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22 July 2015

Interview with the Director of the Experimental Tuberculosis Unit, Institut Germans Trias

Pere-Joan Cardona:"Tuberculosis is one of the great challenges facing mankind"

After graduating in Medicine in 1992, he obtained his specialty in Clinical Microbiology in 1997 and his doctorate in 1999. Since 1997, he has been Director of the Experimental Tuberculosis Unit at the Institut Germans Trias i Pujol (IGTP). Its goal is to try to explain the disease and develop new diagnostic, preventive and therapeutic products using experimental models and clinical trials. The Unit has been a member of 7 European Union consortia and a Grand Challenge, sponsored by the Bill & Melinda Gates Foundation and the US NIH. Dr. Cardona has founded two spin-offs: Archivel Farma (2000) to develop the therapeutic vaccine RUTI; and Manremyc (2013), to develop Nyaditum resae®.

Question: You will be a speaker at the next PharmaProcess, presenting a food supplement for the treatment of tuberculosis. Can you tell us what this product consists of?
Answer: Yes, we are presenting Nyaditum resae®, a formulation based on the bacterium Mycobacterium manresensis, which is inactivated by heat. M. manresensis is a bacterium that is found in drinking water and belongs to the same family as Mycobacterium tuberculosis, the causative agent of tuberculosis. We use it for oral administration so that the intestine's immune system comes to tolerate its presence. Consequently, when an individual comes into contact with M. tuberculosis, the immune system is already used to a similar presence and develops a balanced immune response, that is, without generating an excessive inflammatory response. This fact is essential because tuberculosis is induced by an over-response to M. tuberculosis.

This is a paradigm shift; until now, the strategy against M. tuberculosis was to destroy it at all costs, either using chemicals or vaccines. When we discovered that, in actual fact, simply being infected by this bacillus does not cause any health problem, only inducing small lesions measuring less than 1 mm, and that after a certain time, it is expelled naturally from our body, we understood that the strategy needed to change target and "reeducate" the immune system by inducing this tolerance.

But Nyaditum resae® is not really a medicine, right?
Right, as M. manresensis is already present in a food (drinking water). Nyaditum resae® can be considered a nutraceutical.

¿What role do nutraceuticals play in the pharmaceutical industry? Do you think that it is a trend that will grow in the future?
The nutraceuticals' main advantage is the fact that their presence in foods gives them an excellent tolerability and safety spectrum. Furthermore, being a natural product, they are not a "chemical" and, therefore, are not associated with any concept of toxicity. So I do think that their use will increase in the future, as people increasingly fear the potential side effects of traditional drugs.

You have come to an agreement with an Indian company to market this product in India. Why India and not another country?
India was our first target because it has the world's highest incidence of tuberculosis (2.2 million in 2014) and also the highest mortality from this disease (300,000 deaths in 2014). In any case, our intention is to make agreements around the world, with similar companies.

It seemed that tuberculosis was practically a forgotten disease. But that's not so, is it?
Tuberculosis is one of the great challenges facing mankind. It has been defined as "the inseparable companion of the human species". When Australopithecus was around, they had tuberculosis too. Historically, it is estimated that it has already killed more than a billion people. And coming back to the present, in 2015, the number of cases increased half a million. Currently, nine million new cases are diagnosed each year! And 1.5 million people die from it each year. There are several factors that favour its spread. First of all, its "discretion": the tuberculosis patient takes at least 45 days to be diagnosed after symptoms appear (chronic coughing, weight loss, low-grade fever,...). It's very discrete.

AIDS has contributed significantly to its worldwide distribution, but there other less well-known risks, such as diabetes mellitus, more and more people living in increasingly crowded urban areas, or the growing globalization of human activity. We have to remember that transmission is airborne ... and there is no risk factor for becoming infected. Anyone can become infected. By linking it with immigration or poverty, it has become a stigmatized disease, a disease no-one wants to talk about, and that is why we live in the illusion of thinking that it has been eradicated. When someone from the middle class has tuberculosis, he hides it. It's as if it didn't exist. You can come out and say you have cancer, but not tuberculosis. Nelson Mandela died of a "respiratory tract infection", but everyone knows he died of tuberculosis. Today, no statesman can die of tuberculosis!

Nyaditum resae® is a product created at Manremyc, a biotechnology spin-off created at the Institut Germans Trias. What goals does this company pursue? What were the reasons that led you to create Manremyc?
Nyaditum resae® is the final fruit, the conclusion, of 20 years of research. Our conviction that it would be decisive in the eradication of tuberculosis forced us to find a way to take it to the market. However, the market was not mature enough for a product like this. So, we took the reins of our destiny in our own hands. Manremyc has only one objective, to find business partners around the world who can understand our product and engage in its production and distribution.

In this respect, what role does public-private collaboration play in the health sector?
In this case, there is a clear relationship. Nyaditum resae® comes from basic research carried out at the IGTP's Experimental Tuberculosis Unit, a public centre belonging to the CERCA network of research institutes in Catalonia. This research, which elucidated the fundamental role played by the inflammatory response in inducing the disease, culminated in the product's design and protection by a patent.

Later on, the IGTP created the spin-off company Manremyc, to which it transferred the universal licence for this patent in exchange for a share in the company's equity and royalties and allowed Dr. Cardona to manage it, and after that, it began its career as a private enterprise. So you could say that it is a "textbook" example of a public-private knowledge transfer process, which is managing to stay operational because the IGTP has continued to receive public funds to improve understanding of the mechanisms of action of Nyaditum resae®.

On the other hand, as Nyaditum resae® is a product with a high social impact, we feel that the public-private collaboration needs to make a quantum leap. Marketing it as a nutraceutical will make it affordable for large-scale distribution campaigns sponsored by public bodies or social impact investors. This will be the second stage of its development: distribution on a massive scale. So we need to leverage our business alliances in order to perform pilot studies among the buying population, in order to study the product's impact on decreasing the disease's prevalence. Once we have this data, the involvement of public players will come automatically.

And do you think that the drug industry values the existence of companies like Manremyc?
Of course. The drug industry is constantly open to new products and strategies for improving the population's health. It's why this industry exists. Although, as I have said, the fact that it targets tuberculosis, a silenced, stigmatized disease, probably will not make Nyaditum resae® a very attractive product.

One last question: what other products is Manremyc working on?
At the moment, we are focussing on the strategy for finding these international partners, and particularly, on following the registration and market launch processes ... After that, we'll see!

Pere-Joan Cardona image

Barcelona, 22 July 2015


Eduard Pérez Moya

(+34) 93 233 21 66
eperezm@firabarcelona.com


 

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