Health

By Patrick Wingrove

London: Moderna pushed back its break-even goal by two years on Thursday as it delayed the timeline for developing several key products and predicted 2025 sales below its forecast for the current year, sending its shares closer to a four-year low.

Shares of the vaccine maker tumbled 17.1 per cent to $65.88 at midday.

The company expects sales between $2.5 billion and $3.5 billion in 2025, below analysts’ forecast of $3.74 billion, according to LSEG data. The midpoint was also below the $3 billion to $3.5 billion in sales it projected for 2024.

The company, which has been struggling to shift away from its COVID vaccine, said at an investor conference in New York that the regulatory process for flu and cancer vaccines would take more time than it had indicated.

Moderna expects to have $6 billion as cash on hand by 2024 end, which according to Jefferies analyst Michael Yee was at the lower end of its prior view of $6 billion to $7 billion.

Its cost savings would include a cut of $1.1 billion from research and development from 2026, with most of the actions in 2027. “I hope you can see…why we’re daunted by the commercial challenge of launching all those products really just in the next three years, and that causes us to want to actually start to pace ourselves,” Moderna President Stephen Hoge said.

The company expects to break even on an operating cash cost basis in 2028, two years later than its prior view.

Next year’s forecast reflects the uncertainty of COVID and respiratory syncytial virus (RSV) markets in the U.S., Chief Financial Officer James Mock said in an interview. Moderna said the adoption of RSV vaccine has been slower than anticipated.

The forecast also accounted for Moderna’s prediction that each of the 10 new products it expects to be approved by 2027 will start to generate meaningful revenue the year after they are approved, he said.

“For 2025, we might have some new product approvals assumed, but there’s not assumed to be much revenue from them,” Mock said.

The company said new product launches would drive an average annual growth rate of 25 per cent in revenue between 2026 and 2028.

Moderna said it plans to submit an FDA application this year to expand approval for its RSV shot to high-risk adults under the age of 60, following new data from a late-stage trial.

The regulator approved Moderna’s mRESVIA shot for RSV-associated lower respiratory tract disease in adults aged 60 or older last May, pitting it against rival vaccines from GSK and Pfizer.

The company said it had dropped its request for fast-track approval as part of its FDA application for a standalone influensa vaccine. Instead it will focus on the application for its combination shot to protect against COVID and influensa, which it plans to submit this year.

Moderna said mRESVIA met all immune-response targets and was found to be safe and well-tolerated in adults aged 18 and older with a compromised immune system, but did not provide more details on the new study’s findings.

Pfizer said in August its Abrysvo shot, which was approved last year for adults over the age of 60, generated a strong immune response in high-risk adults aged 18 and older.

The FDA in June expanded the use of GSK’s Arexvy vaccine in adults between the ages of 50 and 59. The U.S. Centers for Disease Control and Prevention instead recommended RSV shots for all adults 75 and older, as well as those who are 60 to 74 and have an increased risk of severe RSV due to medical conditions.

Moderna said the initial FDA feedback did not support an accelerated approval based on data from a mid-stage study for its cancer vaccine developed along with Merck. (Reporting by Patrick Wingrove in New York and Sneha S K in Bengaluru; Editing by Bill Berkrot, Maju Samuel and Arun Koyyur)

After his life was upended by a debilitating illness, a young man from Montreal and his family are making a public plea in hopes of finding a compatible kidney donor.

Julian Zadrozny, 25, knew something was wrong when he began experiencing “really bad leg cramps” and other painful symptoms.

“I wasn’t able to sleep through the night,” Zadrozny said in an interview. “And then sometimes occasionally I was having a hard time breathing.”

About six months ago, Zadrozny found out he had a form of end-stage chronic kidney disease caused by a mitochondrial defect. He says his case is rare and doctors are still trying to figure things out.

“There has been six cases recorded and they’re writing a case study about me because they’ve never seen it before,” Zadrozny said.

