clinical trials and to develop the polypill.
The trials are due to begin early next year in India and New Zealand, with other markets due to follow later on. A full clinical trials programme for a New Chemical Entity (NCE) will not be required, according to Dr Reddy's, as the medications have been previously approved. Registration of the polypill should therefore be possible on the basis of standard equivalency testing.
The main purpose of the trial is to evaluate how effective the polypill is in lowering known causes of heart diseases, such as cholesterol and blood pressure.
"It is a global trial involving participants in eight countries, and it has enormous health implications for developed and developing nations," says Dr Chris Boalch, New Zealand Trade and Enterprise Sector Director.
"All the medicines in this pill are no longer covered by patents, so it will be cheap to produce and more affordable for people developing countries. The medicines also treat several related conditions, and combining them may benefit people who can't afford regular visits to the doctor," said professor Rodgers.
The European cardiovascular drugs market is estimated to reach $36.3bn (€28.9bn) in 2012, according to a study by Frost and Sullivan.