In August, 2018, regional Association of medical and pharmaceutical manufacturers combining manufacturers of world-class medical products and pharmaceuticals was created with the support of the Ministry of Health and Ministry of industry and science of the Sverdlovsk region. The nonprofit structure allows to consolidate efforts of domestic manufacturers for successful competition with foreign companies and effectively use experience when creation and introducing new technologies, carrying out of scientific researches. Even now, production facilities of Association’s members are enough to meet the demand of the population of the Middle Urals for quality medicines.
ROSINSULINE
(injectable solutions Rosinsuline P, Rosinsuline M, Rosinsuline C )
Manufacturer:
ОOО Zavod Medsintez (Ekaterinburg
- Novouralsk)
Indications:
It is used as maintenance therapy for insulin dependent people suffering from diabetes mellitus. Difference in forms of release is stipulated by еhe duration of the drug effect (from 6 to 24 hours).
Fact:
Since 2018 analogue insulin – aspart – and more complex drug - Rosinsuline glargine have been being tested.
Insuline aspart is supposed to bring to market in 2020 and glargine in 2021. The most popular solutions for subcutaneous injection of Rosinsuline are sold in all regions of Russia and abroad. More than 5 million packs have been released since the start of production.
Prices in pharmacies of Ekaterinburg: P – 350 rubles; Rosinsuline C – from 1003.6 to 1280 rubles: Rosinsuline M
– from 1109 to 1367 rubles.
TRIAZAVIRIN
Manufacturer:
ОOО Zavod Medsintez (Ekaterinburg
- Novouralsk)
Indications:
Broad-spectrum antiviral drug in
hard capsules with active substance
– synthetic analogue of the bases of purine nucleosides (guanine) with pronounced effective action against RNA-containing viruses. It is used for flu treatment in adults.
Fact:
At the beginning of 2020 the drug was sent to China for testing in treatment of COVID-2019. In the Sverdlovsk region 150 thousand packs of triazavirin were purchased and sent to infectious disease departments of hospitals for treatment of patients with coronavirus infection. Treatment effect analysis is conducted under the control of the State Research Center of Virology and Biotechnology of Russia.
Prices in pharmacies of Ekaterinburg:
from 590 to 1039 rubles.
PRIMAPUR
Manufacturer:
ОOО Zavod Medsintez (Ekaterinburg
- Novouralsk)
Indications:
First Russian infertility drug.
Fact:
In 2019 Medsintez by agreement with IVFarma released 4 series
of pharmaceutical substance of recombinant follicle-stimulating hormone used in IVF procedure (in-vitro fertilization) and the first 4 manufacturing batch of finished
dosage forms of the drug for clinics. In the near future the volume of Primapur production should reach 1 million of prefilled disposable syringe that is more than 200% of the existing market of such medicines in Russia. It is used in clinics.
Prices in pharmacies of Ekaterinburg: not distributed through the pharmacy network. For use only in a clinical setting.
ALEXANDER PETROV:
Medical investments have never been so important
Long before import substitution became a state priority, Medsintez, the flagship plant of the Sverdlovsk region's pharmaceutical industry, set the goal to provide Ural and Russia markets with high-quality and affordable drugs. Today, the company's products are in demand throughout the country. According to experts, a number of the drugs are really unique. Alexander Petrov, Chairman of Medsintez Board of Directors, told about groundbreaking developments, production standards and production investments.
The Medsintez plant is one of the biggest enterprises of the industry in the Ural region. How have you managed to hold the flagship position for so many years?
Medsintez was launched 17 years ago. Over the time, the company has been supplying vital medicines to the market. I believe the main secret of our success is the fact that our products are in demand. They are used in hospitals on a daily basis. They are consumed by patients, that is people who need this type of therapy. From the start, Medsintez chose to work in the area of manufacturing vital and socially important drugs.
The second component is the initially set high level of drug quality. In 2003, we decided to work in accordance with GMP standards, which correspond to European ones. At that time, it was not obligatory in Russia. Of course, at early stages, we had to invest heavily in staff training, equipment and clean rooms. In fact, the entire plant framework was built from scratch. We did not privatize anything, and no one donated anything to us. Our goal was to create an enterprise meeting European standards and a European quality level.
That being said, these two factors - the properly chosen production area and a high quality level - were determinative. Today, our products are sold all over Russia, and our customers are fully satisfied with them. As for us, we keep working.
One of the main product items of the enterprise is Rossinsulin. Reportedly, over 6 million packages has been manufactured since the production launch. Who is the main consumer?
