02 October 2009

And maybe their own peptides...

How the donkey "Mercedes" overtookSvetlana Sinyavskaya, STRF.ru
In Russia, it is possible to create unique medicines that are decades ahead of the development of foreign pharmaceutical giants, Professor Vladislav Isakovich Deigin, an employee of the Institute of Bioorganic Chemistry named after M.M. Shemyakin and Yu.A. Ovchinnikov, president of the Peptos Group of Companies, is convinced.

The Doctor of Biological Sciences is used to proving his beliefs in practice.

To love and numbOur body is surprisingly wisely arranged, I thought, listening to the story of Vladislav Deigin, Doctor of Biological Sciences, president of the Peptos group of companies, about peptides.

It is necessary to help bear the pain during childbirth (including the baby) – please, natural pain relief endorphin ("hormone of happiness"), which is released in large quantities in women in labor. The hormone oxytocin, which is actively produced in the female body at the time of the emergence of a new life and during breastfeeding, is responsible for stimulating the uterus during childbirth, for the rush of milk from nursing mothers, for the feeling of love and affection.

These "miracle workers" are called peptides in scientific language. Actually, these are the same proteins, but if proteins consist of a chain length (from fifty to several hundred) amino acids, then peptides are small fragments of proteins consisting of two and up to fifty amino acids.

Peptides are universal regulators of many processes occurring in our body. They are responsible for emotional reactions, anesthesia, sleep, sexual behavior, aggression, and so on. Peptides are also responsible for stimulating or suppressing immunity. It was these properties of peptides that Vladislav Deigin turned into medicines (he has been working with the immune system for more than 25 years). The drugs developed by him have been helping people for a long time and are decades ahead of the developments of foreign pharmaceutical companies.

Record-breaking "Timogen"Creating a medicinal product of an original peptide nature is not an easy and important scientific task.

Peptides are low-toxic, but they live in the body for a very short time (sometimes fractions of a second), constantly splitting until they disappear. With immunodeficiency, for example, it would be good to make sure that one or another peptide "lingers" in the body longer and does not bring undesirable side effects. Vladislav Deigin managed to create such a drug.

The notorious "Timogen" could be found on pharmacy shelves in many countries of the former USSR. "This is our first drug (already generic), it was developed by the IBH of the USSR Academy of Sciences together with the Military Medical Academy. It was the world's first synthetic immunostimulator, which was used for the Soviet Army, was used for submariners, nuclear power plant workers, in Chernobyl," recalls Vladislav Deigin. – The guys from the sunken submarine Komsomolets were also immediately injected with Timogen. There are a lot of interferons and other immunostimulants on the market now, but Thymogen has not lost its popularity either. In particular, because due to the lack of toxicity, it is allowed not only for children, but also for pregnant women."

However, this is not why we ventured to call "Timogen" a record. In the early 1980s, scientists of the USSR Academy of Sciences, together with military doctors, began to deal with the problem of immunostimulation with the help of peptide drugs. Already in 1987, the drug "Timogen" was created and sent for clinical trials, and in 1989 it was on the market. It took only six years from the idea to the market, and it was a world record.

There are more than 5,000 registered medicines in the world, of which only 1 percent are peptides and proteins. In 2004-2005, the American pharmaceutical market was estimated at 280 billion dollars, of which 28 billion were "earned" by peptides. In other words, each peptide-protein drug gives 10 times more income than a standard drug. For the whole history (information since 1946) The Soviet Union and Russia have created about 20 medicines, of which 12 are peptides, of these 12 three drugs were created in Peptos (this is 8 percent of the world's peptide drugs).

Two more drugsThe mirror image of "Thymogen" – "Thymodepressin" – suppresses the immune system (this is necessary for the treatment of various autoimmune diseases, such as psoriasis, atopic dermatitis, rheumatoid arthritis, some allergic reactions).

The first substance purposefully suppressing immunity – cyclosporine A – was discovered in the 1970s in Switzerland, but although this drug acts mainly on the immune system, it is so toxic that a person can die from side effects.

"We have been working on the creation of a drug that would suppress the immune system at an early stage (after the formation of stem cells) and would act almost without side effects for 12 years," says Vladislav Deigin. "And we managed to create the first and only immunosuppressor in the world, which is allowed for children from the age of 2."

