Analysis: Drugmakers look to help Ukrainians in drug trials after Russian invasion

Tricida

11/03/2022 11:00

By Manas Mishra
    March 11 (Reuters) - The Russian invasion of Ukraine has
left drugmakers scrambling to find ways for patients enrolled in
clinical trials there to receive their medicines as millions
seek shelter from bombardment and flee to neighboring countries.
    Ukraine, as well as Russia, have become important countries
for studying new drugs because patients there have a dire need
for medicines to treat cancer, neurological and gastrointestinal
disorders. Russia and surrounding countries account for 10% of
people in clinical trials, analysts estimate.
    Russia's two-week-old invasion and bombardment of Ukraine
has rapidly created a humanitarian crisis, curtailing access to
food, water and medical supplies and damaging hospitals in major
cities. More than 2 million people have fled Ukraine.
    "The health system is becoming engulfed in this conflict,
engulfed in this crisis," the World Health Organization's
emergencies director Mike Ryan said this week. "We've seen now
that some hospitals are being abandoned by the authorities
because they simply cannot function."
    Two of the pharmaceutical companies with the most clinical
trials in Ukraine - U.S.-based Merck & Co  MRK.N  and Swiss
drugmaker Roche  ROG.S  - said they were assessing how to
continue delivering medicines to patients. Combined they have
about 100 clinical trials underway there.
    At least seven companies, including Pfizer Inc  PFE.N , have
said they are experiencing disruptions to trials or patient
enrollment in the region. The full scope of delays in Ukraine is
unknown. But there were 502 ongoing trials in Ukraine, according
to research firm GlobalData.
    Roche alone has 33 trials underway in Ukraine accounting for
 1.5% of the active trial population across its global studies. 
    A Roche spokesperson said the company is trying to identify
sites in nearby countries like Poland, Slovakia and Romania that
could take on its patients in clinical studies.
    "The situation for those patients is currently very
challenging and we are actively working on solutions to ensure
continued access to treatment for these patients, including if
they have left Ukraine and moved to other countries," the
spokesperson said in an email.
    Patient visits to clinics in the Ukraine capital Kyiv run by
Laboratory Corporation of America  LH.N , which conducts trials
for drugmakers, have been canceled since the week beginning Feb.
21, LabCorp told Reuters. 
    Paul Evans, chief executive of Velocity Clinical Research,
which does not currently operate in Europe, said the industry
faced similar challenges in the region when Russia annexed
Crimea in 2014.
    "But that wasn't an all-out war situation," said Evans,
adding that conducting research in Ukraine now is nearly
impossible. "You can probably finish existing trials in Russia.
But there is probably a disincentive to starting a new trial
there."
   
    PATIENT RECRUITMENT ON PAUSE
    Pharmaceutical companies often run large clinical trials
across many countries. Ukraine and Russia have been sought after
given a willing patient population and lower cost of doing
business compared to the United States and Western Europe. 
    Jefferies analyst Chris Howerton said trials in Ukraine
provide access not only to the experimental drugs, but 
medicines they are tested against. Trials still enrolling
patients will likely shift to other areas if the war drags on,
he said.
    Merck, which has nearly 60 ongoing trials in Ukraine - the
most among all companies operating there - said it had paused
enrolling new patients in Ukraine and Russia. The company said
on Monday at a conference that it was trying to get products to
people enrolled in trials as well as to commercial customers.
    Mounting sanctions against Russia do not include medicines.
There are 842 trials underway in Russia, making it the sixth
largest site for clinical studies worldwide, according to
GlobalData.  urn:newsml:reuters.com:*:nL5N2V60CR
    But experts also cited fresh challenges to conducting
clinical business in Russia, such as lack of air travel for
investigators outside the country.
    Johnson & Johnson  JNJ.N  said it had paused screening and
enrollment of new patients in Ukraine, as well as in Russia and
its ally Belarus.
    Pfizer, which said it was conducting 27 clinical trials in
Ukraine, has paused recruitment of new patients.
    U.S. drug developer Karuna Therapeutics  KRTX.O  suspended
enrollment for a trial of its lead schizophrenia drug in
Ukraine. Chief Executive Steven Paul told Reuters it could
recruit more patients in the United States, if needed.
    California-based Tricida Inc  TCDA.O  said it expected to
report data from a trial of its experimental kidney disease drug
in the fourth quarter instead of the third, as 15% of patients
in the study were from Ukraine.
    Said Velocity's Evans: "In Ukraine, you've got a complete
breakdown of society there. You can't possibly be doing clinical
research in a war zone like that now."
 

 (Reporting by Manas Mishra in Bengaluru; Editing by Ankur
Banerjee, Caroline Humer and Bill Berkrot)
 ((Manas.Mishra@thomsonreuters.com;
www.twitter.com/Manaswrites15))