29 May 2008

Scientists from Pushchino revive domestic pharmaceuticals

Tablet in the "metal"Rafael Mardanov, Rossiyskaya Gazeta – Federal Issue No. 4670 of May 28, 2008

The Security Council of the Russian Federation instructed the government to develop and adopt a strategy for the development of the domestic pharmaceutical industry by October 1. What can be the contribution of Russian scientists to the implementation of this plan? The correspondent of "RG" talks about this with the chairman of the Pushchinsky Scientific Center of the Russian Academy of Sciences, Deputy Director of the Institute of Bioorganic Chemistry of the Russian Academy of Sciences, Academician Anatoly Miroshnikov.

Rossiyskaya Gazeta: Today they are talking about more than 90 percent of Russia's dependence on imported medicines. Do we still have a chance to change the situation?

Anatoly Miroshnikov: Undoubtedly there is, and in the most dynamically developing field – biopharmaceuticals, based on the achievements of biotechnology. They allow us to obtain medicines identical to the regulators and active substances that are produced by our body. There are already a number of genetically engineered drugs, where bacteria, yeast or animal cells, less often plant organisms, are used as producers of medicinal substances. Genetic engineering technologies are indispensable in the production of blood components. As you know, there is not enough donor blood everywhere. In addition, it is increasingly burdened with hepatitis, HIV and other infections. I'm not talking about the long-known antibiotics, vitamins, amino acids and enzymes created on the basis of biotechnologies.

And for the further development of biopharmaceuticals, fundamental work is needed primarily in the field of molecular and cellular biology, bioorganic chemistry, genetic and cellular engineering, photobiology and biophysics. Just where the institutes of the Pushchinsky Center have good results.

RG: Almost every institute engaged in fundamental science can report on the results. But few people have moved beyond this stage: lack of money, lack of branch science, shortage of personnel, etc. negate the efforts of scientists. In short, it does not come to innovation, it does not come to receiving goods.

Miroshnikov: The problems are familiar, but nevertheless we manage to innovate. A few years ago, RG reported that the production of domestic genetically engineered insulin was launched for the first time in Russia at the experimental production base of the Institute of Bioorganic Chemistry of the Russian Academy of Sciences. Today we are covering 14 percent of Moscow's needs for it.

Moreover, in Pushchino we are starting to produce drugs in a full cycle: from substances to ready-made dosage forms. In addition to insulin, at our institute and at several other Russian enterprises, growth hormone and an anti–leukemia drug, interferons beta and gamma, another anti-cancer drug and a genetically engineered blood factor are being produced or will soon begin to be produced from domestic substances. Each of them will cost 15-20 percent cheaper than foreign drugs of the same class.

At the initiative of the Russian Academy of Sciences and on the basis of resolutions of the governments of the Moscow region and Moscow, a plant for the production of genetically engineered drugs "Bioran" is being built in Pushchino. The total cost is more than three billion rubles. This is a multifunctional production with a constantly updated nomenclature.

RG: Who will supply equipment for this high-tech enterprise?

Miroshnikov: The technology of drug production itself is ours, but the project of the plant is made by a Western company, since there are no designers of such a profile left in Russia. The equipment is also imported, for the same reason. Moreover, there are no specialists in the country to work on new equipment. Again, we will cook abroad.

In a word, only science remains ours. And here we are definitely not lagging behind the West. Thanks to the high authority of the Pushchinsky Center, several hundred scientists trained by us work in the most prestigious laboratories in the world. But when we build the plant, I am sure that unique specialists will have incentives to do science in Russia, and some of those who left will come back.

RG: What should be the role of the state in the revival of the domestic pharmaceutical industry?

Miroshnikov: It's easier for a scientist to split a DNA molecule and insert the right gene there than to "collect" more than four dozen signatures under construction permits alone! And I also had to register new drugs, look for an investor, a place for a factory, executors of orders, etc.

Now about the position of the state. There are three ways to create a modern production in Russia. The first one is funded by private capital. But when investing money, he is not interested in infrastructure development, social sphere, personnel training. These problems will be the concern of the state for a long time. The second way is Western capital. Hopes are also futile: I do not know of any high-tech production that the West or the East would build in Russia. In the best case – "screwdriver technologies". There remains only the third way – the state. It can earn money if the mechanisms of public-private partnership begin to operate. The principle, as you know, is declared, but not implemented.

It is necessary to create a biopharmaceutical corporation in the country under the auspices of the state, which would focus on the production of modern substances using biotechnology methods. This structure should cover the whole range of problems from the development and production to the sphere of circulation of medicines, from the training of young specialists to their employment with the provision of housing. We still have competitive technologies for obtaining modern medicines that can be "wrapped in metal" by building biopharmaceutical plants.

A separate issue is distribution. Colleagues from Kazakhstan said: when a drug from abroad and locally produced compete at a state competition for the purchase of medicines, preference will be given to the latter. With one condition: its cost cannot be higher than the price of an imported analog by more than 20 percent. Think about it: not cheaper, but higher! This is how the state supports the activities of its own companies.

And with us – exactly the opposite. Here are some interesting figures. In the second half of 2005 alone, it was possible to save 300 million by replacing 5-9 names of imported medicines purchased under the DLO state program with domestic analogues. Not rubles, dollars. This is the approximate cost of a large modern full-cycle plant. These calculations were sent to the Ministry of Health and Social Development, but they did not wait for an answer.

Portal "Eternal youth" www.vechnayamolodost.ru29.05.2008

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