Interview of the Executive Director of JSC Biochemist to Rossiyskaya Gazeta

Industry development

30.12.2020

Defeat the pandemic

Saransk plant increased production of coronavirus drug 10 times in three months

One of the main events of the past year for the Russian pharmaceutical industry was the creation of a domestic drug for COVID-19. The first coronavirus drug to receive permanent registration has been put into production at the Biochemist Saransk plant. Will it be possible to fully cover the Russians' need for a new tool? Are our pharmaceutical manufacturers ready to face the challenge posed by the epidemic around the world? Dmitry Zemskov, the executive director of the company, answered these and other questions from RG.

Dmitry Nikolaevich, it would not be an exaggeration to say that the past year has been a real test of strength - it has been marked by the coronavirus pandemic. For the enterprises of the domestic pharmaceutical industry, it turned out to be, perhaps, doubly difficult. To maintain production, ensure the safety of employees, develop and launch the production of new drugs to combat COVID-19 - all these tasks had to be solved by the plant's management as soon as possible. How do you rate this year? What role did he play in the development of the company and the pharmaceutical industry as a whole?

Dmitry Zemskov: Indeed, the past year has been difficult for all of us. It would not be an exaggeration to say that the coronavirus epidemic has become a disaster that has brought together scientists, doctors, businesses, and authorities. We worked as a single team, everyone acted quickly, smoothly and clearly. After all, thousands of human lives were at stake.

Since the first days of the epidemic, our company has been at the forefront of protecting the health of Russians, ensuring the country's drug safety. We have proven our ability to work in the most difficult conditions of the pandemic, and we have proven our efficiency and high organization. We urgently redesigned the production line, highlighting the priorities that are important in the context of the pandemic. And they actively began to develop their antiviral program.

Despite all the difficulties, 2020 has become a truly revolutionary year for us. The pride of the company is the drug against the new coronavirus infection - areplivir. A brilliant team of specialists worked on its creation: scientists, technologists, developers, researchers, doctors, clinicians, apparatchiks - people who worked without holidays and weekends. In record time, a safe drug was created, which has already shown its effectiveness and saved many patients.

How has the epidemic affected the interaction of drug manufacturers with government agencies?

Dmitry Zemskov: We have already talked more than once about the enormous help and support from the state. In particular, Decree No. 441, which accelerates the process of completing documentation for effective drugs during the pandemic. We have worked hand in hand with the government and are grateful to the authorities for the opportunity to bring our innovative medicines to Russians in a timely manner. Let me remind you that it took only three months from the development to the release of the drug.

But I would like to emphasize that clinical trials, pharmaceutical expertise and expert evaluation were carried out on a full scale, and permits for clinical trials were issued this time not in months, as before, but in a matter of days. The results of these studies were also evaluated quickly. This stunningly effective government tool has made it possible to provide strategically important drugs to Russians in the shortest possible time.

I am convinced that this practice needs to be further developed. If we manage to extend the mechanism developed by the government in the fight against COVID-19 to Russian innovative drugs, at least for the main areas of medicine - oncological, cardiological - it will be a huge breakthrough. Our patients will win, and healthcare will win.

By the decision of the Government of the Russian Federation, drugs based on favipiravir are included in the list of vital drugs. Unfortunately, today there is still a shortage of these drugs in pharmacies. What is the reason? Has it been possible to establish cooperation with the regions for operational deliveries?

Dmitry Zemskov: We have enough raw materials, and we are ready to meet the need for this medicine. We have reached the target capacity for the production of the drug and can produce one million packages per month. In September, when we started, the production volume did not exceed 100,000 packages per month. Thus, we were able to scale production 10 times in three months! This is a labor feat of the specialists who work at Biochemistry.

Currently, virtually the entire volume of the drug is sent to the regions at the request of the ministries of health of the subjects. We are in direct contact with the regional authorities. In addition, the Areplivir - Doctors campaign was launched. Her goal is to create stocks of this drug in medical centers for the free treatment of doctors working in the "red zone". We believe that the health of patients directly depends on the health of the doctor. The drug has already been sent to medical staff in Moscow, Samara, Saratov, Sverdlovsk, Leningrad regions, Perm Krai and, of course, the Republic of Mordovia. The action is gaining momentum.

How has the geography of exports changed during the pandemic?

Dmitry Zemskov: Today, the company's priority is to provide citizens of all subjects of the Russian Federation with vital and essential medicines. And we are doing everything for this. We will be ready to resume export deliveries approximately in the second quarter of 2021.

We have already told you about the representative office we have opened in Vietnam. This is a fairly promising market. We pay great attention to cooperation with the Vietnamese authorities and try to increase our export coverage.

The company receives a huge number of requests for drugs from different parts of the world. We are also considering the Latin American and Mexican markets, and we are working with the Russian Ministry of Industry and Trade, which has proven mechanisms to make it easier for pharmaceutical companies to go abroad. But, I repeat, all this is only after we provide the Russian healthcare system.

By tradition, at the end of the year, they not only summarize the results, but also make plans for the future. What goals do you set for yourself and your team for the near future? How would you like to see the company?

Dmitry Zemskov: The company's management has adopted a strategic development plan for the company. One of the main goals is to reduce the dependence of Russians on imported drugs. We will continue our policy of import substitution and providing affordable, highly effective and safe medicines to the people of our country. New therapeutic groups and more than 100 new molecules will appear in the product portfolio. Registration of our own active pharmaceutical substances for the production of ready-made medicines is already underway.

The priority is to expand the range of antibacterial and antiviral drugs, including those for COVID-19. The company also plans to create new products in the neurology segments. We attach particular importance to the production of HIV drugs, about 20 of which are currently under development, and some are already being registered. It is planned to open new laboratories and expand the site for the production of tablets and capsules.

We see Biochemist as a powerful research and production platform capable of producing innovative medicines, from molecules to packaging, on our own premises.

The key question

"RG" I wrote that a few years ago at Biochemistry A research and production center for the creation and production of modern antibiotics has appeared. How is pharmaceutical research conducted today? Can I tell you about the most promising developments?

Dmitry Zemskov: Of course, we won't reveal all the secrets. I can only say that research is ongoing. We are currently working on the next generation of antiviral drug: it is based on a combination that delivers the active substance even better into the body's cells. This molecule will be improved, and it will be tried to be applied to various infections. We live in a dynamically changing world and must have a full arsenal of effective means to combat viruses, microbes and other pathogenic pathogens.

Oncology is an important area for us. Biochemik is developing a wide range of anticancer drugs to combat almost all types of cancer. No one in Russia has such a nomenclature portfolio of medicines. Moreover, we are working to ensure that substances for cancer drugs are also produced here. We bring up to 40 new drugs to the market every year, and most of the medicines are import-substituting. As before, we focus on the production of the latest antibacterial drugs. Our production facilities will almost completely cover the needs of the Russian market for innovative drugs. This will not only solve the problem of import substitution in this area, but also make medicines more affordable.

Rossiyskaya Gazeta, 12/30/2020.

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