Cocktail Drugs

Sudhir Chowdhary, BV Mahalakshmi
Posted: Monday, Jul 21, 2008 at 2112 hrs IST
Updated: Monday, Jul 21, 2008 at 2112 hrs IST

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: Medical researchers are moving closer to affordable, multiple-target, fixed combination polypills for prevention and cure of cardiovascular disease, HIV, malaria and tuberculosis (TB).

The first to hit the retail chemist stores in the next two years would be five-in-one drugs for treatment and prevention of heart attacks and stroke. Such drugs will offer millions of heart patients the convenience to strictly comply to their medications by simply popping a single pill—containing medications for dilating arteries, relaxing heart muscles, removing excess water and salts, preventing clot formation, and reducing bad cholesterol—thereby getting rid of the boring yet essential exercise of swallowing four to five tablets a day.

Drug maker Cipla seems to have an early mover advantage. Says Amar Lulla, joint managing director, Cipla, “We have made a headstart by launching two-in-one and four-in-one combination drugs for heart ailments. Currently, we are working on more combo pills for people affected by heart attacks. Besides, clinical trials are progressing for a five-in-one pill.”

Dr Reddy’s Laboratories (DRL) is another player in the arena and claims to have completed trials for its four-in-one polypill. Analysts inform that several varieties are being developed around the world for different types of cardiovascular disease. Some of the institutes are Spanish National Centre for Cardiovascular Research (CNIC), and the Ferrer laboratory in Spain. Among big pharmaceutical majors, Pfizer, AstraZeneca, GSK and Aventis are some of the companies that have shown interest towards polypill development.

These may have a small market share, to begin with—$750 million at launch time in 2010 out of the $11-billion pharmaceutical market for cardiovascular segment. The calculation rests on the assumption of sales of products sold in single dosage format as opposed to the fixed dosage combos, reflected by polypill constituents.

However, excitement in the market seems to indicate a steep growth curve. “We have completed trials for our four-in-one polypills in India and the data is under compilation. We expect to make an application to the Drugs Controller General of India (DCGI) soon. Now, the global clinical effort is on and regulatory approvals have been received for pilot trials from USFDA, MHRA, TGA (Australia), Medsafe (NZ) and DCGI (India). Besides, we have a partnership with University of Auckland for the trials,” says Raghu Cidambi, advisor, Dr Reddy’s Laboratories. Clinical trials would involve 600 people from five continents. They would be drawn from New Zealand, India, Australia, Brazil, China, South Africa, the US...

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