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Kaluga Pharmaceutical Cluster — an Environment for Development of Innovations

Irina NOVIKOVA, Executive Director of the Kaluga Pharmaceutical Cluster association


The pharmaceutical cluster is a unique eco-system, with all links in its chain operating with high efficiency. What contributed to its development and viability?

I am certain that the system’s efficient operation is largely due to the cluster approach. Kaluga Region was one of the first to choose this development model. This principle is the foundation for successful development of a range of clusters, including the pharmaceutical. The cluster model provides a clear understanding of investor needs, allowing training centers to prepare required specialists and participants to implement projects of any complexity within the shortest terms. Effective cluster development requires coordinated efforts of regional management bodies at all levels, their active collaboration with the business community and with cluster management companies. Kaluga Region has established such a system, and this allowed us to maintain leadership in industrial production growth and new investments for many years.

Kaluga’s cluster is gaining significance in supplying Russian consumers with high-quality medical products. What ICD drugs do the region’s pharmaceutical companies currently produce?

Virtually all products in portfolios of “anchor” companies, as well as product and innovation portfolios of the cluster’s small and medium enterprises are applied in the most promising fields of therapy. These include cardiology, oncology, endocrinology, treatment of respiratory and gastroenteric diseases. Our pharmaceutical companies manufacture neurological drugs, drugs for treatment of the musculoskeletal system, immunomodulators, genitourinary system drugs and reproductive hormones. Importantly, cluster participants manufacture vital and essential drugs: diclofenac, articaine, xylometazoline, indapamide, dalargin and many others.

One of the most important directions is the development of pharmaceutical substances. How is this work carried out?

Finished pharmaceutical substances and source materials for their synthesis are developed, among others, by BION LLC. In 2016 alone, the company brought seven new products to the market. It has established a new production line for manufacturing of substances for advanced antitumor drugs. BION has so far registered or is in the process of registering over 30 pharmaceutical substances. Each product is unique. I would also like to note Mir-Pharm’s success in development of finished form products. The company’s strategy is a continuous search for highly-efficient drugs that are either not available on the national market or available in quantities insufficient to satisfy current demand. They introduced drugs like Mifepristone, Mirolute, Ginepristone, Ginestril, Traneskam, Meksiprim. Those were later included in the STADA product portfolio and are now manufactured to its order. In 2017, the company registered 6 drugs, and early this year – another three. It is currently in the process of  development and registration of 50 new drugs intended for use in gastroenterology, gynecology, urology, emergency treatment, neurology and oncology. Among them are highly-demanded import substituting gynecological drugs – Atosiban and Carbetocin. They are expected to become the first Russian generics of original drugs.

What projects will be implemented in the cluster format in the nearest future? Are there plans to launch new production plants?

Recruitment of investors, improvement of localization and integration processes, expansion of production capacities at existing plants and opening of news ones, infrastructure development – there are major projects planned for each of these directions. Two new plants will be opened this year for manufacturing of finished medical products – by Russian companies Pharm-Sintez and Sphere-Pharm. We are also expecting the commissioning of an integrated laboratory complex by Hemofarm by the end of the year. The complex will support the expansion of the company’s research and development efforts. New investors are being recruited, among other things, by expanding the specialized site for pharmaceutical manufacturers at Kaluga SEZ. Another direction is associated with infrastructure development by expanding services and creating a network of local service suppliers. One of the examples is construction of the Sozvezdiye 220 kV substation to support new technological connections to the Obninsk power hub. Among educational projects is further equipment of the Practical Training Center and creation of a laboratory for synthesis of active pharmaceutical substances at the National Research Nuclear University MEPhI. Another priority is support of exports of cluster participants. The regional government has achieved considerable progress in this direction by providing direct financial support, tax preferences and by establishing collaboration with various foundations and agencies.

Support of exports is identified as a priority in the new Pharma-2030 program. What is your assessment of its predecessor – Pharma-2020?

Most of the support measures defined in Pharma-2020 were originally suggested by pharmaceutical manufacturers themselves. The Ministry of Industry and Trade offers support to local companies, including by subsidizing transfer of technologies. The governmental regulation “On restriction and conditions of admission of drugs originating from foreign countries…” simplified the path to success in securing state contracts for local manufacturers. One of the undisputed successes of Pharma-2020 was the volume of investments made by foreign companies into local pharmaceutical production. Since 2007, participants of our cluster alone have invested over 50 billion rubles. This process is continuing: we have signed four agreements for establishment of pharmaceutical plants within the region. Cluster participants are actively participating in program directions like organization of manufacturing of substances, development of innovation drugs and manufacturing of import substituting medical products. Thus, Sanatmetal CIS is planning to open a plant for manufacturing of various implants and prosthetic appliances in 2018.

What novelties do you expects from the Pharma-2030 program?

On the one hand, we are expecting an expansion of current subsidies for financing of clinical research, organization of manufacturing – not manufacturing of specific substances, but creation of technological lines. On the other hand, we are relying on export support measures. The current economic situation in Russia allows our participants to expand production volumes and creates good prospects for exports of finished pharmaceutical products.


In addition:

Kaluga Pharmaceutical Cluster association was established in 2012 to provide methodological, organizational, expert, analytical and information support to the pharmaceutical cluster.

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