Russian biotechnology represented by one of the...

On the website of the newspaper "Farmvestnik" there was an online interview with the chairman of the board of directors of the company "BIOCAD" Dmitry Morozov.

Dmitry Valentinovich Morozov was born in 1965 in Moscow. In 1998 he graduated from the Russian Academy of Economics. Plekhanova majored in Finance and Credit, and also successfully completed his studies at the Moscow International Higher School of Business "MIRBIS" under the Master of Business Administration program. Until the end of the 1990s, he served as Deputy Chairman of the Management Board of CentroCredit Bank. In 2001 he founded CJSC "BIOCAD".

It is included in the list of persons (top 500) included in the reserve of managerial personnel under the patronage of the President of the Russian Federation. He is a member of the Council for the Development of the Pharmaceutical and Medical Industry under the Government of the Russian Federation.

He is married and has three children.

CJSC "BIOCAD" is a Russian biotechnology company that was established in 2001. The company is both a full-cycle research and production structure. The development of the company's drugs is carried out by its own research division, drugs are produced at a modern plant located in the village of Petrovo-Dalneye of the Krasnogorsk district of the Moscow region according to GMP standards.

At its core, the company's activities are focused on the development of original and generic drugs in the urology/gynecology, oncology and neurology segments. In 2004, the company received a US government grant of $ 1.7 million for the development of interferon-beta.

Valentina
Good afternoon, Dmitry Valentinovich! You have received a financial education. Why did you decide to create, for example, not a bank, but a pharmaceutical company? What attracts you to this business? Is it difficult to manage a pharmaceutical company without having a specialized education?No, it's not hard.

What difference does it make what to manage? I position myself not as a specialist in the field of biotechnology, medicine or pharmaceuticals, but as a manager. In fact, I haven't run a company for a long time. It is managed by the CEO and managers. My role is much smaller than before – when I was the CEO myself. Most of my life has been connected with the banking business. But then I was attracted not so much by pharmaceuticals as by biotechnology. It was something of a challenge. The fact is that for many, many years, foreign companies that actively sell their products in Russia have been imposing some idea that you can't do anything here, that your scientists are not capable of anything other than fundamental science, and the products are of poor quality. Only we, there – abroad, can bring you deliverance. Obviously, in order to maintain the status quo, this idea is hammered into the heads. The lower the level of self-awareness of market players, the easier it is. And it's a challenge for me. Our drugs prove the opposite: we can do no worse than they can. And we can compete with them, if not on equal terms, then in certain niches, gradually winning positions. I am glad that the state understands this now. In general, it is ridiculous to say that in Russia, which was the first to send a man into space, created a nuclear industry and made many other discoveries, we cannot synthesize various chemical substances.

Ivan Nikolaevich Homeless
Dmitry Valentinovich, welcome! Your biography indicates that you are included in the reserve of managerial personnel under the patronage of the President of the Russian Federation. What does it give you? Maybe there are some benefits, advantages... How to get into this reserve?To be honest, I don't know how to get there.

It does not give any benefits and advantages. Inclusion in the reserve is a kind of signal: if something happens, they can call me and offer to do something, help solve some issue, perform some task. I'm ready for that.

Kirill
Greetings! The new mayor of Moscow, Sergei Sobyanin, recently dismissed Mikhail Remizov, director of the State Unitary Enterprise "Stolichnye Drugstores". Do you expect a further purge of personnel? Do you think it is possible to defeat corruption in general with regard to the purchase of medicines? what do you think is needed for this?The fact that the current system of purchasing medicines in Moscow is ineffective is clear to everyone.

I cannot comment on the resignation of the General Director of the State Unitary Enterprise "Stolichnye Drugstores". But I will say that the system must change. It seems to me that it is necessary to more clearly implement the laws that exist. The Ministry of Economic Development now has some amendments to 94 FZ. When they are accepted, it will be even more difficult to cheat at auctions. The more regulations come out that prevent the use of existing schemes to limit competition, the better. That is, it is necessary to legally close all loopholes. And they will be closed, I'm sure. As soon as this happens, we will see real competition, there will be a strong drop in prices. This will accordingly increase the availability of medicines for people. And it will be useful for market participants as well. They will finally be able to think about the cost of their products, about optimizing production processes, and begin to fight unnecessary costs. We now have a large number of both inefficient domestic production facilities and inefficient Western representative offices.

