Research and Development:

Q: Have you already begun to develop the medicines that are going to be part of the SynBio portfolio?

A: Research has begun on practically all medicines in the portfolio. For six of them preclinical studies are either underway or already completed. Two drugs have already past Phase 1 clinical trials (safety, pharmacokinetics and pharmacodynamics research) while another has completed Phase 2 clinical trials (selection of dosage).  

Q: Do you plan to hold clinical trials in any other countries besides Russia?

A: Yes, we intend to carry out clinical trials in Europe, as we plan to offer our medicines not only on the Russian market but on international markets as well. We intend to apply for permission from the European Medicines Agency to carry out clinical trials for at least two of our drugs in the European Union by 2015.

Strategy and Development Prospects:

Q: Where do you intend to produce your medicines?

A: We plan to produce both the active ingredients and the finished pharmaceutical products at our own facilities according to European GMP standards. The project calls for the creation of two production complexes for which we are presently seeking sites. The decision on the first facility will be made in the near future. According to our plans, by 2014-2015 SynBio should have at least one functioning production complex and the second should be nearing completion.

For an innovative company such as SynBio , it is critically important to have one’s own production capacity, as this is the only way to guarantee the high quality of the products.

Q: How do you plan to sell your medicines?

A: First of all, we are currently fully focused on research and development. Our primary task is to develop medicines and ready them for the market, medicines that represent progress in the treatment of several serious diseases. And we need to make these medicines as effective and safe as possible.

In terms of our approach to sales, we will focus on hospital needs and state procurement programs – the nature of our medicine portfolio warrants such an approach.

SynBio in the Context of the Russian Pharmaceutical Industry:

Q: What does this project mean for the Russian economy?

A: SynBio is a great example of how the innovative development program for the Russian pharmaceutical market can be realized. In autumn of 2009 the Ministry of Industry and Trade approved the strategy for the development of the Russian pharmaceutical industry through the year 2020. One of the goals of this strategy is to double the share of Russian medicines on the domestic market (raising the share to 50%) as well as an eight-fold increase in the export of medicines. We are confident that our project will make a contribution toward the achievement of these goals.

However, even more importantly, the project aims to bring to the market a number of innovative medicines which represent real progress in the treatment of socially significant diseases. Thus, this project will raise the quality of life for Russians and, consequently, have a positive impact on economic development.