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The Sweet Success

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Launching a new blood sugar drug in the diabetes capital of the world should be a no-brainer. But the Rs 1,400-crore diabetes market in India, a nation of 43 million diabetics, is not for the faint-hearted. There are 700 brands of diabetes pills, and counting. Generics abound — for instance, Amaryl, the market leader from Mumbai's Sanofi-Aventis, has 54 generic versions. Drug price control and competition have kept prices in check.

So, the launch of two patented diabetes drugs, that too at a premium, could well have ended up a non-starter. But data show both sitagliptin and vildagliptin — from Gurgaon's MSD Pharmaceuticals and Mumbai's Novartis India — have become hot sellers. The two drugs and their combination with metformin — a drug that is taken as the gold standard in oral diabetes treatment — have got a 3 per cent share, with revenues of Rs 45 crore in the 12 months to July 2009. Januvia, MSD's brand of sitagliptin, debuted in April 2008, while Galvus and Jalra, brands of vildagliptin hawked by Novartis and Indian firm USV, followed five months later. Amaryl and its combination with metformin own 4.8 per cent share.

"The response to Galvus and Jalra has been much better than estimated," says Ranjit Shahani, vice-chairman and managing director, Novartis India. An MSD spokesperson claims Januvia is the best oral diabetes drug launch in five years. "A turnover of tens of crores in the first year of its launch is good, given this topline is driven by healthy demand," says Monica Gangwani, head of Synovate Healthcare, a research agency. In June 2009 alone, doctors wrote about 74,000-plus prescriptions for the products, according to ORG-IMS. So what have they done right?

Unmet Need, Price And Promotion
Part of the answer lies in the drugs themselves. The two molecules act differently from others. Gliptins work by imitating the body's natural way of regulating blood glucose. They signal the pancreas to secrete insulin only when blood sugar goes up. This takes away some common side-effects — sudden and dangerous drops in blood sugar between meals. Also, it does not cause weight gain unlike some older drugs.

Januvia is the first in a class of new diabetes drugs that has a low risk of side effects seen with some older drugsDoctors say they now have another option to postpone the use of insulin in patients with type 2 diabetes. (Type 1 diabetics are always given insulin as their body produces none). "Indian patients don't prefer to inject themselves with insulin if they can avoid it," says Shashank Joshi, consultant endocrinologist at Mumbai's Lilavati Hospital. Diabetes is a heterogenous disease impacted by factors such as genes, diet and lifestyle. Often, more than one drug is needed to control it. "Doctors are not happy with the drugs in the market," says a senior executive with a large Indian generics firm. "There is an unmet need." Joshi, who has about a thousand patients on the drug, says his patients have responded ‘dramatically' to gliptins.

The gliptins are the first patented diabetes drugs to hit India. This has guaranteed pricing flexibility to the firms. Yet, both companies seem to have realised early on that affordability is the key to volumes. MSD has launched Januvia, a once-daily tablet at Rs 43 a pill. That's a fifth of the price at which its parent firm Merck sells it in the US. And Galvus, taken twice daily, retails at Rs 19 per pill, bringing the daily cost of treatment to Rs 38. This is seen as reasonable by other firms. "In the absence of generics, a company can set a price the consumer can afford," says an executive of the generic firm that sells diabetes drugs. "With no patent cover, prices are sometimes lower than what consumers would be willing to pay." He says generic competition would have ensured the price per gliptin pill was Rs 10.

In addition to the usual doctor-engagement programmes, some new strategies have helped the products. The first is by moving the debate from price to value. In addition to its differential pricing model, MSD has set up a customer care programme to offer free diagnostic tests, diet and lifestyle advice to Januvia users. About 4,000 doctors have recommended patients to this programme. This allows MSD to offer more than just the pill to the patient for Rs 43 a day. It has another benefit: tracking compliance, a thorny issue, and getting early outcomes' data. MSD says this Indian customer-focus has helped. "Januvia has set the benchmark for all patented general physician products," says Naveen Rao, MD, MSD Pharma.

The second strategy is to leverage Indian generics firms who have built strong therapy franchises and distribution networks. "Our tie-up with USV has helped us increase market presence," says Novartis' Shahani, whose firm is new to the diabetes market in India. "It also helped fast establish vildagliptin in the target segment where USV had already proved strengths." USV, a leading generic diabetes drugs maker, buys vildagliptin from Novartis and markets it as Jalra, which kicked off with more prescriptions a month than Galvus.

While both strategies have been tried with generic drugs, they have had limited success. Sustaining the customer care initiatives in a price-sensitive market with many cheaper generics around has been tough. In the case of co-marketing, generics firms do not see the logic of buying a drug from an MNC that they can make or buy cheaper beyond the initial launch period. With a patented drug, such an agreement might be more sustainable. "Not only are these drugs first in their class, their marketing has also been scientific and innovative. The result of these strategies is the drugs have got wide acceptance despite being relatively high-priced," says Gangwani.

The drugs are still at the premium end of the market. There are medicines that retail for a quarter of that price. For now, doctors prescribe gliptins almost always as add-ons to drugs such as metformin, and not as first line of treatment. "Cost is the limiting factor," says Joshi. Further, older drugs have a more established track record on safety and efficacy.

 The Safety Factor
The safety of diabetes drugs came into the spotlight in 2007 when a study found a higher risk of heart attacks in users of Avandia or rosiglitazone from UK's GlaxoSmithKline. The firm refuted this charge, and the drug continues to sell with a warning on cardiovascular risks.

Long-term cardiovascular safety of the gliptins is also currently under study. While gliptins are seen as safe, there is always the chance that other side-effects could come to light with prolonged use. Last week, the US drugs regulator, FDA, said it had received 88 reports of acute pancreatitis or sudden inflammation of the pancreas in Januvia users between October 2006 and February 2009. But Merck denied causal relationship between sitagliptin and pancreatitis after reviewing clinical trials and post-market data.

More gliptins may launch in India, though when is uncertain. Bristol Myers Squibb recently got US approval to launch saxagliptin. And alogliptin from Takeda is undergoing a cardiovascular study as requested by FDA, though it has applied for approval in Japan. This could make the market more competitive. There are no generics in this segment, but the cost of therapy will play a role.

Even now there is no significant difference in the safety and efficacy of gliptins currently in the market, says Shahani. Unless new data comes in, they will primarily fight a marketing battle.


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