On 11th of November, there has been a grand opening of an innovative vaccines and biotechnological production of NANOLEK located in Kirov. The new production is based on the most modern technologies, some of which are pioneer representatives in Russia, and fits high-set international quality standards, which is demonstrated by numerous partnerships with large multinational companies (Sanofi Pasteur, Merck, Celltrion, Egis, Aspen, TEVA etc.) which results in a number of socially important products brought into Russian market.
Since late 2014, the factory has been producing medications in solid dosage forms: products of its own development as well as those within the framework of contract manufacturing. In a biotechnological site of NANOLEK products in vial and parenteral dosage forms will now be manufactured with volumes predicted to reach up to 42 million pre-filled syringes and 35 million vials per year. The area of land around the plant pledges further expansion and an increase in output quantities.
From the foundation day the company has been actively developing a set of vaccines aiming at completing and further growth of the National Vaccination Calendar. The first vaccine to be produced by NANOLEK will be POLIMILEX – an inactivated vaccine for polio prevention, with state registration expected to be completed in the nearest time. The vaccine will become the first inactivated polio vaccine to be manufactured in Russia. In partnership with Bilthoven Biologicals (Netherlands) NANOLEK has been conducting a transferal of the vaccine’s production technology to the biomedical plant from 2012, with vaccine supply for public health services in Russia planned to begin in 2017.
The government is currently passing on a policy targeting the extension of use of the inactivated polio vaccine within the confines of National Food Industry Commission, which totally supports the strategy of the World Health Organization, which aims at a global annihilation of polio and allows to eliminate the chance of getting infected through a vaccine-associated polio completely. As many epidemiologists claim, there are two types of polio vaccines - an inactivated poliovirus vaccine (IPV) and an oral poliovirus vaccine (OPV). Contact with people, vaccinated with the latter may pass on the infection to those, who haven’t undergone vaccination yet. This is the origin of the so-called vaccine-associated polio. To avoid those cases, in 1990s the first two vaccinations were IPVs. This significantly dropped the probability of getting a “handmade” infection and moreover it allowed children who were intolerant to OPV to be vaccinated.
Considering the global deficit of demand for the inactivated polio vaccine, in future, as the production continues to expand, there is a scope for international growth, including UNICEF.
The NANOLEK Company has completed the cycle of clinical testing of the inactivated vaccine for prevention of poliomyelitis (IPV). This testing was performed within the joint project with the Bilthoven Biologicals Company (Netherlands) on the setting up production of a full cycle of the inactivated vaccine for prevention of poliomyelitis (IPV).
The program of clinical testing was developed and carried out in full accordance with requirements of World Health Organization and Ministry of Health of the Russian Federation. At the first stage, in the research with participation of adult healthy volunteers, the high safety of a vaccine, shown earlier in a number of the researches conducted in Europe, was confirmed. The second stage, studying of indicators of a reactogenicity and immunogenicity of a vaccine for children, in comparison with the foreign analogue registered in the Russian Federation, confirmed safety and high immunological efficiency of the vaccine being studied.
The Bilthoven Biologicals Company has been specializing on production of vaccines since 1909. IPV vaccine of the Bilthoven Biologicals company is applied both in the countries of the European Union, and exported to other countries of the world. The joint project of the NANOLEK Company and the Bilthoven Biologicals Company on the setting up production of a full cycle of the first national IPV vaccine was declared in 2012. The total amount of partners investments in the-is project is about 100 million RUB.
The IPV vaccine is included to the National Vaccination Schedule and is considered as a strategically important medicine. This project is very important, because there was not any local production of the inactivated vaccine for prevention of poliomyelitis in Russia by now: the foreign companies medicines are purchased for vaccination. According to experts, lack of local production of the IPV vaccine constrains development of the National Vaccination Schedule regarding transition from use of a live oral vaccine to inactivated vaccine, that all developed countries of the world had already made.
The NANOLEK Company performs localization of the IPV vaccine production at the premises of its enterprise in the Kirov region in accordance with the GMP Standards and in compliance with all international requirements to the biological medicines production.
Zydus Cadila, a leading global healthcare company headquartered in Ahmedabad, India has entered into a contract with a consulting company, Sarvac Limited to look for partners to market its vaccines in Russia and CIS. This is in line with the group’s mission of reaching out with innovative therapies to bridge unmet healthcare needs, globally.
The group is seeking a partner to co-market its vaccines in Russia and CIS. With this, Zydus aims to become one of the leading vaccine providers in not only India but also worldwide including the BRICs.
Zydus Cadila’s initiatives in the research and manufacture of vaccines is spearheaded by its Vaccine Technology Centre (VTC). VTC has two state-of-the-art R & D Centres, one located in in Catania, Italy and the other in Ahmedabad. The group has indigenously developed, manufactured and was the first to launch India’s first vaccine against H1N1 (Vaxiflu-S) in 2010. VTC’s Rabies Vaccine Manufacturing facility has received WHO pre-qualification, and is one of the largest Rabies manufacturing facility in India.
About Zydus Cadila
Headquartered in Ahmedabad, India, Zydus Cadila is an innovative, global pharmaceutical company that discovers, manufactures and markets a broad range of healthcare therapies. The group employs over 16,500 people worldwide. As a leading healthcare provider, it aims to become a global research based pharmaceutical company by 2020. The group has a strong research pipeline of NCEs, biologics and vaccines and has over 1200 scientists engaged in R & D and is dedicated to creating healthier communities globally.
About Sarvac Limited
The consulting company Sarvac Limited has long recognized experience in vaccines promotion and partners search for vaccine technology transfer. In 2012, Sarvac Limited successfully found a Russian partner for the Dutch manufacturer of inactivated polio vaccine localization (fill & finish). At present, the company works on projects of partners search for monoclonal antibodies, vaccine production equipment and travel vaccine localization.
Russian drugmaker Nanolek and Dutch vaccines producer Bilthoven Biologicals, which was acquired by Serum Institute of India in 2012, have officially commissioned a new plant for the production of vaccines in the Russian Kirov region, reports The Pharma Letter’s local correspondent.
According to plans of the partners, at the initial stage they will focus on the production of Russia’s first vaccine against poliomyelitis. That means that already next year the volume of production of the vaccine will amount to 2 million doses of a total demand of more than 3.5 million doses per year.In the long-term the production will be increased up to 10 million doses per year.
According to Vladimir Khristenko, president of Nanolek, a joint venture between RusNano with Russian biotechnology company Epidbiomed,the new vaccine will be by 10%-30% cheaper than its foreign analogues, which will help it to successfully compete with them in the domestic market.
Mr Khristenko added that the new vaccine will be supplied both to the domestic and foreign market, and in particular for the needs of the World Health Organization (WHO) and the UN Children's Fund (UNICEF).
The launch of the new production facility is part of the recently announced ambitious plans of Nanolek for a significant increase of its production capacities in the coming years from the current 1.5 billion to 4 billion tablets. As part of these plans, the company is considering implementing a number of partnership projects with some global pharma majors, among which are Sanofi Pasteur, Merck, Aspen, Egis, Celltrion and Teva, which involves the establishment of contract manufacturing of their drugs at the facilities of Nanolek.
The companies have entered into an exclusive agreement to find partners in Russia and the CIS for localization and distribution of inactivated polio vaccine (IPV).