Between the Russian science and industry is a narrow isthmus on which manage to pass only a few. Development of original drugs are expensive, and what little Russian pharmaceutical company boasts the release of domestic innovative drugs. One of them — the company
a portfolio of these three drugs. As the company is now living, how to communicate with the government, competitors, partners, said its CEO Timothy Petrov.
Timothy Petrov: "The dream of every manager pharmaceutical company — the company to become the author of a new pharmaceutical blockbuster that would have gone down in history not only Russian, but also a global pharmaceuticals"
— Initially, this strategy of the company was laid by its founder Michael Nazarenko, and we're trying to continue this trend.
On the other hand, to date, the search for new molecules greatly facilitates computer modeling and high-technology screening, which deals in particular KhimRar. But in my opinion, the most important role here plays luck. The fact that we have in the portfolio at the date of the original three innovative drug, I would refer to a certain luck. A lot of people, organizations and institutions engaged in research for years and actually achieve very much, but do not bring your design to the final point. May interfere with the lack of funding or the human factor: ill or, God forbid, died researcher — and with it all goes away. So fade entire schools, libraries are not stored or made secret, and when they become available, this information is no longer needed, other people have arrogated to themselves the palm. Although these materials are classified seriously thinned out in the 90's, when many developments have left the country together with our scientific staff. This is one reason today is not too rapid development of innovation in Russia. To this situation has changed, it takes time, and the government support is very important. The state represented by structures such as the Ministry of Industry, Ministry of Education, provides significant financial support for innovation. We, for example, through government contracts with the Ministry of Industry are conducting three major projects in the field of Radiopharmaceuticals and tuberculosis. There are many other programs and institutions, such as "Skolkovo" and "RUSNANO".
But I would be very cautious about the word "success", most of the projects we have on the stage of start-ups and in many ways we owe them the appearance of mere luck. To date, one innovative product we have already registered, and he shows himself well in Radiopharmaceuticals as a diagnostic tool. We're going to conduct clinical trials of another therapeutic radiopharmaceutical. We want to take such a big important niche as the treatment of metastatic processes in bone that occur against the background of cancer. And one more product that we have this year will bring to market — is "Celexa" — for the treatment of cerebral circulation, unique in the world no. There are similar products, but clinical trials have shown that the comparative clinical effectiveness and safety of the drug has no analogues. So far, we do not list them on the market, solving marketing problems.
Perhaps we can indeed reasonably describe as an innovative company, but I want to stress that this is not only our merit. We work in the community, and any innovation, in my opinion, as well as talent, can make its way only when it is demanded.
How did your innovative drugs?
— Most of the ideas are not born in our company. People have come to us with ideas, we — just a tool to implement them. Someone left with nothing, someone was staying, we tried something and could not get the project. But something remains. Yes, there was a lot of work to bring to the finished product. But these ideas have already been developed to some extent, been the experience of drugs in laboratory practice. That is, we saved at a very early stage of their development.
Issue of innovative products for the company — it is a matter of enthusiasm or benefits?
— That's a good question, what principle determines what will the company. Generics are calculated well, less risky and costly, although the margin is considerably lower. On the other hand, probably, any pharmaceutical company manager wants his company to become the author of a new pharmaceutical blockbuster that would have gone down in history not only Russian, but also a global pharmaceuticals, and, of course, would bring considerable profit.
After all, our primary goal — not primitive making money and creating a product that seriously and permanently change the quality of life for the better. We live in a very aggressive and quite a dangerous environment. We cope with it because we have a margin of safety. And when the body's own resources, this is not enough, the man seeks the help of medicine. As a former doctor — even though the former doctors do not happen — is convinced that the citizen should be available to the most modern drugs. Man honestly working and paying taxes, so the government should take a greater part of the provision of such drugs on himself.
Today, it is, unfortunately, not in its entirety. But I believe that the dialogue with the State Company now very good. Maybe not so smoothly and the legal framework leaves much better, but the general direction is correct. The state gives money for innovation, so that companies had the opportunity to turn out scientific potential to compete with Western schools and in the end the public offer domestic product of high quality. For us the main value — it's not gas, not oil, and human resources. The population of Russia is becoming every year less and less. According to analysts, we are getting closer to the critical point, and the goal of our company is to turn this process into reverse. So we are working in relevant areas, such as tuberculosis, cancer, diseases of the female reproductive system.
So the innovative way of pushing us an awareness of their mission and the instrument of its implementation — is innovation. In generics is also nothing wrong with that. But it is a product of today. For example, the efficacy of antibiotics every day falls because pathogens occurs stability thereto. So you need to move on, to look for new drugs.
What kind of bumps in cooperation with the state you have mentioned?
