Portfolio Company of RUSNANO, NovaMedica Began Construction of a Pharmaceutical Plant in the Kaluga Region

30 May 2017

Russian pharmaceutical company NovaMedica announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the territory of "Vorsino" Industrial Park in the Kaluga Region.

The key partner of the Russian company in that project is Pfizer—one of the world’s largest pharmaceutical companies; NovaMedica and its shareholders concluded the partnership agreement with Pfizer in December 2016. Pfizer will become the investor of plant construction and will transfer to NovaMedica the right to manufacture and commercialization of a portfolio consisting of more than 30 vital pharmaceuticals (in the form of injections), third part of which is not currently produced in Russia. The portfolio includes preparations for treatment of severe bacterial and fungal infections, cardiovascular, inflammatory and oncological diseases. The majority of them is included into the list of vital and essential drugs (VED) and some of them are also included into the Russian list of population drug coverage (PDC) and into “7 ICD codes” program.

The project of the plant has been prepared by M+W Group, one of the world’s leading companies in the market of designing of complex industrial facilities. The plant design capacity is more than 38.5 million production units (cartridges and vials) per year. The total area of production and accessory buildings and constructions will be approximately 23,000 sqm. The manufacturing lines will be equipped with production facilities of leading European manufacturers: BOSCH, Ziel, GEA-lyophyl, Bausch+Ströbel, Belimed, Seidenader, Optima, Mediseal, Uhlmann and others.

The plant’s manufacturing department is represented by sites producing sterile injection preparations: lyophilizates and solutions in vials and cartridges. There is also a possibility of further expansion of production of high-demand forms of injection products: pre-filled syringes, dropper bottles, disposable infusion bags. The project includes creation of isolated units for production of standard and cytostatic drugs.

It is planned that the construction of the plant, its instrumentation and preparation for operation will be finished in 2020. The plant will meet the requirements of not only Russian but also international standards of Good Manufacturing Practice (GMP); that will allow NovaMedica to export the products to international markets in future.

“The pharmaceutical industry of the Kaluga Region is the most fast growing area in the regional economy. The cluster of pharmaceutics, biotechnologies and biomedicine that has been created six years ago, now includes 63 members, has the ‘bronze status’ of the best European cluster practices and is one of the pilot innovative territorial clusters. The enterprises of that cluster produce more than 140 medicinal preparations and pharmaceutical substances. We attribute the further development to increased competitiveness and diversification of these products. In this regard NovaMedica’s plans are in line with ours. It is planned to produce the pharmaceuticals on the plant that are not produced in our country. We wish the company good luck in implementation of the project. For its part, the industry is ready to render the partners all necessary assistance”, said the Governor of the Kaluga Region Anatoly Artamonov.

“We are happy with the fact that the plant construction project has reached the next stage: engineering works have been finished, and the implementation of the challenging and interesting process of creation of manufacturing complex is ahead. Our common goal is putting in operation a modern plant meeting the highest standards of the global industry. We will share with NovaMedica our knowledge in the sphere of cutting-edge technologies of production of complex high quality preparations. This new plant will become a reliable supplier of pharmaceuticals essential for the public health system. It will be of real benefit for patients, doctors and Russian medical industry as a whole. I am sure that my colleagues from NovaMedica will do their best to construct the plant meeting the demands of patients”, said the President of business unit “Pfizer Base Therapy” Europe and the member of the Board of Directors of NovaMedica, Petra Danielson-Wale.

“NovaMedica gathers pace quickly—in April 2017, the Technological Center with R&D laboratories and pilot production was opened, and it is developing innovative dosage forms. A little over one month passed, and we open a new page—we commence the construction of GMP-plant in partnership with the giant of global pharmaceutical industry—Pfizer. The work on creation of that plant has been in progress literally since the moment of signing of the partnership agreement. We completed a very important stage preceding beginning of every construction—designing. Pfizer professionals from various countries having a great experience joined the project to ensure that the design of NovaMedica’s plant is perfect in every respect. That collaboration has already provided the NovaMedica’s team with an invaluable experience, and assured us that the project will be successfully implemented in highly effective manner”, considers the Chairman of the Board of the Management Company RUSNANO and the chairman of the Board of Directors of NovaMedica, Anatoly Chubais.

“The commencement of the plant construction is an important stage of NovaMedica’s sequential strategy of localization of innovative products and technologies in Russia. The project would be impossible without the conditions created by the state for the development of our industry. We bless the authors of ‘Pharma 2020’ Programme—the Ministry of Industry and Trade, as well as the Ministry of Health and our shareholders—RUSNANO and Domain—for their consistent support, which helps to think widely, make ambitious and long-term plans and to implement them steadily. We are grateful to our shareholders for their strong intellectual contribution and all-round support that motivates NovaMedica’s team to breakthrough development. And, of course, we are inspired by the possibility of gaining a unique experience in the process of collaboration with the leader of global pharmaceutical industry—Pfizer”, says the Chief Executive Officer of NovaMedica, Aleksandr Kuzin.

Additional information

Reference

RUSNANO Joint-Stock Company was founded in March 2011 through reorganization of state corporation Russian Corporation of Nanotechnologies. JSC RUSNANO contributes to implementation of the state policy on the development of the nanotechnology industry by investing directly and through investment funds of nanotechnology in financially effective high-technology projects providing the development of new production facilities in the Russian Federation. Its primary investment focus is in electronics, optoelectronics and telecommunications, healthcare and biotechnology, metallurgy and metalwork, energy, mechanical engineering and instrument making, construction and industrial materials, chemicals and petrochemicals. 100 percent of shares of JSC RUSNANO are owned by the state. Thanks to investments RUSNANO currently opened 84 factories and R&D centers in 30 regions of Russia.

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

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

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NovaMedica is a modern Russian pharmaceutical company founded in 2012 by Domain Associates LLC, U.S. venture capital firm, and RUSNANO, JSC. NovaMedica’s strategy is aimed at search, registration and localization in Russia of intellectual property rights for innovative pharmaceuticals products and technologies, as well as at development and implementation of own R&D projects.

NovaMedica owns intellectual property rights within Russia and the CIS on 36 innovative developments from the portfolio of the RusnanoMedInvest venture fund. These preparations are for antiviral and anti-inflammatory therapy, treatment of ophthalmic diseases and epilepsy, innovative technologies for detection of oncological and infectious diseases.

Also NovaMedica is working on creation of a number of its own products. R&D department of the company plans to develop about 15 innovative drugs until 2022. These are drugs for treatment of diseases in the field of gastroenterology, pain management, neurology, ophthalmology and rheumatology.

In April 2017, NovaMedica opened the Technological Center “NovaMedica Innotech” that has the latest technological capabilities previously unavailable in the Russian pharmaceutical industry. The company also has a developed infrastructure for promoting and selling pharmaceutical products.

For more information, please visit www.novamedica.com