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 Russian biopharmaceutical company with its own high-tech complete cycle production corresponding to the GMP standards, which specializes in the production of import-substituting and innovative pharmaceuticals, both in-house developed and invented with the help of international partners, with a focus on the prevention and treatment of socially significant diseases.

Production facility BMC NANOLEK:  Lyovintsy village, Orichevsky district, Kirov region
Launch of production facility: December 2014
Territory size: 14 hectares
Production facility area 28,000 sqm
Compliance with EU GMP, ISO standards

Complete cycle production Solid dosage pharmaceuticals (capsules and tablets), inactivated and recombinant vaccines, biopharmaceuticals

Production volumes per year:

  • 1 billion tablets / capsules
  • 42 million filled in syringes
  • 35 million vials.

For more information please visit at the website www.nanolek.ru/en