Tuesday, September 29, 2020

Pandemic hobbles drugmakers in recruiting for new studies

Apr 29. 2020
The Novartis campus in Basel, Switzerland, on Jan. 16, 2019. MUST CREDIT: Bloomberg photo by Stefan Wermuth
The Novartis campus in Basel, Switzerland, on Jan. 16, 2019. MUST CREDIT: Bloomberg photo by Stefan Wermuth
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By Syndication Washington Post, Bloomberg · James Paton · BUSINESS 

A study evaluating a Novartis cholesterol drug stopped enlisting patients due to Covid-19, just 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 medicine, a 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 to use telephone or video visits instead, and 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 an interview with Anna Edwards. "We're doing our best to mitigate that."

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 from sites in the U.S. and U.K., Novartis said last month. The delay shouldn't have a long-term impact on the trial if enrollment can resume in coming months.

"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.

Covid-19 is having an impact on clinical trials in areas such as respiratory diseases that 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. regulator last month cited reports of deviations from clinical-test procedures related to 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 and Co., delayed most new study starts and paused enrollment in most ongoing trials, but will continue tests for patients who are already enrolled. And, 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.

 

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