22 June 2009

Russian biopharmaceuticals: until the thunder breaks…

Genetic engineering in a farmless stateNatalia Bykova, STRF.ru
Does Russia really need a big trouble to understand how important it is to have its own pharmaceutical industry?

– notes the deputy director of the Institute of Bioorganic Chemistry named after M.M. Shemyakin and Yu.A. Ovchinnikov of the Russian Academy of Sciences (IBH RAS), Academician Anatoly Miroshnikov. After the tragedy in Beslan, Miroshnikov managed to secure funding for the development of a new effective hemostatic drug, it was created, but it never reached production. There are other technologies ready for implementation in the institute's portfolio. But who will make the medicines?

The M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences has ready-to-implement developments of human albumin, some blood factors and enzymes, on the basis of which antiviral and antitumor drugs can be created. Also, scientists of the Institute have developed a new analogue of insulin, which has a faster and prolonged effect. Of the technologies that have entered the market, the first domestic insulin and growth hormone.
Miroshnikov Anatoly Ivanovich, Academician, Deputy Director of the M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences, Chairman of the Presidium of the Pushchina Scientific Center, Vice-President of the All-Russian Public Organization "Yu.A. Ovchinnikov Society of Biotechnologists of Russia.

Biotechnology Corporation and the Pushchino PlantAnatoly Ivanovich, IBH RAS is one of the academic institutes whose developments have already been presented on the domestic pharmaceutical market.

Does this mean that the main task of the "Pharmaceutical Industry Development Strategy 2020" – import substitution of medicines – is gradually being solved?– I would say that we are moving along this path, but we are still very far from even 50% import substitution of medicines.

Today, most modern drugs are genetically engineered, and in this respect Russia has hopelessly lagged behind the leading scientific powers, because for a long time, 25 years, fundamental science was not funded in the country. Only relatively recently, Rosnauka began to allocate grants for the development of fundamental research, with the condition that in the future they will have some practical application. The process, as they say, has started, but I personally do not believe that the long-term gap will be overcome before 2020.

In this sense, the experience of IBH RAS in the production of insulin is also indicative. In 1978, when the era of biotechnological production began in the world pharmaceutical industry, our institute also began to work quite successfully in this direction. By 1990, just three years after the launch of the production of genetically engineered insulin in the United States and Denmark, we received a strain-producer of this drug and began semi-production studies at the Stepnogorsk Biochemical Plant in Kazakhstan. The lag from the West was minimal at that time. But after 1991, everything "died". Science and the chemical industry in Russia were on the verge of survival, and the pharmaceutical market, including the insulin market, began to be divided by Western manufacturers. Only in 2000, the Mayor of Moscow, Yuri Luzhkov, issued an order to create a pilot production of genetically engineered insulin on the basis of the IBH RAS, and three years later we began to supply the medicine to Moscow clinics. Doctors admit that it is not inferior in quality to foreign and at the same time has a lower price, but we cannot expand production to serial production, because drug flows to clinics and pharmacies have been formed for a long time, and no one wants to let new players into the market. The fact that our drug is not inferior in quality and wins in price does not play a decisive role. The main thing here is well–established ties, with strong roots, perhaps a tradition of kickbacks. As a result, 90 percent of the domestic market of genetically engineered human insulin belongs to American and Danish manufacturers.

Are you doing something to change this situation, or, in your opinion, is it already useless?– Over the past four years, I have been fighting for the construction of a serial plant in Pushchino.

It would seem that the issue has almost been resolved – by a decree of the Government of the Moscow Region, on the initiative of the Russian Academy of Sciences and IBH, JSC "Bioran" was created, which should lead a project to create an industrial production of genetically engineered medical drugs; we were even allocated a construction site. But, unfortunately, a crisis broke out, and Bioran did not receive a loan. If the state had provided a refund guarantee, there would have been money.

Our state believes that only private capital should act as an investor, and private capital, as you know, does not like to invest "long money", because it can in a shorter period, with much less effort, get a hundred and two hundred percent profit. Therefore, there is virtually no pharmaceutical industry in the country. In the best case, domestic enterprises pack and sell Chinese or Indian substance "not the first scientific freshness" under the Russian brand.

All our letters to various authorities, conversations about the fact that the lack of our own pharmaceutical industry threatens national security, lead to nothing. Is the construction of a biopharmaceutical enterprise an unsolvable problem for the state? No, it's just that no one takes responsibility for the final result, for entering the drug market. As a result, almost all new drugs ingloriously complete their journey at the stage of development funded by Rosnauka. Previously, at the exit from the laboratories, they were picked up by the Ministry of Health, then the Ministry of Industry, now this chain is broken. Everyone relies on private capital, whose attitude to long-term projects I have already mentioned. It turns out that we have capitalism, as it were, and as if it does not exist.

What do you think the state should do? Restore the Rosnauka – Ministry of Health – Ministry of Industry chain? Somehow oblige private capital to invest in domestic pharmaceutical production?– I believe that during the transition period, while private investors are afraid to invest in the production of domestic medicines, it is necessary to create a state corporation of biotechnologies.