The insulin plant was launched in 2008. This means it entered the market 12 years ago. The production capacity of the finished insulin dosage form workshop is 10 billion IU per year. The end consumer is, of course, patients. They receive the drug from the state free of charge. The Medsintez's goal was to build import-substituting production and offer the country a product of high international-level quality, yet at a lower price. Once the recombinant insulin entered the market, prices dropped by 30%.
Accordingly, the state was able to redirect the savings to other therapies. In view of the fact that the number of people with diabetes grows, the scope increases. They require various therapies. By the way, let me notice that in other countries, even in North African ones, the percentage of insulin use with diabetes is much higher. Their coverage is really broader, so we have work prospects too.
Medsintez is also known for manufacturing Triazavirin, which is a hot topic now due to anti-COVID-19 measures. How big, in your opinion, is its role in complex therapy? How did it prove itself?
According to doctors who use for prophylaxis, the drug shows its efficacy. Doctors who deal with Covid patients have been taking a pill a day for a long time. By a strange coincidence, they don't get coronavirus. Along with that, Triazavirin is also used to treat patients at early stages of the disease. According to an order of the Ministry of Health, doctors may do this even if COVID-19 is not given on the label. This is because currently there are no drugs which officially can help with the coronavirus infection. There are only guidelines that the Ministry of Health provides based on the internationally accumulated experience. Of course, some vaccine search activities and clinical trials are under way. Still, doctors administer drugs based on their observations and daily practice.
As for Triazavirin, its developers and researchers - such as Valery Charushin and Oleg Chupakhin, members of the Russian Academy of Sciences, as well as Vladimir Rusinov, a corresponding member of the Academy of Sciences - are confident that the drug is effective for coronavirus because this is an RNA virus. In fact, Triazavirin was created to suppress RNA viruses in the human body.
By now, the drug was purchased by the Ministry of Health of Moscow. Recently, in a Vesti-24 footage, a patient had our drug on their shelf. This is an encouraging fact because this means that the medical community trusts in it.
Late last year, the Ministry of Health registered Primapur, a new drug for infertility, which is a 100% Russian development. Is it already used in clinics?
Primapur was created in cooperation with IViPharma. This company is the developer of the drug, the follicle-stimulating hormone alpha. The Medsintez plant, in its turn, has been selected as a manufacturer and now produces both the substance and the finished dosage form (a disposable syringe pen). As soon as the drug was released, and the first test batches were made, they were immediately purchased and used in clinics of Moscow. Primapur has actually been a long-expected product, and it is affordable by the way. Nevertheless, its efficacy is not inferior to that of its international analogue.
It is also important that the Medsintez plant is the only enterprise in the CIS and, in fact, all over the world that produces a recombinant human follicle-stimulating hormone. We managed to market it and gain recognition in clinics. In fact, this is a victory. I dare say this is a super breakthrough. Especially in light of our country's policy aimed at increasing the birth rate. We will be happy if our drug can help women who have been struggling with conceiving to give birth to a healthy child.
Ural region's clinics buy the medicine too. I know that private in-vitro fertilization clinics have acquired the first batches too, although they are more conservative. Now, they are trying it out to make sure it works. By the way, the efficacy was confirmed not only by Russian but also by German specialists. And we expect that the drug can take the niche it deserves in this country.
Do you think it is really important in the current situation to invest in medicine, pharmaceutics and production of new drugs and medical products?
In view of the current situation, I mean the coronavirus pandemic, many countries are considering investments in medicine, production of medical products now. These are primarily medical masks and antiseptics. New businesses pop up. New vaccines are searched. Multiple companies have already contacted us with proposals to invest in this area. But this is not our business. This is a different area. We invest in clinical trials of Triazavirin.
There is serious growth. There is a real boom in the Sverdlovsk region. For example, in the regional Ministry of Industry and Science, I saw numerous samples of masks, protective suits, disinfectants and air disinfectants which are produced in the Sverdlovsk region and used during the pandemic.
I am also the head of the Association of Medical and Pharmaceutical Manufacturers of the Sverdlovsk region, so I understand the situation. There are more than 50 manufacturers of medical products and three major pharmaceutical plants in the region. This is a very important area, and I am sure it will keep growing. I contact with epidemiologists. Now, the specialists are waiting for a superflu wave. We don't know when this is going to happen, yet we have to be prepared. The Sverdlovsk region is protected in this respect. We have many enterprises, developments and experience. We are successfully coping with the coronavirus infection. And I believe that we will have very good final results in terms of the deaths to disease cases ratio adjusted to the population density.