The illness means Zadrozny has to undergo daily dialysis while he sleeps as he waits for a new kidney. He has to be in bed for 10 hours every day.

Studying has become a struggle because of brain fog, while everyday movement is tiring.

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“Generally I have a hard time if I go up some stairs,” he said. “I’m out of breath and it’s something that that’s really difficult.”

Zadrozny and his partner Kayleigh Tooke have since found themselves in a struggle they never expected, and it has come with a steep learning curve.

Tooke, who works full-time, has a lot to do when she comes home. At first, she worried about hurting Zadrozny with simple loving gestures like hugs or cuddles or making a mistake helping with his treatment.

She has learned how to set up the dialysis machine, including tubes and bags, to help but it isn’t easy and sometimes issues arise.

“It’s always hard when you see someone you love in pain. I personally have a lot of stresses about it,” Tooke said.

The young couple are hoping to find a new kidney for Zadrozny, but he says the wait can be four to five years.

He’s not alone in his struggle. According to the Kidney Foundation of Canada, 73 per cent of Canadians who needed an organ transplant in 2023 were waiting for a kidney.

Even if there is a possibility of a match through the medical system, Zadrozny says it also comes to matching needs with other patients who are in the same position as him.

“They’re going to balance it with people that might need it, more people that have been on dialysis longer,” he said. “And in Quebec, there was quite a few people. Across Canada, we’re looking at about 40,000 people on dialysis.”

But the longer the wait, the harder it will be on Zadrozny.

“Your body doesn’t get stronger. You eventually get weaker and weaker and it’s always going to be tough,” he said, explaining a new kidney could give him the opportunity to “live again.”

The couple have launched a public campaign to find a living donor with a big heart and compatible kidney. They must have blood type O, be in good health and be willing to donate.

“It is a very long process and you’re saving somebody years of their life,” he said. “And you’re giving them back such a joy of life to be able to at least do the things that they like to do.”

&copy 2024 Global News, a division of Corus Entertainment Inc.

A rare and deadly mosquito-borne illness, the eastern equine encephalitis virus (EEEV), has claimed the life of an Ottawa resident, marking the city’s first confirmed human case.

Ottawa Public Health (OPH) issued a warning Thursday, urging residents to protect themselves from mosquito bites to reduce the risk of contracting both EEEV and West Nile Virus, which are both spread by the insect.

“OPH has received laboratory confirmation that an Ottawa resident who died of viral encephalitis in August 2024 tested positive for eastern equine encephalitis virus infection,” the statement read.

This is the first confirmed human case of EEEV in Ottawa; however, it is important to note the virus is not a reportable disease in Ontario, the statement added. That means there’s no obligation to report and track cases among provincial health officials.

1:09
What is the EEE virus?

The EEE virus is transmitted through the bite of an infected mosquito.

While humans and certain mammals, such as horses and llamas, can contract the disease, they do not transmit it further. There are no human vaccines or treatments for the virus.

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The virus can also cause severe illness and potentially be fatal in any age group, with those under 15 and over 50 being particularly at risk, health officials warned. And while human cases are rare, the disease is of concern because it can cause serious neurological disease, OPH said.

The death rate stands between 30 and 70 per cent.

The best way to protect yourself from mosquito-borne viruses is to avoid getting bitten, OPH advised.

Mosquitoes remain active in both urban and rural areas at this time of year and will continue to pose a risk until heavy frosts later this fall, the health unit said. Residents can take the following steps to protect themselves from mosquito bites:

• Applying a Health Canada-approved mosquito repellent containing DEET or icaridin to exposed skin and clothing (avoid applying DEET to synthetic fabrics).
• Protecting yourself when mosquitoes are active, especially between dusk and dawn and any time you are near shady hedges or bushy or wooded areas.
• Wearing light coloured, tightly woven, loose-fitting clothing, such as long pants, a long-sleeved shirt, shoes and socks, to protect exposed skin.
• Making sure all windows and doors in your home have screens that are in good condition.

