NANOLEK Finished Clinical Studies of Inactivated Poliomyelitis Vaccine for Preventive Treatment

11 November 2015

NANOLEK has announced the completion of the clinical studies cycle of inactivated poliomyelitis vaccine for preventive treatment (IPV). The studies were conducted as part of the joint project with Bilthoven Biologicals (the Netherlands) to organize the full-cycle production of IPV.

The clinical studies program was developed and implemented in full compliance with the requirements of the World Health Organization and the Ministry of Health of the Russian Federation. During the first stage of the studies involving healthy adult volunteers the company confirmed the vaccine’s high safety that had been demonstrated previously in a series of studies held in Europe. The second stage, namely, the study of vaccine’s reactogenicity and immunogenicity in children compared to the foreign alternative registered in Russia, confirmed the safety and immunological efficacy of the vaccine in question.

Bilthoven Biologicals has been specializing in vaccine production since 1909. The inactivated poliomyelitis vaccine produced by Bilthoven Biologicals is both used in the EU and exported to other countries. The joint project between NANOLEK and Bilthoven Biologicals to set up the full-cycle production of the first Russian IPV was announced in 2012. Total investment volume by the project’s partners amounts to approximately RUB 100 mln.

IPV has been included into the National Vaccination Schedule and is a medicine of strategic importance. This project has a great value as previously there was no local inactivated poliomyelitis vaccine production in Russia and vaccination medications were imported from foreign companies. According to experts, the lack of local IPV production prevents the National Vaccination Schedule from starting to use inactivated vaccine instead of live oral one which every developed country has already done.

NANOLEK realizes the IPV production localization at its own facility in the Kirov Region in accordance with GMP standards and complying with all international requirements regarding biologic drugs production.

Vladimir Khristenko, the president of NANOLEK, refers to this stage of the project as important for the company. “World Health Organization has developed a stage-by-stage plan for complete transition to vaccination using inactivated poliomyelitis vaccine worldwide. As a result, we understand the high responsibility of our company to provide Russian patients with quality Russian-made vaccines. Finishing the clinical studies phase, we enter the final stage of the drug localization project. The realization of these studies has been made possible due to the support of key research groups that are working on developing and studying vaccines in Russia. The project findings amply prove the safety and efficacy of the vaccine for children.”

Reference

NANOLEK is a private biopharmaceutical company counting RUSNANO among its shareholders and having its own high-tech full-cycle production compliant with GMP standards and ISO standards. NANOLEK specializes in manufacturing import-substituting and innovative medicines both of their own design and produced with the participation of their international partners, and is focused on preventive treatment and therapy of socially important diseases. NANOLEK’s portfolio is formed according to the most significant import-substituting therapeutic tendencies. It includes cardiovascular medicines, tumoricidal drugs, innovative vaccines with the influenza virus cell vaccine and the first Russian inactivated poliomyelitis vaccine among them. Currently, there is another series of innovative biotechnological drugs in development stage. NANOLEK works together with the largest international pharmaceutical companies: Sanofi Pasteur (France), Merck (Germany), Celltrion (South Korea), Egis (Hungary), etc.

The production site of NANOLEK Biomedical Complex at Lyovintsy (Orichevskiy District, Kirov Region)

Full-cycle production of solid dosage forms (capsules and tablets), inactivated and recombinant vaccines, biotechnological pharmaceuticals.

Start of production: December 2014
Site area: 14 hectares
Total area of the complex: 28,000 square meters
In compliance with EU GMP, ISO

Yearly output:

•   1.5 billion tablets/capsules

•   42 million prefilled syringes

•   35 million vials.