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VESTNIKPHARM EVOLUTION 2017

CONTENTS

FACTS AND FIGURES4. EVOLUTION STAGES OF KALUGA REGION’S CLUSTER OF PHARMACEUTICS, BIOTECHNOLOGIES AND BIOMEDICINE

OPINION8. ALEXANDER TOPORKOV

Board Member of NP KPC, Director for Communications with Governmental Agencies at SC Nearmedic, academician RAMTS: “The future of the Russian pharmaceutical industry is closely associated with Kaluga Region”

9. IRINA NOVIKOVA

Deputy General Director KRAID, Executive Director of NP KPC: “The goal of Kaluga’s pharmaceutical cluster is to be among the top three pharmaceutical clusters in Russia”

PHARM DIGEST10. The Industrial Development Fund approves co-financing for a medical production facility

10. Mir-Pharm to find accommodation in SEZ Kaluga

11. Interpharmglass – new member of the Kaluga pharmaceutical cluster

11. MiraksBioPharma to build a plant at the SEZ Borovsk site

26. Training center opens a unique “clean room” module

26. Launch of experiment for control symbol marking of pharmaceutical drugs for circulation monitoring

27. Children’s medical center to be created in Obninsk

27. New GPP and GSP rules in effect from March 1

PHARMACEUTICAL INDUSTRY12. STRUCTURE OF THE CLUSTER OF PHARMACEUTICS, BIOTECHNOLOGIES AND BIOMEDICINE

14. IN-CLUSTER COLLABORATION -SYNERGETIC EFFECTS

SCIENCE AND EDUCATION16. OBNINSK PROVIDES OPPORTUNITIES FOR BREAKTHROUGHS

Interview with A. Goverdovsky, General Director of JSC SSC RF – PEI, doctor of physics and mathematics

18. SINGLE VECTOR FOR SCIENTIFIC DISCOVERY

Interview with V. Galkin, doctor of medicine, Director of the A. Tsyb MRRC – branch of NMRC of the RF Ministry of Healthcare

22. NIFHI IS THE PRINCIPAL RUSSIAN MANUFACTURER OF RADIOPHARMACEUTICAL AGENTS

Interview with V. Duflot, Innovations Director of L. Karpov NIFHI

MANUFACTURING28. IN LINE WITH THE LATEST TECHNOLOGICAL TRENDS

Interview with R. Bogarin, Project Development Director of NEARMEDIC PLUS

30. STRENGTHS AND WEAKNESSES OF CONTRACT MANUFACTURING

Interview with I. Voskoboynikova, Director of PharmVILAR holding company, candidate of pharmaceutical sciences

33. NOVO NORDISK CONTINUES TO INVEST IN RUSSIA

Interview with Sebnem Avsar Tuna, Corporate Vice-President of Novo Nordisk for Russia and CIS

36. OCPC IS DEVELOPING AS AN INNOVATIONS COMPANY

Interview with V. Puchnin, General Director of the Obninsk Chemical and Pharmaceutical Company

38. ACHIEVING MAXIMUM AFFORDABILITY OF MEDICATION

Interview with I. Yefremov, Director of BION

40. “THE HARDEST PERIOD IS OVER…”

Interview with I. BRAGINSKAYA, General Director JSC Berlin-Pharma

44. THE COMPANY’S TECHNOLOGIES ARE SECURED BY PATENTS IN 40 COUNTIES

Interview with T. Bikbov, Development Director of Partner-M, candidate of chemical sciences

47. THE KALUGA PLANT IS AIMING FOR FULL-CYCLE PRODUCTION

Interview with I. Reich, Vice President of AstraZeneca for Russia and Eurasia, General Director of AstraZeneca Russia

PUBLICATION OF THE MINISTRY FOR ECONOMIC DEVELOPMENT OF KALUGA REGION

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FACTS AND FIGURES

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of pharmaceutics,biotechnologiesand biomedicine

Phar maceu tics

Bio technol ogies

Bio medi cine

CLUSTER

evolution stages

Established in 2011. Specialization – preclinical and clinical research, development, synthesis and commissioning of manufacturing of pharmaceutical substances and radiopharmaceutical agents, industrial manufacturing of finished pharmaceutical products and substances, infusion solutions and parenteral nutrition products.

2011

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FACTS AND FIGURES

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Legal establishment of the Kaluga Pharmaceutical Cluster in the form of a nonprofit partnership (NP KPC). The previously formed Agency for Innovation Development – Center for Cluster Development of Kaluga Region (KRAID) provides methodological, organizational, expert, analytical and information cluster support, acting as the coordinator for NP KPC.

The cluster is assigned the status of a pilot innovations regional cluster by a resolution of the government of the Russian Federation, entitling it to receive subsidies from the federal budget. In 2013, the amount of regional and federal budget financing totaled 232 million rubles.

20122013

2012 2013

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Under a trilateral agreement with the Eurobiomed cluster and Bavaria cluster, NP KPC became a member of the European Cluster Platform bringing together more than 200 clusters worldwide. The cluster cooperates with the European MediconValley pharmaceutical cluster, the Pan-Hellenic Union of Pharmaceutical industries (PUPI), the BIOTURKU cluster (Finland) and others.

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FACTS AND FIGURES

2014 2015

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Federal subsidies received in 2014 (27.5 million rubles) are used to begin the creation of a Practical Training Center based at the Medical Faculty of the Institute of Nuclear Power Engineering of the National Research Nuclear University MEPhI. The first training and research laboratories are completed in 2015. The value of equipment acquired and installed with joint financing exceeds 72 million rubles. In 2016, the center’s laboratories were equipped with a “clean room” module.

In 2015, after an expert assessment performed by the European Secretariat for Cluster Analysis (ESCA) among 750 clusters, 5 Russian clusters received bronze certificates of Cluster Excellence. Among them – the Kaluga pharmaceutical cluster that received the highest rating in the Health and Medical Science category. Performance assessment was conducted by comparison with 19 leading European clusters of similar specialization.

2014

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FACTS AND FIGURES

2016

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After a competitive selection process, Kaluga’s pharmaceutical cluster was included in the list of innovation clusters for participation in the program “Development of innovative clusters - leaders of world-level investment attractiveness”, a priority project of the Russian Ministry of Economic Development. A total of 22 applications were submitted for the competition, of which 11 clusters from 11 RF constituent subjects were selected. Selection as one of the leaders entitles KPC to seek various types of support from the RF Ministry of Economic Development, other departments and development institutions to achieve advanced growth rates, develop entrepreneurship support mechanisms and integrate itself into global value chains.

Within the scope of the Russian business mission headed by Russian Deputy Minister of Industry and Trade Sergei Tsyb, NP KPC signed an agreement with one it Italy’s major clusters – C.H.I.C.O. (CLUSTER OF HEALTH, INNOVATION AND COMMUNITY). The parties agreed to exchange information and experience, implement joint projects and organize cooperation between Russian and Italian universities, research centers, medical facilities and specialized companies

Today, the REC is a participant of the RF Modern Research Infrastructure project. In 2016, 40 people completed instructional and practical training on its equipment, with eight of them later becoming laureates of the UMNIK-2015 competition. The REC is currently involved in development of 18 innovative products that are at various research stages.

Laboratories of the center for Virtual and Simulation Technologies in Medical Education based at the K. Tsiolkovsky Kaluga State University acquired special simulation equipment due to an investment of 24.3 million rubles from the federal subsidy for development of the pharmaceutical cluster.

Skolkovo Foundation and the PAM biopharmaceutical alliance signed an agreement for use of the REC as a technological site for Skolkovo resident companies. In return, 5 PAM resident companies have acquired Skolkovo community member status: NPK Medbiopharm, Tiacen LLC, Cyclomemorin LLC, Cardio-Plus LLC and Lufaten LLC.

Opening of a regional engineering center (REC) in the field of pharmaceutics, medicine and biotechnologies in Obninsk. The center was created with 77 million rubles of federal and 33 million rubles of regional investments. Private project partner – Park of Active Molecules Alliance of Competences (PAM). Public partner – KRAID.

2015

2016

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The cluster of pharmaceutics, biotechnologies and biomedicine created six years ago is currently one of the 11 national clusters included in the list of innovation leaders. It holds a bronze ESCA Cluster Excellence certificate. Its growth rate is much higher than that of the region’s other industries. Its successful development is driven by a balanced infrastructure created due to a systemic approach to current operations and strategic view of all processes evolving within the industry.

I am certain that the future of the Russian pharmaceutical industry is closely associated with Kaluga Region. It has created a truly unique “ecosystem” that embraces all aspects of development and introduction of pharmaceutical and biomedical products: research centers, small research commissioning enterprises and engineering centers, major international and Russian pharmaceutical plants (including those of “Big Pharma”), clinical centers and educational facilities. NP KPC was established to coordinate all these processes and quickly resolve potential issues. It represents the interests of all cluster members.

The cluster is currently developing cooperation links with all players of Kaluga Region’s pharmaceutical and biotechnological market. Cooperation efficiency is clearly demonstrated by Nearmedic Pharma, which used its proximity to the production complex of STADA, a major European pharmaceutical company, to build a highly efficient partnership. At design stages of its own plant, Nearmedic Pharma was contracting

manufacturing to STADA facilities in Kaluga Region. This allowed it to increase production volumes of its products three-fold even before its plant was commissioned. Apart from that, Nearmedic specialists were undergoing training and qualification enhancement at the STADA Hemopharm plant. Today, Nearmedic cooperates with the BION group on joint research for development and synthesis of new products. BION itself is a great cooperation success story. Its joint research and development projects with international pharmaceutical company Bayer HealthCare led to development of an innovative pharmaceutical compound. After production scaling, the compound was integrated into manufacturing of Elastagen, and considerably enhanced the efficiency of Teraflex – a Bayer HealthCare product. Contractually, BION is Bayer HealthCare’s sole supplier of the compound.

Each year brings new examples of long-term cooperation within the

cluster, proving that scientific, technical, manufacturing and educational cooperation established within KPC allows all participants to achieve maximum efficiency, optimize costs, create new jobs and, most importantly, move towards import substitution in the pharmaceutical sector. All these efforts are effectively supported by Kaluga Region’s administration and designated development institutions.

OPINION

THE FUTURE OF THE RUSSIAN PHARMACEUTICAL INDUSTRY IS CLOSELY ASSOCIATED WITH KALUGA REGION

ALEXANDER TOPORKOV

Member of the Board of NP Kaluga Pharmaceutical Cluster, Director for Communications with Governmental Agencies at SC Nearmedic, academician RAMTS

AFTER AN EXPERT ASSESSMENT PERFORMED IN 2015 BY THE EUROPEAN SECRETARIAT FOR CLUSTER ANALYSIS (ESCA) AMONG 750 CLUSTERS, ONLY 5 RUSSIAN CLUSTERS RECEIVED BRONZE CERTIFICATES OF EXCELLENCE. AMONG THEM – THE KALUGA PHARMACEUTICAL CLUSTER THAT RECEIVED THE HIGHEST RATING IN THE HEALTH AND MEDICAL SCIENCE CATEGORY.

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2016 was a year of significant events and achievements. The most important of them was the success in the competition of the Russian Ministry of Economic Development that in-cluded the cluster into its list of participants for the priority project “Development of innovative clusters - leaders of world-level investment at-tractiveness”. At the end of the year, the region’s government and the ministry signed an agree-ment for support of the pharmaceutical cluster. Preparation of the tender application involved elaboration and approval of the Strategy for Development of the Pharmaceutical Cluster up to 2020, which defined unique cluster participant projects that would allow us to achieve interna-tional levels in the nearest future. The cluster is expected to manufacture 50 billion rubles worth of products each year.

2016 was also a year of actual commissioning of the synchrotron at the proton medical com-plex of the A. Tsyb Medical Radiological Research Center (MRRC), and opening of a “clean room” module at the Practical Training Center of the Institute of Nuclear Power Engineering of the National Research Nuclear University MEPhI.

We participated in 19 nationwide and interna-tional events. The second international Pharm Evolution forum was a success. Three coopera-tion agreements were signed during a business mission to the Altai pharmaceutical cluster.

As far as pharmaceutical resource training is concerned, we implemented 95 educational pro-grams for retraining and qualification enhance-ment.

Another important project – Healthy Heart Days - was implemented in cooperation with STADA. Residents of Obninsk, Maloyaroslavets and Balabanovo were offered the opportunity to have their cardiovascular systems checked for free at a mobile medical center. Various devia-tions were identified for 54 of the 1168 partici-pants, two of which were urgently hospitalized for prevention of heart attacks. This socially sig-nificant project was implemented with support from KRAID and the Russian Federal Medical-Bi-ological Agency (FMBA). Hopefully, such events will become a tradition.

