A timeline of Aduhelm’s rise and fall

The story of Aduhelm has been rocky now for years. Biogen turned heads when its controversial Alzheimer’s therapy won accelerated approval from the FDA against the advice of its own advisory panel in mid-2021. The company had high hopes for the antibody at that point, pricing it at an average of $56,000 per year. Aduhelm would encounter a series of blows after that – rejected coverage, dismal sales, discontinued trials. Biogen would ultimately pull the plug on the drug this year.

Now, Biogen aims to prioritize other Alzheimer’s programs like the lecanemab, which was jointly developed with Eisai and FDA-approved in July 2023. Biogen noted in a statement that insights gained from Aduhelm hold value for the company. Ultimately, Biogen recorded a $60 million charge tied to wrapping up Aduhelm’s development.

A timeline showing the ups and downs in Aduhelm’s journey in reverse-chronological order follows. Stock data are from Yfinance and annotation chart …

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FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder

Zuranolone molecule image from PubChem

FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness.

The former approval represents a milestone as the first ever FDA-authorized oral medication specifically for PPD, a condition estimated to affect one in five new mothers. 

Still, the rejection for MDD, which affects more than 21 million American adults, sent Sage’s stock valuation reeling. In early afternoon trading, SAGE shares were down 52.24% to $17.24. In contrast, Biogen stock was up 0.47% to $270.19. 

Sage’s optimism for Zurzuvae in PPD treatmentt

In a business update call, CEO Barry Greene attempted to accentuate the positive. “We&#…

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The story behind Biogen’s 1,000 job cuts and R&D refocus

Cambridge-based biotech Biogen has unveiled plans to cut 1,000 jobs, or 11% of its workforce, as it prepares for the launch of its newly approved Alzheimer’s disease drug, Leqembi (lecanemab) that it developed with Eisai.  This move follows a pattern of significant layoffs, with the company having cut 885 jobs last year after the troubled rollout of its Alzheimer’s drug Aduhelm.

The scope and rationale for the Biogen job cuts

Last year, Biogen eliminated 885 positions following the rocky launch of its initial Alzheimer’s drug Aduhelm in 2021. The latest job cuts are part of Biogen’s new “Fit for Growth” strategic plan aimed at prioritizing resources towards high-value programs with growth potential. The plan intends to deliver $1 billion in gross operating expense savings by 2025. After reinvesting $300 million into product launches and R&D, this would result in $700 million in net savings based on the company’s projections.

“As we looked at the R&…

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Leqembi could mark new era in Alzheimer’s treatment progress: An overview of the evolving drug development scene

[AkuAku/Adobe Stock]

Today, the FDA granted traditional approved to lecanemab (branded as Leqembi), a monoclonal antibody from Eisai and Biogen for adult patients with Alzheimer’s disease. The agency made the decision on the basis of a confirmatory trial that showed its clinical benefit.

The drug, which reduces the formation of amyloid plaques in the brain, is the first of its kind to transition from an accelerated approval to a traditional approval for Alzheimer’s treatment.

Leqembi’s annual launch price is $26,500.

Following approval, lecanemab stands to potentially gain Medicare coverage with qualifications.

The approval of Leqembi is a positive step forward and will spur further advances and investments in Alzheimer’s research, according to Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF).

“We final…

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CMS continues to restrict coverage of amyloid-targeting antibodies for Alzheimer’s

[Image courtesy of CMS]

CMS has denied the Alzheimer’s Association’s request asking for broader reimbursement support for FDA-approved monoclonal antibodies targeting amyloid.

In April 2022, CMS decided to limit coverage of such antibodies for Alzheimer’s to clinical trial volunteers. At that time, aducanumab from Biogen (Nasdaq: BIIB) and Eisai (TYO:4523) was the only FDA-approved antibody for the neurodegenerative condition.

CMS noted in an announcement that its latest decision rests on the current lack of evidence that amyloid-targeting antibodies are effective against Alzheimer’s.

