Ksenia Tyumeneva, the Head of the Partner Projects Department of Pharmasyntez Group, tells about the strategy of the group of companies in innovation portfolio development.
— How much is Pharmasyntez interested in the innovative drugs segment?
— This is one of the priorities. We have come a long way as a manufacturer of generic drugs (our portfolio includes more than 200 products registered in Russia, of which two are original and one is a candidate). Having gained competence in the development and introduction of generic drugs to the market, we are ready to move on to the production of more complex dosage forms and innovative drugs with higher added value.
We are urged to do that both by our own ambitions and due to the situation on the market. It will be increasingly more difficult to maintain high growth rates by developing only generics, because the number of new offers in this segment is growing rapidly.
— How many innovative drugs does the group have now?
— Five, all at different stages of implementation. Since the launch of such drugs takes at least ten years and requires large investments, we will be able to bring to the market the products that are currently undergoing clinical trials within three to five years. But in the ten years time, original drugs should take a significant share in the company’s revenue.
– Your innovative drugs are intended for the treatment of various diseases. Is there a priority area?
— All of them are intended for the treatment of socially significant diseases: diabetes mellitus, infectious diseases (tuberculosis, HIV, hepatitis), oncological and orphan diseases. The key provision of our innovation portfolio development strategy is that the molecule should meet the needs of society, solve unresolved problems, and treat the disease more effectively.
Pharmasyntez started with anti-HIV and anti-tuberculosis drugs. With the opening of factories in Tyumen and St. Petersburg, we mastered the production of anti-diabetes and anti-cancer drugs. In these areas, we have strong capacities in production, marketing and distribution.
— Is it more important for you to create innovations independently or in partnership?
— Now everything is with partners. According to statistics, it is one out of ten thousand innovative developments that reaches the consumer. It is risky to have the entire chain, from development to market launch, within one and the same company. Startups often work in development with the money provided by venture funds, and after results are received, a partner from the pharmaceutical industry joins the process. We consider only molecules that have already passed certain stages of development or clinical research as potential candidates.
— How are the potential candidates selected?
— They come to us in two ways. The first is when we understand what developments are relevant for our key therapeutic areas, and we are looking for developers of the right molecule. The second is when the developers themselves come to us. All the projects that we implemented started like that.
If we are interested in a drug or a molecule, the business development department initiates a multi-stage examination, based on the results of which it makes a decision to reject the drug or include it in the company’s portfolio.
The examination takes place as follows: first, our advisers evaluate the scientific and medical components of the project. At the early stages, we involve the company’s internal experts who are competent in this nosology. We also analyze the delayed effectiveness based on the conducted research. As a rule, 99% of offers are eliminated at these stages. The drugs that are selected fit well into our product line.
— Could you describe the selection process of any of the drugs?
— The PF-114 drug, used for chronic myeloid leukemia, including with the T315I mutation, which may later receive orphan drug status, currently has no direct registered analogues on the Russian market. It gives hope for a cure to patients with resistance or intolerance to drugs of the previous generation.
Encemab is aimed at solving a problem that is relevant for many regions. While there is no effective remedy for the prevention and treatment of tick-borne viral encephalitis, infected patients are injected with immunoglobulin from donated blood, which involves the risk of adverse effects. The drug still has to undergo several stages of clinical trials, but we assume that the hypothesis about its effectiveness for the emergency prevention and treatment of tick-borne encephalitis will be confirmed.
— What is the most valuable knowledge that you have acquired from partner projects?
— Firstly, it is the experience of conducting partner projects as such. It includes the preparatory stage, verification of documents, structuring of the transaction, preparation and approval of contracts, etc. There are pitfalls at each stage. This helps to better work out subsequent transactions and manage risks more effectively. Secondly, it is the knowledge that partners share during technology transfer.
— What are the prospects for the innovation segment in Russia?
— In the near future, we can expect more domestic developments. However, state support is needed for the further development of innovations in the pharmaceutical industry. The capacity of the Russian market is insufficient to make innovative projects look attractive. To develop a drug with the intention of entering export markets immediately (especially the US and the EU), we need huge investments. The Pharma-2030 program can give an impetus to the development of original Russian drugs.
Pharmasyntez’s innovative portfolio*
|Perchlozon® (INN Thioureidoiminomethylpyridinium Perchlorate)||Treatment of pulmonary tuberculosis, including in cases with multiple drug resistance||Irkutsk Institute of Chemistry named after A. E. Favorsky of the Siberian Branch of the RAS|
|Saterex® (INN gosogliptin)||Treatment of type II diabetes||Pfizer|
|Serogard® (INN adezmapimod)||Prevention and treatment of post-surgery adhesions||Irkutsk Research Center of Surgery and Traumatology|
|Encemab®||Emergency prevention of tick-borne viral encephalitis||Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the RAS|
|PF-114||Treatment of chronic myeloid leukemia with Philadelphia chromosome||Fusion Pharma|
*As of 01.07.2021.