NovaMedica began construction of a pharmaceutical plant in the Kaluga region

Print 30 May 2017

May 30, 2017, Kaluga region, IP Vorsino -  Russian pharmaceutical company NovaMedica, a portfolio company of RMI, 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 industrial park “Vorsino” in the Kaluga region.

The key partner of Russian company in this project is Pfizer, one of the largest pharmaceutical companies in the world, a partnership agreement with which NovaMedica and its shareholders signed in December 2016. Pfizer becomes an investor in the construction of the plant and transfers NovaMedica the rights to manufacture and commercialize a portfolio of more than 30 vital medicines (injectable dosage forms), one third of which is currently not manufactured in Russia. The portfolio includes drugs for the treatment of severe bacterial and fungal infections, cardiovascular, inflammatory and cancer diseases. Most of them are in the list of vital and essential medicines (VED), some are also included in the Russian list of essential drugs (RLED) and in the “7 Nosologies” program.

The plant will be built in the Industrial park “Vorsino” in the Kaluga region. NovaMedica concluded an agreement with the Government of the Kaluga region and the Kaluga City Administration to acquire a land plot for the construction of a pharmaceutical plant in the region in 2013.

The project of the plant is created by the company “M+W Group”, which is one of the world leaders in the market of complex industrial facilities designing. Planned capacity of the plant is more than 38.5 million units of production (ampules and bottles) per year. The total area of production and auxiliary buildings and structures will be about 23,000 square meters. The lines will be equipped with technological equipment of the leading European manufacturers: Bosch, Ziel, GEA-lyophyl, Bausch+Ströbel, Belimed, Seidenader, Optima, Mediseal, Uhlmann and others.

The production unit of the plant is represented by sites for production of sterile injectable preparations: lyophilized and solutions in bottles and ampules. There is also a possibility of further expansion of production under demanded forms of injection products: pre-filled syringes, bottles, disposable packages for infusion. The project includes creation of isolated blocks for production of standard and cytotoxic drugs.

The company is planning to complete plant construction and equip it with equipment, having prepared for operation, in 2020. The plant will meet the requirements not only Russian, but also European and Eurasian standards of good manufacturing practice (GMP), which will allow NovaMedica to export its products to international markets in future.

Anatoly Artamonov, Governor of the Kaluga Region:

“The pharmaceutical industry in the Kaluga region is the most dynamically developing direction in the regional economy. The cluster of pharmaceuticals, biotechnology and biomedicine, created six years ago, today unites 63 participants, has a “bronze status” of the best European cluster practices, is one of the pilot innovative territorial clusters. Enterprises, located here, produce more than 140 medicines and pharmaceutical substances. We relate further development with increased competitiveness of these products and expansion of its range. In this sense, NovaMedica’s plans coincide with ours. NovaMedica is planning to produce those medicines that are not produced yet at the created production site. We wish the company success in implementing of the project. For its part the region is ready to provide partners with the necessary assistance”.

Petra Danielson-Vale, President of the Business Unit “Pfizer Basic Therapy” in Europe and Member of the Board of Directors of NovaMedica:

“We are pleased with the new stage of our partnership with NovaMedica, which is aimed at providing Russian patients with access to locally produced high-quality vital drugs. It is important to note not only our joint efforts, but also the support we receive from the Kaluga Region Government in the implementation of the project. The upcoming stage is the construction of the modern production complex of NovaMedica, to which Pfizer will transfer of production technologies of more than 30 sterile injectable products from the company's portfolio”.

Anatoly Chubais, Chairman of the Executive Board of RUSNANO:

“NovaMedica is rapidly developing: in April 2017 the Technological Center with R&D-laboratories and pilot production was launched, where innovative dosage forms are already being developed. A little more than a month has passed and we are opening a new page – we are launching the construction of the GMP plant in partnership with the giant of the world pharmaceutical industry, Pfizer. Moreover, the work on the creation of this plant is being carried out literally since the signing of the partnership agreement. On the part of Pfizer professionals with the vast experience from different countries of the world joined the project so that the plant was designed flawlessly from all points of view. This joint work has already given the team of NovaMedica invaluable experience, and we obtained confidence that the project will be implemented successfully and with great efficiency”.

Alexander Kuzin, CEO of NovaMedica:

“The start of construction of the plant is an important stage in the consistent strategy of NovaMedica to localize innovative products and technologies in Russia. This project would not be possible without conditions created by the state for the development of our industry. We thank the creators of the “Pharma 2020” program – the Ministry of Industry and Trade, as well as the Ministry of Health and our shareholders: RMI and Domain Associates – for the consistent support, which helps to think grandly, build ambitious and long-term plans, and confidently implement them. We are grateful to our shareholders for the powerful intellectual contribution and comprehensive support motivating the team of NovaMedica for a breakthrough development. And, of course, we are inspired by the prospect of obtaining a unique experience in the process of working together with the leader of the world pharmaceutical industry, Pfizer”.

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NovaMedica is a modern Russian pharmaceutical company founded in 2012 by Domain Associates LLC, leading U.S. venture capital firm, and RMI LLC). 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 innovative developments from the portfolio companies of RMI LLC. Today NovaMedica’s pipeline already has 36 IP for preparations 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 with a complex of R&D laboratories and pilot production in Technopolis “Moscow”. The Technological Center 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.

Read more about us on www.novamedica.com, follow us on Facebook and LinkedIn

Contacts for media: Tatiana Albaut , +79175451241

About Pfizer. Applying innovations and using global resources Pfizer works to improve the health and well-being of people at every stage of life. We strive to establish high standards of quality and safety of ongoing research, development and production of drugs. The company's product portfolio includes medicines, including vaccines, as well as well-known vitamins and other products maintaining health. Every day Pfizer employees work in developed and developing countries to improve prevention and treatment of the most serious diseases of our time. Following its commitment as one of the world's leading biopharmaceutical companies Pfizer collaborates with health professionals, government agencies and local communities to provide and expand availability of reliable, qualitative medical care around the world. For more than 150 years Pfizer has been trying to improve the lives of those who rely on us. To learn more, please visit www.pfizer.com. We are also on Twitter as @Pfizer and @Pfizer_News, LinkedIn, YouTube and subscribe to us on Facebook Facebook.com/Pfizer.

The Kaluga region is the leader in terms of industrial growth among Russian regions. The volume of industrial production of the region has grown almost 5 times, 477 billion rubles have been attracted to the economy, 94 large enterprises were opened during 10 years. The region is among the top three of the National rating of the investment climate. More than 160 companies from 90 countries worldwide are implementing their projects in the region. In 2016 exports from Kaluga region enterprises to non-CIS countries has almost doubled.

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