The nanotechnology corporation allocates money for projects to create solar panels – I'm not a big expert in this, but, in my opinion, such initiatives have no end or edge. According to biotechnologies, we can definitely say what the return on investment will be in one year, two, three, ten years... This is quite predictable. But in order for this direction to move forward, the state must share risks with private investors. Otherwise, we will just stand still.

It is necessary to preserve plants, not technologiesDoes IBH RAS have developments ready for implementation?

– We have ready-made developments of human albumin, which forms the basis of blood plasma, some blood factors, and a number of other enzymes on the basis of which antiviral and antitumor drugs can be created.

In addition, a new technology has been developed for obtaining an insulin analog – it acts faster than usual and its effect is prolonged, but this technology is not yet ready for implementation, since the patents of foreign developers for similar forms of insulin have not expired. As soon as these patents become obsolete, we will launch a more modern insulin into production, maybe in cooperation with the CIS countries. Of course, we are ready to transfer other technologies for the creation of medicines developed at IBH RAS to interested enterprises.

Of the developments that have entered the market, it is worth mentioning insulin, which is produced at the pilot plant of our institute, and alpha-2-interferon or growth hormone, which is produced by Pharmstandard. The fact that Pharmstandard has taken our technology for producing human growth hormone into production is an exceptional case, but it confirms that our drugs are effective and in demand. Growth hormone successfully treats dwarfism, which is well diagnosed at an early age, and today the number of people with this disease in Russia has decreased by an order of magnitude.

But analogues of these drugs are already on the world market. Why spend so much time, effort, money on development, testing, organization of production and bringing to market something that is much easier and cheaper to buy? Do you not share the position of those who advocate the benefits of generics?– No matter how scary it sounds, but Russia, apparently, needs a big trouble to understand how important it is to have its own pharmaceutical industry with a full cycle of creating at least vital drugs.

This is necessary to ensure the national security of the country. Imagine if the supply of insulin from abroad suddenly stops - the lives of hundreds of thousands of people with diabetes will be at risk. It seems that this will never happen? But we have already received similar lessons. The development of the 7th blood factor, which stops bleeding, began only after the tragedy in Beslan. The director of the Hematology Research Center of the Russian Academy of Medical Sciences, Academician Andrey Ivanovich Vorobyov, called me and said that we could not save many of the wounded precisely because of the lack of this drug. Russia receives it from Denmark, but it is too expensive and is purchased in small quantities, in emergency cases it is simply not enough. In the hope of getting funding for the development of the "7th factor", Andrei Ivanovich and I went to the Minister of Education and Science Andrei Alexandrovich Fursenko, and he supported us. We received money and created a strain-producer of the drug. Now it is necessary to conduct its preclinical tests, but there is no money for these purposes anymore.

It turns out that developers are being ordered drugs that obviously have no chance of advancing even to the stage of preclinical trials, not to mention the market stage...– It is also necessary to develop drugs to maintain a high level of scientific research in the country.

I think Rosnauka is primarily concerned about this. If something suddenly happens - I am skeptical about the hysteria around swine flu, but there can be any epidemic – we will still be able to deploy our own production of medicines fairly quickly, even at the cost of large financial investments. Although ideally such production should be created before the problem arises. The Japanese, for example, built a plant for the production of genetically engineered albumin with a capacity of 40 tons per year, and preserved it until they needed a large amount of plasma at once.

Can the institute, to begin with, follow the path of creating experimental productions of already developed drugs, that is, do the same as with insulin?– Frankly speaking, production is a burden for the institute.

Twenty years ago, I could not have dreamed in a terrible dream that I would be engaged not in science, but in production issues. But using the example of insulin, we proved that the Academy of Sciences is able to complete the project to create a drug, starting from basic research and ending with the delivery of the development to the pharmacy in the form of a drug. But we will not be able to produce the entire line of drugs on our own, because the main task of the Academy of Sciences is to develop fundamental research, on the basis of which promising medicines are created. As I have already said, for this purpose it is necessary to build a plant in Pushchino (and apparently not only there), where there are conditions for the development of the biopharmaceutical industry: seven specialized institutes in physico-chemical biology, two universities, an experimental base with an international certificate. Insulin, interferon, blood factors, and many other drugs could be produced there.

Breakthrough direction – blood componentsWhich areas of biotechnology development will be the most breakthrough in the coming years?

– The Institute of Bioorganic Chemistry of the Russian Academy of Sciences, as well as other academic institutes, has quite a lot of developments on the basis of which medical preparations, including original ones, can be created.

It's too early to talk about them.

The most breakthrough direction, I think, is blood components. Do you know who donates blood here? Homeless people and alcoholics who can be infected with AIDS, hepatitis, anything. The blood control system is imperfect, besides, there are several forms of hepatitis that are not yet identified. The whole world is following the path of creating genetically engineered blood components. The Japanese are already launching the production of genetically engineered albumin. We also have it, while it is still under development.

Then, with the development of genomics and proteomics, technologies for the creation of drugs for the treatment of certain, mainly rare diseases will arise every year.

Another promising direction of pharmaceuticals is monoclonal antibodies, which in small doses, literally with one injection, treat very serious diseases. Russia buys in small quantities the Western anticancer drug "Herceptin", which has a very powerful effect. But in our country, unfortunately, work in this direction has not even begun.

Portal "Eternal youth" http://vechnayamolodost.ru/22.06.2009

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