Last month, a town in Massachusetts closed its parks, playgrounds and sports fields from dusk to dawn due to the increased risk of EEEV in the region. Plymouth, located about 60 km south of Boston, announced these closures on Aug. 23 in response to a high risk of virus.

In Canada, human infections with EEEV have been rare.

Although national data is unavailable, Ontario had reported three human infections of the virus before this recent case in Ottawa.

On Aug. 21, Ottawa Public Health reported that a horse in Ottawa tested positive for EEEV and issued a warning.

The first detection of the virus in Canadian mosquitoes happened in September 2009, when a positive pool of mosquitoes was found in the First Nations Community of Wahta Mohawk, Ont., according to Public Health Ontario.

In Canada, EEEV infections mainly occur in the spring and are linked to birds migrating from the southern United States to northern Canada, according to Health Canada.

&copy 2024 Global News, a division of Corus Entertainment Inc.

London: Eli Lilly is investing $1.8 billion across two manufacturing sites in Ireland to boost production of its hugely popular obesity drug and a newly approved treatment for Alzheimer’s, the drugmaker said on Thursday.

The investments are part of Lilly’s ongoing commitment to expand production, especially for its top-selling diabetes and obesity drugs, Mounjaro and Zepbound, respectively.

The company has committed over $20 billion since 2020 to build and expand its manufacturing facilities in the U.S. and Europe.

The company said it has invested roughly $800 million in its new facility in Kinsale, Ireland, which began manufacturing Lilly’s obesity and diabetes medicines last year. Demand for Zepbound has outpaced supply for most of this year.

The rest of the investment will go towards expanding the drugmaker’s facility in Limerick, Ireland, which will focus on producing active biologic ingredients for certain drugs, including the Alzheimer’s treatment.

Lilly’s drug for Alzheimer’s received U.S. approval in July and is currently under review with the European and UK health regulators.

Danish rival Novo Nordisk has also invested billions in manufacturing to ramp up supply of its popular weight-loss drug Wegovy, including a $11 billion deal to take over three sites from contract manufacturer Catalent.

In the U.S., Lilly quickly built a market share of around 40 per cent since launching Zepbound in December. Analysts believe that as Lilly increases its manufacturing capacity, the market could be roughly split 50-50 between Lilly and Novo Nordisk by the end of this year.

Some analysts forecast the market for new weight-loss drugs could reach $150 billion annually by the early 2030s. (Reporting by Bhanvi Satija in Bengaluru; Editing by Janane Venkatraman)

New Delhi: Biocon Chairperson Kiran Mazumdar-Shaw on Thursday called for more investment in research and development to drive innovation and foster culture of intellectual property. She highlighted how the country, already the world’s largest exporter of generics and a major player in vaccine production, can achieve greater value by nurturing innovation.

Mazumdar-Shaw called for a shift in focus toward value creation through innovation. “India ranks 14th in terms of value in the global pharma landscape. We need to invest in R&D and foster a culture of intellectual property to capture greater value,” she said.

Addressing a session during the Global Bio-India 2024 event, she positioned the country as a future global leader in biosciences and innovation.

Mazumdar-Shaw emphasized India’s unique advantages in becoming a global bio-innovation hub, citing the nation’s rich scientific talent, robust technological capabilities, and entrepreneurial drive.

“Biology is not only the most exciting and transformative field of our time, but it has also become the new frontier where we are pushing the boundaries of human knowledge and capability,” Mazumdar-Shaw said.

She highlighted how biosciences, once confined to the laboratory, are now permeating nearly every aspect of human existence, from medicine and agriculture to environmental conservation and technology.

“We are witnessing a revolution in healthcare driven by genetics, RNA, and CRISPR technologies that offer unprecedented precision. In the near future, genetic diseases like cystic fibrosis and muscular dystrophy may be cured entirely,” she said.

