By Manas Mishra and Michael Erman
(Reuters) – U.S. drugmakers Eli Lilly and Co and Bristol Myers Squibb said they are delaying the start of new clinical trials in part to free up doctors and healthcare facilities to deal with the surge in patients infected with the new coronavirus.
Lilly and Bristol are the biggest drugmakers yet to announce clinical trial delays in the face of the pandemic that has killed over 16,000 people worldwide, after several small biotech companies said last week that they would be pulling back on drug studies.
The moves are not related to clinical trials testing drugs or vaccines that could be used to treat or prevent COVID-19, the respiratory illness caused by the virus.
The U.S. Food and Drug Administration last week urged switching to virtual patient visits instead of in-person monitoring when conducting clinical studies as it anticipated the outbreak would disrupt them.
Pfizer Inc, Merck & Co, AbbVie Inc, and Johnson & Johnson were not immediately available for comment on their trials policies.
Delaying clinical trials could hurt future revenue for pharmaceutical companies as it lengthens the time it takes for drugs to receive approval and reach the market. It could also hurt patients by limiting their access to experimental treatments being studied.
Lilly said the move would delay the timeline for ongoing late-stage studies of its experimental gastrointestinal disease treatment mirikizumab.
The Indianapolis-based drugmaker said there will not be any delay in other ongoing late-stage trials.
It added that it would analyze ongoing trials on a study-by-study basis, as discontinuing them would disrupt the treatment course for patients. But it plans to continue most trials where patients are already enrolled.
Lilly said it does not anticipate any change to its full-year financial forecast as a result of the coronavirus outbreak.
Bristol posted a message to clinical trial investigators on its website on Friday, saying it will put off beginning new clinical trials for at least three weeks because of the impact of the rapidly spreading coronavirus pandemic.
The New York-based drugmaker said it will not initiate any new sites for clinical trials until April 13, noting that the timeframe of the halt could extend further.
It also said studies involving healthy volunteers should be put on hold if they are at a natural break point until at least April 13.
Bristol did not say how many trials or which drugs in development might be affected.
FINANCIAL COST TO HOSPITALS
Conducting clinical trials is a good source of revenue for non-profit and academic hospitals, but are not as significant for for-profit hospital companies, Jefferies analyst Brian Tanquilut said.
Large publicly listed hospital operators in the United States include HCA Healthcare, Tenet Healthcare Corp and Community Health Systems.
Lost revenue from clinical studies can directly impact staffing and operations as sites are usually paid per visit, according to Nariman Nasser, an executive at Continuum Clinical, an industry consultant that works with trial sites.
Large hospitals and academic centers also stand to lose fees that cover costs for things like building space, maintenance and operating costs, Nasser said in an email.
Last week, U.S.-based Iveric Bio Inc delayed enrollment in a trial of its eye disease drug, two days after Provention Bio paused a study of a diabetes drug but allowed trial patients to complete their treatment course.
(Reporting by Manas Mishra in Bengaluru and Michael Erman in Maplewood, N.J. ; Editing by Shinjini Ganguli and Bill Berkrot)