OPINION

We have a clear plan, a “roadmap” of measures and projects for 2017. One of the primary directions is further development of infrastructural projects. This implies, first of all, creation of a laboratory for synthesis of active pharmaceutical substances at the Practical Training Center that will be used for development of finished pharmaceutical products and “carriers” for isotopes in radiopharmaceuticals, as well as construction of a control and analysis laboratory for sanitary and environmental measurements.

Implementation of these major projects will require considerable financial investments. For this, we are relying of the federal subsidy allocated to support clusters selected for the “Development of innovative clusters - leaders of world-level investment attractiveness” project by the Russian Ministry of Economic Development. Successful completion of these projects will allow us to “close” the resource training cycle by equipping the Practical Training Center with facilities for all types of educational scientific work, including synthesis of active pharmaceutical compounds, development and design of finished dosage forms of pharmaceutical and radiopharmaceutical products, and finished pharmaceutical product quality control. It will also facilitate the process for allocation and approval of sanitary protection areas to existing and new cluster members, reduce research costs associated with scheduled

inspections of operating production facilities.

Cluster participants have plans for a number of important projects. Thus, Hemopharm and AstraZeneca will participate in a pilot project that involves marking of certain pharmaceutical products with control (identification) insignia. The project was initiated by the Russian Federal Service for Supervision in Healthcare acting on the assignment of the Russian Government’s First Deputy Chairman Igor Shuvalov. Hemopharm will begin construction of an integrated laboratory complex for localization of its R&D division in Kaluga Region. Pharm-Synthesis plans to complete construction of a microbiological laboratory for pharmaceutical product manufacturing. Work will be continued on introduction and registration of new drugs and pharmaceutical products. There are plans to commission two new production facilities – the Pharm-Synthesis plant for manufacturing of finished pharmaceutical products and the SANATMETAL CIS plant for manufacturing of implants and medical products.

There is yet another important event anticipated in 2017. NP KPC has applied for a field audit by the experts of the European Secretariat for Cluster Analysis with hopes to receive a silver Cluster Management Excellence certificate. A positive assessment will allow the cluster to remain the undisputed leader in the sector.

IRINA NOVIKOVA

Executive Director of NP KalugaPharmaceutical Cluster, Deputy General Director of the Agency for Innovation Development – Center for Cluster Development of Kaluga Region

KPC. RESULTS FOR 2016 OUTLOOK FOR 2017

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PHARM DIGEST

“Kaluga Region’s pharmaceutical cluster is developing with stability. This is reflected not only in appearance of new enterprises, but also in increased localization of manufacturing and development of cooperation. The cluster currently has 63 participants. Mir-Pharm is a company with a scientific research base that can strengthen the positions of the Kaluga pharmaceutical cluster in the Russian market”.

Anatoly ARTAMONOV, Governor of Kaluga Region

IDF APPROVES CO-FINANCING FOR A MEDICAL PRODUCTION FACILITY

MIR-PHARM TO FIND ACCOMMODATION IN SEZ KALUGA

The expert council of the Industrial Development Fund (IDF) has approved the 300-million-ruble loan for development of a new import substitution facility. Sphera-Pharm’s plant at industrial park Vorsino is expected to manufacture complex saline and amino-acid solutions for treatment of protein deficiency in blood pre- and post-surgery, as well as blood cleansing solutions for patients with acute and chronic renal diseases that are currently severely under-manufactured in Russia. Upon achievement of design production capacity in 2018, the company is expected to gain a 18-19% (value average for product range) share of the market through reduction of imports that currently represent 49% of the market. The project value is over 3.54 billion rubles, of which 2.4 billion rubles have already been invested in construction.

Overall, the fund is investing 1.5 billion rubles in four import substitution projects in Obninsk, Kondrovo and Borovsk District, which will require an additional 5.7 billion rubles in private investments.

Under an agreement between the government of Kaluga Region and Mir-Pharm, the company will build a pharmaceutical drug production facility in the Kaluga special industrial manufacturing economic zone. The company has selected a site located in Borovsk District bordering with Moscow Region. Project investments of around 450 million rubles will be used to build a production plant with capacity to manufacture 500 million pills and 100 million capsules per year. Mir-Pharm manufactured products are distributed not only in Russia but also in several neighboring countries. A number of them are included in the list of vital and essential pharmaceutical drugs. Mir-Pharm is successfully implementing an import substitution program that allows it to replace expensive imported products with affordable national equivalents of adequate quality.

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PHARM DIGEST

“The advantages of Kaluga Region as a center for localization of pharmaceutical production is its beneficial geographic location that provides access to the high-capacity consumer market of central Russia and its modern transport and logistics infrastructure that opens routes to pharmaceutical markets in Europe and Asia. For development of the pharmaceutical industry, the region has established an efficient system of support for innovation activities, which includes an engineering center, business incubators, a high-tech technopark, etc. The infrastructure in continuously improved – today we offer clear and transparent conditions for accommodation within the region’s industrial sites, relieving investors from infrastructural risks, and offer consulting assistance in the “single window” format. We are currently in the process of filling up the Borovsk site of the Kaluga special industrial manufacturing economic zone. We expect it to become a center for major pharmaceutical manufacturers. Considering the industry’s specifics, we have developed special tax regimes for pharmaceutical manufacturers, linking starting dates of taxation grace periods not to their construction processes, but to issue dates of required licenses”.

Anna TROFIMOVA, Deputy General Director, Agency for Regional Development of Kaluga Region

International investment company MMTI (Hong Kong) will invest in construction of an Interpharmglass plant for manufacturing of primary pharmaceutical packaging. An agreement on the matter was signed with the company’s representative office in 2016. The plant will be built in the Kaluga SEZ. For its facility, the company chose a 15-hectare site in Lyudinovo District. Interpharmglass Kaluga plans to produce neutral borosilicate glass for manufacturing of pharmaceutical glass tubes, ampules, flasks and cartridges. The plant’s range will allow it to replace imports of highly-processed national materials – silica sand, caustic ash, potassium carbonate, etc. – with primary pharmaceutical packaging. Such packaging has high potential for exports to countries with advanced pharmaceutical industries, while not classifying as a primary good. The total amount to be invested in the project is 4.763 billion rubles. Commissioning of the first production line is scheduled for the 1 quarter of 2018, the second and third – for 2019 and 2020.

The agreement between Kaluga Region and MiraksBioPharma covers the implementation of an investment project involving construction of a plant in the Kaluga SEZ. The company selected a 6.8-hectare site in Borovsk District. The total amount of investments is 3 billion rubles. The plant will manufacture pharmaceutical substances and finished pharmaceutical products. MiraksBioPharma is the developer and manufacturer of innovative non-hormonal drugs used for comprehensive treatment of mastopathy, uterine myoma, papilloma viral infection, as well as preventive treatment for breast and ovarian cancer, cervix carcinoma and other diseases. All products are manufactured according to GMP standards and are distributed in Russia and countries of the Customs Union.

INTERPHARMGLASS – NEW MEMBER OF THE KALUGA PHARMACEUTICAL CLUSTER

MIRAKSBIOPHARMA TO BUILD A PLANT AT THE SEZ BOROVSK SITE

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PHARMACEUTICAL INDUSTRY

STRUCTURE OF THE CLUSTER OF PHARMACEUTICS, BIOTECHNOLOGIES AND BIOMEDICINE

70% share of innovation companies

9,020 people employedby organizations participating in the cluster

3,626 work at armaceutical plants

80% of cluster products - finished pharmaceutical products

>

38 small innovation and design companies

+

63 enterprisesand organizations arepart of the cluster

PRODUCTION COMPANIES

OUTPUT VOLUME GROWTH for cluster companies is significantly higher than the average growth rate of the Russian pharmaceutical product market and growth rates of other industries in Kaluga Region:AstraZeneca Industries

Berlin Pharma (BerlinChemie/Menarini)

Berachim

BION

Iloks

SC Mir-Pharm (Mir-Pharm, OCPC)

NEARMEDIC Plus

Novo Nordisk Production Support

RPG PharmVILLAR

Partner-M

Portioned Products

Sphera-Pharm

Pharm-Synthesis

Hemopharm (STADA CIS)

12.7 bln rublesin 2014, 13% growth against 2013

19.0 bln rubles in 2015, 49.6% growth against 2014

7.4 bln rublesin 2015

27.5 bln rubles in 2016

>35.0 bln rublesby the end of 2017

>

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PHARMACEUTICAL INDUSTRY

STRUCTURE OF THE CLUSTER OF PHARMACEUTICS, BIOTECHNOLOGIES AND BIOMEDICINE

Leypunsky Institute of Physics and Power Engineering

Karpov Scientific Research Institute of Physics and Chemistry

Scientific Research Company Medbiopharm

Institute of Nuclear Power Engineering of the National Research Nuclear University MEPhI

Tsyb MRRC – branch of NMRC of the RF Ministry of Healthcare

Tsiolkovsky Kaluga State University

Agency for Innovation Development – Center for Cluster Development of Kaluga Region

Agency for Regional Development of Kaluga Region

Regional Engineering Center (REC) for the pharmaceutical industry

NP KPC

Park of Active Molecules Alliance of Competences

High Tech Technopark

12 industrial parks: built-to-suit / brownfields / greenfields

Kaluga special economic zone: 2 sites with total area of 1042 hectares

600employees of cluster companies completed training in 2016

>

SCIENCE AND EDUCATION INFRASTRUCTURE

Nearly 1000 people are currently undergoing training at medical faculties, departments of pharmaceutical and radiopharmaceutical chemistry, general and special chemistry, radionuclide medicine, biology, material engineering, nuclear physics and ecology to support the pharmaceutical cluster. Training is conducted under 90 specialized programs.

OUTPUT OF FINISHED PHARMACEUTICAL PRODUCTS

1015 varieties of pharmaceutical products

varieties of pharmaceutical products

2013

59varieties of pharmaceutical products

2015

109 varieties of pharmaceutical products

2016

139 varieties of pharmaceutical products

At registration stage of registration

In long-term development

— value of research and development works and projects performed by cluster participants in 2016

bln rubles2.5

ВЕСТНИК14

PHARMACEUTICAL INDUSTRY

IN-CLUSTER COLLABORATION

SYNERGETIC EFFECTS

NEARMEDIC PHARMA ACTIVELY COLLABORATES WITH CLUSTER PARTICIPANTS IN SEVERAL DIRECTIONS:

Collaboration with Hemopharm allowed the company to optimize its plant design process and to arrange contract manufacturing of significant volumes of Kagocel at Hemopharm production facilities even before its own plant was commissioned. In addition, dozens of high-grade specialists (process engineers, chemists, operators) underwent training at Hemopharm to prepare for work at the NEARMEDIC PHARMA plant.

01 02 Collaboration with the cluster’s small and medium innovation companies is demonstrated by NEARMEDIC PHARMA’S cooperation with BION – one of Russia’s leading developers of pharmaceutic substances.

NEARMEDIC PHARMA + HEMOPHARM + BION

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ВЕСТНИК 15

PHARMACEUTICAL INDUSTRY

Cluster participants managed to achieve considerable synergetic effect in joint scientific research and development efforts. Thus, the Institute of Nuclear Power Engineering became the principal contractor under the state contract for development of 99mTc, 68Ga and 188Re-based radiophar-maceuticals for efficient prostate cancer diagnostics and treatment executed within the scope of the federal special-purpose program “Research and Development in Priority Directions of the Rus-sian Scientific and Technological Complex in 2014-2020” (Measure 1.4). Co-contractors are cluster participants the Tsyb MRRC of the RF Ministry of Healthcare and the Karpov Scientific Research Institute of Physics and Chemistry. Participation in this important project will contribute to further development of competences of cluster participants and their mutually beneficial cooperation.

Mir-Pharm and STADA CIS have executed a 50 million euro agreement for license assignment and supply of innovation pharmaceutical products. Under the arrangement, Mir-Pharm plants will be manufacturing pharmaceutical compounds in accordance with GMP standards and supplying them to STADA CIS for further use in manufacturing of finished pharmaceutical products. This technological chain allows Mir-Pharm to scale production of innovation pharmaceutical substances and begin manufacturing of pellets (microcapsules), and STADA CIS – to expand the range of its manufactured medical products to 50 varieties.

Cluster participants are cooperating on development and application of the W-188/Re-188 rhenium generator for treatment of oncological diseases, ophthalmic applicators for internal radiotherapy of malignant neoplasms in ocular organs and I-125 micro sources for brachytherapy. The project based at the Leypunsky Institute of Physics and Power Engineering is implemented in collaboration with the Karpov Scientific Research Institute of Physics and Chemistry (NIFHI), with further practical testing of its results at the Tsyb MRRC center for brachytherapy of prostate cancer. Local manufacturing of micro sources, for which there previously was virtually no alternative, provides Russian clinics with essential radiopharmaceuticals, allowing them to considerably reduce the cost of performed surgeries.

