Some Alzheimer’s experts and Wall Street analysts have been skeptical about the drug’s benefits, especially after Biogen reversed its decision to seek regulatory approval in … (biogen) Biogen’s C-suite remains bullish that its controversial Alzheimer’s disease drug aducanumab will be approved in the coming weeks, citing a rare glimmer of hope from a … A US Food and Drug Administration (FDA) advisory committee on Friday will review the Biogen drug aducanumab, which would be the first new Alzheimer’s drug to hit the market in nearly 20 years if … The company's overall revenue was down 6% year over year. AP. Biogen’s data from one large clinical trial were “robust and exceptionally persuasive,” FDA reviewers wrote, endorsing the drug’s effects on the cognition of Alzheimer’s patients. FDA set to approve a new Alzheimer's drug - a first in nearly 20 years - by March after Biogen showed its treatment may slow the progress of the … Biogen said on Thursday it filed for regulatory approval in Japan for an Alzheimer's disease drug it developed with local partner Eisai Co. U.S.-based Biogen and Eisai have jointly developed three experimental drugs for Alzheimer's, which affects millions around the world and has not seen a new treatment in decades. While that wouldn't preclude the success of Denali and Alector's Alzheimer's candidates, it might sour the market on investing in the companies and hurt their chances for additional funding. FDA praise for Biogen’s Alzheimer’s drug sends it stock soaring by nearly 44 percent If approved, it would be the first new medicine to treat the disease in nearly two decades. Cowen estimates that 2.2 million Americans have mild dementia due to Alzheimer’s disease. He's also a co-host of "The Readout LOUD" podcast. Merck’s Keytruda was second, with 2019 sales of $11 billion. Buried on page 255 of the agency’s briefing, statistical reviewer Tristan Massie concluded that the sole positive trial of aducanumab cannot outshine the negative one, writing that “there is no compelling, substantial evidence of treatment effect or disease slowing and that another study is needed to confirm or deny the positive study and the negative study.”. This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. However, if aducanumab is approved, I see this as a positive for Alector, as it opens the door for other, similar drugs. 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The companies ended two studies early in March 2019 when the drug didn't seem to work, then reversed that decision in October 2019, saying that later results showed aducanumab was effective in high doses. Safe in small amounts, combats brain cell death, clears amyloid and tau out of the hippocampus. Part of that has nothing to do with aducanumab and more to do with a collaboration between Biogen and Denali in which the two companies are working on developing Denali's treatment for Parkinson's disease. Returns as of 03/09/2021. Market data powered by FactSet and Web Financial Group. In its third-quarter report, the company said sales for its lead drug Tecfidera, which treats multiple sclerosis, were down 15%, with price pressure from generic drugs cited as the reason for the drop. A second, nearly identical study did not show a significant benefit, but “upon closer review,” the FDA agreed with Biogen’s argument that the sum of all the data suggests aducanumab is helpful to patients. On that day, a panel of outside advisors spoke out against approving the drug, saying the proof that it slows the progression of Alzheimer's was lacking. Trading on the stock was paused Nov. 6 because of the hearing, but in after-hours trading over the weekend, it was down more than 7%. But FDA reviewers said an analysis of the data did not suggest that ARIA biased the trial. Cumulative Growth of a $10,000 Investment in Stock Advisor, Does Good News About Biogen's Alzheimer's Drug Mean Bad News for Rivals? In this case, I don't see why any success Biogen has with aducanumab would hurt Denali. Shares of Denali, which is in the process of developing its own Alzheimer's medication, were up last week. If anything, one company's success with an Alzheimer's drug might make the FDA more inclined to carefully look at other candidates as well, particularly if competition could bring down the price of aducanumab. And while no one is saying aducanumab can cure Alzheimer's, any drug that slows the disease would be a blockbuster -- worth a potential $5 billion a year, according to research by Evaluate Pharma, with some reports putting the number at nearly twice that. But even restricted use would translate into blockbuster sales. Exclusive analysis of biotech, pharma, and the life sciences, By Damian Garde and Adam Feuerstein Nov. 4, 2020. Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of "The Readout LOUD" podcast. In a lengthy document released Wednesday, FDA staff appeared to endorse approving the treatment, which would become the first new Alzheimer’s therapy in nearly two decades. The reviewers did not explicitly call for FDA approval, but the tenor of their remarks appeared to support Biogen’s case. That may have more to do with the overall positive market sentiment than any deep-dive thought about how it will be impacted by a potential aducanumab approval. A drug developed by Biogen to treat Alzheimer’s disease is on track to be approved by the Food and Drug Administration after a “highly persuasive” clinical trial, according to reports Wednesday. Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer. Biogen application for Alzheimer's drug accepted in Europe. +0.35%. What about lithium? According to Alzheimers.net, it is the is sixth leading cause of death in the United States and the only disease among the top 10 causes of death that has no cure. +0.71%. Can you please fix it? Boston Globe / Getty Images En español | It's been more than a year since Biogen announced it would seek federal approval for its drug, aducanumab, to treat some people in the early stages of Alzheimer's disease. We’re motley! Biogen is paying Denali nearly $1 billion toward that effort, so good news for Biogen could possibly mean more research and development money for Denali. WASHINGTON — One of the biggest drug decisions in … The future of aducanumab, Biogen’s treatment for Alzheimer’s disease, appears brighter after reviewers at the Food and Drug Administration indicated they believed the drug was sufficiently safe and effective. The way lithium is ignored as a treatment option is astounding. Why Is Everyone Talking About Biogen Stock? However, not every FDA reviewer was convinced by Biogen’s read of the data. Does the new Alzheimer’s drug contain cannabis or synthetic cannabis ? However, Denali, whose headquarters are in south San Francisco, has its own Alzheimer's drug, DNL788, which it is developing with Sanofi (NASDAQ:SNY). In a surprising twist, Biogen announced it will file for FDA approval of its Alzheimer’s drug, after stopping its study of the therapy last spring On the safety side, a frequent side effect of aducanumab is a painful but manageable swelling of the brain called ARIA. On the first point, FDA reviewers wrote that a deep look at the data suggested that a small number of patients with rapidly progressing Alzheimer’s might have skewed the study. If approved, aducanumab would be the first drug to reduce cognitive decline by targeting and eliminating clumps of a toxic protein called beta amyloid that are believed to destroy the brain. Approval of Biogen’s therapy would be a milestone for the long battle against Alzheimer’s, a harrowing brain-wasting disease that affects some 5.8 million Americans. I am not a physician but I find your observation intriguing. No. It slowly and progressively destroys memory and thinking skills. In order to do that, please contact my colleague Amanda Garces ,[email protected]>. The FDA was more impressed by the second study, in which it said it found that high doses of the drug slowed the progression of cognitive, functional, and behavioral decline in Alzheimer's patients. The commentary, which provides the first glimpse at how FDA scientists view the oft-debated treatment, comes ahead of a Friday meeting of outside advisers, who will issue a nonbinding vote on whether to recommend aducanumab’s approval. After 18 years without a new treatment for Alzheimer’s disease, an extra three months for the Food and Drug Administration to decide on Biogen ’s … The question is: Will hurt them or help them? Sales for its muscular atrophy drug Spinraza, facing competition from Roche's (OTC:RHHBY) Evrysdi, were down a reported 10% in the quarter. The sheer potential for profit in a growth area such as Alzheimer's would spur additional research. Nursing home with the disease. Odds are increasing that Biogen Inc.’s experimental and somewhat controversial Alzheimer’s disease drug may get approved after Food and Drug … However, instead of binding to amyloid plaques, AL002 works by assisting the triggering receptor expressed on myeloid cells 2 (TREM-2) proteins in the