Andrey Ivashchenko: Russian pharmaceutical companies has the competence to create and produce its own innovative medicines
Over the past decade, domestic pharmaceuticals have made a huge leap. But even more ambitious goals are set for it in the Pharma-2030 Development Strategy. How the leading companies in the industry plan to achieve them was told to “RG” by the Chairman of the Board of Directors of the ChemRar Group, Doctor of Technical Sciences, Professor of the Russian Academy of Sciences Andrey Ivashchenko.
Andrey Aleksandrovich, in your opinion, is it possible to achieve Russian sovereignty in innovative pharmaceuticals? If yes, then due to what?
Andrey Ivashchenko: Issues of technological sovereignty are regulated by the Concept of Technological Development until 2030, which the government approved in the summer. Within the framework of this document, the concept of critical technologies is introduced. Pharmaceuticals are included in this list. Of course, advanced technologies can be bought, but it is not the technology itself that is important, but the line of its further development in order to reach the next technological level. Otherwise, it will become outdated, and you will have to buy a new one again. This shouldn’t happen. All critical technologies must not only be their own, but also have development lines under them: a pilot industrial site, a central factory laboratory, an applied institute that develops such technologies, and finally, fundamental science that supports the work of applied ones.
Is our business able to cope with this task on its own or does it need government support?
Andrey Ivashchenko: We now have new factories in our country that can make any modern copy drugs (generics). We could produce modern innovative drugs if we had access to patents for them. But they belong mainly to Big Pharma — this is the USA and Western Europe, and no one will just give us these patents. And the generic manufacturing business is low-margin ; the profit from it is not enough for serious innovative developments. We have fundamental science, scientific traditions, new ideas arise, but beyond that there is a “valley of death.” Scientists do not have the money to bring their promising ideas to at least the first phase of clinical trials. And businesses do not have enough money to take these developments at an early stage and finance the further process. Only a few companies, like ours, lead development from the early scientific stages to drugs that are brought to market. But there are only a few such companies in Russia. And for innovative pharmaceuticals there should be dozens, if not hundreds. We need a balanced program of innovative import substitution, grants, so that scientists with their developments go further — conduct preclinical work and begin clinical trials.
Do we seem to have development institutions for this?
Andrey Ivashchenko: If there were, they would be used. Yes, there are cheap loans, but they are suitable for the construction of production. For venture projects they are almost absent. And the search for innovative drugs is a risk area. The only fund that was created by the Ministry of Industry and Trade and the Russian Venture Company about five years ago is very small; it financed literally three or four developments in the field of pharmaceuticals. In principle, it is necessary to recapitalize it and create new ones that will support projects in the first and second phases and bring them to the level where a pharmaceutical manufacturer is already involved. And now, due to the fact that there is no support, even promising developments do not cross the “valley of death”, remain on the shelf or go into articles that no one needs. Innovation in the field of living systems, the creation of new drugs, is the longest innovation process and the most expensive, since they must be tested on humans. To find a promising molecule and go through the first and second phases of the clinic, you need at least several million dollars and three to five years. Regulations should encourage such investments.
If Western sanctions suddenly become even tougher, and Big Pharma, contrary to its claims, leaves our market, what risks will arise for the healthcare system and patients?
Andrey Ivashchenko : If they stop supplying innovative drugs that are included in the standards of treatment, patients will suffer. In this case, there is only one solution — compulsory licensing. Then Russian manufacturers will make this drug, but it will take them a year or two. Of course, businesses need to be encouraged to carry out promising developments and have some kind of backlog so that in such a development of events they can quickly launch production. This would be the right decision, but a tactical one. Because this will still not create an innovative pharmaceutical industry; it will be the same generics, that is, copies. And we need a strategy. In order not to depend on imported supplies, we need to produce our own innovative medicines.
Yes, foreign pharmaceutical companies continue to supply drugs that have already been registered, but they have suspended clinical trials of new drugs that are now entering the US and European markets in our country. This means that we simply will not have the next generations of innovative drugs. And they are needed not just because it is something fashionable, like a telephone, but because resistance to existing drugs arises. And not only in the treatment of infectious diseases — AIDS, hepatitis C, influenza, coronavirus, but also severe non-infectious diseases — cancer, autoimmune diseases. Therefore, in addition to the need to deal with defects in existing drugs, we need to look at what innovative breakthrough drugs appear and make our own.