Since 2015, Mir-Pharm, the Obninsk Chemical and Pharmaceutical Company, BION and NEARMEDIC PLUS are cooperating on a number of import substitution projects. Their significance for the Russian pharmaceutical industry is in the companies’ expansion of the range of locally produced finished pharmaceutical products and pharmaceutical substances, 70 to 85% of which were previously imported. This cooperation resulted in 2 new medications and 2 pharmaceutical products being brought to the market as well as in completion of works for creation of a technological platform for chemical synthesis of pharmaceutical compounds for manufacturing of cytostatic drugs. 12.5 million rubles in federal subsidies allocated for joint projects largely contributed to facilitation of their progress, allowing the companies to save 20-25% on costs.

INSTITUTE OF NUCLEAR POWER ENGINEERING OF THE NATIONAL RESEARCH NUCLEAR UNIVER-SITY MEPHI + TSYB MRRC OF THE RF MINISTRY OF HEALTHCARE + KARPOV SCIENTIFIC RE-SEARCH INSTITUTE OF PHYSICS AND CHEMISTRY

NEARMEDIC PHARMA + HEMOPHARM + BION

MIR-PHARM + STADA CIS

LEYPUNSKY INSTITUTE OF PHYSICS AND POWER ENGINEERING + KARPOV SCIENTIFIC RESEARCH INSTITUTE OF PHYSICS AND CHEM-ISTRY + TSYB MRRC OF THE RF MINISTRY OF HEALTHCARE

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2 4MIR-PHARM – OCPC + NEARMEDIC PLUS + BION

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In 2016, SC Rosatom and Kaluga Re-gion signed a unique agreement. The signing ceremony took place at the Institute of Physics and Power Engi-neering, which experts believe man-aged to invoke the state corporation’s interest in Obninsk’s scientific po-tential. What drives this interest?

The state corporation has developed a new vision of the future. It now has three prior-ities. First, to reduce costs, i.e. to improve the efficiency of each employee. Second, to develop new products. Third, to enter global markets. These are the three whales that Rosatom currently stands on. Obninsk has quite a few enterprises that fit into this strategy that are focused on creating new products and that have all the chances for penetration of international markets. Inci-dentally, in the global context, nothing is of as high demand as humanitarian products – for medicine, education, ecology, securi-ty. Kaluga Region’s capabilities are unique in this sense – it’s home to the Medical Ra-diological Research Center, the All-Russian Research Institute of Agricultural Radiology and Agroecology, Scientific Technical Com-pany Typhoon, the Institute of Physics and

Power Engineering and the Scientific Re-search Institute of Physics and Chemistry. It has tremendous educational potential. In Obninsk, there’s the Rosatom Qualification Enhancement Center, postgraduate depart-ments of scientific institutes, and the basic higher education facility - the Institute of Nuclear Power Engineering of the National Research Nuclear University MEPhI. Just re-cently, a nuclear class was created. There is also the Atomstroy Scientific Research and Design Institute of Installation Technology and a great production facility at the Signal plant. Obninsk provides great opportunities for breakthrough. I’m glad that people at Rosatom have an understanding of where the corporation should be moving and are making their stake on technologies for the benefit of the people.

The Institute of Physics and Power Engi-neering is mastering new high-potential di-rections in research and development aim-ing at bringing their results to the market, including international markets. In 2016, the institute received a registration certif-icate for mass production of micro-sources for brachytherapy, making surgery afford-able for tens of thousands of people.

This is just one of our projects. Another one is microspheres with yttrium-90 that are efficient for treatment of hepatic onco-

SCIENCE AND EDUCATION

Andrei GOVERDOVSKY, General Director of JSC SSC RF – PEI, doctor of physics and mathematics

OBNINSK PROVIDES OPPORTUNITIES FOR BREAKTHROUGHS

ВЕСТНИК 17

logical diseases. Yet another is the radium-223 alpha-emitter that is provisionally called the metastatic lesion killer. By mechanically ad-justing this set, you can treat almost all types of oncological diseases. This is not available anywhere else in the world. 2016 was a break-through year in this regard. These technolo-gies were not invented today. However, their movement “towards the consumer” was greatly facilitated with the appointment of the Medical Radiological Research Center’s new director Andrei Karpin. He clearly stated what he needed for treatment of patients be-coming, essentially, our customer.

Today, the need for support of ad-vanced scientific research is discussed both on federal and regional levels. Can it be said with reference to the Institute of Physics and Power Engi-neering, that this support has become tangible?

Of course, we do feel this support. Every year, our scientists win competitions for state subsidies provided by the Russian Ministry of Education and Science, the Russian Science Foundation, the Russian Foundation for Ba-sic Research, etc. At the same time, we would like it to be taken into account that our scien-tific developments often require significant time and one year of financing is not enough. We need long-term financing for 5-10-year long projects.

What is the current professional framework like? Is the number of young scientists on the rise at the in-stitute?

Our institute was the first scientific center A.E. Likhachev visited in 2016, after his ap-

pointment as General Director of Rosatom. He said that he was very impressed by our young scientists, their eyes burning with enthusiasm, by their ideas and knowledge. Moreover, we now have a large group of young people that we intend to promote in the most active way. We’re currently in the process of forming a group of 25 people (aged 22 to 40) that will be the so-called pool of the general director’s preemptors. They can evolve into a very good team that will lead the institute further – with physicists, chemists, technol-ogists, lawyers, economists, engineers and designers.

Our specialists, including young scientists, no longer work to put some report on the shelf, they know exactly what and why they are doing. Each result must bring benefits to people.

Who else and in what directions does the institute collaborate with?

One of the most vivid cooperation exam-ples is the joint project implemented by the Institute of Physics and Power Engineering, the Medical Radiological Research Center and the Karpov Scientific Research Institute of Physics and Chemistry in the field of nu-clear medicine. It involves development and mass production of iodine-125 micro-sources. The locally produced agent costs several times less than imported equivalents and is just as efficient. Within the scope of the Obninsk project, treatment has already been provided to more than 50 oncologic patients, and our institute’s employees are already working on a new type of micro-sources to treat not only prostate cancer, but other oncologic diseases as well. Delivery of these micro-sources and other products of our “non-energy” projects to new, including international, markets – is another objective that the institute is facing today.

ПРОИЗВОДСТВО SCIENCE AND EDUCATION

JSC “RF State Scientific Center – A.I. Leypunsky Institute of Physics and Power Engineering” is one of Rosatom state corporation’s leading scientific and research centers. It has conceived and implemented ideas for construction of fast fission-neutron reactors and reactors with direct conversion of nuclear energy into electrical energy. The Institute of Physics and Power Engineering is a global leader in application of liquid metals as heat sources in nuclear power stations with fast reactors, marine vessel and space-based nuclear power units. Its works in the fields of nuclear physics, nuclear power technologies and nuclear security have gained global recognition. The institute conducts experimental research in the fields of nuclear laser physics and plasma physics, radiation material science, radiochemistry and new science-intensive technologies, including nano-technologies, hydrogen energy technologies and radiation medicine.

COMPANY DETAILS

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Vsevolod GALKIN, doctor of medicine, professor, Director of the A. Tsyb MRRC – branch of NMRC of the RF Ministry of Healthcare

SINGLE VECTOR FOR SCIENTIFIC DISCOVERY

SCIENCE AND EDUCATION

THE A. TSYB MRRC — BRANCH OF NMRC OF THE RF MINISTRY OF HEALTHCARE

There’s no other place in Russia and, probably, in the world with such a great variety of means for cancer treatment as in Obninsk. Without exaggeration, the science city can be called the center for radiation medicine and radio pharmaceutics that is solving the most complex problems faced by modern medicine. What forms the center’s core today?

In the modern world, science is no longer represented by a lone scientist with a pen and paper in hand screaming “Eureka!”. It is generally represented by scientific institutions with many years of experience, well-equipped laboratories and testing sites, by close cooperation of establishments of various specialization, plants and research centers that join efforts to achieve a specific goal.

Distinguished scientific schools began forming in our city more than 60 years ago. At the Leypunsky Institute of Physics and Power Engineering – one of the leading Russian state science and research institutions in the field of nuclear energy, the Karpov

Scientific Research Institute of Physics and Chemistry – the country’s leading radiation and chemistry center, and many others. An important role for consolidation of scientific potential and creation of a nuclear medicine center in Obninsk was played by the establishment of the National Medical Radiological Research Center, of which the Tsyb MRRC is currently a significant part.

This combination of efforts and knowledge of the city’s scientific schools, development of a single vector for scientific discovery and advancement with consideration of specifics of each institution allows them to solve the most complex scientific and practical problems, including those of significance to modern medicine. Cooperation facilitated the development and advancement of an entire range of unique national medical technologies, including those associated with ionizing radiation.

Speaking about technologies, how are they conceived?

More than 10 years ago, a group of scientists from the MRRC urological department came up with the idea of

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using radioactive iodine for treatment of malignant tumors of the prostate gland, drawing from international experience and laboratory research. Sodium iodide of the highest medical standard was produced by the Karpov Scientific Research Institute of Physics and Chemistry in Obninsk and packed into a strand by a Belgium company. This facilitated the start of clinical testing of a product that was at that stage not fully localized. Simultaneously, the Institute of Physics and Power Engineering and our center began development of our own technologies for strand creation and equipment of production facilities for their mass production. It was not an easy job! However, in 2015, through cooperation of Obninsk’s institutes, Russian clinics received a fully localized high quality pharmaceutical product for low-dosage internal radiotherapy of prostate cancer.

There are multiple examples of collaboration among the city’s scientific and research institutions targeted at development of unique technologies, but I will speak about just two more. The first is a collaboration project between the Institute of Physics and Power Engineering and the Medical Radiological Research Center for development of an innovation radiopharmaceutical product based on microspheres of human blood albumin and yttium-90 radionuclide to be used in treatment of hepatocellular carcinoma. The second is joint project between the Tsyb MRRC and the Karpov Institute of Physics and Chemistry for preclinical testing of a radiopharmaceutical product based on samarium-153 embedded in a thermosensitive capsule to be used for local radiation treatment.

Naturally, it is impossible to cover all projects and achievements in a short interview. However, it wouldn’t be right not to mention national technologies in the field of hadronic radiotherapy…

It’s true. Much more attention is being paid to radiotherapy in our country in recent years, specifically hadronic radiotherapy. Our center was the one that developed technologies for treatment with all types of hadronic therapy, but their implementation was only possible through cooperation with many institutions. I must say that these projects could only be realized due to strong support from the Governor and the administration of Kaluga Region. I’m implying projects like development of a complex from neutron and neutron capture therapy with the use of a

pressurized water reactor that was implemented with the Karpov Institute of Physics and Chemistry; or development of a complex for neutron therapy with the use of a compact NG-24 neutron generator that was fulfilled in partnership with the N.L. Dukhov All-Russian Scientific Research Institute of Automatics. The methodology for ionic therapy un the basis of the U-70 accelerator was developed with Institute of High Energy Physics of the Kurchatov National Research Institute.

Last year you demonstrated a unit that will allow more effective treatment of oncological diseases – the Prometeus proton therapy complex. How was its concept conceived, what is the essence of the project and its advantages?

The Tsyb Medical Radiological Research Center is a branch of the National Medical Radiological Research Center of the Russian Ministry of Healthcare. It was founded in 1962 for development of methods of radiation therapy, prevention and treatment of radiation injuries, research of biological and medical effects of ionizing radiation.

Today, the MRRC is Russia’s leading

institution dealing with issues of radiology and radiation medicine, development and medical application of high-tech radiological methods of diagnostics and treatment of patients with oncologic and non-oncologic diseases. Most of the center’s developments are based of the principles of improved efficiency treatment, organ conservation and enhancement of the quality of life.

ADVANTAGES

Comprehensive approach allowing the center to perform required examinations and treatment and provide the patient with access to innovation technologies for prevention, diagnostics and treatment of malignant tumors.

COMPANY DETAILS

ПРОИЗВОДСТВО SCIENCE AND EDUCATION

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It has been established quite some time ago that exposure of biological tissue to a proton (nucleus of the hydrogen atom) beam results in a sharp increase in the number of ionizations, i.e. destruction of molecules at the end of the proton run. This allows to achieve higher dosage absorption in the depth of the tumor while causing minor damage to surrounding healthy tissue. To implement this idea, around 60 proton therapy centers were created worldwide; however, vast introduction of this undoubtedly progressive method of radiation therapy is hindered by the need for development of highly complex and expensive accelerators and virtual lack of medical support (dosimetry, focusing, patient positioning, etc.).

In recent years, the RAS Lebedev Physical Institute and Protom JSC

developed and produced a compact and significantly cheaper proton accelerator named Prometeus. With support from the Ministry of Industry and Trade and the Ministry of Healthcare of Russia, specialists from the Tsyb MRRC and Protom performed necessary experimental, preclinical and clinical tests, obtained the first Russian permits for clinical application of the complex, arranged the required medical support and began treatment of patients with various tumors in the head and neck.

