24 June 2009

Seriously ill pharmaceuticals

How to cure Russian pharmaNatalia Bykova, STRF.ru
"There is no need to build illusions that the pharmaceutical market will be opened to domestic drugs just like that, where competition is very strong.

The organization of any pharmaceutical production in the country receives tremendous opposition from all sides, which probably have their own interests in ensuring that the market situation does not change," said the director of the I.Y. Postovsky Institute of Organic Synthesis, academician Valery Charushin in an interview STRF.ru about the prospects of promoting Russian developments in pharmacies and clinics.

Among the developments of the I.Ya. Postovsky Institute of Organic Synthesis are the first domestic synthetic antibacterial drug "sulfidin", the anti-tuberculosis drug "larusan", the antitumor drug "lysomustin", the antiviral drug "triazavirin", the anti-inflammatory drug "silativit", cardiotropic substances and radioprotectors.

Valery Nikolaevich, which of the results of recent research by scientists of the Institute can become the basis for the development of new drugs?– First of all, it is necessary to mention the work on the creation of the anti-inflammatory agent "silativit", cardiotropic substances and radioprotectors, which we must basically complete within the next two to three years.

In particular, we are at the final stage of preclinical study on Silativit and have prepared documents for the Federal Service for Supervision of Healthcare and Social Development. In parallel, work is underway on the use of the drug in veterinary medicine. Tests carried out in a number of livestock farms in the Sverdlovsk region have shown the high effectiveness of this tool. In accordance with the recommendations of the Ministry of Agriculture of the Sverdlovsk region, more extensive tests will be carried out in the very near future, which will allow to assess its economic effect (approximately it leaves 9 rubles for 1 ruble of costs).

Among the completed projects is the creation of a class of biologically active substances that affect the functioning of the cardiovascular system, in particular, lowering blood pressure, having very good antiplatelet properties. The original structure of this class of substances gives them advantages over already known medicinal compounds of the same plan due to an unusual combination of pharmacological properties, but there is still much to be done, since the preclinical study has not yet been completed.

Technologies for the production of two original medicines – antiviral "triazavirin" and antitumor "lysomustin" are also waiting in the wings. Experimental and technological regulations have already been prepared and approved for them, experimental batches of substances have been developed. Preclinical trials and the first phase of the clinic have been successfully conducted for triazavirin; lysomustin has already been approved for medical use for two indicators and is undergoing clinical trials to expand the spectrum of action. Initially, it was assumed that it would be effective only in the treatment of lung cancer and melanoma, but during clinical trials there were grounds to believe that lymphomas and brain metastases also fall within the scope of the drug. According to our calculations, the drug "lysomustin" can provide import substitution for a significant number of foreign analogues, such as "nimustin" (Japan), "zanosar" and "karmustin" (USA), "mustophoran" (France), etc., due to the significantly lower cost of the course of treatment of patients. In addition, the use of "lysomustine" will improve the methods of drug treatment of tumors, increase their effectiveness and reduce the side effects of antitumor chemotherapy.

Domestic drugs are cheaperWhat is missing in order for the original medicines created at your institute to appear in domestic clinics and pharmacies?

To achieve success in the commercialization of pharmaceutical developments, we need a strong and reliable partner in the person of an interested pharmaceutical enterprise, capable not only to establish the production of substances and finished dosage forms, but also to overcome all bureaucratic obstacles and overcome the costs associated with the organization of clinical trials, registration of drugs and their positioning on the market.

Today, the Institute has such a partner in the face of the dynamically developing plant "Medsintez", which is part of the medical holding "Juno". This company is engaged in two of our drugs – "lysomustine" and "triazavirin".

The industrial release of lysomustin is planned on the basis of Medsintez, which this year is implementing a pilot batch of the drug in the amount of 2 thousand doses (1.5–2.0 million rubles). However, market analysis has shown that the organization of mass production of only one "lizomustin" is economically unjustified due to the fact that you will have to invest a lot of money in the organization of a new production site - everything is considered there – energy, equipment, employee compensation. It will take quite a long time until it all pays off. Therefore, the plant plans to create industrial facilities for the production of a whole line of antitumor drugs – both our "lysomustin" and generic cytostatics. Production facilities with an area of 3000 sq. m. have already been prepared. design work on the organization of production has been completed and started, the possibility of implementing "lizomustin" in Russia and CIS countries is being studied.

It has already been calculated, what are the needs of the intended sales markets?In terms of prevalence, oncological diseases are in second place after cardiovascular diseases.

Thirty percent of male smokers suffer from lung cancer; up to seven thousand newly diagnosed skin cancer patients are registered annually in Russia. There is a need for "lysomustine", especially considering that it costs an order of magnitude cheaper than imported analogues. In addition, as I have already said, it is possible to expand the clinical indications for this drug, and therefore increase the market volume. So far, the approximate market estimate is 10-20 million US dollars.

Of course, we have no illusions that our drug will just open the market for antitumor drugs, where competition is very strong. The organization of the production of any drug in the country receives enormous opposition from all sides, which probably have their own interests in ensuring that the market situation does not change. It took the intervention of high-ranking officials before the same "Medsintez" began to produce insulin, and not domestic, but on the basis of an imported substance. An administrative resource plays a very important role in this issue.

