Innovative Russian medicines: we are waiting for you…
The Russian pharmaceutical market is waiting for innovations no earlier than 2018Irina Vlasova, GZT.RU
The creation and introduction of innovative medicines to the market in today's Russia is impossible without Western partners, but foreigners do not consider Russians competitive in this area.
It is hardly worth waiting for the mass appearance of innovative domestic medicines in pharmacies before 2018.
More and more Russians are dying of diseases and fewer of our compatriots are being born, on average Russians live less than citizens of civilized countries for more than 10 years.
The population has a lot of complaints about healthcare, and the technologies at most domestic pharmaceutical enterprises are far behind foreign ones. According to Roszdravnadzor, out of 400 manufacturers, only 56 have sites that meet European production standards.
Modern, innovative Russian medicines should stop the process of population extinction. To create them in Russia and provide them with a 50% market share by 2020 - this task was set by the country's leadership back in 2008.
Several venture funds, RUSNANO, other specialized specialized organizations and departments, as well as several dozen companies began to implement it. Now, at the First International Forum of the Adam Smith Institute "Development and production of innovative drugs in Russia", which began on November 17, experts made the first forecasts and assessed the processes taking place in the domestic pharmaceutical industry and in the pharmaceutical market of Russia as a whole.
The share of innovations in the pharmaceutical market of the Russian Federation. Source: CMI "Farmexpert"
What is needed?
To obtain a state-of-the-art medicine, we need ideas, normal state regulation and society's need for the drug (willingness to buy it), as well as modern production, modern trained personnel and financial resources.
Can Russians compete with their Western counterparts in this area today? Harry Sven Krishnan, CEO of Novartis Pharma Innovation company, answered this question evasively, but the media perceived it as negative.
There are ideas, but they are old
Vsevolod Tkachuk, Dean of the Faculty of Fundamental Medicine of Lomonosov Moscow State University, told about the presence of hundreds and even thousands of ideas that were developed 15 years ago and can be implemented into new medicines. According to him, "dozens of institutes of the Russian Academy of Sciences conducted screening of tens of thousands of candidate molecules for drugs," there are already real developments in gene therapy, in the field of growing skin cells, liver, vessels for the regeneration of patients' organs, which have reached the clinical stage of research. But scientists at the institutes of the Russian Academy of Sciences do not have the finances to implement ideas, they cannot interest business, and business itself does not go to scientists, Tkachuk complained.
What does the business think about this? "When an idea is brought to us, we first of all look at how much it is protected by a patent," Oleg Korzinov, Director of Innovative Development at the HimRar Center, told reporters. "Unlike our Western colleagues, whose ideas are first protected and then published, our scientists publish their results first."
It is clear that a reasonable business with this approach will not invest in new drugs: it takes at least 10 years and $ 22 million to develop and bring the drug to the market, and competitors can overtake an investor expecting a return on future sales of the drug in a couple of years.
In addition, to create innovative drugs, trained entrepreneurs and scientists are needed "in a modern way", said Andrey Ivashchenko, director of the HimRar High Technology Center, adding to academics that "energy decreases with age" and "hungry youth should be in command."
There will be no way out into the world without partners
According to Tatiana Nikolenko, Director of Infrastructure Programs at RUSNANO, there are many people who want to receive state investments for their pharmaceutical projects. 1,818 applications were submitted to RUSNANO, but the absolute majority of them do not meet the criteria under which the state is ready to invest in the project: scientific justification of new technologies for the production of medicines and the availability of the author of the application for the possibility of real production – a production site and personnel.
The Russians have their advantages in a number of positions, Nikolenko noted, but still Russian developers will have to focus on world manufacturers and cooperate with them, possibly abandoning the "Napoleonic plans" for this. She confirmed that if they "receive an interesting project, they first look for a Western partner who can evaluate the innovation," because this means that there will be an international license.
This may include, in particular, the creation of Russian "delivery vehicles" in the patient's body of a promising molecule already available to the Western partner, explained Gennady Shirshov, executive director of the Union of Russian Pharmaceutical Manufacturers (SPFO).
A private foundation will think 10 times
Private investors conduct no less rigorous selection of projects. Among the proposals they receive, there are both their own developments of Russian scientists, and contract research on the proposals of Western partners, as well as Western developments that lose patent protection. They are usually transferred to Russian partners for better competition with analogs (generics) already available on the market, said Alexey Konov, Investment Director of the Bioprocess Capital Ventures venture fund. According to him, one of the pharmaceutical clusters for the creation of new drugs will be created on the basis of the Moscow Institute of Physics and Technology.