Unique accuracy of targeting of the fine scanning proton beam and reduction of the probability of damaging surrounding vital structures makes this approach truly irreplaceable, for example, in radio therapy of brain tumors.

Medical specialists and scientists from the MRRC and Protom have already

applied Prometeus complexes to provide treatment to more than 80 patients in Protvino and Obninsk with excellent preliminary results.

Has there been any progress with the idea for creating an all-Russian center of nuclear medicine in Obninsk that is being discussed on the governmental level?

After the approval of the plan of measures for development of nuclear medical centers by the Russian government in 2015, Obninsk acquired a viable opportunity to become the locomotive for advancement of the most high-tech and science-intensive directions in medicine. Advantages of the country’s first science city in this field are undisputable. It is a concentration of federal enterprises of the nuclear physics segment, which are capable of developing and multiplying advanced radio pharmaceutics, designing and producing synchrotrons for proton, neutron and ionic radiotherapy. The region has the necessary infrastructure and technological base for introduction of the newest nuclear medicine technologies into clinical practice. There is active development of innovation pharmaceutical companies, and the National Research Nuclear University MEPhI is training specialists in the respective field. Clearly, this interest in radiological technologies needs to be consistently developed, and further expansion of collaboration of science, education, production, business and governmental agencies will allow the future center of nuclear medicine to become a scientific and production asset for development of the national radiopharmaceutical industry, a universal base for provision of high-tech medical services of radiation diagnostics and treatment.

WE HAVE OBTAINED THE FIRST RUSSIAN PERMITS FOR CLINICAL APPLICATION OF THE PROMETEUS PROTON THERAPY COMPLEX AND BEGAN ACTUAL TREATMENT OF PATIENTS WITH VARIOUS TUMORS IN THE HEAD AND NECK.

SCIENCE AND EDUCATION

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What normative document regulates commercial medical services?

Apart from the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation”, there are regulations on provision of paid services by medical organizations that establish the procedure and terms for provision of such services. The procedure for provision of commercial medical services is also regulated by

the law “On Protection of Consumer Rights”. Providers of medical assistance must also comply with normative acts of the Russian Ministry of Healthcare. And, of course, medical activities are governed by the Federal Law “On Licensing of Certain Types of Activity”.

How does a consumer formalize relations with a medical facility that provides commercial medical services?

By signing a contract for provision of medical services that establishes such terms as the scope of services, period of provision of services, their price and guarantees of the parties.

Obviously, people are prepared to pay for healthcare. What services are of most demand?

There is growing demand for high-tech types of medical assistance and for services of high quality. Consumers are prepared to pay for quality and this results in growth of popularity of multi-disciplinary clinics and

medical institutions, where patients can receive comprehensive medical assistance. In modern conditions, with an overwhelming deficit of time, there is growing demand for services that can be received on weekends and at night. Medical tourism is also relevant.

Medical institutions assign attention to training of their specialists, including by organizing internal master classes, lectures and training courses, by using remote learning programs. Could your agency contribute to these efforts?

Of course. Our goal is to consult and provide information support to small and medium businesses operating in the fields of trade, science, education, healthcare, culture, social security, employment, physical culture and sports, as well as in other cases established by federal laws. Improvement of the quality of services provided to consumers is the agency’s direct objective.

COMMERCIAL MEDICINE: PRESSING ISSUES

Alla DEMINA, acting General Director of the Agency for Development of Small-Form Trade and Utility Services in Kaluga Region

In recent years have demonstrated a consistent trend for denationalization of healthcare and growth in the share of commercial medicine. The sector is becoming more attractive. This raises the question of the quality of provided services and transparency of the regulatory framework in healthcare.

*Based on materials provided by the Agency for Development of Small-Form Trade and Utility Services in Kaluga Region, an autonomous state institution of Kaluga Region

COMMENTARY

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What results achieved by NIFHI in recent years do you consider the most significant?

Our institute is the principal manu-facturer of radiopharmaceuticals and medical equipment (technecium-99m generators) in Russia. Our share on internal markets of technecium-99m generators and iodine-133 based radio-pharmaceuticals are 85% and 80%, re-spectively. NIFHI is also the exclusive Russian market supplier of radiophar-maceuticals based on samarium-153 and carbon-14. Our only competitor in manufacturing of radiopharmaceuti-cals in Russia is the Medradiopreparat plant of the Federal Medical and Bio-logical Agency’s Federal Center of Nu-clear Design and Development. There are no other significant manufactur-ers of radiopharmaceuticals.

In recent years, there has been rap-id development in manufacturing of one of the key medical purpose radio-nuclides – molybdenum-99, which is used to charge technecium-99 gener-ators. So far, we have achieved a mo-lybdenum-99 production level of 300 curie per week. Radiopharmaceuticals are “highly perishable”, but our capac-

ities allow us to consistently supply this essential product to all specialized clinics in Russia on a weekly basis. Ra-diopharmaceuticals are also supplied to the Crimea, Armenia and Kazakh-stan.

What is the scope of application of NIFHI products?

More than 200 Russian clinics suc-cessfully apply our products for diag-nostic and therapeutic purposes. They are used in a range of diagnostic pro-cedures: scintigraphy of the thyroid gland, salivary gland and the brain; radionuclide angiography and ventric-

Vladimir DUFLOT, Innovations Director of L. Karpov NIFHI

NIFHI IS THE PRINCIPAL RUSSIAN MANUFACTURER OF RADIOPHARMACEUTICAL AGENTS

SCIENCE AND EDUCATION

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ulography. The effluent from the tech-netium generator is used for multiple production of a sterile sodium pertech-netate solution that is used a separate radiopharmaceutical substance, and to produce radiopharmaceuticals with technecium-99m with the aid of desig-nated reagent kits.

Iodine-131 based products are used for diagnostics and treatment of socially significant diseases – for examination, scanning and scintigraphy of the thy-roid gland, including for diagnostics of dysthyroidism, A-cell thyroid cancer and metastases, kidney functionality, etc.

A unique samarium-153 based prod-uct is used by oncologists for reduction of pain intensity and hindering of met-astatic tissue growth. It is also used in rheumatic practice.

The carbon-14 based radiopharma-ceutical that has no analogues in Rus-sia and that is used for detection of Helicobacter pylori (Hp) through a non-invasive breath test is, unfortu-

nately, underused in medical practice due to its insufficient promotion.

What projects in the fields of ra-dio pharmaceutics and nuclear medicine is the institute work-ing on today?

We have successfully completed the governmental contract for preclinical testing of an innovation therapeutic ra-diopharmaceutical product based on io-dine-131 marked metaiodobenzylguan-idine used for treatment of suprarenal pheochromocytoma. The radiopharma-ceutical will be used for diagnostical and treatment of malignant suprarenal neuroendocrine tumors (pheochromo-cytoma) and for radionuclide therapy of a range of malignant neuroendo-crinal tumors, including the paragan-

glioma, neuroblastoma and thyroid medullary carcinoma, irresectable metastases of neuroendocrinal tracts and carcinogenic tumors. The radio-pharmaceutical product is especially valuable for neuroblastoma treatment. Combination of a diagnostic and ther-apeutic drugs based on the same car-rier molecule but with differing levels of dosage activity is the most efficient method for treatment of malignant tu-mors that guarantees positive therapy results. In case of successful clinical testing, iodine-131 marked metaiodo-benzylguanidine will be registered in Russia. We are also actively working under contracts within the scope of the federal special-purpose program “De-velopment of the Pharmaceutical and Medical Industry in Russia up to 2020”. Our directions are preclinical testing of a radiopharmaceutical product based on samarium-153 embedded in a ther-

L. Karpov NIFHI JSC was established in 1957 (at that time – as the Obninsk branch of the Karpov Scientific Research Institute of Physics and Chemistry) as a radiation and chemistry center equipped with powerful cobalt-based gamma units, electron accelerators and a research pressurized water nuclear reactor for studying of effects of various types of radiation on substances and materials. Today, NIFHI’s principal objectives include development and implementation of radiochemical, nuclear physics and radiation chemistry

technologies, research of interaction of nuclear and ionizing radiation with substances and materials. Its main directions include the creation of a spectrum of diagnostic and therapeutic radiopharmaceutical products (RPP); researching of mechanisms of interaction of ionizing radiation with substances, development of technologies for radiation synthesis and modification of chemical compounds, provision of radiation exposure services for different types of materials, products, etc.

COMPANY DETAILS

ПРОИЗВОДСТВО SCIENCE AND EDUCATION

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mosensitive capsule to be used for lo-cal radiation treatment and preclinical testing of a radiopharmaceutical prod-uct based on samarium-153 embed-ded in a polymer capsule for radiation treatment of spinal metastatic tumors. Both products are unique and have no analogues anywhere in the world. Our institute has already received two pat-ents for radiopharmaceuticals based on the β-radiating radioactive samar-

ium-153 isotope, and another patent application has been submitted for an invention that is currently undergoing expert evaluation.

Our further plans include develop-ment of products based on yttrium-90, xenon-113, etc. Our twin-needle tech-necium-99m generator, for which we just recently obtained an industrial model patent, is undergoing a regis-tration procedure required for com-missioning of its production. Several investment projects – expansion of molybdenum-99 production facilities, creation of an experimental production facility for separation of fission xenon for radiopharmaceuticals and modern-ization of iodine-131 and samarium-153 based radiopharmaceutical production to comply with GMP standards – are at various stages of completion. Any day now, we are expecting to launch the GMP-modernized technecium-99m

generator charging shop to enter inter-national markets with its products.

What decisions and at what lev-els do you think are required for intellectual products to become industrial ones within short pe-riods?

Science-intensive products, such as medical purpose radionuclides and ra-diopharmaceuticals that are manufac-tured, for example, by Polatom, have a lower cost and therefore a lower price in comparison with our products. In Poland, the state subsidizes costs asso-ciated with utilization of nuclear reac-tors. We, on the other hand, are forced to include them into our prime cost, which makes our products more expen-sive on the internal market and uncom-

petitive on international markets. I am certain that support provided by our government should also be thoroughly thought through – that’s the only way for it to be efficient.

Can NIFHI be referred to in the context of development of inter-national cooperation? Are there established collaborations with-in the Kaluga pharmaceutical cluster?

Through our operator V/O Isotope JSC, we have arranged regular supplies of molybdenum-99, a vital medical pur-pose radionuclide, to Iran, South Korea and Malaysia. Test supplies are being made to Japan, Brazil and countries of South East Asia. We are examining the possibility of supplies of feed isotopes samarium-153 and iodine-131. I am cer-tain that NIFHI has much greater po-tential as far as international coopera-tion is concerned.

There is rather successful develop-ment of cooperation with Russian com-panies (NIIAR JSC, IRM JSC) and scien-tific centers (A.I. Burnazyan Federal Medical and Biophysical Center).

Within the pharmaceutical cluster, we are closely collaborating with the Tsyb MRRC. The Institute of Physics and Power Engineering uses our mo-lybdenum-99 to manufacture a modifi-cation of its technecium-99 generator.

We cooperate with the National Re-search Nuclear University MEPhI in preparation of applications in the field of nuclear medicine for submission to various foundations. Thus, we pre-pared an application for the Ministry of Education and Science project 5-100 “Development of New Selective Ra-diopharmaceuticals and Methods for Nanovector Delivery of Radionuclides to Cancerous Tumors”. This project will allow our institute and Russian science in general to advance to lead positions on the global level.

WE ARE SUPPLYING MOLYBDENUM-99, A VITAL MEDICAL PURPOSE RADIONUCLIDE, TO IRAN, SOUTH KOREA AND MALAYSIA. TEST SUPPLIES ARE BEING MADE TO JAPAN, BRAZIL AND COUNTRIES OF SOUTH EAST ASIA. NIFHI HAS GREAT POTENTIAL AS FAR AS INTERNATIONAL COOPERATION IS CONCERNED.

SCIENCE AND EDUCATION

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Some backgroundOur clients joke that EMS is something

from the realm of space science. And they’re partially right. EMS (electrical myostimulation) was first applied for post-flight rehabilitation and adaptation of soviet cosmonauts. Thereafter the technology found successful application in medicine and sports, and is now enjoying tremendous popularity throughout the world.

How does it work?Our brain controls contraction and

relaxation of muscles through electronic impulses. The exercise unit generates the same types of impulses that, through a tight-fitting suit, provoke muscles to work with extremely high intensity – tens of cycles per second!

Why is EMS more efficient than regular gym training?

