Russian-British-German Biopharmaceuticals

RUSNANO creates a new international player in the market of innovative pharmaceuticals

RUSNANO announces the acquisition of 41.37% in the authorized capital of the project company LLC "SinBio" for 900 million rubles. within the framework of the previously signed investment agreement between JSC "ISKCH", JSC "Pharmsintez", CJSC "Cryonics", FDS Pharma LLP (UK) and Dmitry Genkin as a private investor.

SynBio LLC is a project to create innovative medicines and BioBetters class drugs, implemented with the support of RUSNANO and bringing together several key Russian and international development companies. The largest private shareholder of SinBio is JSC Human Stem Cell Institute (HSCI), a leading Russian biotechnology company engaged in the development, implementation and commercialization of its own original drugs based on cellular, gene and postgenomic technologies. The project is an outstanding example of Russian-British and Russian-German cooperation in the field of innovation and new technologies.
Now the project company "SinBio" is developing 9 medicines based on three technological platforms, "Histone", "Polyxen" and "Gemacell", intended for the treatment of diseases of the liver, vascular system, acute leukemia, growth hormone deficiency, diabetes mellitus.
The SinBio project also involves the creation of its own modern production complexes. They will organize the release of those pharmaceutical substances and finished medicines that are already successfully undergoing clinical trials.
The headquarters of the project company "SinBio" is located in Moscow, and research laboratories are located in England, Germany and Russia. The project company "SinBio" was established in 2011. The project participants have many years of experience in the field of drug research and development both in Russia and in the European Union.

Bringing the project to the international market, SinBio LLC acquired a controlling stake (50.24%) of Xenetic Biosciences PLC (AIM: XEN.L) for £12.8 million. As a result, the Russian company for the first time initiates the creation of a new powerful player in the global market of innovative pharmaceuticals. The acquisition of a controlling stake in Xenetic Biosciences will allow to capitalize the operating expenses of SinBio LLC and thereby increase the overall capitalization of the project company.

Xenetic Biosciences is a developer of innovative drugs that works closely with the world's leading pharmaceutical companies. A striking example is the interaction with Baxter International Inc. on the development of a series of drugs for the treatment of hemophilia – blood clotting factors conjugated with polysialic acid.

The terms of the transaction involve the exchange of royalties between the companies. SynBio LLC will have exclusive rights to sell all developed drugs in Russia and parts of the CIS and receive 10% of their worldwide sales to Xenetic. Xenetic, in turn, will receive 10% of the sales of SynBio LLC in Russia.

At the moment, SinBio LLC is developing nine medicines based on three technological platforms. Eight of them will be developed in close cooperation with Xenetic using two technology platforms:

• long–acting drugs using polysialic acid are BioBetters class drugs for the treatment of diabetes mellitus, Alzheimer's disease, chronic renal failure and a number of other diseases (PolyXen® platform). In this project, PolyXen technology is used to create long-acting drugs based on recombinant human therapeutic proteins and polypeptides: epoetin alpha, insulin, interferon alpha, granulocyte growth factor and somatotropic hormone;
• preparations based on the intracellular human protein histone H1 for the treatment of oncological and a number of other diseases (Histone platform). Two leading drugs are intended for the treatment of oncological diseases of the blood and ischemic diseases. Modified recombinant human histone is used as the only component in the creation of an anti-leukemic drug and in the protein/nucleic acid complex to increase the efficiency of delivery of gene therapy drugs to cells.

Research on all drugs from the portfolio has already begun. Two drugs have already passed the first phase of clinical trials (safety, pharmacokinetics and pharmacodynamics studies), another one has passed phase IIa (dosage selection).

SynBio LLC conducts clinical trials not only in Russia, but also abroad, which is necessary to bring drugs to international markets. A histone-based drug for the treatment of acute leukemia has passed phase I clinical trials in Germany and is currently undergoing phase IIb clinical trials in Russia (phase II clinical trials against non-Hodgkin's lymphomas have also been initiated). The second drug, prolonged erythropoietin, aimed at the treatment of renal insufficiency, has passed phase IIa in India.

"This transaction is an important stage in the development of the domestic pharmaceutical business," said Olga Shpichko, Managing Director of RUSNANO. "For the first time, the RUSNANO project company initiates the creation of a new powerful player in the global market of innovative pharmaceuticals."

As part of the agreement between SinBio LLC and Xenetic Biosciences, it is envisaged to nominate two members to the Board of Directors of Xenetic Biosciences: Roman Knyazev (Senior Investment Manager of RUSNANO) and Dmitry Genkin (Chairman of the Board of Directors of Pharmsintez OJSC).

Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of the Rusnano press center

01.12.2011