Behind The Headlines: Pfizer Finds New Ways To Support Dementia Research
Last week, pharmaceutical giant Pfizer announced it was backing new avenues of funding for neurodegeneration research the area that includes research into Alzheimers and other diseases that cause dementia. This news comes just five months after Pfizer announced it would scale back its investment in dementia research, choosing to fund external projects rather than producing research in-house. At the time, the announcement made headlines with many speculating on what the move could mean for the search for new dementia treatments.
Pfizers announcement also comes in the same week that two Phase III clinical trials for Alzheimers disease were stopped early. While there are still a number of potential treatments in the later stages of clinical trials, this setback highlights the need to continue investing in early research and novel ideas.
What Should We Take Away
First and foremost, Pfizers announcement is welcomed new investment for dementia research.
Secondly, when we see headlines like those in January, its important to bear in mind that the moves we see may just be a business strategy, rather than a negative indication of how research is developing across a disease area. Companies may leave a research area just to jump back in once an advancement is made in the field by someone else. Investment from pharmaceutical companies is vital for a healthy pipeline of potential treatments, but we shouldnt necessarily adopt a Chicken Little approach when one company changes tactics.
Together with these initiatives, and with your support, Alzheimers Research UK believes the pioneering research happening today will bring about life-changing treatments for dementia.
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Over 6 Million Americans Suffer From Alzheimer’s
In recent years, some major drug companies abandoned efforts to research brain diseases, including Pfizer and Boehringer Ingelheim in 2018 in fact, Biogen had given up on Aduhelm at one point during the clinical trials in 2019 before reversing its decision after decades of failure in search of a breakthrough.
The controversy surrounding the Biogen drug, including its potential cost, comes against a landscape of massive, unmet need for dementia treatment and a disease that costs the U.S. as much as $259 billion annually. More than 6 million Americans have Alzheimer’s or another form of dementia, according to estimates from the Alzheimer’s Association, and by 2050 that number could reach over 12 million people at a cost of $1 trillion annually.
That is why some dementia drug experts are focusing on the renewed attention and fresh financing rather than the potential negatives from the Biogen approval, according to Dr. Jeffrey Cummings, a neurologist at the University of Nevada, Las Vegas, who publishes an annual review of the Alzheimer’s drug development pipeline. His research consistently showed the drug-failure rate at 99.6 percent before the Biogen approval, a stark contrast to the 1 out of every 5 cancer drugs that are successful.
In recent history, The National Institutes of Health spent two to three times more on heart disease and cancer research than on dementia, while a lack of qualified participants for clinical trials also slowed progress.
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Best Patients Advice For Families
The new drug is certainly not meant for everyone with Alzheimer’s, says Julia Biernot, MD, a behavioral neurologist at the University of Maryland School of Medicine, Baltimore. “It’s important to know that it is most likely going to be indicated in patients who have mild Alzheimer’s disease or mild cognitive impairment, as opposed to more advanced disease. And there may be potential side effects that need to be discussed with patients and their families.”
The most common, according to Biogen, is a condition known as ARIA — amyloid-related imaging abnormalities, found in 41% of patients in one study. These problems include temporary swelling in the brain and small areas of bleeding.
While she calls the approval “an exciting development overall,” Biernot also cautions families that the treatment would probably be needed indefinitely.
“There isn’t a profile for the best patient,” Schneider says. The clinical studies enrolled people with mild cognitive impairment or MCI, a precursor to Alzheimer’s, and with mild Alzheimer’s. “That’s the group in which the drug has been tested,” he says. “Not necessarily tested and shown to be effective, but tested.”
“I think people who come with symptoms, with MCI due to Alzheimer’s or with mild Alzheimer’s, who wish to try the monthly infusions for a year and a half , we would be happy to support them,” Schneider says. He stresses, however: “Families need to do their own research and talk to their doctor.”
Pfizer Halts Research Into Alzheimer’s And Parkinson’s Treatments
Pfizer has announced plans to end its research efforts to discover new drugs for Alzheimer’s and Parkinson’s diseases. The pharmaceutical giant explained its decision, which will entail roughly 300 layoffs, as a move to better position itself “to bring new therapies to patients who need them.”
“As a result of a recent comprehensive review, we have made the decision to end our neuroscience discovery and early development efforts and re-allocate to those areas where we have strong scientific leadership and that will allow us to provide the greatest impact for patients,” Pfizer said in a statement emailed to NPR.
