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‘New drugs, generics both needed for total healthcare’
-Live Mint

There are also ways in which we can help Indian institutions that have come to us seeking access to our technologies

Bangalore: A key perception change is emerging in the global pharmaceutical industry on the long-established divide between the so-called generics and innovative business. While the two are still at loggerheads in several developed as well as developing markets, the world’s top drugmakers are reinventing the wheel. Paris-based Sanofi SA, the world’s third largest drugmaker, which spent about 14% of its $40 billion revenue on research and development in 2011, says both generics (low-cost copies of medicines after patent expiry) and innovation models (drug discovery through research) are complementary in the industry’s new strategy—to sell a total healthcare solution rather than focus on individual products.

Sanofi’s global head of research and development (R&D), Elias Zerhouni, who was in India earlier this month, said generics come from innovation and the innovator naturally expects the expiry of his patent protection, which leads to generics. The company doesn’t see the two segments as one against the other while providing a comprehensive treatment solution to patients, he said in an interview. Edited excerpts:

* The regulatory environment is getting stricter worldwide, the new discovery pipelines of drug companies are getting narrowed. What is the way out for companies like Sanofi that are heavily dependent on new molecules for growth? Are you planning some new models?

I don’t know if we can have a solution without innovation. If anybody thinks they can take care of Alzheimer’s without new discoveries they are dreaming. So we can’t stop research for what I call ‘deep innovation,’ and not marginal innovation. We’re committed to it because we don’t believe that the people of the world overcome the disease burden coming their way without new discoveries. You can have all the generics in the world but they are not going to solve all the problems.

At the same time, the generics are important (but only) if you can combine cheaper generics with innovative drugs to treat patients suffering from multiple complications. Sanofi’s philosophy is to go beyond selling a pill or injection, but to provide a total healthcare solution to patients. For example, we have conducted a study in India involving about 18,000 people, where we found that many diabetics also suffer from high blood pressure. While we can provide the most efficient insulin to treat the diabetes, there is also available a quality blood pressure drug that is a cheaper generic. And we also consider the purchasing power of people in each market. So that we can offer better medical solutions at affordable costs helping the patients to avoid complications.

* Considering the difficulties some pharma companies are going through on the research front, will collaborations increase? And what does India offer in this regard?

Absolutely. I think it is going to be very important to find good ways of collaborating with the private sector, between companies, because it is too costly now (to do it alone). It’s really important to collaborate on disease biology. I think it’s in the interests of everyone because governments always ask: what is the return on investments? You see healthcare costs going up, solutions for chronic diseases are lagging. Collaboration will have to occur in a more transparent way, hopefully with better government policies.

There are also ways in which we can help Indian institutions that have come to us saying: Could you please give us access to your technologies? That is exactly what we’re doing here. I don’t have a particular agenda, to be honest. I want to be pragmatic and opportunistic about what is good and what happens.

* You restructured your research operations in France recently, cutting jobs. What is the strategy for research? Are you cutting on research spending?

No, not at all. Our R&D (research and development) budget is staying steady. There is no decrease in spending. What we’re doing though is changing the manner in which we are investing in R&D resource.

That has to do with a fundamental shift in our understanding of what needs to be done for R&D to be more productive than what it has been in the past. Let’s face it, productivity of R&D at pharma companies has not been very good.

So what I’ve been doing is reinventing the way we do R&D, and you have to restructure to do that. We started restructuring in the US, Germany and now France.

The idea is that: It’s clear that from the scientific standpoint we’ve made great progress in understanding normal biology, but not so much on understanding disease biology. For a long time, we believed that you can simulate disease biology in the lab with mice and other models but it has not been predictive, neither in safety nor efficacy. So we have to change the way we do that research and to do what I call ‘true translational medicine’, whereby you try to check and verify as early as possible in disease biology in humans, human samples, how, in fact, the disease develops so that you can develop better solutions, more innovative vaccines and drugs. Biology is also more complex than what we thought, therefore, it’s unlikely that any one organization, however large it may be, can really master the biology. So we’re extremely good at developing drugs and vaccines. The problem is that we’re not very good at biology. And it’s not just us. It’s the industry and academic world. So the restructuring is based on these things: One is to open up and lower the barrier between in-pharma research and out-of-pharma research. Have our scientists be able to interact openly in an ecosystem of research which has become global. Concentrate our research to avoid disbursing into too many sites. In the US, for example, we’ve concentrated our research at Boston.

* You’ve spoken about the dangers of fast-moving diseases like SARS (severe acute respiratory syndrome). How well prepared are we to handle these kind of pandemics? What systems have we instituted to make sure we can deal with them in a better way?

We’re much better prepared than we were 10-20 years ago because there are better systems around the world of public health and surveillance. We have created, if you will, a worldwide system of surveillance.

Look, we have two cases of potential SARS in Saudi Arabia and Qatar right now. We know about them, 10-15 years ago, I don’t think we’d have known. We are better prepared at detection and identification. Look at pandemic flu. We picked it up in Mexico before it even crossed the border. That is unusual. That is remarkable. Is the world at a greater risk? Yes. Because of plane travel, contact with the environment is increasing in certain regions where organism can pass from animals to men. But we’re better prepared and also, we’re understanding that we need to be vigilant at all times.

* Which new vaccines are you working on? And what’s been the progress on the potential AIDS vaccine?

We’re working on dengue, we published some results recently, which were mixed. In one way we have proven that our technology is safe, it is effective against three of the four strains but not against the fourth one. We want to understand is it just in Thailand, is it worldwide, we’re continuing to study. We’re working on nosocomial infections (hospital-acquired infections) like clostridium difficile (which causes severe diarrhoea). We are trying to get into an advanced phase for that. For AIDS, we contributed half of the vaccine that was the first one to show any efficacy for HIV. We continue to provide our technology for that. That is another example of collaboration. It wouldn’t have worked if it was just us or just the US partner. We’re also constantly exploring different vaccines. We think that improving the immunity of older individuals across the board is a good thing.