RUSNANO Portfolio Company Nanolek Will Fully Satisfy the Demand of Russia in the Inactivated Polio Vaccine

17 August 2017

Notwithstanding the increased demand in inactivated polio vaccine, biopharmaceutical company Nanolek will in the years 2017 and 2018 reach the volume of the vaccine manufacturing, which will make it possible to fully satisfy the demands of the Russian market and provide for the uninterrupted supplies of the vaccine to medical institutions

According to the Health Ministry of the Russian Federation, there is a deficit in the inactivated polio vaccine (IPV) due to the increased world demand in it. Since its foundation, RUSNANO portfolio company Nanolek has been actively involved in the development of the vaccines portfolio. The first vaccine to be manufactured by the company was POLIMILEX®, an inactivated vaccine for prevention of poliomyelitis, the clinical trials and registration of which are completed. The technologies are transferred in cooperation with Bilthoven Biologicals (the Netherlands). This vaccine will be the first inactivated polio vaccine manufactured in Russia.

Nanolek expects to fulfil all obligations to the Ministry of Health on shipping the IPV until the end of the year 2017 and is ready to supply the required amounts in the year 2018.

The manufacturing site of Nanolek in the Kirov Region is a technological complex, created according to GMP and ISO standards and consisting of three autonomous process buildings with advanced high-technology equipment. The complex provides for the use of several full-cycle manufacturing technologies: manufacturing of biotechnological manufacturing in pre-filled syringes and bottles, manufacturing of solid forms.

From the end of the year 2014, the plant has been involved in manufacturing solid-dosage forms of both its own medicines and within the limits of the contractual manufacturing. At the end of the year 2016, the plant started manufacturing in the biotechnological building. The plant space provides for further expansion and increase of the manufacturing capacities.

Nanolek is also implementing the innovative solution of the recombinant season vaccine for the annual immunization for the purpose of the flue prevention. As a result of preclinical studies it was proved that the product has a high safety profile and high immunogenicity. Clinical trials of the 2nd stage are performed. The entrance to the market is expected in the year 2022.

“In relation to recommendations of the World Health Organization, now we switch to using the most effective inactivated polio vaccine. Full switch should be completed by the end of the year 2019. Nanolek is the only manufacturer of such vaccine in Russia and is ready to satisfy the demand of the country in it in full. The innovative pharmaceutical complex of the company meets the international standards and all the requirements for the manufacturing of modern innovative medicine. Agreements with the majority of the largest pharmaceutical world companies confirm that,” said Olga Shpichko, the Managing Director on Investment Activity of the Management Company RUSNANO.

Additional information

Reference

RUSNANO Joint-Stock Company was founded in March 2011 through reorganization of state corporation Russian Corporation of Nanotechnologies. JSC RUSNANO contributes to implementation of the state policy on the development of the nanotechnology industry by investing directly and through investment funds of nanotechnology in financially effective high-technology projects providing the development of new production facilities in the Russian Federation. Its primary investment focus is in electronics, optoelectronics and telecommunications, healthcare and biotechnology, metallurgy and metalwork, energy, mechanical engineering and instrument making, construction and industrial materials, chemicals and petrochemicals. 100 percent of RUSNANO’s shares are state owned. Thanks to RUSNANO’s investments, there are currently 87 factories and R&D Centers opened in 32 regions in Russia.

Management of assets of RUSNANO JSC is carried out by Limited Liability Company established in December 2013, RUSNANO Management Company. Anatoly Chubais is the Chairman of its Executive Board.

Work to establish nanotechnology infrastructure and carry out educational programs is fulfilled by RUSNANO’s Fund for Infrastructure and Educational Programs, which was also established during the reorganization of the Russian Corporation of Nanotechnologies.