By effect, one 20-minute EMS session is equivalent to a 2-hour gym workout. This is due to the fact that it SIMULTANEOUSLY activates over 500 muscles! What is more valuable is that it also stimulates deep muscles and stabilization muscles. Thus, to achieve results, you only need 20 minutes! You don’t even need to get your own sporting gear – the club has individual sets prepared for each client. All you need is a pair of sneakers.

How does the training session proceed?

All sessions at JustFit Exclusive Club

are supervised by personal instructors with specialized training. The EMS-unit is adjusted in accordance with the capabilities and goals of each client. The session is composed of various exercises, starting from a static plank and finishing with intensive interval-based complexes designed in accordance with the Tabata protocol. Each session is followed by a lymphatic drainage massage.

Who is EMS-fitness for?Apart from general precautions that

relate to sports, EMS-workouts are not suitable for pregnant women, for people using cardiac pacemakers, people with oncological diseases, epilepsy and inguinal hernia. In cases of spinal disc herniation, when EMS can be recommended, it is necessary to pre-consult a doctor.

The impulses are absolutely safe for humans so even breastfeeding mothers can have regular EMS-workouts. We actually have discounts for young mothers, and they can – and should – bring their youngsters with them as the fitness center is equipped with play areas, playpens and toys.

What problems can be solved through EMS?

Just 2-3 weekly 20-minute sessions will allow you to lose excessive weight, get rid of cellulitis, strengthen your muscles, get rid of back, leg and neck pains, build muscle mass, streamline your figure, restore muscles after injuries, stimulate metabolic processes, normalize your pressure and improve endurance. A single

session can burn up to 500 kcal! And, of course, you will be able to solve the key problem – lack of time for workouts.

Without doubt, special attention should be paid to healthy nutrition. That is why we offer our guests an important bonus by developing individual meal plans for them.

FITNESS FOR THOSE WHO NEVER HAVE TIMEThe intriguing EMS-fitness phenomenon is rapidly coming into fashion. What is this training and what differentiates it from a regular gym workout? We decided to set the record straight and applied to specialists from the JustFit Exclusive Club at 33 Korolyova St. in Kaluga. After all, they know all the secrets of the technique.

A WORKOUT LASTS JUST 20 MINUTES AND NOT A MINUTE MORE!

We look forward to seeing you at:33 Akademika Korolyova St.

+7 (961) 121-11-11facebook.com/justfit.kalugavk.com/justfit_kalugainstagram.com/justfitkalugakaluga.justfitclub.ru

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PHARM DIGEST

TRAINING CENTER OPENS A UNIQUE “CLEAN ROOM” MODULE

The new OINPE training block has opened a clean room module for the Center of Practical Training of Pharmaceutical Industry Specialists. The project was launched to resolve the issue of specialized resource availability encountered by pharmaceutical cluster participants and is currently the first and only project of its kind in Russia. In 2015, the center’s training and demonstration laboratories were equipped with a clean room module of educational and research designation.

The first stage of the project involved the acquisition and installation of a clean room module with a set of engineering equipment. The second project stage was implemented in 2016, resulting in creation of a clean room testing laboratory outfit with unique measurement and research equipment. The project was financed through a federal subsidy provided to Kaluga Region for development of the innovation cluster of pharmaceutics, biotechnologies and biomedicine.

Russian Prime Minister Dmitry Medvedev signed a regulation “On conducting of an experiment for control (identification) symbol marking and monitoring of circulation of certain types of medical application drugs”. The experiment is part of the priority project “Introduction of an automated system for tracking movement of pharmaceutical drugs from manufacturer to end consumer for purposes of protection of citizens from falsified pharmaceutical drugs and effective withdrawal of counterfeit

and inferior drugs from circulation”.

Marking will be performed on a voluntary basis against applications of participants of pharmaceutical drug circulation in the period from February 1 to December 31, 2017. The document approves the general regulation on the experiment, defines its objectives, dates, participants, marking formats and responsible executive federal agencies.

DETAILS

The Obninsk Institute for Nuclear Power Engineering (OINPE) was established in 1985 on the basis of the Moscow Engineering and Physics Institute (currently – the Obninsk Institute for Nuclear Power Engineering – branch of the MEPhI national Research Nuclear University). OINPE provides training in 13 specializations, offers 3 baccalaureate directions, and 12 masters and postgraduate specializations. The faculty consists of 343 teachers, of which 53 are doctors of science, 150 - candidates of science, including 10 acting members of specialized Russian and international academies. OINPE has access to a unique experimental base of more than 15 Obninsk-based scientific research institutions with the most advanced equipment.

LAUNCH OF EXPERIMENT FOR CONTROL SYMBOL MARKING OF PHARMACEUTICAL DRUGS FOR CIRCULATION MONITORING

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CHILDREN’S MEDICAL CENTER TO BE CREATED IN OBNINSK

NEW GPP AND GSP RULES IN EFFECT FROM MARCH 1

In February 2017, the government of Kaluga Region and ValKon company signed an agreement for an investment project to build a Children’s Medical Center in Obninsk. The contracting parties have agreed to create a multi-discipline center that will provide affordable high-quality medical services to residents of Kaluga Region and the Central Federal District. The center will have advanced high-tech equipment.

The project with estimated total investments of 800 million rubles is expected to create around 450 new jobs. The medical center will accommodate an outpatient and inpatient departments for children, a surgery block with three operating rooms, a maternity welfare center, a complex for radio diagnostics with CT and MRI scanners, a pharmacy and trade and service organizations to support the medical business.

According to the Federal Service for the Supervision in Healthcare and Social Development (Roszdravnadzor), on March 1, 2017, the Russian Ministry of Healthcare’s enacted its directives approving the rules of good pharmacy practice (GPP) and good practice for storage and transportation of pharmaceuticals (GSP). These practices establish the requirements to transportation and storage of pharmaceuticals as well as the operation of pharmacies with all types of ownership. The above normative acts assign special attention to the creation and functioning of quality management systems at organizations conducting pharmaceutical activities, which will help improve the quality of services provided by pharmacies.

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Apart from finished pharmaceuticals, Nearmedic also manufactures medical products. What does the company’s product portfolio include today?

According to data provided by the IMS Health data analysis company, the Nearmedic Plus manufactured antiviral medication Kagocel has been holding the lead in sales (in natural volumes) for four years in a row. The drug is a three-time laureate of the Russian Pharma Awards (in 2014, 2015 and 2016) of Russia’s practicing physicians, and was the winner of the international Green Cross pharmacists’ award in 2015. Growth in Kagocel sales volumes indicates that the drug has gained recognition not only among the specialists, but patients as well.

The Nearmedic Group is currently introducing its range of type 1 native collagen-based medical products, Collost, to the Russian and international markets. Due to their unique qualities of a bio-resorbable implant with a

retained native structure, this range of medical products has broad application in various fields of surgery, stomatology and cosmetology. Collost products are used as a biodegradable material to fill up bone defects, for contour correction of soft tissue, and for securing non-infected wound surfaces. This is if we speak about Nearmedic products that are already known in Russia and abroad.

As any other company that strives to develop and expand its horizons, we are also actively developing and introducing new pharmaceutical drugs, molecular and genetic test systems, medical products and biomedical technologies in our own production and clinical practices. Thus, the mentioned Collost technology is implemented in the newly developed line of medical products for bone tissue regeneration. Original methods underlying these products allow us to produce bone implants with a high level of safety and efficiency in comparison with available analogues, and will be used in surgical stomatology, orthodontics, traumatology and orthopedics.

MANUFACTURING

IN LINE WITH THE LATEST TECHNOLOGICAL TRENDS

Roman BOLGARIN, Project Development Director of NEARMEDIC PLUS LLC

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In 2015, the company won a competition for support from the Industrial Development Funds. What pharmaceuticals and technologies participated in the competition?

It was not exactly a competition. Companies submitted bids that were submitted to technological, industrial and financial expert assessment, based on which a decision was made on whether to grant them loans. This is what happened with our project for creation of Russia’s first full-cycle production facility for manufacturing of agents used for personal identification and establish kinship. The project is currently at the stage of establishment of the production line at the Nearmedic Pharma plant in Obninsk.

Is your company involved in any collaboration within the pharmaceutical cluster?

Kaluga’s pharmaceutical cluster is a great example for formation and development of a classic-model cluster, which consolidates small, medium and

large research and production companies allowing the creation of a complete value chain within a single region. In other words, the pharmaceutical cluster is, first and foremost, a highly efficient cooperation network for all its participants. Several of our projects, including the project for introduction of the newest anti-tuberculosis drug, are implemented with participation of research and production companies that represent Obninsk’s small and medium businesses. We are actively collaborating with Kaluga Region’s leading medical centers on projects for introduction of advanced diagnostic test systems for socially significant diseases.

Apart from that, Nearmedic Group is involved in governmental programs for development of regional and industrial clusters and collaborates with other cluster participant on R&D and production issues. In February 2017, two new Nearmedic representatives jointed the Kaluga pharmaceutical cluster: Nearmedic Pharma - the group’s production complex in Obninsk, and project company JoinTechCell. So, we are continuing to expand our cooperation.

Can you say a few words about your long-term developments?

As I already said, the group’s project company JoinTechCell has become part of Kaluga’s pharmaceutical cluster. In intends to shortly introduce a new medical product – a separator and centrifuge-shaker system for extraction of stromal-vascular fractions (SVF) from fatty tissue. The resulting product (set) will be a sort of a mobile laboratory, convenient and easy to use.

Throughout the world, cellular technologies in regenerative medicine are an advanced growth direction. SVF have been successfully used in treatment of all types of skin damage (burns, trophic ulcers), urogenital diseases, for restoration of damaged ligaments and articular cartilage (ruptures and fractures), as well as for enhancement of efficiency of traditional treatment methods and improvement of the quality of life. SVF are used for in case of diseases, for which there are no known effective methods of therapy or when possibilities for therapy are limited. By advancing in this direction, Nearmedic follows its previously chosen development strategy: to be in line with the latest technological trends and to bring its own new products to the market that are to become brand names in their respective fields.

Nearmedic Pharma, the pharmaceutical company of state corporation Nearmedic, began

operations at Obninsk industrial park in 2015. The area of the plant built with a 4-billion-ruble

investment is 22,000 m2. Its capacity is up to 100 million packages of pharmaceutical drugs

per year. The plant complies with GMP, ISO and FDA requirements. The unique facility embraces

the entire production cycle – from synthesis of primary substances to manufacturing of finished

products. The entire line of the plant’s output is composed of proprietary products. Nearmedic’s

portfolio includes nearly 20 products.

COMPANY DETAILS

THE COLLOST TECHNOLOGY IS IMPLEMENTED IN THE NEWLY DEVELOPED LINE OF MEDICAL PRODUCTS FOR BONE TISSUE REGENERATION

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PharmVILAR is celebrating its 10th anniversary next year. What are the most significant results achieved within this period? What are the company’s priority plans?

First of all, the company created a modern plant for manufacturing of finished pharmaceutical dosage forms and substances, organized manufacturing of its own original pharmaceuticals and contact manufacturing of a wide range of pharmaceutical drugs. It has obtained a GMP certificate. The plant is staffed with qualified specialists led by general director Cyril Kalinchenko, a top-level professional who deeply cares for results. The reliability and professionalism of the company are valued by our partners in contract manufacturing. Thus, this year we are launching a new sector for manufacturing of soft dosage forms: ointments and gels. We will also definitely be working to expand the range of pharmaceutical drugs and substances – both for our own manufacturing and to offer our partners.

PharmVILAR – at least in the format of the Kaluga pharmaceutical cluster – is one of the few companies with considerable practical experience in contract manufacturing. How is this form of cooperation evolving? What are the strengths and weaknesses of today’s contract manufacturing?

Contract manufacturing of pharmaceutical products is a relatively new model in our country. And we did stand at its origins and establishment, which was not easy. Today, this model for supplying consumers with high-quality pharmaceuticals enjoys full recognition within the national pharmaceutical industry. It is actually an extremely serious endeavor. Development and application of such a model requires the manufacturer to be highly client-oriented – sometimes even to the detriment of its own products. Of course, as any business model, contract manufacturing has strengths

MANUFACTURING

STRENGTHS AND WEAKNESSES OF CONTRACT MANUFACTURING

Irina VOSKOBOYNIKOVA, Director of PharmVILAR holding company, candidate of pharmaceutical sciences

and weaknesses. I’ll mention just a few. The advantages are in the opportunity to utilize available equipment to maximum capacity, to continuously solve new problems and master new technologies, to receive remuneration without investing in marketing and promotion. The disadvantage is in the low margin earned from contract manufacturing, while all risks associated with the quality of manufactured products are vested in the contract manufacturer.

PharmVILAR cooperates with major pharmaceutical companies like PharmFirm Soteks, Canonpharma Production, Valenta Pharm, Nizhpharm, Pharmstandart, etc. What is the nature of this cooperation?