Pfizer added that it will “continue to fully support” development on tanezumab and Lyrica, two treatments targeting chronic pain, as well as programs researching rare neurological diseases.
The round of several hundred layoffs “will take place over the coming months” at its research and development labs in the Northeast specifically, sites in Cambridge and Andover, Mass., and in Groton, Conn.
“Any decision impacting colleagues is difficult however, we believe this will best position the company to bring meaningful new therapies to market, and will bring the most value for shareholders and patients.”
“The current medication for Alzheimer’s disease is approved, essentially, because it’s better than nothing,” Jebelli said last week.
And so, the paper explains, other companies plan to carry these efforts forward:
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Should You Start Taking Enbrel For Alzheimers What The Science Says
In 2006, this small pilot study had found that injecting etanercept into the spines of probable Alzheimers patients resulted in sustained cognitive improvement. It involved 15 patients treated weekly for six months.
A follow-up single case study a year later in the Journal of Neuroinflammation reported one patients rapid cognitive improvement within minutes of his Enbrel injection. One week later, his cognition skills were still markedly approved.
The author of both studies is Edward Tobinick, MD, an internist who continues to use Enbrel for this and other off-label uses at his clinics in California and Florida. According to the website ScienceBasedMedicine.org, however, Tobinicks studies are weak at best, due to design flaws and Tobinicks lack of expertise in the field of neurology.
No other studies using the spinal injection of Enbrel on Alzheimers patients have been conducted to confirm Tobinicks findings.
In 2015, while Pfizer was making its discovery, one double-blind, randomized, placebo-controlled trial using Enbrel for Alzheimers was being published in the journal Neurology. It was conducted by Clive Holmes, a professor of biological psychiatry at the University of Southampton in Great Britain, and Pfizer had supported the research.
From these existing studies, there is not enough evidence at this time to use Enbrel off-label to treat Alzheimers.
Alzheimers Researchers Shift Focus After Failures
The possible reinvention of a three-decade-old, off-patent drug is among alternative approaches receiving fresh attention after broad failures by major drug companies.
A health-care start-up called Partner Therapeutics began last year with a single product: a leukemia medicine approved in 1991 that doctors rarely prescribe anymore. The drug, Leukine, made so little money that its previous owner did not even bother to disclose sales. It just dumped them on revenue reports under “other.”
But now researchers in Colorado are testing Leukine’s ability to regulate the immune system as a treatment for Alzheimer’s disease.
The possible reinvention of a three-decade-old off-patent drug is among alternative approaches receiving fresh attention in Alzheimer’s research after broad failures by major drug companies. Once-promising treatments that targeted the removal of amyloid plaques, an accumulation of debris on brain tissue that is a key sign of Alzheimer’s, have consumed billions of dollars in vain.
As a result, big companies are retrenching. That mostly leaves start-ups and academic labs to test new hypotheses, including ways to get rogue inflammatory agents in an Alzheimer’s patient’s brain under control.
Drugs targeting another protein accumulation in the brain called tau protein tangles, as well as anti-inflammation drugs, immune modulators, gene therapy, insulin and cannabis compounds, are among other avenues still being pursued.
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Debate Over Targeting Beta Amyloid Formations
Known among scientists as aducanumab, it works by offering an array of identical antibodies that are cloned from white blood cells. These antibodies are chosen for their targeting abilities, since they can identify specific proteins, called beta amyloids, that have constructed particular formations in the body.
There is extensive evidence suggesting that these beta amyloid formations, also known as “pathological aggregates” or “plaques,” are a major driver of Alzheimer’s disease, though the exact causal mechanisms are still not fully understood, according to Christian Pike of USC’s Leonard Davis School of Gerontology. Nonetheless, he says the antibodies can help prevent these plaques from forming, before directing other particles to break them apart, a process that’s clearly identifiable in before-and-after neural imaging.
For an analogy, it may be helpful to think of the beta amyloid proteins as young people walking around a city over the course of the day, where the city is the human body, and the day is a human lifespan. In certain cities, as afternoon turns into evening, individual young people start to congregate, and some of those congregations can turn toxic, and begin to cause problems. The antibodies delivered by Aduhelm act like law enforcement officers, arriving on the scene, identifying troublesome gatherings, surrounding them, separating them, then ordering bystanders to make the young people disperse.
Pfizer To End Alzheimer Parkinson Research Patients Disappointed
17 January 2018
Drugs giant Pfizer is ending research into Alzheimer and Parknsons according to reports.
