05 May 2015

How to make the production of antibiotics interesting for the pharmaceutical industry?

"Society should invest in the research of new antibiotics"

Daria Shubina, VademecumThe resistance of bacteria – pathogens of infectious diseases to drugs is a global health problem, the solution of which is of concern to all states in the world.

The problem is exacerbated by the low investment attractiveness of the development and production of antibiotics – the cost of such drugs is low, and to bring one new drug to the market, you need to spend about $ 1 billion. John Rex, Senior Vice President and Head of the Infectious Diseases Department at AstraZeneca, spoke about the current situation on the global antibiotic market, the difficulties of launching new drugs and the expectations of Vademecum pharmaceutical manufacturers.

– According to a recent estimate by Jim O'Neill, former chief economist at Goldman Sachs, the economic damage from drug–resistant bacteria could reach $100 trillion by 2025, and human losses - 360 million if this situation is not brought under control. Do you agree with this assessment? What is your prognosis?

– The estimate of $100 trillion is quite reasonable. I believe that without antibiotics, the economic losses would already be huge. Thanks to antibiotics, we can do a lot today. In the "era without antibiotics" people died regularly from stupid, in modern opinion, infections. And we are still waiting for the opportunity to cope with any infections, to perform surgical operations without the risk of infecting patients, but most importantly, we want to have antibiotics for all occasions at the very moment when we need them. Therefore, it is important to have antibiotics in the arsenal, regardless of how expensive it is to develop and bring them to market. I will give you the example of Ebola, although it is a viral disease, but the approach is the same – in this case we simply could not do anything, and this gave rise to a worldwide panic. Bacteria that have no drugs against them can produce the same effect.

– In one of the interviews you said that the "era without antibiotics" will undoubtedly come again. How soon?

– Well, there will be no full return, of course, because not all bacteria are drug resistant. But in fact, you don't need 100% superbugs to make the situation extremely frightening. It will be enough even that 10% of bacteria will develop resistance to antibiotics. Agree, if you have at least a 10% chance that during the operation you can catch a deadly infection, will you think? SARS 10 years ago began with a local outbreak in Southeast Asia, which spread very quickly. Tourism stopped, planes and hotels were empty, and the economic damage to the Asia-Pacific region reached $30 billion. That is, the damage from infection can be much more significant than the actual number of cases of the disease. Another, earlier example is scarlet fever in the 40s, when parents were forced not to let their children out of the house. The experience of using antibiotics shows that there is always a threat that a bacterium will arise that they will not cope with. Now a lot of efforts are being made to solve this problem, but there is no complete volume of medicines that we need. And one or two new drugs will not help here - we need a long–term plan that will allow us to discover new antibiotics, bring them to market and at the same time make them affordable. This is a difficult task.

– How often do new antibiotics appear on the market?

– Not very often, so there are not so many of them on the market now. For a long period (until the 30s) we lived without antibiotics at all. If we talk about classes of antibiotics, then, for example, the class of quinolines that appeared in the 60s now has five to six drugs, and in the class of oxazolidinones, which have been on the market for 15 years, there are only three drugs. In 2010 , IDSA [The American Society of Infectious Diseases – Vademecum] has proposed to develop 10 new drugs by 2020. Over the past five years, five drugs have entered the market, a sixth is being prepared for release, but almost all of them do not differ much from each other.

– What are the main difficulties of bringing new drugs to the market?

– A new antibiotic aimed at an unusual pathogen of infection will most likely not be used very actively. How many people will need it? In addition, it is necessary to conduct clinical trials of a new drug. This requires patients with this disease, sometimes thousands of such people are needed, which, of course, is bad for them. And the bad thing for the drug is that there are no opportunities for clinical trials. This is a fundamental problem: it is impossible to create a drug when the disease has not spread disastrously widely.

Can we prevent bacteria from becoming resistant to antibiotics? Not particularly. On the contrary, whenever we use a drug, we can provoke bacterial resistance. And if people die, it is impossible not to use the drug.

Another economic problem: the development of a drug takes decades and requires serious costs, so society should invest in research. At the same time, in order to develop one drug and get regulatory approval for it, you will have to spend money on studying a lot of things that will not work or will not be needed later. British economists Priya Sharma and Adrian Towse have built a mathematical model of the cost of putting one drug on the market. Any models are not completely correct, but they allow us to understand the situation as a whole. So, according to this model, five years should be spent on development, eight on clinical research, and a total of $600 million should be spent. The drug will be on the market for 20 years, during which sales will amount to $ 2.5 billion. It seems to be a good scenario, but one cannot ignore the fact that the value of money changes over time. They are worth more today than tomorrow. In the industry, we assume that money is getting cheaper by 10% every year. That is, it turns out that after 33 years of working with the drug, you will only incur losses – within this coordinate system, they will reach $ 50 million.

– Nevertheless, antibiotics are interesting to market players. For example, Megsk did not spare more than $9 billion for the acquisition of Cubist. And what is the structure of this market as a whole?

– Despite the fact that new companies are joining the game, in general there are quite a few of them. According to the calculations of Michael Kinch, managing director of the Yale Center for Molecular Research, over the past 15 years, 14 companies have appeared in this market, and 36 have left it. The total number of companies that are actively working on antibacterial programs is currently no more than 10. Historically, the largest players in this market are Pfizer and GSK.

– What is AstraZeneca's activity in this direction?

– Our company has a number of antibiotics in its portfolio and continues development and research, usually in partnership with other companies. Currently, we have new drugs to fight gram-positive and gram-negative bacteria. The drug directed against gram–positive microorganisms has been approved worldwide, and against gram-negative ones has recently received approval in the United States. Another drug to fight gram-negative bacteria is at the stage of clinical trials.

– States are trying to change the situation somehow, various programs and funds are being created to assist in the development of antibiotics, the FDA has curtailed the approval process of such drugs, increased the validity period of their patent protection. But the market situation is not changing much. How to make the production of antibiotics interesting for the pharmaceutical industry?

– It is necessary to change the economic format of work. A way to push companies to develop may be to refund the tax deduction to companies that spend money on developing new antibiotics. Let's assume that the amount of expenses is $20 million. If you have a diversified business and you profit from other areas, then a 50% tax deduction means that $10 million will go to pay off your taxes. If your company has no income, then you get a check for $10 million. This option allows you to reduce costs, but does not make the process free, since you will still have to invest your half, your $10 million. You won't make any money until you invent a new medicine. This method is used in the UK and Australia.

In addition, antibiotics should be developed and put on the market to insure the possible occurrence of new infectious diseases. Why does the country buy an armadillo, after all, not in order to use it? It is needed in order to apply it if necessary, and not wait 20 years for the development and production of this ship. Antibiotics are the same. We have to think of them as a safety net. So far, this idea has not been implemented by anyone. But there is no doubt that it should be implemented.

Portal "Eternal youth" http://vechnayamolodost.ru05.05.2015

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