Is our pharmaceutical science and practice capable of creating such drugs? If it is able, why doesn’t it create it, and our unique medicines are unknown in the world?
Andrey Ivashchenko : Of course, they exist. But every developed market defends itself against others. Often an innovative drug is registered in Europe, but it is not allowed into the USA — they force a European company to move to America, register there, pay taxes there, and only after that it is allowed to introduce its drug to the American market.
But when force majeure occurs, as was the case with coronavirus, few countries were able to make their own vaccine, their monoclonal antibodies and their own antiviral drugs. But Russia did it. The pandemic has demonstrated that we have all the elements necessary to create the latest innovative drugs. The question now is to do this as normal, before another covid comes to us. Before the next covid comes, we need to rebuild our regulation , use resources not only to build factories, but also to finance new developments.
You gave an example of a breakthrough in our pharmaceutical science and practice in connection with the pandemic. But many still believe that Russian medicines cannot be trusted. Why do you think?
Andrey Ivashchenko: To be fair, it must be said that this situation is changing. For example, we often invite representatives of the patient community to our plant and show the entire process, from the production of the substance to the packaging of the finished medicine. And when people see with their own eyes the work culture and the level of science, their opinion changes. Indeed, over the past ten years, we have built many factories that are better in terms of their level than many factories in foreign countries. Secondly, there is active propaganda of foreign Big Pharma . When a domestic innovative drug comes out and begins to displace a foreign one from some Baltic territories from the market, a bunch of publications appear in obscure publications that discredit ours. Moreover, the information attack has been going on for several months. But the situation is still changing. Now a competition is being planned among innovative Russian drugs, the best of them will be selected according to various criteria — experts will be from the Academy of Sciences, from the Ministry of Health. For our part, we are ready to cooperate and unite in this.
What innovative developments do you currently have in your portfolio?
Andrey Ivashchenko : For example , we produce a drug for the treatment of HIV, which has become the best in its class in the world, and we are squeezing out foreign competitors. But HIV is treated, as a rule, not with one, but with two or three drugs, and we are developing combinations with different mechanisms of action. We hope that in a year or two they will appear on the market and become the best in the world for treating HIV, including resistant forms. The result is developments for hepatitis C that will make it possible to compete with drugs from unfriendly countries, available only for a lot of money. At the same time, the substances for them will be completely domestic. This year, an effective innovative drug for depression, anxiety, and panic attacks, including those caused by Covid, was released. Compared to older antipsychotics on the market, it is not addictive and has no withdrawal symptoms. We are launching a whole series of innovative drugs for oncohematology and the treatment of autoimmune diseases. These are all innovative molecules, and we hope that within two years we will know how effective they are in the clinic. If everything is ok , we will ask for expedited registration so that they become available to patients as quickly as possible.
How is your company going to implement the Pharma 2030 program in terms of producing its own Russian substances?
Andrey Ivashchenko: All the drugs I’m talking about are and will be produced in a full cycle. Now our production of substances can no longer cope, so we are increasing it five times at once and launching new capacities at the beginning of next year.
How involved is your company in developing talent and new leaders for the pharmaceutical industry?
Andrey Ivashchenko: Searching for new molecules requires not dozens, but hundreds of specialists. We cooperate with many universities that train chemists, biologists, mathematicians, and physicists. In some places these are joint master’s programs, in others – internships. At Phystech we have a basic department where we train specialists in mathematical modeling of new drugs, analysts, and biostatisticians . We cooperate with the educational center “Sirius”, Moscow State University. Lomonosov. We support several startups in Skolkovo. We also have our own business incubator, where we finance youth projects in the field of living systems. If they are successful, they become separate companies. There are more and more guys who like to synthesize, work in laboratories, and create something real. The main problem today is that such a specialist must learn some subtle things in the “master-apprentice” mode. But we either have old laboratories or academic laboratories that have long gone into fundamental science, and there are not many applied institutes. But we really hope that the Concept of Technological Development will support development lines around leading universities, and the guys will have the opportunity in their senior years to study in real projects — pilot industrial, experimental design. New technologies and ideas appear where there are scientific schools. We have very strong mathematical, physical, and chemical scientific schools with centuries-old traditions. This is such a fertile environment, water it a little with living water and sprouts will immediately appear. This is what you should count on.
Source: https://rg.ru/