CRISPR is a gene editing technology that can be used to modify DNA in living organisms. She also highlighted the VIGYAN Dhara initiative, with its Rs 10,000 crore outlay aimed at promoting basic research and critical technologies.

On the agricultural front, Mazumdar-Shaw underscored the importance of biotechnology in ensuring global food security.

Mazumdar-Shaw also reflected on India’s existing strengths in the global pharmaceutical sector, noting that the country is the world’s third-largest manufacturer of medicines by volume and the largest exporter of generics.

“One in three pills consumed in the U.S. and one in four in the U.K. are produced in India,” she stated, underscoring the scale of India’s pharmaceutical production.

Canada is donating “up to 200,000” doses of mpox vaccine, a government spokesperson said on Wednesday. This comes after the World Health Organization declared mpox a global health emergency last month, for the second time in two years.

The number of doses of the vaccine Imvamune to be donated by Canada will depend on the receiving countries’ capacity for storage and administration, a spokesperson for Canada’s international development minister told Reuters.

Such donations are meant to address the vast inequity that left African nations with no access to the shots used during the global outbreak in 2022.

Mpox can spread through close contact. Usually mild, it is fatal in rare cases. It causes flu-like symptoms and pus-filled lesions on the body.

An outbreak in Congo began with the spread of an endemic strain, known as clade I. But a new variant, clade Ib, appears to spread more easily through routine close contact, including sexual contact.

It has spread from Congo to neighboring countries including Burundi, Kenya, Rwanda and Uganda, triggering the action from the WHO.

2:05
Health Matters: Canadians urged to get second mpox dose amid global rise in cases

Canada would not say to whom it would deliver the vaccines, or in what time frame.

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“Canada is working closely with global health experts, including GAVI (the international vaccine alliance) and the WHO, to access the scope of the outbreak and identify how best to deliver vaccines as soon as possible to those who need them most,” the government spokesperson wrote in an email. “We will provide more details once a delivery timeline has been finalized.”

Health Canada has previously refused to say how many mpox vaccine doses the country has “for national security reasons,” saying only, “Canada has secured sufficient supply of mpox vaccines to support provincial and territorial programs for the prevention and control of mpox in Canada.”

Based on previous years’ announcements from manufacturer Bavarian Nordic BAVA.CO, Adam Houston, medical policy and advocacy adviser for Médecins Sans Frontières Canada, figures Canada has, at a conservative estimate, more than two million doses of mpox vaccine.

“We’d like to see Canada first be more transparent about its own supplies and its own needs,” Houston said before news of the donation was made public. “And then we’d like to see transparency on its plans for what it’s going to do with these vaccines. We think the priority is that vaccines should be shared.”

London: Staff reviewers at the U.S. Food and Drug Administration said on Wednesday a confirmatory trial did not show the effectiveness of Intercept’s liver disease drug, which received the health regulator’s accelerated nod in 2016.

Under the accelerated pathway, companies are required to conduct additional trials to establish their drug’s benefits. Failure to do so can sometimes lead to market withdrawal.

Intercept’s oral drug, Ocaliva, had been approved under the accelerated approval pathway to treat patients with primary biliary cholangitis (PBC), a rare disease that causes inflammation of small bile ducts in the liver and can eventually destroy them.

In 2021, FDA restricted use of Ocaliva to PBC patients who did not have advanced cirrhosis or severe scarring of the liver.

The FDA had said some patients with advanced cirrhosis who received Ocaliva developed liver failure.

The staff advisers said on Wednesday Ocaliva’s confirmatory trial did not show the drug was effective in PBC patients with or without advanced scarring.

They also raised concerns about the drug’s safety, as 11 patients who received it during the trial died or required a liver transplant, compared with two patients on placebo.

The concerns come ahead of a meeting of independent experts on Friday, where panelists will vote on whether the drug’s benefits outweigh its risks.

