Import substitution and solving the problem of antibiotic resistance remain a priority for the industry

Promomed 08 April 2022

The Biokhimik plant became part of Promomed Group five years ago, which was the start for the modernization of the enterprise. The analysis and introduction of new technologies in production allowed not only to launch mass production of an important «reserve antibiotic» with vancomycin as active ingredient, but also to start the production of modern drugs for the treatment of significant diseases. Today the company's portfolio includes more than 180 drug products.

«Considering the universal problem of antibiotic resistance there is no doubt about the urgent need to localize the production of substances of effective antibacterial agents, in particular, medicines for the treatment of severe nosocomial infections,» the Promomed Group believes.

Antimicrobial resistance occurs when bacteria develop mechanisms that protect them from the effects of antimicrobial drugs by destroying the active substance. Bacterial infections are more difficult to treat, which requires the use of increased doses or combinations of antibacterial drugs, which may be due to the presence of pronounced side effects.

For many years, the world scientific community has tried but failed to solve this problem, while cases of the appearance of multi-resistant bacteria have been reported, where «medicine is powerless». One of them was reported in the United States in 2016, when a patient was found to have a superbug resistant to 26 types of antibiotics available in the United States.

In this regard, the World Health Organization has called on the governments across the world to develop a plan to control antibiotic resistance.

The head of the Federal Medical and Biological Agency (FMBA) of Russia Veronika Skvortsova, who held the post of Minister of Health of the Russian Federation at that time, also said that Russia would continue work to develop new antibiotics that meet all Russian and international quality standards. At that time, fifth-generation antibiotics in tablet form were developed only in the United States.

At that time, the Biokhimik plant in Saransk, which was put into operation in 1959 for the production of drugs of the penicillin, streptomycin and ampicillin groups, became part of Promomed Group. The plans of the pharmaceutical company included a large-scale modernization and reconstruction of the plant, which allowed it to be one of the first to participate in the implementation of a unique and important project for the whole country for the development and production of domestic antibiotics of a new generation.

«The significance and complexity of the project consisted in the fact that it was necessary to begin the development and production of own substance,» the company staff recalls. «This was supposed to reduce the dependence of the Russian pharmaceutical industry on foreign partners, raw materials for antibiotics were then imported into our country from other countries, which contradicted the interests of Russia's national security. The uniqueness was in the launch of full-cycle production without the use of imported components.»In December 2016, during Veronika Skvortsova's visit to Saransk, an agreement was signed on the establishment of a pharmaceutical research, production and engineering center «Antibiotics» on the basis of Biokhimik. Later, it became the company's main facility for the production of modern antibacterial drugs.

When the reconstructed workshop for production of ampoule was just opened, all attention was focused on the priority task – production of the reserve group antibiotics.

Promomed Group became a pioneer, starting with the production of a «reserve antibiotic» with the active ingredient vancomycin, which was not produced in Russia before at full-cycle enterprises, despite its importance.

The drug is used in the treatment of endocarditis, sepsis, infections of bones and joints, lower respiratory tract, skin and soft tissue. It was produced using imported raw materials. Vancomycin is prescribed only in the most extreme cases, when a patient does not respond to first-line medicines.

«At the end of August 2017, during the visit of Russian President Vladimir Putin to Saransk, the first sample of a drug with vancomycin as active ingredient, produced at the Biokhimik plant on a full cycle, was handed over as part of a report on the progress of the project on the development and production of domestic antibiotics,» the company's speakers said.

For the first time in Russia, Promomed Group mastered the full cycle of its production without imported components, from the producer strain to the finished dosage form,» recalls Nikolay Yushchuk, Academician of the Russian Academy of Sciences, President of the Evdokimov Moscow State Medical and Dental University.

«The modernization of the enterprise, the study and introduction of new technologies in production allowed us not only to provide patients in Russia with a drug that is strategically important for the national pharmaceutical security, but also to start the production of three more modern antibiotics belonging to the class of glycopeptides,» Promomed Group comments.

The production of proprietary substances in all known nosologies remains the number one task for all participants of the pharmaceutical market. Joint efforts of pharmaceutical companies and the goverment will make it possible to change the situation so that each domestic manufacturer has its own production of substances; this is especially important for the products included in the list of vital and essential medicines (VED). The Russian Government is currently focused on solving this important problem, which will allow us to break the dependence on import of pharmaceutical substances in the future, Promomed Group believes.