Farmak pharmaceutical company (Kyiv) will expand its focus to the development of products, which could be presented on global markets, Farmak CEO Volodymyr Kostiuk has said. “In development, we are now focusing on well-regulated markets. The molecules we are developing will be interesting for the global market,” he told Interfax-Ukraine on the sidelines of the Ukrainian Pharmaceutical Forum organized by Adam Smith Conferences in Kyiv.
Kostiuk said that the new molecules, which are developed by scientists of Farmak, “are complex medicines, they will require large investments in development, great knowledge.”
He said that Farmak will continue its strategy of launching at least 20 new products per year on the market, and in the coming years it will be drugs which patent protection expires.
According to him, these are drugs based on 118 molecules.
Kostiuk also said that Farmak plans to increase its export share to 40%.
PJSC Farmak is one of the three leaders in the pharmaceutical industry of Ukraine. It is a member of the Association Manufacturers of Medications of Ukraine (AMMU). The beneficiary of the company is the head of the supervisory board, Filia Zhebrovska.
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.”
Private joint-stock company Farmak, a pharmaceutical company from Kyiv, is mulling a possibility of exporting own substances to the countries of the European Union (EU), Farmak Chief Operating Officer Pavlo Pavlyk has said.
“There are a number of projects with European companies. There are a number of orders. We are now looking at innovative substances in order to develop and produce them for the EU countries,” he told reporters on Monday.
Pavlyk also said that in May-June 2020, Farmak expects an FDA inspection, which will allow the company to supply drugs to the U.S. market.
Farmak is one of the three leaders of the pharmaceutical industry of Ukraine. It is a member of the Association Manufacturers of Medications of Ukraine (AMMU). The company’s beneficiary is head of the supervisory board Filia Zhebrovska.
The National Anticorruption Center of the Republic of Moldova has denied information spread by a number of mass media about the opening of criminal proceedings against Farmak pharmaceutical company (Kyiv) in connection with its participation in tenders for the purchase of insulin. The press service of the company said, with reference to official information from the Moldovan agency, no criminal proceedings were opened against Farmak in connection with its participation in public tenders in Moldova on November 30, 2018 for the purchase of insulin analogues in the framework of the National Program for Diabetes Prevention and Treatment for 2019.
Farmak called on all media that disseminated false information about its participation in criminal proceedings in the Republic of Moldova with a request to refute this information as false and harmful to the business reputation of the company, the statement said. In addition, the company asked mass media representatives to always contact it for official comments to verify any information about Farmak.
PJSC Farmak is one of the three leaders in the pharmaceutical industry of Ukraine. It is a member of the Manufacturers of Medications of Ukraine Association. The beneficiary of the company is head of the supervisory board Filia Zhebrovska.
JSC Farmak pharmaceutical company (Kyiv) at the end of June 2019 received two new GMP (good manufacturing practice) certificates for two production sites and a new storage area commissioned at the beginning of the current year from the Polish regulatory authority, the press service of the company has said. According to the report, these sites have undergone planned recertification and confirmed their compliance with the EU’s GMP requirements.
The company passed state recertification conducted by the regulatory authorities of Ukraine and Poland in March of the current year. In particular, the company passed a GMP recertification by the State Service of Ukraine on Medicines and Drugs Control and a planned recertification of production sites, where products for the Polish market are manufactured, on the part of the Chief Pharmaceutical Inspectorate of Poland. According to the results of inspections, 19 production sites received national GMP certificates, and two more production and storage areas received European GMP certificates.
“This once again proves that the conditions in which Farmak products are manufactured comply with the European requirements. Today, all finished drug manufacturing facilities have national GMP certificates, 14 of them are certified by European regulatory authorities in Croatia and Poland. No one pharmaceutical company in Ukraine has such a level of European recognition,” Olha Oleksiychuk, the director for quality at Farmak, said.
PJSC Farmak pharmaceutical company (Kyiv) has raised a five-year loan from the European Bank for Reconstruction and Development (EBRD) in the amount of EUR 15 million (equivalent of UAH 427.838 million). An Interfax-Ukraine correspondent has reported that the loan agreement was signed between the bank and the pharmaceutical producer on Tuesday.
Farmak Executive Director Volodymyr Kostiuk said that the company has raised around EUR 72 million from the EBRD since 2006. “The EBRD is our strategic partner, we will continue working with it,” he said.
Kostiuk said that the attracted funds are intended to expand production at the Farmak’s facility in Kyiv.
“We want to develop and conquer new markets, but today we do not have enough production capacity, so the expansion of production is very important for us,” he said.
The borrowed funds will be sent, in particular, to finance the expansion of production facilities, and the construction of a new laboratory and production complex.