It is true that all of the mentioned companies are our good partners. We are cooperating in a range of directions: from developing

formulas and technologies for manufacturing of finished products to manufacturing of substances, contract manufacturing and a variety of other directions. AnviMaks, Influnet, Metformin Canon, Eksportal, Angionorm, Analgin-Ultra, Citromon-Ultra – these is hardly an exhaustive list of our contract manufactured products. Our partners trust us and we try not to let them down.

What technological specifics allow the plant to ensure high quality of manufactured products?

As I already mentioned, in 2015, we received the GMP certificate that implies that PharmVILAR manufactured products comply with international and Russian standards. The plant uses advanced equipment supplied by world-renown manufacturers. Our strong point is the ability to manufacture pharmaceutical products in sachet form. By volume of output of this dosage form, we are one of the leaders among Russian manufacturers. In development

Scientific and production company PharmVILAR is a dynamically growing pharmaceutical manufacturer. Since the launch of its first workshop for production finished medical forms in 2008, it has commissioned two more.

The company is one of the leaders of the Russian pharmaceutical industry in the field of manufacturing of pharmaceutical products in sachets. It is also successfully expanding production of effervescent tablets.

With advanced technologies, equipment and production processes, including know-how, at its disposal, the company actively participates in the import substitution program by development cardiological, anti-flu, hypoglycemic, antiulcer and other agents.

Provision of contact manufacturing services is one of the company’s priority directions.

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of technological processes for manufacturing of our products, we apply the latest pharmaceutical ingredients as we have accumulated considerable knowledge in this field. PharmVILAR has for many years been successfully offering products supplied by major international manufacturers of auxiliary substances on the Russian market. These include various types of lactose, starch, silica dioxide, other types of fillers, disintegrators, lubricants,

binding agents, etc. Our main strength is definitely in our specialists – technologists, mechanical engineers, analysts and other creative thinkers who come up with non-standard solutions for complex technological problems.

Does PharmVILAR develop partnerships within the KPC? How do you assess the potential for development of the KPC and the current situation of the Russian pharmaceutical market?

We have just recently joined the KPC and are currently in the process of

establishing partnerships with other cluster participants. We participate in organization of professional seminars and conferences. I think that the KPC is one of the most respected pharmaceutical organizations in Russia with tremendous potential for development. I think that one of the priorities – which is already being actively explored by NP KPC – is training of qualified specialists for pharmaceutical companies, of which

there is clear deficit. Regarding the current situation on

the Russian pharmaceutical market – it is rather favorable for development of national production facilities. There were several regulations adopted in recent years that grant preferences to national manufacturers in development and production of pharmaceutical drugs. I would like to say a few words about a problem that is relevant for all our pharmaceutical plants – the organization of manufacturing in Russia of standard samples of substances needed for control over registered and manufactured products. We currently purchase such samples abroad. This is inconvenient, expensive and inefficient.

Does PharmVILAR participate in the import substitution program? What is in the pipeline right now? What are the priorities?

We are definitely vitally interested in offering efficient pharmaceuticals manufactured by PharmVILAR on the Russian market within the scope of the import substitution program. We participate in it by both manufacturing our own products (thus, we register Dezgrippin – an analogue for the foreign-manufactured Antigrippin) and providing services of contract manufacturing of import substitution pharmaceuticals.

One of our priorities is development of slow-acting forms of well-known cardiological drugs, medications for treatment of the digestive system, expansion of the range of effervescent tablets, gels and liniments, as well as active substances and premixes. We are also trying to increase the volume and nomenclature of contract manufactured products.

What professional principles and targets should be followed in your opinion to ensure successful development of a pharmaceutical company?

I would like to use contract manufacturing as the example in answering this question. For a company’s services to be of demand and to ensure that it attracts only reputable clients, it needs to have a license and GMP. Contract manufacturing of excellent-quality products requires advanced equipment and qualified personnel, knowledge and experience in technologies of production of pharmaceuticals and the capability for practical application of the latest achievements. The company also needs resources to provide contract manufacturing services within a narrow profitability range at competitive prices; it needs to be able not only to manufacture, but also to develop pharmaceutical products on the basis of its own research laboratories (analytical and technological) and registration department. I would like to emphasize again that the most important things are client-orientation and the ability to precisely and quickly react to client requests.

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MANUFACTURING

Last year, Novo Nordisk and the government of Kaluga Region signed an agreement on implementation of another investment project in the region. What is the essence of this agreement and why was it decided to continue investments in Russia?

That is correct. Last year, during the St. Petersburg International Economic Forum, Kaluga Region’s Governor Anatoly Artamonov and Lars Rebien, who was at that time CEO of Novo Nordisk, signed an agreement on the intention to implement an investment project in Kaluga Region. The document details the parties’ agreement regarding construction of a new workshop for assembly of pre-filled FlexPen insulin injectors at the company’s plant in Kaluga Region – another step in the consistent investment policy implemented by Novo Nordisk on the strategically important Russian market. The investment project

fully complies with the priorities and objectives defined in programs for socio-economic development of Russia, specifically, the objectives of the Strategy for Development of the Russian Pharmaceutical Industry up to 2020. We believe that it greatly contributes to the development of the Russian pharmaceutical sector, to introduction of advanced technologies and improvement of treatment of pancreatic diabetes. But primarily, the project’s results will have a beneficial effect on the patients’ lives, making Novo Nordisk products more accessible to millions of Russians.

What advantages will the new workshop bring to consumers? What products are in the current portfolio of Novo Nordisk’s plant in Kaluga?

We want to be sure that we are doing all we can to help our patients, wherever they are. This is why we are here and why we are expanding our project for manufacturing of modern

Sebnem AVSAR TUNA, Vice President, Novo Nordisk for Russia and CIS

NOVO NORDISK CONTINUES TO INVEST IN RUSSIA

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insulins in Russia. The Novo Nordisk plant is currently manufacturing the entire spectrum of modern insulins in the form of pre-filled FlexPen injection pens and Penfill cartridges, and provides the required supply of such insulins to patients in Russia.

The equipment for the new workshop has undergone certification and we are currently assembling and installing the filling line. Upon commissioning of the new workshop within the next few years the company will be able to cover the full manufacturing cycle of insulin (except for substances). This means that, in accordance with the Pharma-2020 strategy, there will be deeper localization of manufacturing in Russia of vital contemporary pharmaceuticals that do not have any analogues. If necessary, in the future the capacity of the plant can be further enhanced, and there is potential for export to EEU countries.

Import substitution is an important component of the strategy for development of the Russian pharmaceutical industry. Does this development vector hinder or contribute to the growth of your company?

The impulse for localization of manufacturing in Russia comes from the Pharma-2020 program. Import substitution is practiced in many countries apart from Russia. Thus, Denmark implemented a similar program in the middle of the recent century. The main goals of this strategy are to create jobs and import technologies. However, localization of manufacturing generally leads to the locally produced product being more expensive than the imported one due to costs associated with setting up of production, import of source materials and assurance of the required quality standard. The cost of labor is also a very important aspect of the price.

From the point of view of economy

of scale, manufacturing of products in a single place is clearly fore profitable and allows the company to offer products worldwide at competitive prices while assuring the highest level of quality. When our management was discussing the Pharma-2020 program with representatives of the Ministry of Industry and Trade at our corporate

headquarters, it was said that we were capable of satisfying the demand of Russian’s for insulin by importing it from Denmark, and that the price of the product manufactured in Russia could be higher.

Obviously, the import substitution policy, on the one hand, helps the country to create jobs and acquire technologies. But on the other hand, it undermines the competitiveness on the specific market and leads to price increases.

What is the scenario for Novo Nordisk’s collaboration with other participants of the Kaluga pharmaceutical cluster, or what should it be?

There are two directions for

PANCREATIC DIABETES – A GLOBAL THREAT

Healthcare institutions worldwide are facing a serious challenge – the spread of pancreatic diabetes, which by its incidence rate is comparable to an epidemic. According to IDF statistics, there are currently more than 415 million people suffering from pancreatic diabetes, or one in 11 adults! In Russia, there are 4 million people with this diagnosis. Ever more are not aware of their disease, which can lead to serious complications. Pancreatic diabetes is

one of the main causes for blindness, amputations and impaired kidney function. Most of the growth is attributed to type 2 pancreatic diabetes, which represents 90% of all cases. Research data indicates that early detection of the disease, before its symptoms become apparent, and optimal control over it ensure the reduction of the number and their severity of complications and extend the life expectancy of patients. An important measure for combating pancreatic diabetes and lightening the

burden of the disease on the healthcare system and the society in general is the supply of the newest anti-diabetes drugs that help prevent complications and allow patients suffering from the disease to maintain a high quality of life. This requires development of the national pharmaceutical industry and expansion of innovation pharmaceutical manufacturing facilities, including manufacturers of vital medications for treatment of diabetes.

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In 2015, Novo Nordisk began manufacturing of modern insulins in Russia at a high-tech plant built from the “zero” cycle at the Grabtsevo industrial park in Kaluga Region. All manufacturing stages comply with GMP standards and international and Russian requirements to pharmaceutical manufacturing. The project applies energy conservation technologies. In 2016, the company announced the expansion of its investments in the Kaluga plant. Novo Nordisk’s investments in the region are in line with the Pharma-2020 Strategy and significantly contribute to the development of the Russian pharmaceutical industry, assurance of the country’s drug security, introduction of advanced technologies and improvement of the quality of treatment of pancreatic diabetes.

MANUFACTURING:

• Secondary packaging of a complete portfolio of modern insulins in Penfill cartridges and pre-filled disposable FlexPen syringe-pens since 2015.

• Preparation for manufacturing of finished dosage forms of modern insulins in Penfill cartridges (production of the solution, filling and secondary packaging) in progress: filling line passed validation in 2016.

INVESTMENTS:

• 100 million USD

• Plant area – 5 hectares

• Total area – 13,000 m2

• 240 jobs (average employee age – 32)

ADVANCED TECHNOLOGIES:

• compliance with international GMP standards, corporate standards and Russian legislation on pharmaceutical manufacturing

• application of advance solutions in the field of safety, energy conservation and protection of the environment

development of Novo Nordisk’s collaboration within the pharmaceutical cluster. The first is to develop the system for training of specialists for Kaluga Region’s pharmaceutical industry. The second – collaboration on issues related to the pharmaceutical market, including manufacturing.

As a Novo Nordisk manager in Russia and the CIS, how do you assess the business climate created in Kaluga Region, specifically, for implementation of pharmaceutical projects?

Establishment of a pharmaceutical manufacturing plant from the “zero” cycle is a very ambitions and complex task even for a global company like Novo Nordisk that has 16 production facilities on 5 continents. I would like to thank the region’s administration and Anatoly Artamonov personally for creating and efficiently operating infrastructure for investment support, for their openness to dialogue, individual approach and expediency in making decisions. For us, as an investor, a constructive dialogue with authorities, transparency and clarity of all procedures, especially when dealing with state and regulatory structures, are very important.

COMPANY DETAILS

THE NOVO NORDISK PLANT IS CURRENTLY MANUFACTURING THE ENTIRE SPECTRUM OF MODERN INSULINS IN THE FORM OF PRE-FILLED FLEXPEN INJECTION PENS AND PENFILL CARTRIDGES, AND PROVIDES THE REQUIRED SUPPLY OF SUCH INSULINS TO PATIENTS IN RUSSIA

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JSC Obninsk Chemical and Pharmaceutical Company (part of SC Mir-Pharm) is one of the most successful pharmaceutical projects in Russia. How is the company developing? What were its results for 2016, and how has 2017 been so far?

Obninsk Chemical and Pharmaceutical Company (OCPC) is developing as an innovations company. This development is based on creation and manufacturing of both new original pharmaceuticals and reproduced pharmaceuticals. We are often the only Russian manufacturer of such products. In 2016, OCPC introduced 6 import substitution generics – Prucalopride (Vegaprat), Biperiden (Bezak), Nifuroxazide (Mirofuril), Ursodeoxycholic acid, Atosiban and Zoledronic acid. We also produced the first commercial series of unique medication Maksar. In early 2017, we registered generics for valproic acid (slow-acting form) and Teriflunomide (Femoriks).

What does the current product line include?

Our main production facility based in Obninsk manufactures finished pharmaceutical products in the form of coated and uncoated pills. These include Miropriston, Ginestril, Ginepriston, Mirolut, Tranexam that are applied in gynecology, antioxidant Mexiprim, nootropic drug Phenibut and antihistamine Diazoline. OCPC’s combined production capacity of finished pharmaceutical products is 500 million pills per year. Apart from manufacturing of finished medial drugs, Obninsk also accommodates a facility for manufacturing of pharmaceutical substances (API), including Dioxidine, Vitaglutam (under a contract with JSC Valenta), Methyl ethyl pyridine hydrochloride, Ethyl methyl hydroxypyridine succinate, Mifepristone, Diazoline, Trimethylhydrazinium propionate dehydrate, Prucalopride succinate, Biperiden hydrochloride, Teriflunomide and other.