For national security, in the interests of the development of domestic production, of course, it is very important to change the situation on the market in favor of the domestic manufacturer of medicines. And what is the meaning of the import substitution program for a simple consumer of pharmaceutical products?First of all, our medicines should be cheaper, since the cost of foreign medicines includes their delivery, more expensive energy and labor.

Secondly, sooner or later the consumer will feel the negative effect of the great dependence of domestic medicine on foreign suppliers. If there is no production of certain medicinal substances in the country today, it means that tomorrow we will not be able to produce more advanced analogues of this substance on our own. Thus, we condemn ourselves to lifelong addiction. What if millions of packages of some modern product are needed tomorrow, and we don't have a single factory that produces at least 100 packages. If we can't produce ten tons of a certain drug, let's buy nine tons somewhere and make one ourselves. With this approach, in an emergency, even if we invest a lot of money, we will still be able to quickly deploy the necessary production.

Strive for Western standardsWhat are the sources of research funding?

How, in your opinion, is it possible to optimize the system of financial support for scientific organizations engaged in the development of new medicines?In addition to the basic budget financing of the Basic Research Program, we have a series of grants from the Russian Foundation for Basic Research, as well as funds received on a competitive basis under the Federal Target Program "Research and Development in Priority Areas of Science and Technology for 2007-2012".

The Institute has won several lots of the Ministry of Education and Science in the priority area of "Living Systems", both research and technological. Thanks to the tangible financial support of the Ministry of Education and Science, a modern technological site has been created in the IOS of the Ural Branch of the Russian Academy of Sciences, including a flexible multifunctional synthetic complex, on which the parameters of technological processes for the synthesis of substances "triazavirin" and "lysomustine" have been worked out.

As a result of the pilot project on the introduction of the scientific performance indicator, the RAS has a relatively good level of remuneration for scientists. The main financial difficulty today, rather, is the lack of funds for the development and renewal of the material and technical base in the broad sense of the word, in particular, for the overhaul and reconstruction of buildings and structures, technical equipment and re-equipment of institutes and universities, the creation of not only "clean", but also technologically advanced laboratories in them. Today, there are other standards of information and engineering support for research in the world, and this primarily concerns areas related to natural science and technical sciences.

For example, I was at Oxford University, which, like our MSU, is located among lawns, has beautiful architecture, centuries-old history, etc. But next to the old buildings of Oxford, a new one has been built, with completely different principles laid down in the design. The modern building is divided into clean and technological rooms, has a very powerful ventilation system and pipelines supplying technological rooms with compressed air, nitrogen, carbon dioxide, etc. They do not carry gas in cylinders on marble stairs, it is supplied either through pipelines, or also in cylinders, but by special elevators. Liquid nitrogen is produced directly in laboratories using special devices.

If, for example, an employee needs to carry out some kind of chemical reaction, then, after performing preparatory operations, he turns on the installation, sets the necessary parameters and goes to drink coffee in a room that is specially designed for such breaks - there you can meet professors, employees of other laboratories, talk with them on professional topics. During this time, the reaction is completed in the laboratory, the scientist remains to see the results of the experiment on analytical equipment, which, which is also very important, is located in a room connected to a synthetic laboratory. In addition, they have rooms for conducting experiments at night, equipped flawlessly from the point of view of fire safety. You can set the reaction for the night, and go home quietly, whereas in Russia even the thought of it is actually a crime. It is important that everything is thought out to the smallest detail in the organization of work, as a result, every detail increases the productivity of scientists several times.

Of course, the process of upgrading laboratories costs both money and time, but in principle, as Western practice shows, everything is solvable. The new Oxford building, which I told you about, was built in just two years, the money for this, several tens of millions of pounds, was allocated by order of the Queen of England.

Who do you think should be the customer of scientific research on the development of new medicines?Giving advice on the reorganization of the management sphere is a thankless task, especially since Viktor Stepanovich Chernomyrdin's rule applies in Russia: "we wanted the best – it turned out as always."

In my opinion, elements of state regulation are needed in this area, such as, for example, a guaranteed order for the production of domestic substances of vital drugs. Who exactly should form this order? I think it depends on the stage of drug development. The initial, so-called fundamental stage, should be supported by the state within the framework of academic, university programs, grants of the Russian Foundation for Basic Research or Rosnauki. The Ministry of Health and Social Development needs to know the need for medicines that are vital for Russia and build its policy based, at least in the future, on domestic drug manufacturers. Rosnauka should provide expertise and scientific and technical support of projects by placing orders on a competitive basis. The next stage is the technological development of the drug, preclinical and clinical trials should be provided by the state (Ministry of Health and Social Development and Rosnauka) and business. In my opinion, this partnership is justified, since it allows each of the parties to minimize the risks that exist until the drug is in the pharmacy network.

The idyllic picture familiar to Western countries, when pharmaceutical companies are constantly thinking about tomorrow, creating and supporting their research units, investing substantial funds in them, sponsoring scientific conferences, striving to find innovations that can lead to the creation of original medicines, unfortunately, is still very far from Russia. Despite the fact that the domestic pharmaceutical market has been steadily growing in recent years and our drug manufacturers are showing signs of interest in scientific developments, nevertheless, the Russian pharmaceutical industry will not develop without the participation of the state in this process.

Portal "Eternal youth" http://vechnayamolodost.ru/24.06.2009

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