Anna Ivanovna
In November, the Biocad company won auctions for three lots, saving the budget 282.5 million rubles, or 90% of the allocated funds. First of all, I would like to express my great gratitude to you! And secondly, to ask, do you think in Russia most contracts are concluded with the use of rollback technologies and significant overpricing? How can this problem be solved? Do you plan to continue the fight for transparency of public procurement?see the answer to question #2

Christina
Good afternoon! How is the construction of the plant in the Leningrad region progressing? At what stage is it now? Please explain the meaning of transferring capacities from the Moscow region to the Leningrad region? What is the difference – to produce drugs near Moscow or near St. Petersburg? Why was the Leningrad Region chosen, and, for example, not Kaluga or Yaroslavl, where pharmaceutical clusters are also formed?Since Biocad has become a resident of the SEZ Neudorf, which, by the way, is not located in the Leningrad Region, but within the borders of St. Petersburg, the company can enjoy all the benefits that are legally granted to participants of special economic zones on the territory of the Russian Federation.

When we compared the regions, the choice in favor of St. Petersburg was obvious. There is a large number of trained personnel and a high standard of living in the city, comparable to Moscow. Plus, there is a very effective interaction between the government and business. In addition, the SEZ "Neudorf" has a high level of site preparation, well–established infrastructure. The design of the enterprise has already been completed. Now the last issues about the land are being resolved – this is paperwork. We should launch the laboratories already in February-March, and in the spring we will start building facilities. However, part of the production will remain at our site near Moscow in Petrovo-Dalny.

Semenov Evgeny
Good afternoon! Why are the prices of state registration of VED for drugs produced by JSC "Biocad" (a domestic manufacturer) several times higher than those of many other domestic manufacturers and in many cases higher than the prices of registration of imported equivalent drugs?These prices are formed on the basis of certain market indicators.

Accordingly, these prices reflect how we work. As the competition in the market increases, prices will decrease significantly. Including registered ones.

Andrey
Dmitry, hello. Your company's portfolio is focused on the public procurement sector. Do you consider this market stable? Do you feel any preferences for yourself (as a domestic manufacturer) or is it difficult to compete with foreigners? And in general, can we assume that there is healthy competition in this sector?Biocad is focused not only on the public procurement sector, for example, we have Genferon, which is sold in pharmacies.

But it so happened that the company works in high–tech areas - we create modern and expensive medicines. In this segment, the state plays the role of the main customer. I don't see any problems of competition with foreigners. I see a problem in the legacy of a system that has been created for many years. We are faced with the nihilism of doctors, with the distrust of officials. All these are remnants of the past. Competition, if it obeys market rules, is not difficult at all. My position is this: the patent has ended – forget that you can receive windfall profits in Russia. But there will be no excess profits for Russian generic manufacturers, and there will be a normal competitive environment.

Maria
Good afternoon! Why are such small salaries in production and quality offered for such a successful company?Often, the quality of candidates for employment is very low.

Unfortunately, we are faced with the fact that there are a large number of people on the market who consider themselves highly qualified specialists, but in fact do not represent any interest for our company. If we see that a person suits us and that he is much more qualified and prepared than the average mass, then we take him. Our salary is absolutely normal – at the market level.

Anton Andreev
Is there a great need for Biocad in qualified production personnel? How is the task of finding specialists solved in a competitive environment? In your opinion, is Biocad an attractive employer and why?Our HR policy is focused on hiring young employees.

Students are often more valuable and useful than people with work experience in other pharmaceutical companies. The Biocada team goes to defend diplomas, in particular, to the St. Petersburg State Chemical and Pharmaceutical Academy. And we immediately make suggestions to the graduates we like, offering them a good social package, including renting apartments for them.