Vladimir PUCHNIN, General Director of JSC Obninsk Chemical and Pharmaceutical Company

OCPC IS DEVELOPING AS AN INNOVATIONS COMPANY

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What are the company’s prospects?

There are currently more than 50 new projects on development and registration stages for medication used for treatment in the fields of gastroenterology, gynecology, urology, intensive care, neurology, oncology. The social focus of the company is demonstrated by its development of orphan drug Mitotane (not available on the Russian pharmaceutical market). The company’s innovative nature was recognized by it being included in the Tech Success rating of dynamic high-tech companies for 4 years. An investment agreement signed last year between the government of Kaluga Region and SC Mir-Pharm implies the construction of a plant for manufacturing of high tech pharmaceutical substances and solid dosage forms. Commissioning of this plant will definitely expand our possibilities.

How does your company collaborate with other participants of the Kaluga pharmaceutical cluster?

There are two companies representing the Mir-Pharm Group in the pharmaceutical cluster: JSC OCPC and LLC Mir-Pharm. Our company is involved in manufacturing and pharmaceutical developments. Mir-Pharm promotes, markets and sells pharmaceutical products. Under a contract with JSC Mizhpharm (Stada CIS is also a KPC participant), OCPC currently manufactures 6 products: Miropriston, Ginestril, Ginepriston, Mirolut, Tranexam and Mexiprim. We are also developing a new drug with Stada CIS. There are joint projects for development of new medications with Bion and the Tsyb MRRC. We are closely collaborating with the Institute of Nuclear Power Engineering in training of qualified specialists. These and other projects are the result of interactions with other members of the pharmaceutical cluster. I believe that KPC development should continue along the lines of joint training programs, development of in-cluster cooperation, stimulation of innovations in Russian manufacturing, organization of participation in professional forums and exhibitions.

JSC Obninsk Chemical and Pharmaceutical Company, a member of the Mir-Pharm Group, began its operations as part of the experimental sector of the RAS Medical Radiological Research Center in Obninsk in 2001.

The company specializes in scientific research and development, manufacturing of pharmaceutic substances and medical drugs in accordance with GMP standards.

High efficiency and safety of medical drugs manufactured by the company are confirmed by clinical tests that were conducted at the country’s major medical facilities with participation of leading specialists representing various fields of medicine.

500mln pillsper year – combined production capacity of the OCPC finished pharmaceutical product manufacturing plant

> 50new projects on development and registration stages

6 import substitutinggenerics introduced by OCPC in 2016

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What does the current BION product portfolio include, and what will form the basis of the company’s development in the nearest future?

The company is working in the B2B segment (international designation of manufacturing of components used in further manufacturing processes). Our customers are manufacturers of finished dosage forms that we see in pharmacies. All finished medical drugs are produced from pharmaceutical substances (active agent that affects the human organism). BION manufactures over 20 active pharmaceutical substances that include agents for improvement of blood supply to the human brain and myocardium, pain relievers, vasoconstrictors, antitumoral substances and peptides.

Will there be a continued increase in the share of affordable locally-manufactured high-quality pharmaceuticals in

Russian pharmacies? What needs to be done for this on federal and regional levels as well as within individual pharmaceutical companies?

Pharmaceutics is a very expensive manufacturing segment as far as raw materials, overheads and scientific research are concerned. We are currently faced with a very contradictory challenge – we need to manufacture modern high-tech drugs and also to make them as assessible as possible for all segments of the population. Achievement of this contradictory objective often hinders the development of the industry itself. At the level of a single production unit, there is the need for introduction of international standards of pharmaceutical manufacturing (GMP), which require regular verification by external audits. This work has been carried out for many years and is bringing very significant results.

What benefits does your company get from participation

Igor YEFREMOV, Director of LLC BION

ACHIEVING MAXIMUM AFFORDABILITY OF MEDICATION

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in Kaluga’s pharmaceutical cluster?

BION was one of the first companies to join the pharmaceutical cluster. Global pharmaceutical leaders have established and are establishing their production plants at various sites in Kaluga Region. The cluster manufactures several hundred varieties of pharmaceutical products, more than 10 products are on the stage of registration, and several dozen are in prospective development. The cluster’s key competency is in manufacturing of innovation and original pharmaceutical substances with supporting technological and procedural engineering. Cluster participants join efforts to resolve resource training issues, and products manufactured by one group of cluster participants are used for manufacturing of finished dosage forms by others. There is collaboration underway for development of new drugs. Thus, BION is using its research and technological base to develop new products for NEARMEDIC, Pharm-Synthesis, Berachim, etc.

How are new directions identified? Why initiates them and how?

New development directions are suggested by external customers in the form of orders for development of production processes for new products or for incorporation of Russian-manufactured substances into pharmaceutical dossiers. They are also identified through researching the Russian pharmaceutical market. The company has a scientific and technical council (CTC) that can recommend the company’s management to take note of promising trends in pharmaceutical market development. The council also reviews decisions on modernization of technological processes and suggestions for improvements in manufacturing of the company’s current products. Final decisions on all issues are made by the company’s management.

How does the company conduct is scientific research?

The R&D department consists of two units – scientific research laboratory and the scientific methodology department. The scientific research laboratory is responsible for development of processes for synthesis of substances “from scratch” and support of

projects at production stage. The principal objectives of the scientific methodology department are development of methodologies for chemical substance analysis, analytical support of scientific research, manufacturing and output quality control. Scientific research activities are strongly supported by a well-equipped facility for new technology scaling and development of test samples and an electronic information and reference system that monitors the latest industry achievements. Another important structural unit is the certified control laboratory that checks the quality of source materials, auxiliary, packaging and labeling materials, verifies the quality of manufactured products. BION is currently conducting research in the field of peptide and stereoselective synthesis, in synthesis of organoelemental substances and heterocyclical compounds, homogenous and heterogenous catalysis, etc. A new research direction is development of technologies for manufacturing of synthetic anti-microbe and anti-tumor drugs.

Summarizing the company’s results for the previous year, what key achievements would you emphasize?

The list of our customers has extended significantly. We now work with manufacturers of medical drugs that previously imported substances equivalent to ours. We registered three new products and are negotiating with manufacturers of finished pharmaceutical products regarding incorporation of these active pharmaceutical substances into registration dossiers. Another important aspect is the confidence of our staff in the company’s future.

Chemical and pharmaceutical company BION has been operating in Obninsk since 2003.

The company is included in the state register of Russian manufacturers of active pharmaceutical substances (APS) used for manufacturing of finished dosage forms of pharmaceutical products. The company’s manufacturing complies with RF standards that are identical to GMP EC.

Among directions of the company’s activities are production of APS for manufacturing of antioxidants, anesthetics, gastroenterological, cardiological, oncological, anti-inflammatory, anti-fungal and other medical drugs; research targeted at development of new laboratory and industrial methods of fine organic synthesis of APS; development of analytical methodologies and designing of custom chemical equipment for fine organic synthesis of APS; development of industrial technologies and scaling of APS manufacturing.

• manufacturing and registration of pharma-ceutical substances;• chemical purification of substances and improvement of their quality to high degrees of purity;• scientific research in various fields of organic

synthesis;• development of technologies for manufactur-ing of organic substances and their support;• training of resources for science-intensive manufacturing in the field of fine organic synthesis.

THE BION RESEARCH AND DEVELOPMENT BASE SUPPORTS THE PROVISION OF THE FOLLOWING SERVICES:

BION PRODUCTS ARE OF DEMAND FAR BEYOND RUSSIA. THEY ARE CURRENTLY EXPORTED TO UKRAINE, BELARUS, KAZAKHSTAN, LATVIA, ARMENIA AND OTHER COUNTRIES

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After three years of JSC Berlin-Pharma’s operation, what specifics have you noted on the Russian market? What contributes to the company’s development and what, if anything, hinders it?

Berlin-Pharma’s plant at the Grabtsevo industrial park is the first facility established by the Berlin-Chemie/Menarini international group in Russia. Today, it is a high-tech complex for manufacturing, control and storage of pharmaceutical drugs. The company complies with GMP safety standards and has the capacity to annually manufacture 47 million packages of medication used in cardiology, neurology, gastroenterology and other fields of medicine.

In the three years of its operation, Berlin-Pharma has been consistently and reliably manufacturing pharmaceutical products that are supplied to the Russian market. We

have so far registered 8 products, with 8 more undergoing registration with the Russian Ministry of Healthcare.

What contributes to our development is the planning and support Berlin-Chemie/Menarini’s efforts to localize manufacturing in Russia. There is a lot of support from the administration of Kaluga Region, agencies for regional and innovation development on all stages of implementation of our investment project, with precise compliance with contractual obligations on their part.

As for hindering factors – I guess “hinder” is not exactly the right word, but what prevents us from developing faster is the very lengthy registration procedure – around 2 years for one product. Naturally, we launch parallel projects. Last year, we obtained several registration certificates for full-cycle production.

What key products does Berlin-Pharma currently manufacture

Irina BRAGINSKAYA, General Director JSC Berlin-Pharma

“THE HARDEST PERIOD IS OVER…”

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for the Russian market? Are you planning to expand the product portfolio or increase production volumes?

Berlin-Chemie/Menarini products are well-known in Russia. They have long earned the trust of healthcare specialists and patients. The company has already registered more than 100 pharmaceutical drugs in Russia, in over 10 therapeutic categories. The concern is always quick to react to Russian market demands and is invariably among the top three major manufacturers of pharmaceuticals that are of continuous demand in Russia. The Russian pharmaceutical market is extremely attractive. We carefully monitor all trends in the pharmaceutical industry and strictly comply with the Russian government’s policy in the field of supply of Russian citizens with high-quality and affordable medicinal products. I am confident that Kaluga’s pharmaceutical cluster will be moving towards maximum substitution of imports and localization of pharmaceutical drug

manufacturing.Our main products lines today are

Mezim Forte, Curantil and Prostamol Uno. We are planning to launch manufacturing of Siofors (3 products) that are intended for treatment of 2 type diabetes, and are preparing for registration of the widely-known Bromhexine Berlin-Chemie.

We are planning to increase production volume, primarily, by expanding the product range, but also by expanding the market. Thus, we are considering the possibilities for exporting products to countries of the Eurasian Economic Union.

What were the company’s results for 2016 and what are its plans for this year?

In 2016, Berlin-Pharma manufactured and sold more than 28 million packages of finished pharmaceutical drugs. This was done in a single-shift mode, i.e. far from our full production capacity.

JSC Berlin-Pharma is part of Menarini Group – a major European pharmaceutical conglomerate. The group operates 9 pharmaceutical plants in different countries.

Berlin-Chemie AG joined the group in 1992. Strategic goals of the consolidated Berlin-Chemie AG/A.Menarini are innovative research and internationalization of the healthcare market. The group has an impressive portfolio of products developed by its own resources and a high potential for establishment of reliable partnerships with other pharmaceutical companies.

In 2010, Berlin-Chemie AG/A.Menarini began the implementation of a major investment project to build a pharmaceutical plant in Kaluga Region. The project includes a plant for full-cycle production of non-sterile dosage forms, and office, laboratory and warehouse complex. The total amount of investments exceeds 40 million euro.

JSC BERLIN-PHARMA HAS THE CAPACITY TO ANNUALLY MANUFACTURE 47 MILLION PACKAGES OF MEDICATION USED IN CARDIOLOGY, NEUROLOGY, GASTROENTEROLOGY AND OTHER FIELDS OF MEDICINE. OR MAIN PRODUCT LINES ARE MEZIM FORTE, CURANTIL AND PROSTAMOL UNO. WE ARE PLANNING TO LAUNCH MANUFACTURING OF SIOFORS (3 PRODUCTS) THAT ARE INTENDED FOR TREATMENT OF 2 TYPE DIABETES, AND ARE PREPARING FOR REGISTRATION OF THE WIDELY-KNOWN BROMHEXINE BERLIN-CHEMIE

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The hardest period is over: when the plant was already built and equipment installed, but it could not begin production due to lengthy procedures for production licensing and registration of pharmaceutical products.

We are now working with stability, and in 2.5 years have overcome the start-up period (inevitable for all new plants) when our costs were higher than our revenues and managed to cover losses for 2013-2014.

Berlin-Pharma has a cooperation project with Merz. What is the nature of this project? How is it developing?

It is too early to speak about the project. I can only say that 3 innovation products that will be manufactured in Kaluga are currently on the registration stage.

Are there any partnership collaborations within the cluster? How do you think such cooperation should develop?

So far, partnerships mostly relate to organizational issues. But there is practical assistance as well – in the form of resource training. We are currently considering collaboration in manufacturing as well. We were approached by an Obninsk-based Russian company regarding packaging of their pills in aluminum blisters. We have the technical capability to do that and can help. However, such a project can only be implemented after appropriate registration with the Russian Ministry of Healthcare, so it’s a long-term prospect.

