Russia's invasion of Ukraine is likely to impact millions of people, not just in the Eastern European nation but around the world as drug developers might face delays in clinical trials conducted in Kyiv and elsewhere.
One biotech, in particular, called out the geopolitical tensions as possible cause for concern. Karuna Therapeutics warned today that timelines for its second phase 3 study in schizophrenia, dubbed EMERGENT-3, are uncertain because 10 of the 19 trial sites are in Ukraine.
The study might not be needed for Karuna to file the drug, KarXT, for approval, according to RBC Capital Markets analysts. But, if the first phase 3 trial, EMERGENT-2, fails to meet its primary endpoint and produce safety data, Karuna could be in trouble. EMERGENT-3 is a "backup option," RBC wrote in a Thursday note.
"While our clinical trial sites in the Ukraine continue to actively recruit and treat patients, if political or civil conditions require it, our sites may need to delay or suspend clinical trial activities," Karuna said in a regulatory filing Thursday. "Our clinical trial sites have contingency plans in place as part of their standard quality management practices for circumstances such as these and are prepared to initiate such plans when and if necessary."
Ukraine is home to about 2,500 public medical facilities that have experience running international trials, and there are about 500 ongoing trials each year, according to clinical research organization Global Clinical Trials. The affect of the conflict on clinical trials could be far reaching. The biopharma industry is actively testing 251 drugs and devices in clinical trials that have at least one Ukraine site, according to the FDA's clinical trials database.
This includes 11 of 195 study locations for Merck's phase 3 trial of Keytruda in combination with Lenvima in patients with endometrial carcinoma. Regeneron also has studies in Ukraine, where it's testing Libtayo in combination with doublet chemotherapy in a phase 3 study in patients with non-small cell lung cancer. Six of that study's 143 locations are in Ukraine.
Ukraine and Russia represent about 1% of Merck's business, a spokesperson said, and the U.S. pharma does not have any manufacturing sites in either country.
"At this point, all our colleagues are safe and accounted for, and we continue to monitor the situation closely to provide whatever support we can to them and to their families," Merck's spokesperson said. "In line with our mission, we are also doing everything we can to ensure access to our medicines for patients."
GlaxoSmithKline could also be affected. The British Big Pharma has 27 Ukrainian sites, out of 235, in its phase 3 study of otilimab in patients with rheumatoid arthritis. GSK previously culled work on otilimab in COVID-19 in October 2021.
A spokesperson for GSK confirmed the company has local pharma and consumer health care teams in Ukraine but no manufacturing operations.
"The situation is evolving and we are monitoring it carefully. Our absolute priorities are the safety of our people and maintaining access to our medicines, vaccines and consumer healthcare products," GSK said in a statement to Fierce Biotech.
AstraZeneca, which has up to 20 active trials in Ukraine, similarly said it's working to protect local employees.
"The safety and wellbeing of AstraZeneca employees remains our top priority and we have taken steps to support colleagues. Furthermore, a team has been established which will do the utmost to ensure continued supply of our medicines to patients," said a company spokesperson in a statement.
Sanofi, which has at least two studies underway in Ukraine for the Regeneron-partnered med Dupixent, confirmed the company is monitoring the situation.
"Our key priority at Sanofi remains to ensure the safety of our people and continuity for the patients we serve," the spokesperson said. "All of our employees based in Ukraine have been asked to stay home and we are monitoring the developing situation very closely."
Takeda said the "situation is fluid," but the Japanese pharma is "doing everything we can to protect our employees and their families and to continue to supply patients with their much-needed treatments.”
Behind pharmaceutical companies' clinical trials are CROs that manage the on-the-ground logistics. Parexel confirmed in a statement to Fierce Biotech that the CRO operates clinical trials in the impacted regions.
"While we will not disclose the specific number of colleagues, customers or vendors impacted, like the rest of the world, we have been and continue to monitor the situation closely and are committed to supporting the continuity of trials in progress," the company said. "As always, the safety and wellbeing of our patients and colleagues remains our top priority."
Of the 45 biopharmas Jefferies analysts cover, nine of them have trial sites in Ukraine, according to a note. Karuna is one of those. Another, Veru, is expected to "appropriately react and maintain timelines" on its study of breast cancer treatment enobosarm because the trial is just starting, the analysts wrote in a note.
TG Therapeutics, another company covered by Jefferies, should not experience "meaningful impact" because the biotech has already asked the FDA to approve its drug ublituximab in patients with relapsing multiple sclerosis. A decision is slated for Sept. 28, 2022. A phase 3 extension study is ongoing with 20 of 85 trial sites in Ukraine.
"Broadly speaking, we do not believe that the emerging conflict in Ukraine will meaningfully impact ongoing trials in our coverage," Jefferies analysts wrote Thursday.
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