Analysis-Drugmakers look to help Ukrainians in drug trials after Russian invasion -Breaking
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© Reuters. FILEPHOTO: After shelling continues in Zhytomyr Ukraine, men use plywood sheets to protect windows at a hospital. REUTERS/Viacheslav Ratynskyi/File Photo2/3
By Manas Mishra
(Reuters] – Drug companies are struggling to provide medicines to patients enrolled at clinical trials in Ukraine. Millions fleeing bombardment have fled to safer countries.
Both Russia and Ukraine are now important in the study of new drugs, because there is a great need to find medicines for patients with gastrointestinal, neurological, or cancer disorders. Analysts estimate that 10% of those in clinical trials are from Russia or the surrounding areas.
Russia’s recent two-week-old attack on Ukraine and its bombardment have created an immediate humanitarian crisis. It has made it difficult for people to access food, water and medicine, as well as damaged major hospitals. Over 2,000,000 people fled Ukraine.
Mike Ryan, the World Health Organization’s emergency director Mike Ryan stated this week that “the health system is becoming embroiled in this conflict and engulfed by this crisis.” We’ve now seen that certain hospitals have been abandoned by authorities as they cannot operate.
Two of the pharmaceutical companies with the most clinical trials in Ukraine – U.S.-based Merck & Co and Swiss drugmaker Roche – said they were assessing how to continue delivering medicines to patients. Together, they currently have around 100 clinical trials there.
Minimum seven businesses, which includes Pfizer Inc (NYSE.) has stated that they have been experiencing delays in patient enrollment or trials. It is not known what the full extent of Ukraine’s delays are. GlobalData reports that there are 502 active trials in Ukraine.
Roche is currently conducting 33 trials in Ukraine. This accounts for 1.5% the total active population of its worldwide studies.
Roche spokesmen said that the company was looking for sites near countries such as Poland, Slovakia, and Romania where it could accept patients to conduct clinical trials.
The spokesperson stated in an email that “the situation for these patients is currently very difficult” and was actively seeking solutions to make sure they continue access to treatment, even if the patient has left Ukraine for other reasons.
Since Feb. 21st, Laboratory Corporation of America (NYSE) has canceled patient visits at clinics in Kyiv for drugmakers.
Paul Evans is the chief executive officer of Velocity Clinical Research. The company does not operate in Europe at the moment. He said that the industry was faced with similar problems in this region after Russia annexed Crimea.
Evans said that it wasn’t a war-like situation and that research into Ukraine is now almost impossible. You can likely finish the existing Russian trials. However, there are likely to be a lot of obstacles in starting new trials there.
PATIENT RECRUITMENT ON PAUSE
Many countries are host to large-scale clinical trials by pharmaceutical companies. Due to their willing patients, and low cost of doing business in comparison with the United States and Western Europe, Russia has been sought out.
Chris Howerton from Jefferies said Ukraine trials provide patients access not just to the experimental drugs but also medicines that are being tested. He said that trials still enrolling patients in the country will most likely move to another area if war drags out.
Merck has almost 60 active trials in Ukraine, making it the largest company operating in that country. However, Merck said on Monday that it was suspending enrollments in Russia and Ukraine. On Monday, the company stated at a conference it wanted to make products available to both commercial and trial customers.
The mounting sanctions against Russia don’t include medicine. GlobalData reports that Russia is the sixth most popular country for clinical research, with 842 ongoing trials.
However, experts pointed to new problems in Russia for conducting clinical business. This includes a lack of international air travel.
Johnson & Johnson (NYSE:) said it had paused screening and enrollment of new patients in Ukraine, as well as in Russia and its ally Belarus.
Pfizer said that 27 clinical trials were being conducted in Ukraine and has stopped recruiting new patients.
U.S. drug-developer Karuna Therapeutics, (NASDAQ:), has suspended enrollment to a trial in Ukraine of its schizophrenia drug. Steven Paul, the chief executive of Karuna Therapeutics (NASDAQ) said that it can recruit more patients in America if required.
California-based Tricida (NASDAQ) Inc indicated that they expect to report data on a trial of its experimental drug for kidney disease in the fourth quarter, rather than the third. The reason being that 15% of those in the study were Ukrainian.
Evans of Velocity said: “In Ukraine you have a total breakdown in society. It is impossible to do clinical research in such a conflict zone.
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