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FDA approves new Alzheimer’s treatment despite risks, unclear benefits

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Enlarge / MRI of a human brain.

The Food and Drug Administration on Friday granted a fast-tracked approval for a new Alzheimer’s disease treatment, which may slightly slow the progression of cognitive decline in the disease’s early stages, but also raises risks of brain bleeds and swelling.

The treatment—lecanemab, brand name Leqemb, made by pharmaceutical companies Eisai and Biogen—is an intravenous monoclonal antibody that targets amyloid-beta proteins, which accumulate in plaques in the brains of people with Alzheimer’s. Researchers have not yet conclusively determined if amyloid plaques are a root cause of the disease, nor whether clearing them can significantly slow or halt cognitive decline.

The FDA’s approval of lecanemab is via an accelerated pathway, which uses “a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.” In this case, the surrogate endpoint was lecanemab’s ability to reduce amyloid beta plaques in the brains of Alzheimer’s patients.

Uncertain efficacy

But, the significance of that and the drug’s efficacy are still uncertain. In a Phase III clinical trial, published this week in the New England Journal of Medicine, treatment with lecanemab over 18 months only slightly slowed cognitive decline in patients with early Alzheimer’s. The trial included 1,795 participants—898 were assigned to receive lecanemab and 897 were assigned a placebo. Their cognitive abilities were assessed using an 18-point scale from an established clinical test for dementia. At the start of the trial, both groups (treatment and placebo) has a baseline score of about 3.2 on the test.  After the 18-month trial, the lecanemab treatment group’s score fell by 1.21 points, while the placebo group’s fell by 1.66 points—a 0.45-point difference that amounts to a 27 percent slower decline in the treatment group.

It’s unclear if that change is meaningful. Dr. Madhav Thambisetty, a neurologist and a senior investigator at the National Institute on Aging who spoke with The New York Times, said that the drug’s ability to clear amyloid plaques was “exciting,” from the perspective of a scientist. But, “from the perspective of a physician caring for Alzheimer’s patients, the difference between lecanemab and placebo is well below what is considered to be a clinically meaningful treatment effect.

The researchers behind the clinical trial noted in their conclusion that “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”

Safety concerns

Meanwhile, the treatment has raised safety concerns, particularly amid reports that three patients given the drug have died from brain swelling and bleeding. That includes a 65-year-old woman with early stage cognitive decline who died of a massive brain hemorrhage. Rudolph Castellani, a Northwestern Medicine neuropathologist who studies Alzheimer’s and conducted an autopsy on the woman at the request of her husband, told Science last November that he believed that the drug weakened the woman’s blood vessels, which then burst from a common treatment for blood clots after she had a stroke.

“It was a one-two punch,” Castellani told Science, which first reported the death. “There’s zero doubt in my mind that this is a treatment-caused illness and death. If the patient hadn’t been on lecanemab she would be alive today.”

A report of the woman’s death was also published this week in the New England Journal of Medicine.

Lecanemab’s prescribing information includes warnings and cautions about brain bleeding and swelling, and the use of blood thinners.

The FDA’s approval comes just a week after lawmakers released the results of an 18-month Congressional investigation into the agency’s much-criticized approval of a similar Alzheimer’s drug, Aduhelm. Data on that amyloid-targeting antibody therapy was even less conclusive than lecanamab’s, and the FDA granted approval over objections from its external advisory panel and internal experts.

Irregularities

The Congressional investigation found the FDA’s approval process “rife with irregularities” and “inappropriate” communications between FDA and Aduhelm’s maker, Biogen. The report also blasted Biogen for setting “an unjustifiably high price” of $56,000 a year for Aduhelm.

“This report documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm,” Energy and Commerce Committee incoming Ranking Member Frank Pallone, Jr. (D-NJ), said at the time.

Following the approval of lecanemab, Pallone released a statement saying: “I’m hopeful lecanemab will live up to its promise of slowing the progression of Alzheimer’s disease for patients and their loved ones. I’m also hopeful Eisai and Biogen have learned from past mistakes and will price lecanemab fairly to ensure patients have equitable access to this drug.