Dr Mikael Dolsten, president of Pfizer Worldwide Research and Development, said in a statement sent to National Public Radio , ”We recognize the immense disappointment in the broader community, and we share this. At a personal level, many of us have seen first-hand the devastation of Alzheimer’s and Parkinson’s.”
He added that due to recent setbacks, Pfizer’s research efforts ”were simply not making the progress necessary to translate into truly transformational therapies for patients.”
According to commentators, the news means the company will likely eliminate 300 positions from its neuroscience discovery and early development programmes, reallocating the money spent on research.
Pfizer officials added in the statement that the company will ”continue to fully support” development on tanezumab and Lyrica, two treatments that target chronic pain, as also programmes researching rare neurological diseases.
According to commentators, one reason behind the decision seems to be the lack of new drugs that have managed to make it from clinical trials and other research.
In fact, according to a Healthline report last year, there has not been a new Alzheimer’s drug in 10 years.
He writes that Pfizer’s decision, did make sense as neurological research requires ”large investments of time and money, talent, patience, and resolve”.
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Could Drugs Prevent Alzheimers These Trials Aim To Find Out
Trial coordinator Eric McDade assesses participant Marty Reiswig for cognitive ability.Credit: Matt Miller/Washington University School of Medicine
Every two weeks, a nurse visits 43-year-old Marty Reiswig in Denver, Colorado, and injects him with an experimental drug called gantenerumab. Every month, Reiswig drives into town for a brain scan to make sure the drug has not caused any bleeds. And every year he flies to St Louis, Missouri, for four days of brain scans, spinal taps, blood analyses and exhaustive tests of his memory and reasoning capacity.
Reiswig is fit and healthy and runs two local businesses. He goes through all of this because he has a rare genetic mutation that almost guarantees he will develop early-onset Alzheimers disease. He hopes that the international clinical trial he has been part of for nine years might prevent, or at least delay, the onset of symptoms that will otherwise arise in just a few years time.
I always do my best to give the researchers as much as I can even if it turns out not to help me, it might help my children, he says.
But Aisen foresees a future maybe just a decade or so down the line in which much of the burden of Alzheimers disease might actually be prevented. Were heading towards screening people from middle age on with blood tests, and treating those who show amyloid abnormalities with drugs that reduce the generation of amyloid plaques, he says. I am optimistic.
Fda Approves Alzheimers Drug Despite Fierce Debate Over Whether It Works
Aducanumab, or Aduhelm, is the first new Alzheimers treatment in 18 years and the first to attack the disease process. But some experts say theres not enough evidence it can address cognitive symptoms.
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The Food and Drug Administration on Monday approved the first new medication for Alzheimers disease in nearly two decades, a contentious decision made despite opposition from the agencys independent advisory committee and some Alzheimers experts who said there was not enough evidence that the drug can help patients.
The drug, aducanumab, which will go by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimers instead of just addressing dementia symptoms.
Biogen, its manufacturer, announced Monday afternoon that the list price would be $56,000 a year. In addition, there will most likely be tens of thousands of dollars in costs for diagnostic testing and brain imaging.
Recognizing that clinical trials of the drug had provided incomplete evidence to demonstrate effectiveness, the F.D.A. granted approval for the drug to be used but required Biogen to conduct a new clinical trial.
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Next In The Dementia Drug Pipeline
For the handful of other developmental Alzheimer’s drugs hoping to clear those same regulatory hurdles and prove their efficacy Eli Lilly‘s donanemab, Roche’s gantenerumab and Eisei’s lecanemab among them there may be a silver lining to ceding first-mover advantage to Aduhelm.
After decades of expensive but thus far largely fruitless research trials, the CEO of pharma giant Eli Lilly, David Ricks, said his firm was “getting closer and closer to the goal” after a positive set of Phase Two results for its offering, donanemab.
Speaking at CNBC’s Healthy Returns Summit in May, a month before the FDA’s approval for rival Biogen’s Aduhelm, he said his team felt “good about the probability of success,” and said he wanted to explore an “accelerated” route too, using what he called “adaptative pathways at the FDA to consider looking at data sooner” that “should be applied in a serious and widespread condition like Alzheimer’s.”
However, he acknowledged that recruitment for the next phase of trials required a significantly larger cohort of participants, and given that it would last 18 months, he did not expect a new approved product before late 2023 at the earliest.
Several experts told CNBC the Biogen drug’s unique threshold for regulatory approval, with treatment potential seeming to trump uncertain real-world benefits, could reinvigorate efforts by competitors like Lilly, who are focused on developing drugs that rely on relatively similar techniques.
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