Independent monitors have paused enrolment in a study testing the COVID-19 antiviral drug remdesivir plus an experimental antibody therapy being developed by Eli Lilly that’s similar to a treatment U.S. President Donald Trump recently received.
Eli Lilly confirmed Tuesday that the study had been paused “out of an abundance of caution,” and said safety is its top concern. The company would not say more about what led to this step.
The U.S. National Institute of Allergy and Infectious Diseases, which sponsors the study, would not immediately comment.
Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help eliminate it. The experimental drugs are concentrated versions of one or two specific antibodies that worked best against the coronavirus in lab and animal tests.
This study was testing a single antibody that Eli Lilly is developing with the Canadian company AbCellera. Trump received an experimental two-antibody combo drug from Regeneron Pharmaceuticals Inc.
Eli Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant emergency use authorization for their drugs to treat COVID-19 while late-stage studies continue.
The paused study, called ACTIV-3, started in August and aims to enrol 10,000 hospitalized COVID-19 patients in the United States, Denmark and Singapore. All would be given remdesivir, which has been authorized in the U.S. as an emergency treatment for COVID-19, plus either the Eli Lilly antibody or a placebo.
The main goals are reducing the need for extra oxygen and the time to recovery. Deaths, relief of symptoms and other measures also are being tracked. All of the drugs are given through an IV.
Such pauses are not uncommon in long clinical studies. Unlike a study hold imposed by government regulators, a pause is initiated by the sponsor of the drug trial and often can be quickly resolved.
2nd vaccine Phase 3 trial halted due to ‘unexplained illness’ of participant
The pause in the Eli Lilly study comes a day after a temporary halt to enrolment in a coronavirus vaccine study. Johnson & Johnson executives said Tuesday that it will be a few days before they know more about an unexplained illness in one participant that caused a pause in its late-stage vaccine study. Johnson & Johnson isn’t disclosing the nature of the illness.
“It may have nothing to do with the vaccine,” said Mathai Mammen, head of research and development for Janssen, Johnson & Johnson’s medicine development business.
Mammen said the company doesn’t know yet whether the ill participant received the experimental vaccine or a dummy shot. He says Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires. It will recommend next steps.
The study of the one-dose vaccine will include up to 60,000 people from multiple countries. The company expects to complete enrolment in the study in two or three months.
Coronavirus: Alberta's top doctor says "we have a challenge" as 1440 cases confirmed over weekend – Global News
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Cenovus Energy shares plummet on news of its $3.8B deal to buy Husky Energy
The all-share deal by Cenovus Energy Inc. to buy Husky Energy Inc. for about $3.8 billion will likely spark more mega-mergers among Canadian oil and gas majors, according to a veteran oilsands analyst.
“This is likely just the start of big deals in Canadian energy land and thus it begs the question of who is next?” said analyst Phil Skolnick of Eight Capital in a report on Monday.
“As seen in the U.S. with the accelerated M&A activity, when there’s one meaningful transaction, there’s likely more to come.”
Several industry observers point to Calgary-based oilsands producer MEG Energy Inc. as the leading potential target, noting Husky’s failed $3.3-billion hostile takeover attempt of its smaller rival two years ago.
In his report, Skolnick presents scenarios where Canadian Natural Resources Ltd. (sometimes referred to by its stock ticker, CNQ) or Imperial Oil Ltd. buy MEG, while also outlining the numbers involved if Canadian Natural combined with Imperial or Suncor Energy Inc., and if Suncor were to merge with Imperial.
“Some (scenarios) have been asked about before and I was just bringing up some new ones _ like a CNQ and Suncor merger is not something I’ve heard out there, but nor was Cenovus-Husky,” he said in an interview.
“I’m not going to give zero chance to anything anymore.”
Analysts generally applauded the surprise Cenovus-Husky hookup announced Sunday for its operational advantages but criticized the plus-20-per-cent premium in the price for Husky.
“The deal does makes strategic sense,” said Manav Gupta of Credit Suisse in a note to investors.
“Like U.S. E&P (exploration and production companies), Canadian energy companies also need to come together, cut costs and become leaner to better adapt to lower energy demand in post pandemic world.”
He said Cenovus’s reputation as an efficient operator in its steam-driven oilsands projects will help Husky overcome its struggles with operational issues, including higher operating and administrative costs.
The companies have identified $1.2 billion in potential annual cost savings which will include workforce reductions.
But Gupta added the premium is “excessive” and joined other observers in predicting Cenovus shares would trade lower, as they did, falling by as much as 15 per cent to $4.15 in Monday trading in Toronto before closing down 8.4 per cent at $4.47.
Husky, meanwhile, gained as much as 14.2 per cent to $3.62 before closing up 12 per cent at $3.55 .
Husky shareholders are to receive 0.7845 of a Cenovus share plus 0.0651 of a Cenovus share purchase warrant in exchange for each Husky common share if the deal is concluded.
Cenovus shareholders would own about 61 per cent of the combined company and Husky shareholders about 39 per cent.
The transaction must be approved by at least two-thirds of Husky’s shareholders but Hong Kong billionaire Li Ka-Shing controls 70 per cent of Husky’s shares and has agreed to vote them in favour of the deal.
The announcement Sunday came just as Calgary’s oilsands companies are about to start rolling out third-quarter financial results, with Suncor Energy Inc. set to report Wednesday and both Cenovus and Husky scheduled to report on Thursday.
© 2020 The Canadian Press
Ant Group raises $34.4 billion in the biggest IPO of all time – CNBC Television
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