Oksana, Saint Petersburg
Dmitry Valentinovich, what did you do after graduating from high school in 1982? (I mean the time period 1982-998). Did you study full-time at the Russian Academy of Economics? You graduated at the age of 33, and how did you and your family survive the perestroika period of the late 80s - to the mid–90s? Where did you work?The site "Biocada" describes my biography in sufficient detail.

Like many at that time, I was engaged in various types of business. Starting from the sale of computers to the purchase of shares in aluminum enterprises.

Uzdenikov Alexey Alexandrovich. LG Life Sciences. South Korea.
Good afternoon, dear Dmitry Valentinovich. Your company pays a lot of attention to new developments. Are you ready to cooperate in the development and implementation of monoclonal antibodies in the production and clinic (tumor necrosis factor inhibitors)? Thanks.Yes, I'm ready.

Vladimir Petrovich
Dmitry Valentinovich, do you plan to promote your products in foreign markets, first of all, the drug Ronbetal. Considering the price/ quality ratio, you could confidently compete with such foreign analogues as Betaferon. In general, how seriously do you consider the export component of the company's activities? To which countries would you like to start supplying your products and what difficulties do you see along the way?Yes, it's obvious.

However, entering any markets is quite a serious financial investment. I'm not talking about the costs of clinical research, but the promotion of drugs. After all, they will not be sold without marketing. Biocad is currently negotiating with Brazil and China. It is planned to supply either Ronbetal or Algeron to these countries. The last drug is currently undergoing clinical trials – the first phase has already been completed. This is cispeginterferon alpha-2b, a completely innovative molecule, a new INN. We are also considering the market of Vietnam and other countries of the Asian region. In addition, a joint venture may be created in Brazil. From the point of view of regulatory issues, I don't see any difficulties – everything is quite transparent and clear.

Peter Veniaminov
Dmitry, good afternoon. How do you assess the potential of Russian pharmaceutical manufacturers in relation to the production and sale of innovative drugs, including biosimilars? Can Russian manufacturers produce drugs comparable in quality and effectiveness with foreign analogues? I am interested because many foreign companies do not take such enterprises as Biocad seriously at all, and often base their promotion policy on the fact that it is not possible to provide comparable quality.Good question.

I feel sorry for those managers of Big Pharma companies who base their work on this principle. Because it means that apart from marketing techniques they don't use anything else. I am convinced that our knowledge of formulas is no worse than the knowledge of the same scientists in the West. We can now buy the same equipment that they use. So I don't see any reason why we can't make the same drug. Everything they say has nothing to do with patient care, it's just one of the types of sales.

Vasiliy
Dmitry Valentinovich, do you personally and your company have an interest in developing truly innovative medicines, for which there are no analogues not only in Russia, but also in the world? Does the Biocad research team conduct similar research or is it focused primarily on solving applied problems?Biocad is 80% focused on applied tasks.

In my opinion, without the ability to efficiently and quickly solve applied problems now, it will be impossible to create high-tech drugs in the future. Biocad and many other Russian companies are simply still very young. We need to go a very long way in a short period of time. We have no other choice.

Victor
Dmitry, hello! Are you guided by the list of 57 strategically important drugs, the production of which should be localized in Russia? Can the existence of this list be of any use to Russian pharmaceutical manufacturers?Absolutely, yes.

This is a very important question. I am glad that the state has defined its priorities. Some of the drugs from this list "Biocad" makes. And not only "Biocad", but also a large number of our colleagues. After some time, there will be fierce competition, and prices will drop very much.

Nikita
Dmitry Valentinovich, how do you feel about the situation that arose when the drug Milanfor was put on the market. In your opinion, is this an accident, a management flaw or a certain intent on the part of competitors? Have you ever encountered similar situations in your work?It is difficult for me to comment on this situation, because I do not quite agree with the working methods of the company that brought Milanfor.

We don't do that and we won't do that.

Novel
It is known that today CJSC Biocad produces drugs used for the treatment of oncological diseases and multiple sclerosis. What was the reason for the choice of these therapeutic areas?It's always interesting to set the bar higher than you can fulfill.

