FEBRUARY 3, 2002
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Auto-Expo 2002
A lot of the big names were missing. Just the same, people came, saw, and drooled over the hot-rods at the biennial automotive fest in New Delhi. A desperate industry even roped in stars to add glamour to metal. Click here for a review of the show.

Show Me The Money
It seems the Finance Minister Yashwant Sinha is going to have a tough time balancing the government's books this fiscal end. Estimates of gross tax collections for the period April-December 2001, point to a shortfall. Unless the kitty makes up in the last quarter, the fiscal situation will turn precarious.
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SIR RICHARD SYKES, Chairman, GlaxoSmithKline
"India Will Become Attractive Only When IPR Is Protected"
 
He heads the second-largest pharma company in the world and was the driving force behind the UK's largest corporate merger. Meet Sir Richard Sykes, Chairman, GlaxoSmithKline, and Rector, Imperial College of Science, Technology and Medicine. In an exclusive interview with Business Today's , Sykes discussed topics ranging from the lack of protection for intellectual property in India, to the possibility of R&D and marketing alliances with Indian companies, to his company's plans for the Indian market in the near future. Excerpts.


Q: The GlaxoSmithKline merger was first announced in January 2000, and fell into place by December of that year. What has been the progress of the integration process?

A: The year 2001 has been very productive as far as progress with the merger is concerned. We had to wait a year before we could consummate the merger. That allowed a lot of things to get sorted out. The companies have come together well with the organisations coming up to speed very quickly. And results, as predicted, are very good.

You talked about savings of $1.3 billion over three years. How much have you saved in this one year?

Yes. That's right on track. Savings are made and they will continue to be made. But the maximum savings will be made over a three-year period.

The last two years haven't been too good for both your companies, Glaxo and SmithKlineBeecham, in India. Sales and margins have slipped. Except for the anti-asthma drug, Seretide, from Glaxo, there has been no new launch from your companies. Are we going to see more launches through the merged entity?

  "Once the regulations change, Indian pharma companies will have to become more research-based."  

The Indian market is a peculiar one because of the status of intellectual property. It's not our intention to launch new drugs in the Indian market in the near future because it's a pointless exercise. Any generic house could copy them and put them in the marketplace and sell them at a lower price. The dynamics of the market will not change until there are clear rules about intellectual property rights. So, for a company like ours, which is a prescription medicine-based company, India will become really attractive only when we get some IPR protection.

But as far as copying of drugs is concerned, that could happen even if you launched a drug in, say, the US. The Indian companies could still buy the drug, copy it, and sell here in India at a much lower price. So does it make sense for you to not launch the drug under your own brand name?

Of course it does. It then means that we are selling the drug way below the price we sell at in the rest of the world. Then that drug can be re-exported and anything can happen. But it doesn't make any business sense to do that. But once IPR is recognised, that will change the whole dynamics of the market.

What drugs are going to come in over the next couple of years from the GlaxoSmithKline stable?

We have a drug for benign prosthetic hypotrophy (BPH). We have a pd5 inhibitor for male erectile dysfunction that will come out this year. And then we have a number of enhancements of our own drugs. Although it's not as perfect as we would want it to be.

Do you plan an Indian subsidiary for launching new products?

No. I think GlaxoSmithKline will be the vehicle. Whether there are any plans to change that, I don't think so. Not to my mind.

How dramatically do you expect the Indian market to change after 2005, when a product patent regime comes into place?

I think the market will change significantly after 2005 because India is potentially a huge market. I think there will be significant changes for companies like GlaxoSmithKline, which have a long history in India. We will introduce all our new drugs here and put in more into R&D in India, something we haven't done before. That will mean more investments coming into India. There are good people in India-good scientists and technical people, a sound educational system, and reliable infrastructure. All these factors taken together make India an attractive market in the long-run.

How will you cope with the way prices are controlled in India. Would it make sense for you to launch new drugs?

  "Intellectual property affords you exclusivity for a given duration of time. When it goes, it goes."  

After the patent regulation, we will know what the rules of the game are. There are no rules at present. Anybody can do anything. Under the new regime, we would be able to make a correct decision on whether to launch the drug or not. In any case, it is not in the government's best interest to deny people the best drugs. I'm sure there will be compromises of the right sort.

How do you rate companies like Ranbaxy, Dr Reddy's and Cipla as competitors?

They are all generics companies. They are not prescription pharmaceutical companies. I believe that when IPR does come to India and the market is protected well, these companies will move in the direction of becoming much more like GlaxoSmithKline. Today, they operate the way they do because the environment allows them to. Once the regulations change, they will have to become more research-based.

You talked about making more investments in India in the area of research. Will alliances with companies like Dr Reddy's or Ranbaxy power that strategy or will you be going on your own?

I think in this industry, alliances, collaboration and interaction with various groups is very important. We don't hold all the intellectual property. We only have a little piece of what we need. We have to make alliances with a lot of research institutes, universities, biotech companies, and other pharma companies. That's a very important part of the business.

