AstraZeneca continues to conduct clinical trials of drugs in Russia

Despite statements by international pharmaceutical companies about the suspension of new trials in Russia after the outbreak of hostilities in Ukraine, the British-Swedish AstraZeneca will conduct a study in the Russian Federation of a new drug for the prevention of COVID-19, which is necessary before its registration. This is so far the only Western pharmaceutical manufacturer that has already received permission to conduct local trials twice this year. Other Western companies are not trying to resume their activity in the Russian market, experts say.

AstraZeneca announced the start in Russia of the second phase of a pre-registration study of a new drug based on monoclonal antibodies for the prevention of coronavirus infection. Approval to test the drug with the working title AZD3152 on 130 patients with reduced immune status was received in August 2023, it follows from registry clinical trials conducted by the Ministry of Health. The company is already recruiting patients and plans to complete the study in the summer of 2024.

After the outbreak of Russian military operations in Ukraine, large international pharmaceutical companies announced the suspension of new clinical trials in Russia and the recruitment of new patients to current ones. This was stated by Pfizer, MSD, GSK, Novartis, Roche and others.

Updated in August this year positions AstraZeneca on the conflict in Ukraine says that the company will not begin “global clinical trials” in Russia.

The company does not contradict its statement: the study of a new drug for the prevention of COVID-19 is local, not international.

But simultaneously with the local study in Russia, AZD3152 has been undergoing a study of effectiveness, safety and neutralizing activity on 3.7 thousand patients in several countries since the end of 2022.

This is not the first local AstraZeneca trial approved this year. In February, the company received approval for a phase 2 trial of the combination of as-yet-unapproved ceralasertib with durvalumab in patients with non-small cell lung cancer. Before this, the last time the company received permission for an international study was in July 2022, possibly based on an application submitted before the February events. The sponsor of both new studies is the Russian legal entity of AstraZeneca, AstraZeneca Pharmaceuticals, and not the Swedish company, as before. AstraZeneca did not immediately provide a comment.

Conducting a local rather than an international study solves several problems, which have also become the reason for the suspension of new research by foreign pharmaceutical companies, points out Ilya Yasny, head of scientific expertise at the LanceBio Ventures venture fund. International studies require the export of patient biosamples to centralized laboratories of pharmaceutical companies abroad, in addition, the EU or US regulator must be able to travel to any center participating in the study, and now this is extremely difficult, the expert points out. In local clinical trials, he says, this is not required.

Despite the monotonous statements of international companies about the suspension of new research in the Russian Federation, each of them determines for itself the extent to which it will be present on the Russian market.

For example, GSK has not received a single permit since April 2022. Johnson & Johnson will conduct the only long-term study of already approved daratumumab against multiple myeloma. Permissions for extended late-phase studies on patients who had previously taken the drug were received in 2023 by Roche, MSD, Pfizer, Sanofi, as follows from the clinical trials registry. Roche confirmed that it is continuing previously started studies, but is not recruiting new patients. The remaining companies could not be immediately reached for comment.

Over the six months of this year, according to estimates by the Association of Clinical Research Organizations (AOKI), the Ministry of Health issued only seven permits to Western companies for international multicenter trials – 13.9 times less than a year earlier; in the third quarter – two more (see “Kommersant” dated August 4). Pharmaceutical companies are not interested in losing the Russian market, which still demonstrates stability, says DSM Group CEO Sergei Shulyak. Moreover, against the backdrop of statements by the authorities about the possibility of using compulsory licensing, he adds.

AstraZeneca has always been closely connected with Russia, invested in supporting startups, and had a large staff of employees, points out Ilya Yasny. According to him, if a company wants to remain on the Russian market, switching to local research in the current conditions is an acceptable way. So far, AstraZeneca’s initiative is an isolated case, says Svetlana Zavidova, executive director of AOKI. According to her, there is no interest from other Western companies in resuming activity in this area on the Russian market.

Polina Gritsenko