brain. April 22, 2020 Last December, Biogen made an exciting announcement: The company was set to submit an Alzheimer’s drug, aducanumab, to the … After consulting with the FDA, which agreed that the positive data were valid, despite the truncated study, Biogen applied for approval for treating early-stage Alzheimer’s disease. How can I learn more? By Deena Beasley and Manojna Maddipatla (Reuters) - Biogen Inc has shown "exceptionally persuasive" evidence that its experimental Alzheimer's disease drug is effective, U.S. Food and Drug Administration staff said on Wednesday, elevating its chances of a swift approval … Sincerely Doreen♥️⁉️. When their results are removed, the numbers favor aducanumab, which is consistent with other studies of the drug, reviewers wrote. If approved, aducanumab would be the first Alzheimer’s drug prescribed to slow cognitive decline and would likely bring in tens of billions of dollars in sales for its developer, Biogen. Alector, which is also headquartered in south San Francisco, has a trio of potential Alzheimer's therapies and its own deep-pocketed collaborator in AbbVie (NYSE:ABBV). Ahead of a Friday meeting on the company’s request to market a treatment for Alzheimer’s disease, the U.S. Food and Drug Administration published reports that suggest it favors approval. Denali and Alector, like any clinical-stage pharmaceutical companies, are risky bets. Here’s what you need to know, Digital event: Combating Covid-19 — Part 2, Digital event: Combating Covid-19 — Part 3. Biogen could use a blockbuster drug these days. Like Denali, Alector's shares rose last week. Aducanumab, if approved, would turbocharge Biogen’s growth and fundamentally change the stock’s outlook for the better. If you’re a subscriber, you’ll be able to find that coverage, A pivotal FDA meeting on Biogen’s Alzheimer’s treatment is near. As a neuropsychologist who had occasion to diagnose Alzheimer’s, I saw bipolar patients who had not followed their lithium regimen develop the disease, while those that toed the line remained free. The furthest along of the three candidates is AL002, with a phase 2 study beginning later this month. LLY. Biogen says aducanumab is a monoclonal antibody that binds to aggregates of amyloid plaques in the brain; by reducing the size and number of these "tangles," it could slow the progression of Alzheimer's disease. STAT+ subscribers will have access to all-day coverage of the Friday advisory committee meeting to discuss Biogen’s Alzheimer’s drug, with regular updates on key presentations, interesting arguments, and eventually the outcome itself. Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. Can I post it on my blog piotrpeterblog.com? In mass. Stock Advisor launched in February of 2002. Reporting from the frontiers of health and medicine, CDC says fully vaccinated Americans can spend time together…, CDC says fully vaccinated Americans can spend time together indoors and unmasked, Will the U.S. have Covid vaccine doses for everyone…, Will the U.S. have Covid vaccine doses for everyone by the end of May? The FDA has not approved a new drug to treat Alzheimer's since Namenda was approved in 2003, with a trail of failed attempts by numerous companies since. The FDA staff comments also buoyed shares of other Alzheimer's drug developers, including a 15% rise in shares of Eli Lily and Co. The … But cannabidiol free of THC is antidepressant, anti-anxiety, and anti-inflammatory. @themotleyfool #stocks $BIIB $SNY $RHHBY $ABBV $DNLI $ALEC. The two companies halted studies on an earlier Alzheimer's drug candidate, DNL747, this summer, believing DNL788 to be a better candidate with lower toxicity. It would be a significant medical achievement. The FDA has not approved a new drug to treat Alzheimer's since Namenda was approved in 2003, with a trail of failed attempts by numerous companies since. Shares of Biogen plunge more than 30% after a Food and Drug Administration advisory panel voted against approving the company’s Alzheimer's disease drug. Is the FDA Delay Actually Good News for Biogen's Alzheimer's Drug? Founded in 1993 by brothers Tom and David Gardner, The Motley Fool helps millions of people attain financial freedom through our website, podcasts, books, newspaper column, radio show, and premium investing services. The Alzheimer's Association estimates that 1 in 3 seniors die with Alzheimer's or another form of dementia, and more than 5.7 million Americans have Alzheimer's disease. A scientist works on Alzheimer's disease research in