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Issue dated - 20th March 2003

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‘Diabetes has already assumed epidemic proportions in the country’

The elegant and soft-spoken Dr Anil Kapur, vice-president, International Operations of Novo Nordisk A/S and managing director, Novo Nordisk India Private Limited, a major player in the insulin market, is a medical practitioner who has played multiple roles in the industry in the last 23 years as medical advisor, medical director, medical marketing and GM heading operations of Novo Nordisk South Asia. He is the editor of Novo Nordisk Diabetes Updates and Endrocrine Newsletter (publication with the Endocrine Society in India) and contributes to magazines for general information such as ‘Value Circle’, for the medical profession and ‘Prerana’ for people with diabetes and has over 90 original and review papers published in reputed journals, nationally and internationally in the area of internal medicine, clinical pharmacology and endocrinology. He has been instrumental in setting up the first diabetes centre in Tanzania and plans to set up about 20 diabetes clinics in Tanzania with funding from Novo Nordisk on the occasion of World Diabetes Day. He is also the Vice-Chairman of the World Diabetes Foundation, a US $60 million effort of Novo Nordisk A/S, to combat diabetes better in the 50 poorest and underdeveloped countries of the world. Dr Kapur, in an exclusive interview with Vijaya K, elaborates on the ongoing insulin price war and the rising alarm of diabetes in India. Excerpts:

In an earlier conversation with Express Pharma Pulse, you had mentioned that it is not possible to further cut the prices of human insulin in India as it is already rock bottom. Then how did Novo manage a significant price cut a month later? What is its impact on your topline and bottomline?

Well, I personally do not call it a price war. Price cut is something that has been going on for many years. To be committed to our motive of social cause through the formation of Diabetic Foundation, we decided to implement a pricing strategy in 50 least developed countries of the world where we would sell our products at a price not exceeding 20 per cent of the existing price. And obviously India is not a part of this. It is in the interest of the people that we have taken this decision.

We have neither made any changes nor talked about it for the past five years until we decided to reduce the price in January this year. We do work closely and we were not in a position to announce our pricing strategy earlier. We are facing generic competition from Russia, Brazil, China, Poland and in India. But we can afford to have our prices.

Though it is too early to assess the impact on our sales, it certainly hits 25 per cent of our bottom line sales and I can already feel that impact.

At least two Indian manufacturers are expected to launch human insulin this year. As an effective entry strategy, they are expected to launch their versions at competitive prices. Will these indigenous brands further bring down the existing price levels? Will a price war commoditise the insulin market? Please comment on the current profit levels and what will be the change post 2005?

I do not think there would be much change in the existing prices. But if it happens, then it will be a great disadvantage for the development of diabetes drugs. We need to have certain returns for the investment we make to develop more products. If the prices fall, obviously, the market does not grow. The solution for treatment of diabetes does not lie in having the lowest price. Enough investment has to be made on educating and training diabetics.

Insulin will become a commodity if the price drops. No one will invest money and there will be no buyers. The production of insulin calls for ensuring quality and appropriateness and that is why there are only a few major players.

Insulin is not a patented product and hence post-2005, there will not be any impact on the insulin market. Frankly speaking, I don’t make any money in India.

The recent price cut effected by Novo is only for insulin vials used for injections, while the prices of cartridges and pre-filled syringes have remained static. Why’s this so?

Well, nobody will sell an expensive car like the Mercedes Benz at the price of a cheaper car. It is not that the MNCs are not sensitive to the needs of the market, but there are several issues. Why should they sell cartridges and pre-filled syringe forms at cheaper rates when the same product is available in another country at higher prices and allow an unscrupulous trader to profiteer.

We will work on strategies to reduce prices of our products which are produced in India with same standards and not available in other countries. We have offered human insulin to the state governments at lower prices. But we will not like if the system leaks and product lands in the private market.

With the advent of new insulin analogues and premixed insulin combinations in the market, the potential for administration errors has increased. Please comment.

If people fail to develop those products, they start talking rubbish. Several years ago, we developed a combination of soluble insulin and NPH which otherwise was cumbersome because they were administered separately. So the companies developed premixed standard ratio of soluble and NPH which gave better results. When it comes to the use of new devices like analogues that mimic the physiological insulin production and premixed insulin combinations they are accurate and we never compromise on accuracy.

What is the progress so far internationally on new insulin delivery systems, especially oral and inhalable insulin? What are the major impediments? When is the oral insulin expected to hit the market? What about Novo’s plans for oral insulin?

Novo Nordisk worldwide has been working on certain areas in injection devices. The insulin doser called Innova, will help see the readings with insulin injector on one side and glucometer on the other.

Another new stop watch device called Innolete will be launched for the convenience of elderly people. We are also working on a sophisticated inhaling device called Erics. This is currently under phase 3 studies.

There are many issues unresolved in oral insulin which is not easy to produce for the simple reason that it should be protected from gastric juices. Once it is destroyed, it is no longer insulin. It has to be adequately protected and allowed to go into the intestine. It has to be produced in such a manner that it disintegrates in a specific part of the intestine and absorbed in sufficient quantities.

I feel that it will take not less than five years to come out with a standard formulation of oral insulin. As of today, there is no oral insulin product in any stage of clinical trials. Novo will not even talk about it unless and until one is taken to the clinical phase.

Inhalables are also not ‘the effective’ delivery system. It is also too early to talk about its advantages and its long term safety is not known as yet.

Could you tell us about Novo’s R&D pipeline? Which are the new products that are slated to hit the Indian market in the next couple of years?

Worldwide, we have over 200 projects in research stage and several products under development stages. We are planning to launch new devices and analogues for the domestic market. Novo rapids, the fast acting analogues and Novomix, the fast acting links are two of them which are slated to hit the market in the second quarter of this year with an eye to tap the niche markets.

We are focusing our attention on improving diabetes care and our market will be focused on new devices forms. Novo Nordisk with an insulin market share of 47 per cent globally, enjoys 75 per cent share in the domestic market where insulin, insulin analogues and devices for injection represent the majority of sales in diabetes care. Novo spends over 15-16 per cent of its total turnover in research and development worldwide.

There is a feeling that the drug industry is creating a false alarm as far as diabetes is concerned. Will diabetes assume epidemic proportions in the next 5 to 7 years in India?

Recent evidence points towards an increasing prevalence of diabetes in the Indian population. There are an estimated 32.7 million people with diabetes in India and only a fraction of them receive proper treatment. India is the country with the highest number of diabetics in the world. The WHO estimates that this number will increase to over 80 million by 2030. If this epidemic is not controlled, it threatens to become the biggest health scourge in the next century. Diabetes has already assumed epidemic proportions in the country.

Could you briefly describe Novo’s partnership with Abbott? Is it only for human insulin or does it extend to Novo’s entire product range as well? Will this extend to pipeline products?

The co-marketing and distribution alliance between Novo and Abbott has been existing for several years (throughout three transitions- Boots, Knoll and now Abbott). This partnership exists for our entire range of diabetes products and will continue for our products in the pipeline as well.

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