Beta interferon was a kind of challenge. A number of well-known institutions in the Soviet Union have been developing it for a very long time, but they have not done anything. And we did. We entered a market where no one was waiting for us. After our drug appeared on the market, a large number of people, including medical representatives of other companies, lost their jobs. Because "Biocad" took a part of the "pie" for itself.

Nina Valeryevna, Yaroslavl
You have already been praised about saving the state budget, and there is something for that: well, at least someone is interested in the reasonableness of spending taxpayer money. But I'm more interested in another question. Did you have any idea about the degree of risk of seriously ill people when you offered to treat them with a new untested drug? And would you subscribe to the proposal: in difficult situations for you (or your loved ones), say, if you had a stroke, so that you would be treated not with European proven drugs, but with domestic ones that have just been released?No one praised Biocad for saving the state budget.

I hope that the funds that have been saved will be used to purchase more drugs so that more people will be helped. This is enough to feel some satisfaction. We do not treat anyone with a new and untested drug. A drug that has already expired a patent, for example, the same beta-interferon, is not new. He would have done it 20 years ago. From the point of view of modern science, this is not such a complex object. So it is incorrect to say that it is new. In addition, the state buys only medicines that have completed the state registration procedure, which means that there were preclinical and clinical studies, careful state quality control and licensing of production. Therefore, the word "untested" is at least inappropriate here. All drugs manufactured by the company "Biocad" have passed all the stages of examination and state control provided for by Russian legislation. I would sign up to be treated with a drug released by Biocad. Moreover, I have a great skepticism about European drugs. Drugs are often made in China and India under European brands.

Nekrasova Oksana
Dmitry Valentinovich, I hear a lot of criticism from colleagues on your company's drugs, in particular on a drug for the treatment of bone metastases in cancer patients – Zolerix. Among the side effects, I can now mention three cases of acute renal failure for the administration of the drug in the Sverdlovsk region, there are also cases of anaphylaxis for the administration of Zolerix. I am an oncologist, my patients have received only Leukostim so far, but alas... the effect on this drug is very weak, and the price is high. Maybe domestic manufacturers are still producing less complex, not as high-tech drugs as those. what are used in oncology? Side effects of drugs are always a risk, it is unacceptable in oncology.Dear Oksana, the efficacy and safety of Leucostim has been compared with the original Neupogen drug in several clinical studies, including a double-blind multicenter randomized trial conducted by leading pediatric hematologists.

Prior to the study, pediatric hematologists also often voiced doubts about the effectiveness of Leukostim. But after they were convinced by experience that there were no differences between Leucostim and Neupogen in a situation when neither the doctor nor the patient knew which drug was administered to them – Russian or imported – all questions were removed. Impaired renal function is a characteristic side effect of zoledronic acid, this is reflected in the instructions for use of the drug. In accordance with the results of international studies of the original preparation of zoledronic acid, reflected in the approved instructions for its use, impaired renal function was noted in 9-15% of patients. Severe cases, such as acute renal failure, are often associated with an incorrect (too fast) mode of administration of the drug, as well as its administration to patients with initially impaired renal function. All these instructions are given in the instructions for the medical use of the drug Zolerix. The development of allergic reactions is also a side effect of zoledronic acid described when using the original drug. It should be noted that in accordance with Russian and international requirements, the Biocad company operates a pharmacovigilance system – the active collection of information about adverse reactions to manufactured medicines and their investigation. If these cases had been reported to the company or to Roszdravnadzor, the company's specialists would have had the opportunity to investigate and establish their connection with the drug used. In the absence of official notices, the reliability of such anonymous statements can and should be doubted.

Vladimir Anatolyevich
Dmitry, good afternoon! How can you comment on the massive refusal of patients with multiple sclerosis to take the drug "Ronbetal" produced by your company? What do you say about the numerous complaints and letters to the local and central Ministry of Health and Social Development about the poor tolerability of the drug and low efficacy? Why is the community of patients – patients with multiple sclerosis – boycotting your products? ThanksAccording to information at the beginning of December 2010, Ronbetal therapy was discontinued in 271 out of 3060 patients.