In a press release Friday afternoon, Eisai announced that it is pricing lecanemab at $26,500 for a year’s supply. That is above the range that the Institute for Clinical and Economic Review estimated would make the drug cost-effective, which the analysis group pegged at between $8,500 and $20,600 for a year’s worth of treatment.

It’s unclear if Medicare will cover lecanemab, which will dramatically influence its marketability. Medicare strictly limited coverage of Aduhelm, due to the high price, lack of evidence of benefit, and risks. Only Medicare beneficiaries in clinical trials have coverage for the price of Aduhelm, which has since been cut to $28,200 for a year’s supply.

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Telus prioritizing ‘most important customers,’ avoiding ‘unprofitable’ offers: CFO

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Telus Corp. says it is avoiding offering “unprofitable” discounts as fierce competition in the Canadian telecommunications sector shows no sign of slowing down.

The company said Friday it had fewer net new customers during its third quarter compared with the same time last year, as it copes with increasingly “aggressive marketing and promotional pricing” that is prompting more customers to switch providers.

Telus said it added 347,000 net new customers, down around 14.5 per cent compared with last year. The figure includes 130,000 mobile phone subscribers and 34,000 internet customers, down 30,000 and 3,000, respectively, year-over-year.

The company reported its mobile phone churn rate — a metric measuring subscribers who cancelled their services — was 1.09 per cent in the third quarter, up from 1.03 per cent in the third quarter of 2023. That included a postpaid mobile phone churn rate of 0.90 per cent in its latest quarter.

Telus said its focus is on customer retention through its “industry-leading service and network quality, along with successful promotions and bundled offerings.”

“The customers we have are the most important customers we can get,” said chief financial officer Doug French in an interview.

“We’ve, again, just continued to focus on what matters most to our customers, from a product and customer service perspective, while not loading unprofitable customers.”

Meanwhile, Telus reported its net income attributable to common shares more than doubled during its third quarter.

The telecommunications company said it earned $280 million, up 105.9 per cent from the same three-month period in 2023. Earnings per diluted share for the quarter ended Sept. 30 was 19 cents compared with nine cents a year earlier.

It reported adjusted net income was $413 million, up 10.7 per cent year-over-year from $373 million in the same quarter last year. Operating revenue and other income for the quarter was $5.1 billion, up 1.8 per cent from the previous year.

Mobile phone average revenue per user was $58.85 in the third quarter, a decrease of $2.09 or 3.4 per cent from a year ago. Telus said the drop was attributable to customers signing up for base rate plans with lower prices, along with a decline in overage and roaming revenues.

It said customers are increasingly adopting unlimited data and Canada-U.S. plans which provide higher and more stable ARPU on a monthly basis.

“In a tough operating environment and relative to peers, we view Q3 results that were in line to slightly better than forecast as the best of the bunch,” said RBC analyst Drew McReynolds in a note.

Scotiabank analyst Maher Yaghi added that “the telecom industry in Canada remains very challenging for all players, however, Telus has been able to face these pressures” and still deliver growth.

The Big 3 telecom providers — which also include Rogers Communications Inc. and BCE Inc. — have frequently stressed that the market has grown more competitive in recent years, especially after the closing of Quebecor Inc.’s purchase of Freedom Mobile in April 2023.

Hailed as a fourth national carrier, Quebecor has invested in enhancements to Freedom’s network while offering more affordable plans as part of a set of commitments it was mandated by Ottawa to agree to.

The cost of telephone services in September was down eight per cent compared with a year earlier, according to Statistics Canada’s most recent inflation report last month.

“I think competition has been and continues to be, I’d say, quite intense in Canada, and we’ve obviously had to just manage our business the way we see fit,” said French.

Asked how long that environment could last, he said that’s out of Telus’ hands.

“What I can control, though, is how we go to market and how we lead with our products,” he said.

“I think the conditions within the market will have to adjust accordingly over time. We’ve continued to focus on digitization, continued to bring our cost structure down to compete, irrespective of the price and the current market conditions.”

