Double liability company Interchem, a pharmaceutical company based in Odesa, has received the permit of the Health Ministry of Ukraine for conducting clinical testing of antiviral medicine Amixin for effectiveness in treatment of coronavirus (COVID-19).
Director General of the company Anatoliy Reder told Interfax-Ukraine that a respective decree of the Health Ministry was signed on May 14.
He also said that the company requested the consideration of the application on clinical trials of Amixin due to the fact that the medicine had previously shown its effectiveness against a number of dangerous viral infections. During preclinical trials, it was proved that tilorone (the active substance of Amixin medicine) has antiviral activity against a number of strains of ordinary coronaviruses.
Several international research centers have already conducted and are carrying out testing of tilorone against SARS-CoV-2 coronavirus.
“As we can see, not only do we consider Amixin as a potentially effective medicine against COVID-19, but also researchers abroad,” he said.
Reder said that, in particular, such trials were conducted at the Institut Pasteur Korea (South Korea), and in two research centers in the United States as well.
“Based on the data of preclinical trials showing the highly effective antiviral effect of tilorone against SARS-CoV-2, we applied to the Health Ministry for approval of the third phase of clinical testing to expand the range of use of Amixin medicine and obtain evidence on its efficiency and safety for treating patients with COVID-19 infection,” he said.
According to Reder, clinical trials of Amixin will be conducted by research centers in three cities of Ukraine. In general, a trial may take three to four months from the moment the Health Ministry gave a permit for conducting it to the pharmaceutical company.
“The duration of the clinical trial will primarily depend on the speed of patient enrollment. At this stage, it is planned to include more than 60 volunteers in the study who, according to the severity of the disease, will be on self-isolation and undergo outpatient treatment,” he said.
Reder said that the research doctors who confirmed their readiness to conduct this trial are highly motivated, first of all, by their scientific interest and the opportunity to make their contribution to the search for a solution, which is so urgent for the whole world of medical and social problem that the new coronavirus has become.
Interchem is one of the leading pharmaceutical companies in the country.
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.
Biopharma pharmaceutical company (Kyiv) urges citizens who came through coronavirus (COVID-19) to become plasma donors to develop a medicine against this disease, which the company is launching. The company told Interfax-Ukraine that hyperimmune immunoglobulin may be effective for specific treatment of COVID-19.
The development of the medicine is carried out under Biopharma’s participation in the work of the International alliance of companies specializing in the production of blood plasma medicines, which also includes Takeda and CSL, Octapharma, Biotest, BPL, LFB, Sanquin, GreenCros, ADMA Biologics.
“Our plasma centers in Sumy, Cherkasy, Dnipro, Kharkiv began plasma blank. All the facilities of our plant in Bila Tserkva, all the forces of our team are directed to the development of medicines. I am sure that effective treatment of COVID-19 will appear,” co-owner of the company Kostiantyn Yefymenko wrote on Facebook.
In turn, businessman Vasyl Khmelnytsky, a co-owner of Biopharma as well, said that the development of an effective medicine against COVID-19 requires the support of people around the world who are ready to donate their plasma after coming through the disease.
“We urge those who have recovered to contribute to the fight against the pandemic and, if their health allows, to become a donor,” he wrote on Facebook.
The company said that Biopharma urged all survivors who wish to become blood plasma donors to contact the company’s hotline. Donors will be transported to their plasma centers, where blood plasma can be donated, and back, and they will get compensation for donation.
The company said that it is ready to register and transfer donors from any settlements.
In addition, Biopharma said that one more direction of the fight against coronavirus infection is the clinical study that have begun to evaluate the effectiveness of Bioven medicine manufactured by Biopharma Plazma LLC in the complex treatment of patients with pneumonia caused by COVID-19 and SARS- CoV-2 coronavirus infection.
At least 46 laboratories, including private ones, are diagnosing COVID-19, the Public Health Center said on Facebook on Tuesday.
According to the report, as of April 28, some 98,719 samples were examined by PCR (polymerase chain reaction) in Ukraine.
The Public Health Center notes that persons with suspected coronavirus who had contact with a patient with confirmed COVID-19, patients with pneumonia, health workers (every five days) and patients who recovered (to withdraw a diagnosis) should be tested.
Five Ukrainian pharmaceutical companies are ready to produce medicines that have been proved to be effective in combating the symptoms of coronavirus disease (COVID-19), Head of the parliamentary committee for health of the nation and medical insurance Mykhailo Radutsky has said.
“Now all legal grounds are being made for Ukrainian pharmaceutical manufacturers to start producing medicines that are used in other countries, but there is great shortage and high cost of such medicines. Today, this is a problem not only in Ukraine,” Radutsky said on the Ukraine 24 television channel on Thursday.
The MP said that there are already pharmaceutical companies capable of producing such medicines, for these companies the Health Ministry is preparing legal grounds for the production of such medicines.
“In Ukraine, five plants have already agreed to produce these medicines, but before that they need legal support. Now, the Verkhovna Rada along with the Cabinet of Ministers is preparing resolutions and legislative acts to allow these medicines production,” the head of the parliamentary committee said.
Domestic pharmaceutical manufacturers have proposed creating a coordination group under the president of Ukraine with the participation of central executive authorities, industry associations and drug manufacturers to quickly resolve the issues of providing medicines during the spread of coronavirus infection.
Pharmaceutical companies that are members of the Manufacturers of Medications of Ukraine Association said this at a press conference at the Interfax-Ukraine agency.
According to association president Petro Bahriy, the working group, in particular, could quickly resolve the problems associated with the increased demand for certain groups of drugs, a shortage of a number of active pharmaceutical ingredients, interruptions in the logistics of medicines, as well as the issues of patent law.
“Today, the enterprises involved in the production of active pharmaceutical ingredients have been stopped, there are problems with the supply of substances, packaging materials, problems with the logistics of medicines, so today it would be very good to form a headquarters and plan our work in the government and the president’s office in such a way as to help domestic manufacturers cope with these challenges and provide the population of Ukraine with medicines,” he said.
The chairperson of the board of PJSC Indar, Liubov Vyshnevska, in turn, noted that the pharmaceutical companies faced a number of problems, including quotas for alcohol without excise taxes.
“Quotas, not even during the epidemic, but in ordinary life, are the Stone Age. Pharmaceutical manufacturers with production licenses should get enough alcohol,” she said.