At the same time, in 119 of these patients, Ronbetal was canceled not for medical reasons – as a rule, due to the lack of Ronbetal in the region, they were transferred to another available interferon drug-beta-1b. Withdrawal of the drug due to the development of side effects in only 5% of patients is a very good result, given that according to international studies, the frequency of withdrawal of Betaferon for medical reasons in the first year of treatment is about 15%. According to studies of original drugs conducted on the territory of the Russian Federation, side effects are the reasons for discontinuation of treatment in 6-6.5% of cases. The relatively high frequency of side effects of interferon-beta is due to its biological effects on the immune system – the same ones that cause its effectiveness. All reports of side effects of medicines and their inefficiency are received by the Federal Center for Monitoring the Safety of Medicines. As of November 2010, this institution received 80 reports concerning the drug Ronbetal. At the same time, the total number of patients taking Ronbetal in Russia is more than 3,000 people. Even taking into account additional cases of adverse reactions reported by patients to the hotline, the frequency of adverse reactions of non-Ronbetal does not exceed the frequency of adverse reactions to the original drug, known from the scientific literature and official instructions for its use.

Egorov Anton Gennadievich
Mr. Morozov, many people know how you managed to register the preparations of the company CJSC "BIOCAD". We are sincerely glad that the registration is now handled by the Ministry of Health. I am very sorry for the patients who will be forced to use your "wonderful" drugs. Tell me, aren't you ashamed of your work and medications?I'm not ashamed of my job.

But I am ashamed when, for handouts from pharmaceutical companies, doctors who are supposed to treat patients, shuffle data and speculate on the lives of sick people. I am ashamed when some employees of Big Pharma, using the plight of sick people, provoke them to certain actions. These are remnants of our market. An ordinary wild native market, that's how some people treat us. Provoking a seriously ill person to some emotional outbursts is not a very difficult task. It would be better to pity people. I am ashamed for my colleagues and for the methods they use.

doctor – clinical pharmacologist
Dmitry Valentinovich! How is the system of post-registration pharmacovigilance organized in your company? Considering a number of questions (in my opinion, of a custom nature) regarding the effectiveness and tolerability of drugs produced by your company, this question, at least in the next 3-5 years, will be very relevant for you. Thanks.Our post-registration pharmacovigilance system is organized very seriously.

I assume that the wave of negativity that will fall on us after the launch of the drug with INN rituximab on the market. It's not just coming down on us. This is faced by all companies that are somehow trying to shake the status quo that has developed over the past 10-15 years. The situation here is generally understandable.

Ivan, Chelyabinsk
Dear Dmitry! By participating in auctions, you sometimes reduce the lot amount by 80-90%, which is much less than the registered price. Most likely, this is a price below the cost of the drug. With what funds are you going to develop your production, pay salaries to employees, or are you going to borrow money from the state for development, and then not give it back, because everything will go to costs?A very funny question.

Biocad has always kept track of expenses. The question of the cost of drugs is key for us. We have a very low level of production costs. This is achieved by a large number of modern technological techniques. By what means? First of all, it should be noted that Biocad is a profitable company. We still have funds not only for salaries, but also for development. You don't have to worry.

Sergei
Good afternoon! In 2010, you supplied the drug Ronbetal as part of the "7 nosologies" for the treatment of multiple sclerosis. Have you participated in the recent auction for the supply of drugs for 2011 and how can you comment on the requirements of the auction documentation on the need to supply 55% of the annual volume within 19 calendar days after the auction?This is all at least strange.

For example, under the terms of the auction, the volume of immediate delivery of another drug, which is also used to treat multiple sclerosis, was one third of the total purchase capacity. And the drug that Biocad produces is necessarily 55%, and urgently – in 19 days. I do not believe in conspiracy theories, I do not believe that this is the evil will of our Minister of Health, as some wanted to present it. All this is nonsense. But, yes, there are a number of non-generic ones (so in the text. non-ordinary? negligent? – VM) performers. For them, complicating the life of a competitor is considered a good thing. We will still supply our drug. But, unfortunately, not to the extent that we would like. However, sooner or later these unequal approaches will disappear.

