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RUSNANO, the Human Stem Cells Institute, Pharmsynthez, Cryonix, FDS Pharma LLP (United Kingdom), and private investor Dmitry Genkin have signed an investment agreement for the SynBio project. The project's purpose is to develop innovative medicines and biobetter pharmaceuticals. Lipoxen PLC, a British pharmaceuticals developer for leaders in the global pharmaceuticals industry, and German company SymbioTec GmbH will be the principal R&D partners for the project.
The partners have established limited liability company SynBio to carry out the project, which has a total budget of 3.2 billion rubles. Of that sum, RUSNANO will co-invest up to 1.3 billion rubles. The other founders will co-invest up to 1.9 billion rubles in the form of monetary resources, intellectual property rights, and shareholding in their own and subsidiary companies. The investment period will be four years, and the project is slated to run seven.
The SynBio project will develop and launch nine pharmaceutical products for Russian and international markets. The medicines are based on three technological platforms:
stem cell technologies for treatment of chronic diffuse liver disease (the Gemacell platform)
intranuclear human protein histone H1 for treatment of cancers and other diseases (the Histone platform)
sustained-release drugs using polysialic acid-biobetters for treatment of diabetes mellitus, Alzheimer's disease, chronic kidney disease, and other illnesses (the PolyXen® platform).
Biobetters resemble biotech pharmaceuticals that already exist in the market, and they differ in that they surpass the biotech preparations by certain characteristics, such as effectiveness.
All the medicines in the project are currently undergoing pre-clinical tests or clinical trials in research laboratories in Russia and Europe. All the pharmaceuticals developed within the project are expected to be sold in the Russian and international markets. Sales of SynBio's drugs in 2015 are forecasted at 700 million rubles.
"Two facilities will be established for commercial production of the innovative medicines, one each in Leningrad and Moscow oblasts," explained Olga Shpichko, RUSNANO managing director. "Manufacturing will be set up jointly with our German and British partners. We regard this as a step toward entering the international pharmaceuticals market."
Artur Isaev, general director of the Human Stem Cells Institute: "It would be difficult to over-estimate the importance of today's events for us and our partners. This is the first time that a Russian company has initiated a M&A in the biotechnology sector to serve the Russian and global markets. The project intends to introduce a number of innovative drugs that will bring real progress in the treatment of socially significant diseases. Our project is an excellent example of how the government's program for innovative development of the Russian pharmaceutical sector can be implemented."
RUSNANO was founded in March 2011 as an open joint stock company through reorganization of state corporation Russian Corporation of Nanotechnologies. RUSNANO’s mission is to develop the Russian nanotechnology industry through co-investment in nanotechnology projects with substantial economic potential or social benefit. The Government of the Russian Federation owns 100 percent of the shares in RUSNANO. Anatoly Chubais is CEO and chairman of the Executive Board of RUSNANO.
Work to establish nanotechnology infrastructure and training for nanotechnology specialists, formerly conducted by the Russian Corporation of Nanotechnologies, has been entrusted to the Fund for Infrastructure and Educational Programs, a non-commercial fund also established through reorganization of the Russian Corporation of Nanotechnologies.
OJSC HSCI (Human Stem Cells Institute, www.hsci.ruNew Window) is a Russian biotech company founded in 2003. The main focus of HSCI is scientific research and development as well as commercialization and marketing of innovative proprietary products and services arising from cell-based, gene and post-genome technologies. HSCI owns the largest personal storage repository of cord blood stem cells in Russia-Gemabank.
At present HSCI is in the process of registering the first gene-therapy drug in Russia, Neovasculgen (for treatment of ischemia of the lower limbs), is receiving approval for clinical trials of the first cell-based drug Gemacell (for treatment of ischemic heart disease and cirrhosis) and is beginning to market a comprehensive set of services for individual skin regeneration-SPRS therapy (based on a technology approved by the Russian health authorities for applying autologous dermal fibroblasts to correct the effects of aging and skin defects). The company is also in the final stages of readying for the launch a multifaceted project of HSCI and RUSNANO to develop and produce new unique medicines for the Russian and international markets (the SynBio project).
In December 2009 the Humans Stem Cells Institute made an initial public offering on MICEX (ticker symbol: ISKJ), becoming the first biotech company in Russia to go public. The beginning of trading of HSCI shares also marked the opening of the exchange’s Market for Innovations and Investments (MICEX MII), a platform for the innovation and growth companies sector created in cooperation with RUSNANО.
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