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SynBio factsheet

SynBio About the Project

SynBio is a long-term project aimed at creating novel medicines, first-in-class and those known as BioBetters. This Project, which has received financial support from RUSNANO, is a collaborative effort of several Russian and international Biotechnology & Life Sciences companies. One of the co-investors in SynBio is the Human Stem Cells Institute (HSCI), one of the leading biotech companies in Russia engaged in the development and commercialization of its own products and services in the areas of cell, gene and post-genome technologies.

Оn the 4th of August 2011, the Human Stem Cells Institute became the final signatory among the participating companies to sign the corresponding Investment agreement. By the end of autumn 2011 the agreement had passed all necessary shareholder approvals and come into effect.

The Project is a significant example of international cooperation between researchers in Russia, Great Britain, and Germany. Special project company SynBio LLC is headquartered in Moscow. SynBio LLC was registered in February 2011 and started to operate as of then.

The aim

The aim of the Project is to develop and launch in the Russian and international markets nine first-in-class and BioBetters medicines based on three technological platforms:

Cell therapeutic product for treatment of liver cirrhosis 

Gemacell
platform

Medicines based on recombinant human histone H1 to treat oncologic and other diseases, including oncohematology and ischemic diseases 

Histone
platform

Sustained action medicines containing polysialic acid for the treatment and/or prevention of diabetes mellitus, Alzheimer's disease, chronic renal insufficiency etc. 

PolyXen®
platform

It’s expected that the sales volume of the SynBio market-ready medicines (those who have already successfully undergone clinical trials) will be RUB 700 million by 2015.

At the moment, all the Project company’s medicines are undergoing different stages of preclinical studies and clinical trials inside and outside of Russia that is necessary for penetrating international markets.

Participants

Several leading Russian and international innovative companies are participating in the Project. The partners’ participation in the SynBio joint venture was structured as follows (following the entry of RUSNANO in the end of November 2011):

RUSNANO

41.4%

HSCI

28.2%

FDS Pharma

11.6%

Dmitry Genkin

11.4%

Cryonix

5.5%

Pharmsynthez

1.9%


In February-March 2014, to execute the conditions of the Investment agreement, all participants of the SynBio LLC (except RUSNANO) consolidated their assets in an asset holding company IceGen LLC, established in August 2011. The consolidation occured through the transfer of the participants’ stakes (except RUSNANO’s) in the charter capital of SynBio LLC to IceGen LLC.

As a result, SynBio LLC has only two participants: RUSNANO (41%) and IceGen LLC (59%), which represents the interests of all other partners in the project, including HSCI. HSCI is a majority shareholder in IceGen LLC with the stake amounting to 48.07%.

R&D

One of key R&D partners of the Project is the British-based Xenetic Biosciencies PLC (former Lipoxen PLC), the bio-pharmaceutical company specializing in the development of high-value differentiated biologic drugs and vaccines in partnership with the world’s leading pharmaceutical producers (including those based on PolyXEN® technology owned by Xenetic Biosciencies). In line with the Investment agreement on the Project, SynBio LLC has become the significant strategic shareholder in Xenetic Biosciences, PLC (AIM.XEN.L). As of mid-January 2012, SynBio’s stake in Xenetic Biosciences amounted to 48.7%, starting July 2012 the stake became 45.3%.

Also participating in the Project is the German biotech company SymbioTec GmbH specializing in the development of innovative products for treatment of cancer and infectious diseases (using Histone H1 - the development of OncoHist novel cancer drug candidate). The Company’s patent portfolio for this includes 20 international patents. Pursuant to the SynBio project agreement, in January 2012 SymbioTec GmbH merged into Xenetic Biosciencies PLC as a wholly-owned subsidiary. 

Medicines that are developed within the SynBio project are currently undergoing various phases of preclinical studies and clinical trials. The project’s research laboratories are located in England, Germany and Russia.

The histone-based drug candidate OncoHist, which is set to treat Acute Myeloid Leukemia, has passed Phase I clinical trials in Germany and now is going through Phase IIb clinical trials in Russia. Also, in Russia a permission has been granted to carry out its Phase II clinical trials against Non-Hodgkin Lymphoma and they commenced in January 2012. Prolonged Erythropoietin set for the treatment of renal insufficiency has passed Phase II clinical trials in India.

Corporate Governance

The Board of Directors is elected at a general meeting of the participants of SynBio LLC. Of the Board’s seven members, three are appointed by RUSNANO and four are selected from the candidates put forward by the other participants of the project including HSCI. 

Budget

The total budget for the Project, planned over 4 years, amounts to RUB 3.224 billion.  Of this amount, RUSNANO provides RUB 1.299 billion in cash. 70% of the total amount shall be provided during Phase one of the Project. Other participants in the Project provide up to RUB 1.925 billion through a combination of cash, intellectual property and shares in their subsidiaries of affiliates etc.

The total expected duration of the SynBio project is seven years.

18 February 2014
HSCI Announces Major Deal to Execute SynBio Investment Agreement

26 September 2011
Pharmaceutical Business Review 
Human Stem Cell Institute and Xenetic Biosciences have entered into collaboration to invest in the international biotech sector. Human Stem Cell Institute and Xenetic Biosciences were the initiators of a major cross-border M&A transaction to form SynBio, with additional financing secured from Russia's State Venture Fund Rusnano.

6 September 2011
Investment agreement for the SynBio project approved at shareholders’ meeting of the Human Stem Cells Institute

4 August 2011
HSCI Announces Terms of the Investment Agreement on SynBio Project


Web: www.synbio-pharma.com