Natalia Ivanovna
Dmitry Valentinovich, good afternoon! On your website there is information about the development of blood clotting factors 7 and 8, i.e. You are moving further into the "7 nosologies" program. Are you planning to make medicines for other diseases in this program?"Biocad" is now paying a lot of attention to this direction.

Technically, it is not at all difficult for us to make other medicines under the "7 nosologies" program. However, I believe that each company should have its own priority areas that are most interesting to it from the point of view of strategy. We still try to focus on our therapeutic areas - oncology, hematology and infectious diseases.

Ilya
Hello! During 2010, the media repeatedly reported on the implementation of your project for the production of drugs based on monoclonal antibodies. Are there any results in this direction already and how are you going to compete with manufacturers of original drugs later?There is.

We are already conducting preclinical trials on primates for rituximab. All other drugs based on monoclonal antibodies, which were announced in our program, are in the preparation stage for admission to preclinical studies. This will happen in the very near future. I think as soon as we finish all the questions related to preclinical trials, we will immediately proceed to the clinic. How are we going to compete? Very simple. We will make a high–quality drug - significantly cheaper at the price that is currently being sold. We will not give bribes and we are not going to pay black cash either.

Nikolay
Dear Dmitry Valentinovich, do you think that simultaneously with the increase in the presence of Russian innovative drugs or modern genetically engineered copies on the domestic market, the activity of discrediting Russian drugs and their manufacturers will also increase?Of course I do.

Nobody wants to give up their market. But it's not scary. If you are confident in yourself, if you have an internal system that allows you to conduct investigations of certain cases, a pharmacovigilance program, if you have trained personnel, I don't see any problems fighting this. Well, let's, we are ready, we will understand each case, publish openly the results of the proceedings, we will show not always correct cases of behavior of market participants. Not a question.

Elena Anatolyevna
Good afternoon! working in a recruitment agency, in recent months I have noticed a sharp increase in the number of employees of Biocad who want to leave the company or have already left and are in a new job search. Have you started making cuts? Or have you cut your salary? How can you comment? Thanks.Of course, like other companies, Biocad is in the process of searching and improving its organizational structure.

At the end of the year, we usually lay off about 10% of our employees. The company is a living organism and we are changing and often we don't need some employees as much as before. We are closing or updating some destinations.

Krasnova Evgeniya Olegovna
Hello! Why don't you respond to the unprecedented surge in patient complaints about the Ronbetal drug produced by your company? Do your company's specialists plan to refine this drug to reduce side effects after its use?Where to refine more?

We have now released the drug, as patients are used to, in a set – with disposable syringes and napkins. Due to the fact that we were in a hurry, initially not enough attention was paid to the technique of administration of the drug. We've improved.

Nikolai Demin
Hello, Dmitry! Currently, your company has established itself well as a manufacturer of generic drugs. Tell me, are you planning to develop original medicines, and if so, when can you expect them to appear on the market?Biocad is currently considering the possibility of releasing a large number of drugs belonging to the original class.

I have already told you about cispeginterferon alpha-2 above. It should appear in 1.5 years. I think it will be a significant competitor to the two drugs that are currently available on the market.

Ekaterina
I am closely following the development of the company "Biocad", and I know that over the past six years your company has developed and brought to the market three major biosimilars: interferon alpha-2b, filgrastim, interferon beta-1b. Can you now announce the developments of what other biotechnological drugs "Biocad" is engaged in today?Of course I can.

This is a whole class of monoclonal antibodies and blood clotting factors. In addition, we can already talk about some chimeric proteins that have improved properties compared to conventional blood clotting factors. We will also, of course, release several improved products designed for patients with multiple sclerosis. These are also chimeric proteins, of a very complex design. We have a large program on chemical preparations, which we partly make ourselves and partly with the St. Petersburg State Chemical and Pharmaceutical Academy. I think there will also be a lot of interesting products that will appear on the market in the very near future. They will not belong to the original class, but they will make up a portfolio that will allow Biocad to be more competitive.

Elena
Dear Dmitry Valentinovich, I have heard a lot of positive things about your company. Tell me how I can get a job with you.It is not difficult to get a job with us.

We regularly post vacancies on staff search sites.

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24.12.2010