Can a company like GlaxoSmithKline save on costs and reduce the time to market by sourcing out R&D to local companies?

Yes, the costs could certainly be brought down that way. That will make our processes more efficient. I believe that new technology will also help us reduce the time to market and make drugs cheaper at the end of the day.

Can you give an example of how you are using technology to speed up things?

To put it simply, it's the sheer scale of R&D today-everybody is duplicating everything; if you bring them together you don't have to duplicate. You have one set of this, one set of that. You don't have to do clinical trials and genetic databases five times. You just have to do them once. So we have set up centres where research groups work on the basic chemistry, and then we have five special labs so that the molecules go to the R&D centres of cardiovascular, cancer and anti-viral diseases. They then take it right through to the proof of concept. We have organised them in a manner that they reach a critical mass in all the therapeutic areas. So that size gives us the opportunity to create a framework with all technology around and everything else in the middle and curtail duplication.

A major reason why drugs, at least the patented ones, are expensive is because of the cost of discovery. The hit rates are low, making the heavy back-end investments prohibitive. What are you doing to improve your hit rate?

Use modern technology. If you go back in time, most drugs were discovered serendipitously. But now, we are starting to understand the underlying mechanism of diseases thanks to modern genetics and molecular genomics. Once you understand the disease, you can target it with more specific drugs.

That will enable us to increase the hit rate. In the past, we were in a blind corner. But we can now see what we are up against clearly. I think that is likely to change the whole dynamics of the business.

In the US there is a move towards generics because of the cost factor...

I think that issue has always been there, but it's not a live one because of the problem of litigation. So if you bring out a drug and there are no generics of that drug, there may still be drugs in the same class. If you take beta-blockers, there would be 15 other similar beta-blockers. Some of them are patent-protected, others are not. The ones that don't have a patent will be a lot cheaper. If you can't differentiate between a molecule and a generic, people will buy the latter since it's cheaper. Why shouldn't they?

Modern drugs have been dominated by antibiotics through the 20th century. What radical changes in medicine will we see in this century?

Antibiotics are interesting because their target is an invader. A bacteria, fungus, virus, or a parasite that comes from outside and we've got to rid of it. But many of the diseases are born in our mechanism. You can't see them. It's a completely different paradigm for treating diseases such as diabetes.

Diabetes is a complex disease. So you can't take a drug for seven days and hope to kill it. You can't cure it, but only treat it. But if you know the genetics behind it, the dynamics of treatment becomes completely different. Knowledge of a person's genetic propensity for a disease goes a long way in preventing its occurrence through making changes in lifestyle and environment. That is one way.

The second way of dealing with diseases is to understand the underlying mechanism. All these allow you to treat diseases in a fundamentally different way. In the 21st century, we will be curing diseases like diabetes or bone-joint, cardio-vascular and neurotic disorders the way we cured infectious diseases in the 20th century. Things like tissue and organ regeneration will also happen.

But will the advantages of these developments ever trickle down to the masses?

It always happens. Initially, only people who can afford it will have access to the technology. But in the second round, people excluded in the initial period will also benefit. Not everybody can access everything initially. But new things eventually become available to the masses. Today, millions of people possess cars. But in 1901, only the extremely rich had them. So we should not stop technology. People who buy it (when it is expensive) drive its growth.

Indian companies like Ranbaxy or Dr Reddy's are licensing molecules to Novartis and Novo-Nordisk. Are the global pharma majors looking at sharing research knowledge with these companies?

That's our competitive advantage. Research base gives us the edge. I don't think anyone's going to share R&D knowledge with their local counterparts. But I still think basic research offers small companies tremendous opportunities because they can work on specific areas, whereas a company like ours is looking at too many different areas all once. The smaller companies should engage in more basic research and then hope to sell the results to the bigger companies.

I understand that in the next 10 years, patents for about four billion drugs are going to go off. That will be a goldmine for Indian generic companies. Will GlaxoSmithKline aim for some sort of an arrangement where it gets a share of this pie?

Intellectual property affords you exclusivity for a given duration of time. When the exclusivity goes, it goes. That's it. You can sell your drugs, but the sales drop. There is no point getting involved in that. Adjust to it, recognise it, and carry on.

What about marketing pacts with local companies for critical mass in sales?

Yeah. Just like some big companies come to us and say, ''Look you have a better infrastructure in Korea or US. So would you sell our drugs?'' We'll go for that, if we believe it is necessary. Apart from having excellent reach in the local markets, our local partners' ethical standards should match ours. They should also be adding something significant to what we already have.

Research in companies like GlaxoSmithKline appears to be more geared to the US, Japan, or Europe. What if markets like India truly open up. Would your labs start working on tackling tropical diseases or those more prevalent in India?

We have been doing a lot of research in those areas. So do other big companies on diseases like TB and malaria. AIDS, of course, is the big one. We are making significant efforts in all these areas. We can't limit ourselves to diseases that affect only a certain part of the world. There is an enormous amount of work being done on Third World diseases.

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