The consequences of Russia’s war for drug development

Since Russian’s invasion began on February 24th, pharmaceutical companies have been assessing the likely impact on their business, with many expressing concern that research studies could be severely interrupted.

Today, Ukraine has approximately 2,500 sites with the capacity to run international clinical trials, with around 500 trials taking place each year. According to the US Food and Drug Administration's (FDA) clinical trials database, 251 drugs and devices were being tested in clinical trials that have at least one site in Ukraine prior to Russia’s invasion of the country.

Since the demise of the Soviet Union and the end of the Cold War more than 30 years ago, companies and labs from around the world have increasingly relied on Ukrainian firms to develop new drugs. Among the organizations affected by the current conflict is Merck, which had clinical trials for endometrial cancer treatment ongoing at 11 sites in Ukraine when the invasion began. AbbVie had 15 Phase 3 studies ongoing in the country, and Sanofi, AstraZeneca, GSK, Eli Lilly and Roche were among the other large pharma firms carrying out research studies in the country.

Karuna Therapeutics, a company headquartered in Boston, US, focusing on neurological conditions and psychiatric conditions, has already warned that its second Phase 3 study in schizophrenia is in doubt as 10 of its 19 trial sites are in Ukraine.

Shortly after the invasion began, Karuna issued a statement saying: “In light of the continuously evolving and worsening conditions in the region, Karuna Therapeutics, Inc. is withdrawing its prior guidance for the timing of topline data for its ongoing Phase 3 EMERGENT-3 trial evaluating KarXT in schizophrenia. At this time, the escalating conflict in Ukraine has created uncertainty around the company's ability to project the timing of topline data from this trial.”

A serious economic setback

The pharmaceutical industry in Ukraine is among the 10 biggest pharmaceutical industries in the Central and Eastern European (CEE) region. While many sectors of the Ukrainian economy struggled to recover from the global economic crises of 2009–10 and 2014–15, pharma was not among them. Between 2010 and 2018 the industry grew by more than 18 percent year-on-year, and became the best paid industry in Ukraine with the exception of air transport.

While Ukraine is not a drug manufacturing hub, the war could lead to the country no longer being a preferred location for clinical trials, which would have a serious effect on the nation’s pharmaceutical sector.

Response to Russia’s offensive

Boehringer Ingelheim has announced it will donate €2.5mn (US$2.8mn) to charitable organizations providing humanitarian assistance to Ukraine. The company issued a statement saying: “Many colleagues are working to ensure the safety and well-being of our employees and their families in any way possible. We are in close contact with our Ukrainian colleagues. At the same time, we are seeking to limit the impact of the conflict on the supply of medicines to patients for humanitarian reasons across both countries.”

CEOs at dozens of biotechs including BioMarin, Rubius, Atai Life Sciences and Blueprint Medicines, along with investors from leading venture firms have written an open letter to global businesses asking them to "cease investment in Russian companies".

Meanwhile, former FDA Orphan Drugs Office Director Tim Coté is filing for a citizen petition for the agency to immediately stop administrative work that relates to pharma companies headquartered in or predominantly owned by Russia.

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