I would say that at this point we are operating rather autonomously, but I do not exclude partnerships of any format. At least we, on our part, are prepared for them.

The complex will comply with global GDP (Good Distribution Practice) standards and will continue the pharmaceutical conglomerates project for localization of manufacturing. Construction of a warehouse center next to the plant will create a highly efficient integrated logistics and production complex.

In February 2016, Kaluga Region and JSC Berlin-Pharma signed an agreement on implementation of the second phase of the Berlin-Chemie AG/A.Menarini investment project. The subject of the agreement is the construction of a logistics complex that will include warehouse and distribution centers.

TOTAL INVESTMENTS —

≈ 10 MLN EURO

SITE AREA — 80 000 М2

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Sergey Lukiyan, Manager of the Kaluga branch of Sberbank of Russia, told us about the bank’s new online services, smart platforms and partnership offers.

What are the bank’s priority directions in its work with corporate clients this year? Were there any new additions to your product line?

In today’s world, people really value convenience and comfort. That is why we assign special attention to improvement of our electronic and online services. One of our new products is Sberbank-Markets.

It is an online trading platform that provides online access to currency market instruments allowing Sberbank’s clients to electronically trade market assets and to simplify and automate execution, confirmation and settlements under transactions with the bank.

Sberbank also has the Sberbank Corporation system that is offered to groups and holding companies. This service allows processing of information about transactions and turnovers on accounts not only with Sberbank but other banks as well. With Sberbank Corporation, group or holding company treasurers can – from their own workplace - monitor, control and accept payments, supervise budget compliance and allocate account debit balance limits among the holding’s divisions while using overdrafts with a common limit.

Our clients also demonstrate high interest in the Sberbank Factoring line of products. This is a portfolio of services for manufacturers and suppliers selling their products with deferred payment. Factoring allows them to develop their businesses by accelerating capital turnover. The key advantages of this product are no collateral requirements and coverage of cash shortages from incoming financing on the following day after shipment of goods.

What business sectors need financial support more than others today?

Considering the specifics of Kaluga Region, which is one of the most attractive for investments, I can say that one of the important business directions requiring financial support is implementation of investment projects involving construction and modernization of production facilities. This is always a long-term process based on detailed planning of actions, professional approach to financing and hedging of risks. In view of the importance of such projects for the region, Sberbank acts in its collaboration with investors as a proactive partner.

We offer project and investment loans, including loans that incorporate state support measures, i.e. security and guarantees from the Agency for Small & Medium Business Support, the Fund for Entrepreneurship Support, subsidy programs of the Ministry of Industry of Trade and the Ministry of Agriculture.

Apart from that, Sberbank provides investor support through special programs for contractors recruited to

build new production facilities and infrastructures. The most demanded products are bank guarantees of advance payment recovery and fulfillment of contractual obligations. Contractor support includes financing of their respective contracts. Since the object of financing is the contract itself, companies can receive loans without providing any security. The main source of loan recovery in this case is contractual income.

Are there any mechanisms simplifying access to loans for small and medium businesses?

In development of partnership programs for corporate clients priority is granted to preapproved offers. These include products like Smart Loan for small businesses, One-Day Loan and One-Day Overdraft for medium and large companies. These offers allow clients to save time and minimize the number of documents required to make decisions on issuing of loans.

BUSINESS SUPPORT AS A PRIORITYOne of the key priorities in Sberbank’s operations is provision of services to corporate clients (both in the small and medium businesses segment and major corporations) representing various spheres of activity and industry sectors. Clients from this category can appreciate the multiple advantages of Sberbank’s corporate programs and its individual approach to achievement of business objectives.

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Partner-M is a unique Russian enterprise – primarily, in its technologies. Can you elaborate on the decision to choose Kaluga Region for your project?

From the moment of its establishment, the principal sphere of the company’s interests was in processing of vegetable proteins - the “building blocks” of life. The universal source used for this purpose is soy. However, soy is not the only alternative for production of proper dietary protein. Our specialists successfully use peas and wheat that have the advantage of being widely available in Russia. In 2015, Partner-M developed a technology for “dry” waste-free processing of peas and wheat – one that has no analogues in Russia, and in 2016 the company began manufacturing of absolutely new types of products – concentrated proteins from wheat and pea flour with protein content of at least 20% and 55%, as well as starch from these crops.

This technology was selected due

to a current deficit of dietary protein in Russia. Apart from that, all known models for manufacturing of protein products are based on application of chemical agents, while our technology uses only purified air. Thus, consumers are offered safe E-index-free and natural products that are manufactured with the use of innovative “green” technologies. These products are recommended for use in manufacturing of emulsified meat products, breads, pastry, pasta products, sauces, starch drinks, etc. They help reduce the prime cost, improve the nutritional value and quality characteristics of the finished product.

The choice of Kaluga Region for implementation of the project was defined primarily by its unique investment climate created through the regional administration’s well-conceived strategy. Kaluga Region is one of the most investment-attractive regions in Russia. The support that is offered by the regional government to small and medium businesses both in implementation of industrial solutions

Takhir BIBKOV, Development Director of Partner-M, candidate of chemical sciences

THE COMPANY’S TECHNOLOGIES ARE SECURED BY PATENTS IN 40 COUNTRIES

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and creation of science-intensive innovation objects should not be underestimated.

What Partner-M products are being used today and how?

We currently manufacture over 50 types of soy, wheat and pea textured products, soy, wheat and pea flour of various grinding fineness (up to 20 microns), including special fine grind soy and pea flour with low urea enzyme content. Our range includes complex functional mixtures and animal protein for meat processing, substitutes for speck, blood plasm and dry milk, flavoring, aromatic and injection mixtures, etc.

Our products are supplied to the food and feed industries. Special types of Amilon flour, enriched with

natural pea and wheat starch, are used in the meat industry, confectionery industry, dairy manufacturing, manufacturing of feed for nonproductive animals and much more. Confectioners use pea Amilon not only for traditional starch applications, but also as an effective technological additive that allows them to reduce the consumption of expensive egg components. Meat and bread manufacturers use wheat Amilon starch flower. Pea Amilon is also of consistent demand among manufacturers of whole milk used for calf rearing, as it allows them to replace expensive imported hydrocolloids in their mixtures.

The food and feed industry also uses our Protelon protein products. Thus, due to high content of raw gluten (55%-60%), Protelon has no analogues on

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the Russian market and is a natural modifier for traditional baking flour. Unique functional and technological characteristics of pea Protelon allowed the development and production of a new type of protein fitness bars. Pea products do not trigger allergies and therefore can be used in manufacturing of special dietary products for people with diseases and especially children suffering from allergies and intolerance to certain types of products.

Our products are of demand not only in Russia. They are highly competitive and are successfully exported to clients in the CIS, Germany, France, China, Canada, Turkey, the Netherlands, Poland, Slovakia, etc.

In 2015, the company received support from the Bortnik Foundation. How significant is the state support that is currently provided to innovation companies?

In 2015, JSC Partner-M applied to the Foundation for Assistance to Small Innovative Enterprises for participation in the Commercialization program. We won a grant of 15 million rubles and got the opportunity to purchase expensive foreign equipment units that are not yet manufactured in Russia. That is why our company is very grateful to the Bortnik Foundation and considers its support in implementation of unique innovation projects in Russia highly valuable.

Timely investments allowed Partner-M to bring competitive innovative products to the market. Thus, the price of 1 kg of Kaluga-manufactured pea starch (from 45 rubles) is three times lower than of

its imported analogues. Considering the fact that this and other products are manufactured from national materials, Russian manufacturers have a privileged position: use of fully Russian ingredients will inevitably have a positive effect on the manufacturing cost of food products and, ultimately – on price tags in stores.

What is the company’s team working on now? How will the project be developing in the future?

Partner-M is currently successfully developing a range of products intended for import substitution. We are patenting a technology for producing hydrolysates from vegetable protein sources and a technology for processing grain for highly efficient manufacturing of sugars and alcohols. We are working to identify conceptually new approaches to assurance of food product safety in the context of wide-spread food caused toxic infections, such as salmonellosis, listeriosis, infections caused by bacterium coli and some other microorganisms.

This year the plant will commission a new line for manufacturing of soy fiber chunks. The line for snack manufacturing if currently on assembly stage. We are also preparing to begin production of local high-quality tempura-type breading that is currently fully imported.

We started work to produce chemically modified ingredients from starch flour. We plan to use peas for development of new products for medical application, e.g. for improvement of intestine microflora. Appearance of new ingredients with express biological efficiency in our product portfolio will allow us not only to develop in the field of food component manufacturing, but also to gain a status of a notable participant of the Kaluga pharmaceutical cluster and to offer its members specialized products with specific medical applications.

JSC Partner-M is operating since 2005.

The company’s specialization is production of range of a high-quality vegetable products demanded by food manufacturers. The company uses locally sources raw materials. Partner-M has a high-capacity Buhler (Switzerland) production line for manufacturing of vegetable chunks at a rate of 2500 kg/hour and designated lines for production of breading and vegetable snacks.

In 2015, with support from the Bortnik Foundation, the company acquired equipment for manufacturing of vegetable proteins and starch. Partner-M develops new biotechnologies for concentration of vegetable and animal proteins, manufacturing of bioethanol, ferment modification of products and protein hydrolysis, creation of biodegradable materials and medical application products.

The company’s technological solutions are protected by patents not only in Russia but in over 40 other countries of the world as well.

COMPANY DETAILSCONSUMERS ARE OFFERED SAFE E-INDEX-FREE AND NATURAL PRODUCTS THAT ARE MANUFACTURED WITH THE USE OF INNOVATIVE “GREEN” TECHNOLOGIES

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How did 2016 end for AstraZeneca in Russia? What were the year’s highlights for the company?

The year was rather successful for AstraZeneca. According to our estimates, the company’s growth in Russia was over 10% (in rubles). This is a good result, considering that many companies had no growth or registered declines. Overall, however, the figure is quite modest. In September, we introduced a pharmaceutical drug for treatment of ovarian carcinoma on the Russian market. This is one of the most common types of cancer with the highest mortality rate among all patients with oncological diseases of the female reproductive system – not only in Russia, but worldwide. Also, in November of last year, we partnered with other pharmaceutical companies in signing of a memorandum on cooperation in the field of immune-oncology with the Russian Society of Clinical Oncology.

What are your company’s plans for 2017? What do you aim to achieve in Russia?

Our plans are always ambitious. For 2017, we are planning to prepare our plant in Kaluga for full-cycle production. We are also planning to introduce two more pharmaceuticals on the Russian market: one is for treatment of lung cancer, the other – for treatment of type 2 diabetes. These are innovative drugs, which, I am certain, will help many Russian patients. We will also continue our collaboration with the Skolkovo biomedical cluster; we are currently considering three potentially interesting molecules for application in oncology. We are always happy to support Russian science.

One of the issues that has recently become very relevant, is the marking of pharmaceuticals. Is your plant going to participate in this project?

Iskra REICH, Vice President of AstraZeneca for Russia and Eurasia, General Director of AstraZeneca Russia

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This is one of the most important projects that we are expecting to be implemented in 2017. I am happy to say that AstraZeneca is an official participant of the marking project. We believe this to be a very significant effort to counteract counterfeit. This initiative raises the issue of the price of pharmaceuticals. We believe that if mandatory marking requirements are harmonized with European ones, this will not affect the cost of our products. Of course, market prices are formed by different participants, including distributors and pharmacies. But we will not be raising our prices.

One of the spheres, in which the state cooperates with businesses, is special investment contracts. Many players express their

interest, however, none of the pharmaceutical companies have yet been able to present an actual special investment contract. What is AstraZeneca’s position on such contracts?

We have proceeded from interest to action. AstraZeneca submitted all documents required for execution of a special investment contract in November 2016. Under the special investment contract, we are offering manufacturing localization for several innovation drugs at our plant in Kaluga with investments of over 1 billion rubles. I hope the contract will be signed in 2017.

*Based on interviews published in The Pharmaceutical Herald

The Russian full-cycle production plant of international biopharmaceutical company AstraZeneca has been operating at Vorsino industrial park since 2015.

The company has invested 224 million USD in the Kaluga project. Apart from its own production facility, AstraZeneca’s activities in Russia include R&D, patient support and corporate social responsibility programs. Commercial manufacturing began at the plant in the first quarter of 2016. In 2017, the company plans to prepare the plant for full-cycle production. In the future, the plant’s production capacity will reach around 40 million packages, or 850 million tablets, per year. The plant will manufacture nearly 30 innovative AstraZeneca products.

The international Randstad Award 2016 named AstraZeneca the best employer in the healthcare industry in Russia.

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