Cloud of side effects hangs over diabetes drugs research

With growing obesity and lifestyle changes, the scourge of diabetes is set to affect as many as 70 million Indians by 2025 from 41 million now.

Intelligence provider Grail Research estimates that the domestic market for diabetes drugs, which was at $480 million in 2008, would grow a healthy 16-20% annually.

Little wonder then that diabetes has a huge presence in the development pipelines of domestic drugmakers, who are betting on this segment to give the market a novel molecule.

Leading drugmakers such as Dr Reddy’s Laboratories (DRL), Glenmark, Biocon and Piramal Life Sciences have drawn up plans to develop novel diabetes molecules. However, recent issues related to side effects of diabetes drugs may cast a cloud on these plans. In 2008, diabetes drug rosiglitazone came under the scanner both in India and abroad as it was found to increase the risks of heart attacks in patients. According to the US Food and Drug Administration (FDA), another drug, exenatide, was found to cause pancreatic problems in some patients.

AK Jhingan, chairman of Delhi Diabetic Research Centre, said the road to a novel medicine for diabetes has to be treaded with extreme caution. “Another recently-introduced diabetes drug vildagliptin caused severe cough in one of my patients and the medication had to be stopped for him for some time. When a new drug comes into the market, there is a lot of hope, but its side effects are seen only after 2-3 years,” he said.
Sujay Shetty, associate director of professional services firm PricewaterhouseCoopers, said though India has expertise in the area of diabetes, it still has a long way to go before it actually develops a new drug for the disease. “People are not very convinced about novel drug development yet. It’s hard to say whether the molecules that companies have are actually novel therapies or ‘me too’ medications with several predecessors,” he said.

This is why, say industry experts, the healthcare fraternity is looking at all new research in diabetes with a cautious eye. Dr Reddy’s diabetes molecule, balaglitazone, is presently in phase III but many experts have already written it off. Research analyst Ranjit Kapadia said there are hardly any chances of the molecule actually coming into the market, and becoming a blockbuster drug.

Bino Pathiparampil, an analyst from equity firm IIFL, said, “The DRL molecule was originally out-licensed to Novo Nordisk but then returned to DRL. Now it is being developed in partnership with RheoScience. There is inordinate delay and lack of focus on this.”Likewise, Biocon’s oral insulin molecule, IN 105, though unique, has obstacles ahead. “The Biocon molecule, which has passed phase II, still has to clear several hurdles. Pfizer’s attempt at providing non-injectible insulin in the form of the inhalable Exubera fell flat due to side effects, with the product ultimately being withdrawn from the market. Insulin in non-injectible form is still a hard dream,” said Kapadia.

Piramal’s diabetes molecule is currently in phase I studies and has a long way to go before it becomes a drug. “There are some hopes pinned on melogliptin, the Glenmark diabetes molecule, but it again depends on how it progresses in the phase III trials and also post marketing surveillance once it enters the market,” said Kapadia. Melogliptin is expected to enter phase III by year-end. According to a Glenmark spokesperson, if it succeeds in the market, it could fetch annual revenues of $2-3 billion.