Pandemic Hobbles Drugmakers in Recruiting for New Studies (3)

A study evaluating a Novartis AG cholesterol drug stopped enlisting patients due to Covid-19, the latest example of how the pandemic is hampering research across the industry.

The Swiss drugmaker has paused new enrollment in a large U.K. clinical trial called Orion-4 that’s evaluating the experimental heart drug inclisiran, Chief Executive Officer Vas Narasimhan said in a Bloomberg Television interview. The potential blockbuster was central to Novartis’s $9.7 billion takeover of Medicines Co. last year.

Novartis is far from alone as regulators around the world ask researchers to avoid in-person interactions and try using telephone or video instead, and as medical centers focus on tackling the coronavirus. Sanofi said it’s seen some slowdowns, without giving examples, while Wolfe Research analysts said the outbreak is probably affecting enrollment for a study of Biogen Inc.’s experimental Alzheimer’s drug aducanumab.

“The real issue for us, and across the sector, has been new clinical trial starts, as well as continuing enrollment of studies that are ongoing,” Novartis’s Narasimhan said in the interview with Anna Edwards. “We’re doing our best to mitigate that.”

Vas Narasimhan, CEO at Novartis AG, discusses why the company is keeping 2020 forecasts intact, and the impact of coronavirus.

Markets: European Open.” (Source: Bloomberg)

Clinical Obligation

Most studies are still on track at Novartis, the CEO said. The company has been able to shift tests to China and other Asian countries. The Orion-4 study, expected to finish in 2024, aims to recruit 15,000 participants in the U.S. and U.K., the company said last month.

With hospitals across the U.K. responding to the pandemic, it wasn’t possible to keep enlisting new patients, according to Louise Bowman, a professor at the University of Oxford and the chief investigator of the trial. The virus has hit the country and its National Health Service hard, leading to more than 21,000 deaths so far.

“At a time when the NHS needed to be gearing itself for the potential of Covid-19, we recognized that clinically our obligations were to stop holding those visits face-to-face,” she said. “It’s a frustration, but we’re keeping careful watch on it and we’ll be back up and running as soon as we safely can.”

The delay shouldn’t have a long-term impact on the trial if enrollment can resume in coming months, according to Novartis.

“There are a few digital technologies we have deployed over the years that are helping us manage this situation,” Narasimhan said on an earlier call with reporters, pointing to the company’s global surveillance hub that monitors its network of hundreds of drug studies and aims to predict potential problems on a minute-by-minute basis.

The pandemic is having an impact on clinical trials in areas such as respiratory disease, where studies of conditions other than Covid-19 could divert hospital resources from tackling the crisis, Sanofi said by email. The drugmaker said it’s maintaining progress on key projects.

The U.K.’s drug regulator last month cited reports of deviations from clinical-test procedures because of the coronavirus. Patients with health problems may be advised to stay away from hospitals or they may be reluctant to visit them, it said.

Another large pharmaceutical company, Eli Lilly & Co., delayed the start of most new studies and paused enrollment in most ongoing trials, but will continue tests for patients who are already enrolled. Erytech Pharma SA, a small drugmaker, said last week that the pace of recruitment for a pancreatic cancer trial has slowed.

The pandemic so far hasn’t hurt demand for existing Novartis medicines -- quite the contrary as patients rushed to buy essential drugs before lockdowns. The company maintained its sales and profit forecast for the year as it reported first-quarter earnings.

(Adds Oxford researcher’s comments in sixth paragraph)

--With assistance from Naomi Kresge.

To contact the reporter on this story:
James Paton in London at jpaton4@bloomberg.net

To contact the editors responsible for this story:
Eric Pfanner at epfanner1@bloomberg.net

Marthe Fourcade

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