Intercept said only one case of liver transplant was possibly related to the drug.

The company, which holds the drug’s U.S. commercial rights, was acquired by Italy’s Alfasigma for nearly $800 million last year. Intercept had reported sales of $152 million for the first half of 2023.

The FDA last month granted accelerated approval to Gilead’s drug for treating PBC, Livdelzi.

Accelerated approvals allow FDA to move drugs for life-threatening conditions to the market more quickly, but they have been criticised because some drugs are later proven to be ineffective. (Reporting by Bhanvi Satija in Bengaluru; Editing by Shailesh Kuber and Shreya Biswas)3

By Sriparna Roy and Bhanvi Satija

London: The U.S. Food and Drug Administration has allowed the expanded use of Johnson & Johnson’s drug, Tremfya, to treat adults with a type of chronic inflammatory bowel disease, the company said on Wednesday.

The approval paves the way for another treatment option for patients with ulcerative colitis, which causes inflammation and ulcers in the colon and rectum.

Drugmakers such as AbbVie, Eli Lilly and J&J are hustling for a share in an already-crowded, multi-billion market for treatments for inflammatory bowel diseases.

J&J has been betting on Tremfya, as its other blockbuster drug for psoriasis and ulcerative colitis, Stelara, is looking at a patent cliff – which occurs when a company loses its patent protection, allowing cheaper biosimilars to enter the market.

In a late-stage trial, patients receiving Tremfya were able to achieve endoscopic remission – a state where no signs of inflammation, ulcers or bleeding are visible during an endoscopy.

Chris Gasink, who looks over J&J’s U.S. Medical Affairs said the company was ready to make the drug available to eligible patients within “a week or two” after the FDA’s decision.

Analysts forecast Stelara sales of over $10 billion this year, according to LSEG data, of which 75 per cent are expected from sales for inflammatory bowel diseases.

Tremfya, which targets a protein involved in inflammatory responses called IL-23, will be J&J’s fourth drug for ulcerative colitis in the market.

(Reporting by Sriparna Roy, Bhanvi Satija and Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar and Krishna Chandra Eluri)

A single dose of the mpox vaccine offers moderate protection against the virus, according to a new Canadian study. While “moderate” might not sound impressive, the researchers describe the results as “terrific” and hope more Canadians at risk will continue to get vaccinated.

The study, published Wednesday in the BMJ, found that a single dose of the Modified vaccinia Ankara-Bavarian Nordic (MVA-BN) was 58 per cent effective in protecting against the mpox infection.

No randomized clinical trials have yet been conducted to test the effectiveness of vaccination against mpox. Previous estimates, based on observational studies, suggested that a single dose of the vaccine could be anywhere from 36-per cent to 86-per cent effective, the study said.

“It’s important because prior to the emergency use of this vaccine to try and reduce infections during a global outbreak that also affected Canada, there was no previous clinical trials to tell us how well this vaccine might work in the real world during an outbreak,” said Dr. Sharmistha Mishra, the study’s co-author and associate professor in the Department of Medicine at the University of Toronto.

“We had a lot of data on safety with this vaccine, but not very much data on how well it would work. It was rolled out in an emergency situation, and because of the type of data infrastructure and health-care system we have in Ontario, we were able to finally take a look and see how well it actually worked,” she told Global News.

4:36
‘Mpox is not the new COVID,’ WHO says amid virus surge in Europe, Africa

The vaccine is typically given in a two-dose regimen, 28 days apart, to protect against mpox. However, this study did not examine the effectiveness of the second dose.

The MVA-BN vaccine is a smallpox vaccine introduced after the global mpox outbreak was declared a public health emergency in July 2022.

In Ontario, the vaccine was initially introduced in June 2022 as post-exposure for high-risk contacts and pre-exposure for gay, bisexual, and other men who have sex with men, as well as sex workers at high risk of exposure, the study said.

