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GEROPHARM Opens a Full-Cycle Insulin Manufacturing Plant in the Moscow Region

3 October 2013

The official ceremony marking the opening of the cutting-edge high-tech complex “GEROPHARM-Bio”, JSC, was held on October 2, 2013; it is the first Russian full-cycle plant manufacturing genetically engineered human insulin: from the substance synthesis to the finished dosage form. The ceremony was held within the Company’s production complex premises located at Obolensk (the Moscow Region, the Serpukhov District).

The GEROPHARM-Bio plant is a large investment project which was implemented as part of the Federal Strategy PHARMA-2020. The project was completed in a relatively short period of time. The construction works began in 2011. The project investments amounted to RUB 1.5 billion. The plant has a total area of 2.5 ha. The area of its production premises is approx. of 10,000 sq.m. The plant will allow to adjust the existing production of genetically engineered human insulin, to launch a fully automated line manufacturing the drug in cartridges and vials, as well as to set up production of new advanced products for the treatment of socially significant diseases, including diabetes. The expected production volume will be 25 mln vials and 5 mln cartridges per year. Most of the tasks in the plant are performed by automated manufacturing systems. The production is organized in accordance with GMP standards.

The commissioning of the “GEROPHARM-Bio”, JSC plant is included in the 2013-2018 Activity Plan of the Ministry of Industry and Trade of the Russian Federation. The plant is a unique one not only in the Moscow Region, but also in Russia, as it creates the conditions for the drug safety; it is the first plant which locates all the stages of socially significant drug production within the country and ensures its independence from foreign suppliers of raw materials.

The official ceremony was opened by the Governor of the Moscow Region A.Yu. Vorobiev. The following guests have participated in a symbolic commissioning of the plant: Assistant to the Minister of Health of the Russian Federation Ye.A. Maksimkina, Director of the Department of Chemical Engineering and Bioengineering Technology at the Ministry of Industry and Trade of the Russian Federation S.A. Tsyb, Head of the Social Control and Trade Administration of the Federal Antimonopoly Service of the Russian Federation T.V. Nizhegorodtsev, Executive Director of the Association of Innovative Regions of Russia, Chairman of the Supervisory Board of the Fund for Assistance to Small Innovative Enterprises in Science and Technology I.M. Bortnik.

Ye.A. Maksimkina in her speech emphasized the importance of the plant in providing the population with drugs to achieve full quality of life. S.A. Tsyb presented the speech on behalf of the Minister of Industry and Trade of the Russian Federation which emphasized the important role of the plant in the development of the pharmaceutical industry and improving the country’s drug safety.

T.V. Nizhegorodtsev noted in his speech that the new plant is “a visible evidence of fair competition”, and that the competition in the drug market is very complicated. “Our aim is to ensure easy marketing of the company’s products throughout the country, as well as to gain benefits from the competition for the health care system,” he said. “The benefits from the competition are price reduction, release of additional funds in the budget which could be used for improvement of the quality of people’s lives.”
Congratulations were also made by the honoured guests at the event. Director of the Diabetes Institute, Deputy Research Director of the Federal State-Funded Institution “Endocrinology Research Center” of the Ministry of Health of the Russian Federation M.V. Shestakova said that the GEROPHARM-Bio plant is the first full-cycle plant, i.e. the plant which produces its own substance. She also noted that the country faces an enormous need for insulin: official data shows that there are 3.7 million people with diabetes in Russia, but it is 3 times smaller than the actual figures. Marina Vladimirovna ended her speech by wishing the company further progress in the field of insulin analogues development.

The Head of the Serpukhov District A.V. Shestun also emphasized the particular importance of the opening unique high-tech production facilities in the region, as well as in terms of creating new work places.

Deputy Chairman of the State Duma Committee on Culture, People’s Artist of the USSR I.D. Kobzon and Director of the Elena Obraztsova Music Charity Foundation N.M. Ignatenko were the honoured guests at the ceremony.

General Director of the Group of Companies “GEROPHARM” P.P. Rodionov expressed his gratitude to all the guests for their congratulations and said: “We are facing an ambitious challenge, and we will achieve the objectives that have been set. The opening of the plant is just the beginning. Next year we will start supplying our products as part of disposable insulin pens. Along with that, we are working to develop the most modern insulins, and we will soon begin registration of new insulins in Russia, the insulins that patients need.”

After the opening ceremony all guests attended the organized tours of the GEROPHARM-Bio plant. In addition to visiting the production premises the guests were given a unique opportunity to see the exhibition of works of the famous Russian photographer Valery Plotnikov. Photo project “Diabetes in Persons” was initiated by “GEROPHARM” in order to attract public attention to the problem of diabetes. The project involved the people for whom diabetes had become a routine lifestyle forever, but it had not taken their zest for life.

“GEROPHARM-Bio” JSC (formerly “National Biotechnologies” JSC) belongs to the Group of Companies “GEROPHARM”. In 1998, the company was initially established to meet the state’s ambitious objective which consisted in setting up a pilot production technology for genetically engineered human insulin as part of the program “Diabetes”. A key aspect is the company’s strategic independence from foreign suppliers. Establishment of new production not only implies providing modern drugs to the population, but also creating new work places. The plant will employ up to 260 highly qualified experts. The project was implemented under the auspices of several major financial institutions: Sberbank of Russia, a long standing partner of the Group of Companies “GEROPHARM”, the European Bank for Reconstruction and Development, as well as VTB Leasing.
“GEROPHARM-Bio” is currently producing short-acting insulin drugs under the trade mark Rinsulin R (solution) and intermediate insulin drugs under the trade mark Rinsulin NPH (suspension), which are manufactured by its own technology. Proteome Factory AG Berlin, Prolytic GmbH Frankfurt am Main, Labor L+S AG, three independent certified European laboratories, appreciated the quality of the genetically engineered insulin substance produced by “GEROPHARM-Bio” and declared it compatible with the U.S.and British Pharmacopoeias. Today, the product has registration in Ukraine and Kyrgyzstan, and is currently under registration in Kazakhstan and Vietnam. The company expects to be audited for compliance with GMP standards by the end of this year; this will expand greatly the Rinsulins’ export routes. Russian insulins provoke general public interest abroad: this fact is confirmed by the participation of the Group of Companies “GEROPHARM” in the following major international pharmaceutical exhibitions and congresses: CPhI South East Asia (Jakarta, Indonesia), BIO International Convention (Chicago, USA). The agreements on further cooperation with a number of companies from the South-East Asia region, Latin America and North Africa were signed as a result of these events.

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