In addition, according to Konov's forecasts, the source of the appearance of new developments in the Russian Federation will be Western research, stopped for various reasons, and in a year Russia will hear about many new similar developments, since they need to invest less in them than in creating a drug "from scratch" (only $ 5-10 million): it happens that part of the research has already been carried out, and drug trials on volunteers have already begun.
According to Konov, their foundation received applications from 600 scientific groups. 65 projects were considered in detail, and 15 of them were financed, and the amount of investments ranged from $ 250 thousand to $ 2 million.
New products need demand
To the question of how many original domestic medicines have been developed in recent years, Gennady Shirshov explained that in 2009 the number of clinical trials of medicines doubled compared to 2008, the path from the development of a molecule to getting a drug into pharmacies takes at least 10 years, so that new domestic ones enter the Russian market widely medicines can be expected no earlier than 2018-2019. Gennady Shirshov added that he does not remember that Roszdravnadzor in recent years registered drugs with "nanosupposing".
According to Ivan Glushkov, head of the Corporate Development Department at STADA CIS, about 20 domestic developments have been brought to the Russian market over the past three years, "although this does not mean that they will linger on the market, since they should be in demand."
What is promising?According to the Research Institute of Public Health Development, cell preparations based on immunocompetent cells, therapeutic antibodies and their fragments obtained by protein design methods, targeted pharmacotherapy, biosensor technologies are promising.
According to the director of the Research Institute Yuri Krestinsky, gene therapy preparations, genetically modified stem cells producing therapeutic proteins, personal cellular preparations are no less interesting. We can expect the appearance of highly specific drugs for immunotherapy, as well as for early immune diagnosis and correction among the novelties.
Development of innovations in biotechnologies. Source: Research Institute for Public Health Development
Directions of innovation development in the pharmaceutical market. Source: Research Institute for Public Health Development
In general, according to the forecasts of the CMI "Pharmexpert", by 2030 the volume of the pharmaceutical market in the Russian Federation may amount to $ 100 billion.
At the conference, new domestic oncological drugs with "targeted" delivery were presented, that is, the delivery of a molecule to a specific part of the body (their Western analogues were developed 20 years ago, but are still too expensive); new thrombolytics for the treatment of stroke, as well as technologies for growing skin cells, cornea of the eye, liver cells for transfers. The needs in the Russian Federation for such drugs are huge.
Problems
Experts refer to the general trends in the pharmaceutical market as a "drift" from individual therapy to standardized medicine and only then a return to personalized medicine, "and personalized medicine is an expensive approach," says Vitaly Omelyanovsky, director of the Research Institute of Clinical and Economic Expertise and Pharmacoeconomics of RSMU.
"In addition, there are no patient registers in Russia, and there is no understanding of the real cost of diseases," he notes. Omelyanovsky complained about the low availability of information about new medicines to patients. In addition, in his opinion, Russians today are not ready to pay for a new medicine if it is just about the convenience of taking the drug.
Experts believe that for greater efficiency in the creation of new drugs, it is necessary to identify key areas where there is potential for the creation of drugs, do not hesitate to use imported developments, acquiring licenses from Western scientists, create a unified training base, which today does not correspond to the world level of training of chemical scientists.
Experts speak not only about the lack of a common guideline for the development of the industry (the Concept of Healthcare Development has not been adopted), but also about absolutely ineffective programs for replacing the cost of medicines for Russians.
According to VTsIOM estimates published a week ago, up to 88% of the cost of medicines Russians pay out of pocket. For the absolute majority of the population, even conventional modern drugs are not available, not to mention innovative expensive medicines. The population buys cheap drugs, most patients no longer have to think about their quality and safety.
In order for business to start producing innovative drugs, according to Larisa Popovich, Director of the HSE Institute of Health Economics under the Government of the Russian Federation, real demand is needed, and there will be no demand without targeted state programs to compensate the cost of medicines for the entire population, similar to those working in developed countries. Today, such programs in the Russian Federation are fragmented and ineffective. "If the situation does not change, the population of the Russian Federation will halve by 2050," Popovich said.
All experts agreed that the vector of development for domestic companies was set correctly, and that there will be reports on achievements, of course, but whether innovative Russian drugs will actually appear in sufficient quantities is a big question, even in developed countries the number of innovations has been declining in recent years.
Portal "Eternal youth" http://vechnayamolodost.ru18.11.2010