Medicines of the future are becoming a thing of the past

The suspension by global pharmaceutical companies of clinical trials of their drugs in the Russian Federation will significantly complicate the access of patients to new generation drugs. In the next ten years, about 300 drugs under development may not enter the market, including those for combating currently considered incurable diseases. Russian developments in these areas are still rare.

In the next ten years, Russian patients may not receive about 300 drugs currently being developed by international pharmaceutical companies. This is stated in a study by the Center for Mathematical Modeling in Drug Development of the First Moscow State Medical University named after I.M. Sechenov.

Estimates are based on the development portfolio of the top 20 global pharmaceutical companies by revenue and a number of biotech start-ups. The center took into account drugs for which at least the first phase of clinical trials is being conducted. A total of 6,000 promising developments were selected. According to statistics, 5-10% of them end with the drug being brought to the market – this is the minimum to recoup the investment, said Kirill Peskov, head of the center.

Global drug manufacturers, including Janssen, Novartis, Pfizer, have suspended new clinical trials in Russia and the enrollment of new patients in ongoing trials since the spring due to the outbreak of hostilities in Ukraine. Completion of clinical trials in the country is a necessary step for the registration of most drugs.

Among the 300 drugs are a number of “breakthrough therapies”, including those for fighting diseases that are now considered incurable, the authors of the study point out.

International companies, according to the center, are testing drugs that could change approaches to the treatment of several forms of cancer in the next two years. Among the promising areas that global companies are engaged in, the center highlights multispecific biological products, gene therapy, etc. Johnson & Johnson, Roche, Pfizer, AstraZeneca have the richest portfolio of developments, says Kirill Peskov.

The number of studies approved by the Ministry of Health began to noticeably decline in the second half of the year. In July-August, the ministry issued 97 permits, which is 24% less year on year. International companies account for about 17.5% of the permits received, although a year earlier they held 50.8%.

Some of the permits were issued for the study of Russian original drugs. Thus, in August, Biocad received permission to conduct clinical trials of a drug against spinal muscular atrophy. A gene therapy drug for this disease was first brought to market by Novartis. Biocad is also developing other gene therapies, for example, the early development of drugs for the treatment of hemophilia A and B has been completed, the company said. Now, according to her representative, this is one of the key areas.

Generium has three original drugs in development, the company says. One of them is a bispecific antibody developed against acute lymphoblastic leukemia. According to Kirill Peskov, this is the only such project in the development of Russian companies. In fact, the drug has a mechanism of action similar to Amgen’s blinatumomab, which was registered back in 2014, he adds.

Russian companies will not be able to provide the market with all analogues of international developments, Ilya Yasny, head of the scientific expertise of the LanceBio Ventures venture fund, believes.

Even the reproduction of drugs brought to the market, the creation of simple, low-molecular substances will take three to five years, and complex biomolecules up to ten years with no guarantees of success, he points out. The situation, according to him, is complicated by difficulties with the supply of equipment, reagents, and the departure of specialists. According to Ilya Yasny, it is necessary to ease the conditions for bringing drugs to the Russian market – without mandatory local clinical trials, or to allow the import of drugs in foreign packaging.

Polina Gritsenko