Still, Canada’s telecom regulator continues to warn providers about customers facing more charges on their cellphone and internet bills.

On Tuesday, CRTC vice-president of consumer, analytics and strategy Scott Hutton called on providers to ensure they clearly inform their customers of charges such as early cancellation fees.

That followed statements from the regulator in recent weeks cautioning against rising international roaming fees and “surprise” price increases being found on their bills.

Hutton said the CRTC plans to launch public consultations in the coming weeks that will focus “on ensuring that information is clear and consistent, making it easier to compare offers and switch services or providers.”

“The CRTC is concerned with recent trends, which suggest that Canadians may not be benefiting from the full protections of our codes,” he said.

“We will continue to monitor developments and will take further action if our codes are not being followed.”

French said any initiative to boost transparency is a step in the right direction.

“I can’t say we are perfect across the board, but what I can say is we are absolutely taking it under consideration and trying to be the best at communicating with our customers,” he said.

“I think everyone looking in the mirror would say there’s room for improvement.”

This report by The Canadian Press was first published Nov. 8, 2024.

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TC Energy cuts cost estimate for Southeast Gateway pipeline project in Mexico

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CALGARY – TC Energy Corp. has lowered the estimated cost of its Southeast Gateway pipeline project in Mexico.

It says it now expects the project to cost between US$3.9 billion and US$4.1 billion compared with its original estimate of US$4.5 billion.

The change came as the company reported a third-quarter profit attributable to common shareholders of C$1.46 billion or $1.40 per share compared with a loss of C$197 million or 19 cents per share in the same quarter last year.

Revenue for the quarter ended Sept. 30 totalled C$4.08 billion, up from C$3.94 billion in the third quarter of 2023.

TC Energy says its comparable earnings for its latest quarter amounted to C$1.03 per share compared with C$1.00 per share a year earlier.

The average analyst estimate had been for a profit of 95 cents per share, according to LSEG Data & Analytics.

This report by The Canadian Press was first published Nov. 7, 2024.

Companies in this story: (TSX:TRP)

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BCE reports Q3 loss on asset impairment charge, cuts revenue guidance

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BCE Inc. reported a loss in its latest quarter as it recorded $2.11 billion in asset impairment charges, mainly related to Bell Media’s TV and radio properties.

The company says its net loss attributable to common shareholders amounted to $1.24 billion or $1.36 per share for the quarter ended Sept. 30 compared with a profit of $640 million or 70 cents per share a year earlier.

On an adjusted basis, BCE says it earned 75 cents per share in its latest quarter compared with an adjusted profit of 81 cents per share in the same quarter last year.

“Bell’s results for the third quarter demonstrate that we are disciplined in our pursuit of profitable growth in an intensely competitive environment,” BCE chief executive Mirko Bibic said in a statement.

“Our focus this quarter, and throughout 2024, has been to attract higher-margin subscribers and reduce costs to help offset short-term revenue impacts from sustained competitive pricing pressures, slow economic growth and a media advertising market that is in transition.”

Operating revenue for the quarter totalled $5.97 billion, down from $6.08 billion in its third quarter of 2023.

BCE also said it now expects its revenue for 2024 to fall about 1.5 per cent compared with earlier guidance for an increase of zero to four per cent.

The company says the change comes as it faces lower-than-anticipated wireless product revenue and sustained pressure on wireless prices.

BCE added 33,111 net postpaid mobile phone subscribers, down 76.8 per cent from the same period last year, which was the company’s second-best performance on the metric since 2010.

It says the drop was driven by higher customer churn — a measure of subscribers who cancelled their service — amid greater competitive activity and promotional offer intensity. BCE’s monthly churn rate for the category was 1.28 per cent, up from 1.1 per cent during its previous third quarter.

The company also saw 11.6 per cent fewer gross subscriber activations “due to more targeted promotional offers and mobile device discounting compared to last year.”

Bell’s wireless mobile phone average revenue per user was $58.26, down 3.4 per cent from $60.28 in the third quarter of the prior year.

This report by The Canadian Press was first published Nov. 7, 2024.

Companies in this story: (TSX:BCE)

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