TORONTO —
Health Canada says it is working with international counterparts to review an experimental pill from drugmaker Merck, which the company reports can reduce hospitalizations and deaths by half in patients sick with COVID-19.
During a news briefing Friday, the Public Health Agency of Canada (PHAC) said Merck first submitted an approval request for molnupiravir, a twice-daily oral antiviral agent taken within five days after the onset of symptoms, as a potential treatment for COVID-19 on Aug. 13.
According to PHAC, the submission was accepted under the Minister of Health’s Interim Order, which allows for the review of “early safety, quality and efficacy data” while later-stage clinical trials take place
Canada’s chief medical adviser Dr. Supriya Sharma said review of the treatment is ongoing as more data from trials becomes available. Sharma said Health Canada will make an approval decision only when all necessary evidence has been submitted and reviewed.
“We are looking at it. We’re going through … the data,” she said.
Sharma said Health Canada has no specific time for completion of the review as it can take “months,” but also that the pill will be evaluated and “held to the standards” as any other medication or treatment.
According to Health Canada, it only authorizes treatments, including those for COVID-19, following a “thorough scientific review of the safety, efficacy and quality data.”
“A treatment must show evidence that it works well, is of high quality and is safe. The available data must demonstrate that the treatment’s benefits outweigh its risks,” the agency said in a statement.
Canada currently has four approved treatments for COVID-19, including Canadian-made COVID-19 monoclonal antibody bamlanivimab and antiviral medication remdesivir. However, these treatments require an IV or injection.
If cleared, molnupiravir would be the first oral pill shown to treat COVID-19.
Merck and its partner Ridgeback Biotherapeutics announced Friday that early results from its trials show that patients who received molnupiravir within five days of COVID-19 symptoms had about half the rate of hospitalization and death as those who received a placebo.
The study tracked 775 adults with mild-to-moderate COVID-19 who were considered to be at higher risk for severe disease because of health problems such as obesity, diabetes or heart disease. Among patients taking molnupiravir, 7.3 per cent were either hospitalized or died at the end of 30 days, compared with 14.1 per cent of those who recieved the placebo.
The results were so strong that an independent group of medical experts monitoring the trial recommended stopping it early.
“It really takes what is the devastating disease and hopefully gives people confidence that it can be manageable,” Merck CEO Robert Davis said in an interview with CTV News.
Davis called the pill a “game-changer” that could potentially be used to treat non-hospitalized, less severe cases of COVID-19 from home.
Earlier study results from Merck showed the drug did not benefit patients who were already hospitalized with severe disease. Experts say this is expected, given that antiviral drugs are most effective before the virus ramps up in the body.
The study results have not been reviewed by outside experts, which is the usual procedure for vetting new medical research.
Merck said it plans to submit the data in the coming days to health officials in the U.S. and other countries to authorize the pill’s use.
A decision from the U.S. Food and Drug Administration could come within weeks after that, and be distributed soon after.
Similar to other antivirals, molnupiravir works by interfering with the virus’s ability to copy its genetic code and reproduce itself, a process known as excessive mutagenesis or “error catastrophe.”
Matthias Gotte, a professor of medical microbiology and immunology at the U of A, led the research and said in an interview with CTV News that the drug attacks the virus, but doesn’t block or inhibit its replication.
Gotte said molnupiravir changes the viral genome, causing the replication engine of the virus to make “sloppy copies” of these altered genomes that are useless and not viable.
While Merck only studied its drug in people who were not vaccinated, Gotte said it may also potentially work in vaccinated patients who get less severe, breakthrough COVID-19 infections.
However, Gotte said it is important to note that molnupiravir is not a replacement for vaccines.
“The principles are completely different. Vaccines, they prevent severe disease, and the drugs are used to treat,” he said. “Once you are infected, the big problem is with these antiviral drugs you can’t use them late, you have to use them as early as possible.”
Eleanor Fish, a senior immunologist with the Toronto-based University Health Network who is not affiliated with the U of A study or Merck, says the approval of molnupiravir would help those who are ineligible for vaccination as well as those most at risk of severe disease.
“We can jump up and down in the U.S. and Canada and say, ‘Hey, we’ve got another tool in our armoury,’ [and] that’s going to be great,” Fish told CTV News.
She added that the drug’s approval in other parts of the world will help countries that are struggling to acquire COVID-19 vaccines.
“I see this more as [an] incredible opportunity, with a limited number of vaccines available globally, to send this out to those jurisdictions where vaccination rates are very, very low,” she said.
MONTREAL – Travel company Transat AT Inc. reported a loss in its latest quarter compared with a profit a year earlier as its revenue edged lower.
The parent company of Air Transat says it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31.
The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.
Revenue in what was the company’s third quarter totalled $736.2 million, down from $746.3 million in the same quarter last year.