a laboratory at Biogen's headquarters in Cambridge, Mass. Biogen shares rose nearly 45% to $355, adding $17 billion to the company’s market value. And in the last few months, it's been working its way through an accelerated review process at the Food and Drug Administration (FDA). Of course, the flip side would be if Biogen's aducanumab is shot down, which could definitely happen if the FDA heeds the advisory panel's advice. Alzheimer’s makes up 60-70% of an estimated 50 million cases of dementia globally. And now a study has shown that lithium increases resistance to viruses. Lithium…this is exciting news. Biogen’s data from one large clinical trial were “robust and exceptionally persuasive,” FDA reviewers wrote, endorsing the drug’s effects on the cognition of Alzheimer’s patients. The Biogen drug, known as aducanumab, does not cure or reverse Alzheimer’s; the claim is … SPX. If one-third of these people were treated with aducanumab, priced at an estimated $50,000 per year, sales would reach $36 billion annually, according to the health care investment bank. Today, Biogen is criticized — and its stock penalized — for selling drugs that are losing market share to low-cost generics or newer, more potent competitors. If you’re a subscriber, you’ll be able to find that coverage here. People experiencing mild cognitive impairment or early signs of Alzheimer’s would be the most likely to benefit from a drug like aducanumab, if it reaches the market. Outside experts worried that the side effect might effectively unblind the study, informing patients that they’d received the treatment and thus creating a bias in the study. Even if aducanumab is prescribed to a fraction of eligible patients, it could still be among the top-selling drugs of all time. The company is optimistic about approval based on the totality of the data. If the FDA approves the drug, that will certainly have an impact on two clinical-stage pharmaceutical companies also working on prospective Alzheimer's drugs: Denali Therapeutics (NASDAQ:DNLI) and Alector (NASDAQ:ALEC). Like aducanumab, AL002 is a monoclonal antibody. The FDA is expected to make a decision by March. However, both businesses have strong support from larger players and would likely benefit if the first Alzheimer's drug in nearly 17 years is approved. Thanks. However, the FDA may have tipped its hand as to how it will decide with its earlier positive statements, and it is expected to issue a ruling by March 7. The FDA review seemed to alleviate two major concerns about aducanumab: the fact that its two pivotal studies had different results, and the possibility that a common side effect informed patients whether they received treatment or placebo. Biogen Inc (BIIB) Q4 2020 Earnings Call Transcript, Copyright, Trademark and Patent Information. It would also be a big deal for Biogen’s bottom line. This was in advance of the FDA's actual hearing with Biogen regarding the drug, which took place Friday, Nov. 6. Baird analyst Brian Skorney said an FDA approval for aducanumab is highly unlikely and expects Biogen to … Alzheimer's is a degenerative brain disease and the most common form of dementia. One of the indications of Alzheimer's is the decline of TREM-2 proteins. The group expects the number of people over 65 with Alzheimer's to increase to 13.8 million by 2050. Just getting this far marks a huge turnaround for Biogen, a Cambridge, Mass., biopharmaceutical company that partnered with Japanese pharma Esai to work on aducanumab. The hyperlink for “lengthy document” early in the article does not work. The latter property might combat inflammatory processes thought to contribute to Alzheimer’s. Shares in Biogen (NASDAQ:BIIB) were up 44% on Wednesday, Nov. 4, to a high of $359.95 after a U.S. Food and Drug Administration (FDA) clinical review signaled that the biotech's phase 3 study on aducanumab showed the drug's effectiveness in slowing the progression of Alzheimer's disease. Thanks for your interest in republishing this article, Piotr. There are no current medicines capable of slowing the cognitive and functional decline that occurs in people with Alzheimer’s disease. Could my husband be on the clinical trial. On Friday, Biogen announced that the FDA accepted its application, complete with phase one to three clinical trials, for the treatment’s approval. BU researchers weigh in on what FDA approval of the drug could mean for treating the devastating disease. AbbVie’s Humira was the top-selling medicine last year, with sales of $19.7 billion.