The Health Ministry of Ukraine has allowed clinical testing of four domestic medicines with the aim of studying their effectiveness for patients diagnosed with coronavirus (COVID-19).
These medicines include Amizon Max, Amixin IC, Bioven and Corvitin, Health Minister of Ukraine Maksym Stepanov said during a press briefing on Monday.
“Some clinical trials are at the final stage. As soon as results are obtained, conclusions on a possibility of using these medicines for treatment of the coronavirus disease will be made,” the ministry said.
The Health Ministry also monitors the information about the development of COVID-19 vaccines in the world. There is no such vaccine at the moment. AstraZeneca has announced its plans to produce the vaccine. Four countries (Germany, France, Italy and the Netherlands) have created an alliance and preordered the vaccine.
“Ukraine has also addressed these countries with a request for putting our country on the priority list for obtaining the vaccine when it appears,” the ministry said.
Pharmaceutical manufacturers of Ukraine register clinical trials of medicines for the treatment of coronavirus (COVID-19), Health Minister Maksym Stepanov has said.
“There are internal enterprises that register clinical trials of medicines, which they produce in our country. Currently, they are Farmak, Borschahivsky Chemical Pharmaceutical Plant, Darnitsa pharmaceutical company, Biopharma and Interchem. They are trying to create medicines to treat COVID-19, including symptomatic ones. For example, Darnitsa brought in a substance for the production of hydroxychloroquine, while Biopharma registered a clinical trial of Bioven,” he said during a press briefing in Kyiv on Wednesday, May 13.
Legalization of drug delivery by certified postal operators amid quarantine will reduce the spread of the disease, according to the Manufacturers of Medications of Ukraine Association.
“This issue becomes especially relevant in the situation when it is necessary to limit unnecessary contacts as much as possible, because a pharmacy becomes one of the places of active contacts. This is especially important for elderly people who urgently need medicines and form the basis of the risk group,” head of the association Petro Bahriy said.
He noted that “the de facto delivery of medicines purchased online exists, but is illegal.”
“Such a service needs to be legalized so that people who need medicines can be quarantined,” he said.
According to the expert, the legitimization of such a delivery will guarantee the quality, origin of drugs and compliance with the mandatory logistic requirements, while involving all certified operators in the delivery will allow delivering drugs quickly and on time.
Director General of InterChem pharmaceutical company (Odesa) Anatoliy Reder, in turn, noted that attracting all the postal operators of Ukraine to the delivery of medicines will enable the widest possible delivery with a significant limitation of contacts and the spread of coronavirus.
According to him, this option will allow people living in remote and rural areas to “get their medicines at the right time and with the guaranteed quality.”
Reder believes that the possibility of delivery will not have a significant impact on the price of drugs.
Тhe State Expert Center of the Health Ministry of Ukraine gave positive conclusions regarding conducting 248 clinical trials of medicines in 2019, which is 19.23% more than in 2018, the center has reported on its website. According to the report, 210 studies were conducted by foreign manufacturers as part of international multicenter clinical studies, and 38 – by domestic manufacturers.
According to the center, an analysis of clinical trials materials in recent years has shown that the most commonly used drugs are used to treat diseases in the field of oncology, psychiatry, neurology, gastroenterology, pulmonology, rheumatology, and other diseases.
Most clinical trials were carried out in Kyiv – 21%. Kharkiv – 13%, Vinnytsia – 10%, Dnipro – 7%, Zaporizhia – 6%, Ivano-Frankivsk – 6%, Lviv – 6%, and Odesa – 5%.
Farmak pharmaceutical company (Kyiv) is conducting pharmaceutical studies of medicines, which were manufactured by the company, in the United States and EU member states, chief scientific consultant at JSC Farmak (Ukraine) Viktor Marhitych said at a press conference at Interfax-Ukraine. “We are conducting a series of bioequivalence studies in the EU. We have very good generics. Their conformity is confirmed by bioequivalence studies in good clinics and laboratories. This is an important area of work that Farmak is doing,” he said.
According to the expert, soon a full research program will be soon completed for the Amizon preparation.
“This is so far our only original molecule, which we are developing according to the full program for original medicines. Over time, the drug research program should be fully implemented, the third phase of research should be completed, after which it will be possible to submit the drug for registration,” Marhitych said.
He said that huge investments are needed for the third phase of drug research.
“The third phase is hundreds of millions of dollars. We will consider how to attract such investments. Our founder, Filia Zhebrovska, said that the drug [Amizon], which is the best seller on the market, should be safe and effective. And we can confirm that the drug is safe and effective, and provide evidence, some of which are published, and another will be published,” the expert said.
In turn, the experts who conducted the research on the drug, in particular, Senior Researcher, Ph.D., at Research Institute of University of Illinois at Urbana Champaign (Chicago, U.S.) David Boltz; Professor in the Department of Microbiology and Director of the Global Health & Emerging Pathogens Institute at Mount Sinai School of Medicine in New York Adolfo Garcia-Sastre; group leader, Ph.D., University of Cambridge (Cambridge, UK) Aartyan te Veltuis and Regents Distinguished Professor & KBA Eminent Scholar, Ph.D., Diagnostic Medicine Pathobiology, Kansas State University, Manhattan, KS Jürgen A. Richt said that cooperation with Farmak started back in the 1990s. According to them, the drug itself is tested “for effectiveness on dozens of strains of viruses, it is proved that it is a powerful antiviral agent.”
Health Ministry of Ukraine has initiated rescheduling of a pilot project on 2D coding (the special QR code on packages) of medicine packages, acting Health Minister Ulana Suprun said at a press conference on Wednesday. “Due to the need to bring 2D coding into line with the EU requirements, we will initiate amendments into the government’s decree, which envisaged the launch of a pilot project from September 1, 2019. Producers and government agencies were not ready for this,” she said.
According to Suprun, profile associations backed rescheduling of the project, in particular because Economic Development and Trade Ministry failed to work out the procedures for introduction of this system.
Director General of Health Ministry’s Pharmaceutical Directorate Oleksandr Komarida has reported that the required amendments now are being drafted for the respective government’s decree and by the end of the week they will be put for a public discussion.
According to Chairman of the Board of Directors of the Association of Manufacturers of Innovative Medicines Vitaliy Hordiyenko, the amendments will affect the content of the information that will be encoded.
He noted that at present production sites of foreign manufacturers had necessary equipment for applying coding, however, it is not used for medicines manufactured for Ukraine, since manufacturers do not know what information the code should contain.
As reported, the Cabinet of Ministers of Ukraine approved a pilot project on introduction of 2D control marking and monitoring of medicines, which is part of the Concept for the Implementation of the State Policy for Prevention of Medication Falsification.
As expected, the project to be fulfilled from September 1, 2019 to December 31, 2020.