On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.
Transat chief executive Annick Guérard says demand for leisure travel remains healthy, as evidenced by higher traffic, but consumers are increasingly price conscious given the current economic uncertainty.
This report by The Canadian Press was first published Sept. 12, 2024.
Dollarama Inc.’s food aisles may have expanded far beyond sweet treats or piles of gum by the checkout counter in recent years, but its chief executive maintains his company is “not in the grocery business,” even if it’s keeping an eye on the sector.
“It’s just one small part of our store,” Neil Rossy told analysts on a Wednesday call, where he was questioned about the company’s food merchandise and rivals playing in the same space.
“We will keep an eye on all retailers — like all retailers keep an eye on us — to make sure that we’re competitive and we understand what’s out there.”
Over the last decade and as consumers have more recently sought deals, Dollarama’s food merchandise has expanded to include bread and pantry staples like cereal, rice and pasta sold at prices on par or below supermarkets.
However, the competition in the discount segment of the market Dollarama operates in intensified recently when the country’s biggest grocery chain began piloting a new ultra-discount store.
The No Name stores being tested by Loblaw Cos. Ltd. in Windsor, St. Catharines and Brockville, Ont., are billed as 20 per cent cheaper than discount retail competitors including No Frills. The grocery giant is able to offer such cost savings by relying on a smaller store footprint, fewer chilled products and a hearty range of No Name merchandise.
Though Rossy brushed off notions that his company is a supermarket challenger, grocers aren’t off his radar.
“All retailers in Canada are realistic about the fact that everyone is everyone’s competition on any given item or category,” he said.
Rossy declined to reveal how much of the chain’s sales would overlap with Loblaw or the food category, arguing the vast variety of items Dollarama sells is its strength rather than its grocery products alone.
“What makes Dollarama Dollarama is a very wide assortment of different departments that somewhat represent the old five-and-dime local convenience store,” he said.
The breadth of Dollarama’s offerings helped carry the company to a second-quarter profit of $285.9 million, up from $245.8 million in the same quarter last year as its sales rose 7.4 per cent.
The retailer said Wednesday the profit amounted to $1.02 per diluted share for the 13-week period ended July 28, up from 86 cents per diluted share a year earlier.
The period the quarter covers includes the start of summer, when Rossy said the weather was “terrible.”
“The weather got slightly better towards the end of the summer and our sales certainly increased, but not enough to make up for the season’s horrible start,” he said.
Sales totalled $1.56 billion for the quarter, up from $1.46 billion in the same quarter last year.
Comparable store sales, a key metric for retailers, increased 4.7 per cent, while the average transaction was down2.2 per cent and traffic was up seven per cent, RBC analyst Irene Nattel pointed out.
She told investors in a note that the numbers reflect “solid demand as cautious consumers focus on core consumables and everyday essentials.”
Analysts have attributed such behaviour to interest rates that have been slow to drop and high prices of key consumer goods, which are weighing on household budgets.
To cope, many Canadians have spent more time seeking deals, trading down to more affordable brands and forgoing small luxuries they would treat themselves to in better economic times.
“When people feel squeezed, they tend to shy away from discretionary, focus on the basics,” Rossy said. “When people are feeling good about their wallet, they tend to be more lax about the basics and more willing to spend on discretionary.”
The current economic situation has drawn in not just the average Canadian looking to save a buck or two, but also wealthier consumers.
“When the entire economy is feeling slightly squeezed, we get more consumers who might not have to or want to shop at a Dollarama generally or who enjoy shopping at a Dollarama but have the luxury of not having to worry about the price in some other store that they happen to be standing in that has those goods,” Rossy said.
“Well, when times are tougher, they’ll consider the extra five minutes to go to the store next door.”
This report by The Canadian Press was first published Sept. 11, 2024.
TORONTO – The U.S. Consumer Financial Protection Bureau has ordered TD Bank Group to pay US$28 million for repeatedly sharing inaccurate, negative information about its customers to consumer reporting companies.
The agency says TD has to pay US$7.76 million in total to tens of thousands of victims of its illegal actions, along with a US$20 million civil penalty.
It says TD shared information that contained systemic errors about credit card and bank deposit accounts to consumer reporting companies, which can include credit reports as well as screening reports for tenants and employees and other background checks.
CFPB director Rohit Chopra says in a statement that TD threatened the consumer reports of customers with fraudulent information then “barely lifted a finger to fix it,” and that regulators will need to “focus major attention” on TD Bank to change its course.
TD says in a statement it self-identified these issues and proactively worked to improve its practices, and that it is committed to delivering on its responsibilities to its customers.
The bank also faces scrutiny in the U.S. over its anti-money laundering program where it expects to pay more than US$3 billion in monetary penalties to resolve.
This report by The Canadian Press was first published Sept. 11, 2024.