— First, there is a money conflict: how much the government spends on health and medicine. By 2015, the cost will be reduced to 2.7% of the budget (383 billion rubles). The officials themselves admit that this is not enough, but in the current economic situation can not al
locate more. Compared with the U.S., Canada, European countries account is not in our favor.
Then, there are big problems in the structure of health care. The legal framework in recent years, is undergoing some changes, but the law is not always in harmony lies on the practice, there are contradictions that an adverse impact including patient. As one example: the state has set limits on the list price VED. Initially, the idea is correct: the government should be involved in the regulation of prices, as it pays for these drugs. But now it has become very profitable manufacturers make cheap drugs. For example, a drug listed price 40 rubles. But the market — an open system that came cheap manufacturer — from India or China — and started selling for 15 rubles. Because of it the next year the maximum allowable price falls to 25 rubles. So it may gradually decline, and many businesses are now saying that it is unprofitable to produce such drugs. That is, if a company wants to dominate the market, sacrificing for this big profits — it can easily achieve this. This is a known tactic practiced by our and foreign companies. And it turns out that the state, being the major player, is still unable to fully control the process. Now this is a lot of talk in the law on public procurement changes are planned. For example, a 94-FZ of now there is no idea of quality control. Why do so many manufacturers, especially Asian, allow themselves to fall so low in price? They save on quality. As a result of drugs entering the market, displacing uncontrollably quality but expensive food. Who suffers as a result? If closed, several companies, that's okay — we have and so the country has at least judging by the license, a 300-350 industrial enterprises. A patient who, say, does not suffer from the most severe but chronic disease will be treated ineffective medicine. Undertreated disease becomes more chronic phase. It is possible that the patient will become invalid. As a result, the age of legal capacity, as a rule, in 40-60 years, we get a bunch of people with chronic sores, depression, do not work or work badly, which is not a creator, and a burden for the state.
We very much hope that in the near future in the law on public procurement will be amended to quality control and anti-dumping mechanisms.
On the question of support for Russian manufacturers: how do you think they should be defined?
— Most likely, when the determination will be introduced in 2013 or 2014, the Russian producer would be the only one who makes preparations for the full cycle of the substance, and not only engaged in the packaging. We, as a member of the Association of Russian pharmaceutical producers are actively involved in the legislative process, and I absolutely agree with this definition, even though our company is working on superpolnomu cycle of substance we produce ourselves, have full responsibility for the quality of the product.
What prevents foreign producer to put the plant here and get the same preferences?
— Plant a complete cycle is quite expensive, depending on the profile of — 20 to 100 million dollars, whether such an investment is justified? Look for a business of any representative of the World "bigfarmy." It may be that the Russian market in total sales is only 5-7%.
Next, who will work at the plant? We do not have experts who know how to work on the standards of GMP. They need to grow up first. This is one of the major problems that arise in connection with the transition in 2014 to the international standards. Therefore, foreign manufacturers have already easier for well-functioning facilities anywhere in Slovenia and China slightly increase production, and here to deliver low-cost packaging line, from where the workers do not need special skills, which do not have high requirements for clean rooms and so on. I would be in their place, doing the same thing.
And thus, they are considered by Russian producers?
— So far, yes. So now we have a conflict. We uphold its definition of the Russian manufacturer, realizing that for us foreigners — main competitors.
How do you solve a problem with the staff for GMP-production?
— The problem with the staff was and is. Educational institutions have not yet had time to react to it. And it's risky from the student to take people at once and throw them into production. But for the young people we look, for example, recently flew to Kazan for pharmaceutical Olympics selected to his most promising professionals. On the other hand, we hold constant staff training, professional development, and not only in Russia.
How will the pharma industry to join the WTO?
— I can not say. But without a problem will not do. Recently, there was a revealing story with patent infringement of our foreign colleagues in one of the drugs. The government procures generic drug, which has not yet ended the patent protection period. It can probably do if you are in the area of economic boycott, like Iran, which is no other way out, because he does not sell anybody anything. But we consider ourselves a civilized country. We joined the WTO and should take into account the rights of ownership to someone else's product.
How do you work with foreign partners?
— We already have significant experience in working with foreign companies. Research project to evaluate the effectiveness and safety of a number of our developments we order there. Because the quality of work of our colleagues here I already do not like something and then have to redo, and the price "they" even cheaper. Also, we are talking about orders for production. For some items, I do not see the need to build another plant — the way of local production and preferences — the more so that the drug is not necessarily then sold only in Russia.
What are your future plans?
— We will be expanding — produce not only drugs, but also medicinal cosmetics, veterinary pharmaceuticals, biotechnology Let us in science. Plus, we will develop a distribution sector.