The pharmaceutical company JSC Farmak (Kyiv) has received a request from the Ministry of Health and scientists regarding the possibility of its involvement in clinical trials of a Ukrainian vaccine against COVID-19, the company has told Interfax-Ukraine.
“Farmak has recently received a request from the Ministry of Health and scientists about the possibility of involving the company in clinical trials of the Ukrainian vaccine against COVID-19. Also, the state received a request for the possibility of industrial production of the vaccine (if its safety and effectiveness are proved),” the company said.
Currently, Farmak is studying the request: the company’s experts are analyzing the available materials related to the development and are consulting with scientists and representatives of the Ministry of Health.
As reported, the state intends to fund clinical trials of the vaccine.
Farmak manufactures medicines in all fourteen therapeutic groups. Among the main directions are anti-cold, endocrinological, gastroenterological, cardiological, neurological portfolios. The company annually introduces to the market about 20 new complex-component modern drugs, and about 100 drugs are currently in development.
Over the past five years, Farmak’s investments in the scientific and technical complex, production equipment, and research activities amounted to UAH 3.4 billion.
In 2019, Farmak received a net profit of UAH 1.056 billion, which is almost the same as in 2018 at UAH 1.05 billion, while in 2018 Farmak increased its net profit by 25.16%.
JSC Farmak is a member of the Manufacturers of Medications of Ukraine Association.
According to the unified state register of legal entities and individual entrepreneurs, the ultimate beneficial owner of Farmak is the head of the supervisory board, Filya Zhebrovska, who owns 80% of the company’s shares.
The Ministry of Health is in negotiations with foreign companies regarding the purchase of vaccines against COVID-19 immediately after their registration, Health Minister Maksym Stepanov has said during the hour of questions to the government in the Verkhovna Rada.
“We are negotiating with AstraZeneca regarding the number of vaccines they will be ready to supply to us. It has already been decided that, if confirmed, we are ready to make an advance payment. In addition, we are negotiating with a Chinese manufacturer, which is also at the third stage of testing. Ukraine was accepted into the COVAX initiative on the distribution of vaccines – 20% of the population, about 8 million doses for our country. The process of signing the relevant agreements, memorandums is underway, so that after the registration of vaccines we could receive them. We also communicate with other companies,” he said.
In addition, the minister said that the Ministry of Health is increasing its capacity to combat the pandemic.
“Laboratory centers are provided with tests for about 1.5 months. The tests are purchased mainly from two Ukrainian manufacturers, they are also purchased at the expense of the World Bank. In five months, we resumed the work of laboratory centers (from four to 69), and increased the number of PCR tests per day from 200 to almost 25,000. The total number of tests made has already reached almost 1.7 million,” Stepanov said.
He also noted that the situation with the incidence of doctors with COVID-19 has changed: to date, the number of sick doctors has decreased by almost four times.
Plans to resume domestic vaccine production are being discussed in Ukraine, Ukrainian Health Minister Maksym Stepanov said in an interview with Radio Liberty.
“You probably know that in Ukraine, apparently back in the 1990s, the production of any vaccine was completely destroyed. Now we have repeatedly talked with the President of the country to start restoring vaccine production. This concerns influenza, this applies to other vaccines, which we use every year,” Stepanov on the air of the Saturday Interview program.
According to the minister, the country has a corresponding scientific potential.
“We have a good school. Of course, this process is not very fast. It will take several years for us to have our own vaccine developed by our scientists. At the same time, I have already held several meetings with our entrepreneurs who have appropriate production lines. Farmak, Lekhim, which have the corresponding certified lines for the production of vaccines,can produce either a Ukrainian vaccine, if it appears, or another,” Stepanov said.
Ukrainian President Volodymyr Zelensky insists that Ukraine will be among the first countries to be able to purchase a vaccine against COVID-19 as soon as it appears on the pharmaceutical market.
The head of state, according to the presidential office, on Saturday held a traditional meeting with representatives of the government, law enforcement agencies and relevant departments on the epidemiological situation in the country and measures to prevent the spread of coronavirus.
Zelensky inquired about progressing of his task of keeping Ukraine on the waiting list for the coronavirus vaccine when it is made.
“Our diplomatic contacts and global resources report that the vaccine is already being produced in several countries. Even if it is ready next year, Ukraine should be among the first countries to purchase the vaccine. We must think about it now. The whole world is lining up,” the president stressed.
Health Minister Maksym Stepanov said that, on the instructions of the president, he conducts consultations and keeps in touch with companies and diplomats from different countries, studying information.
Ukrainian legislation should enable pharmaceutical manufacturers to buy a license for the production of a COVID-19 vaccine, which can be developed by foreign companies, Head of the supervisory board of JSC Farmak (Kyiv) Filya Zhebrovska has said.
“Ukrainian legislation should provide an opportunity so that we can buy or use a license, possibly pay royalties, so that we have the opportunity to produce this vaccine,” the company’s press service reported, quoting her as saying.
Zhebrovska said that the possibility of buying a license to produce a COVID-19 vaccine at Ukrainian production facilities will reduce the price of this vaccine by 15-20% compared with the purchase of the finished product.
As reported, Farmak does not rule out the possibility of joining a consortium, which the European Investment Bank (EIB), together with WHO, created to develop the COVID-19 vaccine. The EIB allocated EUR 7.6 billion to this consortium.
In the middle of May, Farmak, as part of international research, began the third phase of clinical trials of the Amizon drug (Enisamium) in fighting COVID-19 in Ukraine.
Farmak is the leader in the pharmaceutical market with a share of 5.9% in monetary terms. The company annually reinvests of approximately 95% of the profits in its development.
Farmak is a member of the Manufacturers of Medications of Ukraine association.
According to the public register, the ultimate beneficial owner of PJSC Farmak is Zhebrovska, who holds 80% of shares in the company.
The Health Ministry of Ukraine could design an action plan to resume national production of immunobiological preparations and approve it by the end of 2018. According to the draft resolution of the government on the approval of the strategy for the development of the National Program for Immunological Prophylaxis and Protection of the Population from Vaccine-Controlled Infections until 2022 and the plan for its implementation, posted on the website of the Health Ministry, proposals for the resumption of production can be developed and approved in the third quarter.
Together with the Health Ministry, the Economic Development and Trade Ministry, the Finance Ministry, the National Academy of Medical Sciences will also be involved in the designing of the plan.
If the strategy and the plan for its implementation are adopted this year, the ministry will also audit the legislation on registration and re-registration of immunobiological preparations and in the first quarter of 2019, following the audit, will prepare changes to the relevant procedures and submit them for approval by the Cabinet of Ministers of Ukraine.
In addition, in 2018, the issue of limiting the access of unvaccinated children (in accordance with the vaccination schedule) to groups of children will be resolved, and the vaccination will be revised to optimize the vaccination calendar, storage, transportation and registration of immunobiological preparations.
The plan provides for the improvement of the system for the procurement of serums, antitoxins, introduction of incentives for health workers for increasing the level of vaccination, as well as a number of measures to build awareness of the value of immunization among the population and health workers, and the improvement of the surveillance system for vaccine-preventable infections.