The phrase "the first and only one in the world" is also applicable to the next drug developed by the Peptos group of companies – Stemokin. It has been developed since 2000, and was resolved in April 2009. "We have found a peptide that stimulates the development and improvement of the quality of stem hematopoietic cells, starting with the most naive stem hematopoietic cell. There is not even such a code in the structure of the Ministry of Health – a stem cell stimulator, so we registered it as an immunomodulator, but the instructions say that the drug acts through stimulation of hematopoietic stem cells, – says Vladislav Deigin. – Canadians, Germans, Indians are interested in the drug. As a result of research that has been going on for almost a quarter of a century, we have a unique system of three medicines. I work closely with Western firms and I think that in the next 15-20 years they will not have such a system created. With Timogen, we were ahead of our Western competitors, and with this system we went far ahead of them."

Note that so far these drugs, like almost all peptide drugs, are produced in the form of sterile solutions for injection and in the form of nasal spray, but now a new method has been developed in Vladislav Deigin's laboratory to obtain such peptide drugs in the form of tablets and capsules. Experts understand that this simple phrase hides not only a huge amount of work, but also a serious scientific development.

"Peptides consisting of amino acids are "tasty" substances for many enzymes in our body. Therefore, they are quickly split by them when ingested through the mouth. Stabilizing peptides so that they are not quickly "eaten" by enzymes and at the same time remain active and non–toxic to the body is not an easy task for scientists. We managed to create an approach that allows us to stabilize the drug while it passes through the stomach and reaches its "targets", and then, after completing its task, it is safely excreted from the body," says Professor Deigin.

Vladislav Deigin 's Neplach– The development of one drug in the world costs half a billion dollars and takes 10 years.

In Russia, the numbers are different and the quality is different. Today, the law on medicines has been adopted, we are trying to synchronize both production and clinical trials with Europe (by the way, Peptos products are manufactured according to GMP standard). They demand an international level from a domestic pharmaceutical manufacturer, and they give 100 times less money. You can't drive at the same speed in a Mercedes and an old donkey. This contradiction must be overcome, I spoke about it in the Duma, in the Ministry of Industry and Trade – I listened attentively to Vladislav Deigin and, it seems, I could continue listing the problem areas of domestic pharmaceuticals, but then the Doctor of biological Sciences surprised me:

– Our country cannot be changed quickly. I found another way out – patenting. I got my first patent while I was still a student. My professor said that when you are doing something fundamental, you need to think about whether there is any remote practical benefit in this, whether there is patentability of this work. Yuri Anatolyevich Ovchinnikov, my first boss, also demanded to always provide for the possibility of practical application and some kind of introduction from peptide research. At that time – 1975-1976 – almost no one thought about it, there were not even patents, but only copyright certificates. (Our institutes have patented developments within the country. Licensingtorg was engaged in the sale of licenses abroad. After 1995, we bought the copyright certificates and reissued them into patents). Thanks to this, I have considerable experience in communicating with patent specialists and patent offices both in our country and abroad.

Patent protection is what we own, and what 90 percent of our scientists lack. Yes, patenting abroad is a complicated and expensive business, and you need to be able to protect yourself from theft. But otherwise it is impossible!

In 1996, we created the first joint Canadian-Russian scientific enterprise (in Canada). Since there was not enough money to maintain all the patents, we transferred some of the patents to Canada. Canadians began to pay for patent costs and preclinical research (in particular, "Timodepressin"). A laboratory has been created in Canada based on our technology. It is also pleasant for us that in 1993-1995 there were no transgenic mice or other modern models of testing immunological activity. However, a new generation of studies conducted in the USA and Canada in 2008-2009 confirms our results.

I am grateful to the government and Rosnauka for their support, including financial support. The main thing is that the positive steps do not end there, and we would not stop pulling only one leg out of the swamp.

The project "Creation of new potential immuno- and hemotropic therapeutic drugs based on low molecular weight derivatives of peptides and peptidomimetics with increased resistance to enzymatic cleavage in the body" is carried out within the framework of the Federal Target Program "Research and Development in priority areas of development of the scientific and technological complex of Russia for 2007-2012".

We have 20 more interesting drugs on the shelves. For example, we have completed preclinical trials of a drug that suppresses alcohol cravings, but there is no money for a clinic. At the same stage there is a drug that suppresses stress, which is important for emergencies, emergency workers. The markets are huge, we just need to finish what we started.

Portal "Eternal youth" http://vechnayamolodost.ru02.10.2009

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