Promomed is ready to meet the full needs of Russian patients with an Ozempic analogue

Medicines

Industry development

29.12.2023

The Russian company Promomed has already introduced into civil circulation more than 120 thousand packages of "Quincent", its analogue of the original LP from the Danish company Ozempic. The manufacturer told GxP News that it has not applied to government authorities for permission to use other inventions protected by patents and continues to communicate with NovoNordisk.

Earlier, the Russian government granted two Russian companies, Geropharm and Promomed, a compulsory license for semaglutide (drugs for obesity and diabetes Ozempic and Wegovy from Novo Nordisk), the patent for which is valid until 2035. The permits were issued for one year.

"The decision to grant permission to use the invention was made by the Government in connection with the need to protect the health of citizens. Our production and research plans will always focus on prioritizing the provision of life-saving drugs to patients. At the same time, our company's actions always comply with legal requirements. As a socially responsible company, we continue to communicate with NovoNordisk. Such international cooperation will contribute not only to resolving the current situation, but also to the development of innovative activities in our country," the Promomed press service said about the company's plans to extend the license at the end of 2024. Answering a question about production plans for 2024, the manufacturer stated its readiness to meet the full needs of Russian patients, stocks of finished products and production capabilities already allow, if necessary, to supply more than the annual needs of the country.

Promomed emphasized that it had localized the full production cycle of the drug in the Russian Federation: from the substance to the finished dosage form. "The proprietary technology of the substance's production makes it possible to ensure the high quality of the drug, but in some respects even surpassing its predecessor," the press service notes.

Thus, the company is considering the possibility of exporting its "Quincent" to other countries. "We are fully prepared to organize the export development of this product. We respect international standards regarding the protection of intellectual property and will proceed from the requirements of the legislation of each specific country," the press service said.

However, Promomed claims that it has not applied to government agencies for permission to use other inventions protected by patents. "We focus on developing our own technologies for the production of substances and ready-made dosage forms for a wide range of drugs for the treatment of socially significant diseases. Moreover, our country regularly monitors the progress of import substitution and innovation development. In our practical activities and the legal justification of their legality, we also proceed from a firm understanding that in the current political and economic situation our State is primarily aimed at ensuring National pharmaceutical Safety, when patient care is a priority over the possible interests of foreign pharmaceutical companies leaving the Russian market," the company's press service replied.

"Respect and proper protection of intellectual property rights promotes technology development and healthy competition. We see that socially responsible companies, regardless of their country of origin, always prioritize the health of patients and, therefore, will be able to come to an agreement with Russian companies and work together on drug provision," the company believes.

Regarding compliance with the rules of compulsory licensing, according to which companies that have received a license must compensate the originator for 0.5% of the actual revenue, Promomed told GxP News that it is in the process of studying all the details of the resolution.

The Russian representative office of Novo Nordisk declined to comment.

A source: gxpnews.net

Sources