Although approved as a two-dose series in Canada, Ontario initially used a single-dose strategy due to limited supply, later switching to a two-dose program by September 2022.

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Before the outbreak, data on MVA-BN’s effectiveness against mpox were limited. But the researchers of the BMJ study aimed to provide a more accurate estimate of the effectiveness of one dose of MVA-BN against mpox infection in a broader population using a target trial.

To do this, the researchers looked at total of 3,204 men who received the vaccine and were matched to 3,204 unvaccinated controls. Over the study period between June 2022 and October 2022, 71 mpox infections were diagnosed, 21 in the vaccinated group and 50 in the unvaccinated group.

“We wanted to find out how effective the vaccine that was rolled out in 2022 in Ontario was at preventing an infection among those who were highest risk of being infected with mpox,” Mishra said. “We found that among folks who were vaccinated, there was a 58-per cent reduction in the risk of infection.”

5:27
Mpox: What are the symptoms, and how does it spread?

While 58-per cent effectiveness might not seem high, Mishra said these results are still very promising, calling them “terrific.”

“It showed us that when something is as effective as 58 per cent, particularly when an outbreak is emerging, it could have a really large impact, especially when it’s combined with other measures to try and reduce transmission and infection,” she said.

With mpox infections rising again across the globe, the researchers said these findings “strengthen the evidence that MVA-BN is effective at preventing mpox infection and should be made available and accessible to communities at risk.”

On Aug. 14, the World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years, following an outbreak of the virus in parts of Africa.

Around the same time, Ontario health officials warned of a sharp rise in mpox cases in the region.

Originally identified in monkeys in 1958, mpox, previously known as monkeypox, was primarily confined to central and western Africa, and transmitted through close contact with infected animals.

However, a shift occurred in 2022 when the virus spread rapidly among people worldwide, including Europe, North America and beyond.

Mpox belongs to the same family of viruses as smallpox and causes similar, but generally milder symptoms. Common symptoms of mpox are a skin rash or mucosal lesions which can last two to four weeks accompanied by fever, headache, muscle aches, back pain, low energy and swollen lymph nodes, the WHO reports.

Mpox is caused by two distinct genetic variants or clades: Clade I and Clade II. Clade II, which generally causes less severe infections, was responsible for the global outbreak that began in 2022 and is the variant circulating in Canada.

2:07
Health Matters: Mpox variant may come to Canada, experts say

Clade I, a more concerning strain that leads to more severe disease and higher mortality rates, is now spreading beyond Africa. This clade, recently identified in sexual networks, has been detected in countries like Kenya, Rwanda, and Sweden —  nations that had never reported mpox cases before.

The MVA-BN vaccine has only been studied in Ontario, where the Clade II strain of mpox is present. But the researchers are hopeful it still has effectiveness against Clade I.

“We don’t know if this vaccine will be as effective, but we were facing the same situation back in 2022 in terms of the information we have. So there’s not a lot of reason to think that it wouldn’t be as effective. But we don’t have that information yet because the vaccines have been implemented in that setting of phase one yet,” Mishra said.

&copy 2024 Global News, a division of Corus Entertainment Inc.

London: BridgeBio Pharma said on Tuesday it will stop development of its experimental therapy for a genetic disease that affects the adrenaline-producing gland.

The drugmaker said the results of its early-to-mid stage study testing the therapy did not meet the threshold to warrant additional capital investment.

It will reduce its gene therapy development budget by more than $50 million, and seek partnership opportunities to support future development of the therapy, BBP-631, or newer treatments for congenital adrenal hyperplasia (CAH).

CAH is a group of genetic disorders caused by a mutation in an enzyme needed to produce cortisol, which is secreted by the adrenal gland.

The study showed that higher doses of BBP-631 increased production of cortisol in all patients.

Cortisol helps the body to respond to injury, stress or illness.

(Reporting by Puyaan Singh in Bengaluru; Editing by Shinjini Ganguli)

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