Amyloid-targeting antibodies intend to treat Alzheimer’s by targeting and removing amyloid beta, a protein that accumulates in Alzheimer’s patients’ brains. The protein deposits eventually result in plaques that interfere with normal brain function.

Alzheimer’s organ…
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Eisai prepares to share more findings for Alzheimer’s antibody lecanemab

Tokyo-headquartered Eisai Co. is preparing to share efficacy, safety and biomarker findings from its Phase 3 confirmatory clinical study of the amyloid beta-protein inhibitor lecanemab.

The company will present full results from the Phase 3 confirmatory Clarity AD study of lecanemab in patients with early Alzheimer’s disease in a session at the Clinical Trials on Alzheimer’s Disease conference on November 29.

Eisai is jointly developing the antibody with Biogen (Nasdaq:BIIB).

Last week, Roche (SWX:ROG) that its Alzheimer’s hopeful gantenerumab flunked two Phase 3 studies, failing to meet the primary endpoints in either one.

Gantenerumab won breakthrough therapy designation from FDA in 2021.

In late September, Eisai and Biogen reported positive Phase 3 trial results for lecanemab, noting that the drug candidate met primary and key secondary endpoints. Lecanemab recipients had a 27% reduction in disease progression with a p-…

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Biogen beats The Street in Q3 — but revenue down 10%

Biogen (Nasdaq: BIIB) today reported third-quarter results that beat the expectations of Wall Street analysts, upping its full-year guidance.

The Cambridge, Massachusetts–based neurological biotech company earned $1.1 billion, or $7.84 per share, off $2.5 billion in revenue for the quarter ended Sept. 30, 2022. It more than tripled its bottom line even as the top line decreased 10% compared with Q3 2021.

Adjusted to exclude one-time items, Biogen had an EPS of $4.77, 62¢ ahead of The Street, where analysts were predicting EPS of $4.15 and $2.47 billion in revenue.

“In the third quarter, Biogen made important progress toward building a foundation for growth while executing against our core business objectives,” Biogen CEO Michel Vounatsos said in a news release.  “We are excited about the topline results of the Clarity AD trial for lecanemab and believe this potential new therapy could provide a meaningful benefit for Alzheimer’s patients. We also continu…

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Eisai unveils new facility for injectable drug formulation research

Eisai (OTCMKTS:ESALY) has announced that it has completed the construction of a new research building dedicated to the formulation of injectable drugs at the Kawashima Industrial Park located in Gifu Prefecture, Japan.

The Eisai Medicine Innovation Technology Solutions (EMITS) facility will serve as Eisai’s global headquarters for formulation and research.

Traditionally focusing on small molecules, Eisai has ramped up its focus on drug discovery targets to include antibodies, antibody-drug conjugates (ADCs) and nucleic acid drugs.

The EMITS facility will conduct research on injectable drug formulation and drug delivery systems. In particular, Eisai plans to explore liposomal and lipid nanoparticle formulations.

Eisai plans to use AI to enhance drug formulation.

It also aims to manufacture investigational injectable drugs at the facility for clinical trials and develop rapid microbial testing methods for microbiological control and ste…

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Eisai and Biogen report positive Phase 3 trial results for new Alzheimer’s drug

Eisai and Biogen (Nasdaq:BIIB) today announced positive topline data from a Phase 3 trial of lecanemab for Alzheimer’s disease.

BIIB shares are skyrocketing on the back of the data today. They are up 37.6% at $272.12 apiece in mid-afternoon trading.

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody. The global Phase 3 confirmatory Clarity AD clinical trial evaluated it for treating mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.

The drug met its primary endpoint and all key secondary endpoints with what the companies called “highly statistically significant results.” Eisai plans to discuss the data with regulatory authorities in the U.S., Japan and Europe. The company aims to file for traditional U.S. approval and authorization in Japan and Europe by the end of fiscal 2022 (March 31, 2023). Read more

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Biogen is scaling back space outside Boston

According to reports, Biogen has taken steps to scale back costs following the release of its Aduhelm Alzheimer’s disease drug.

The company has moved to sublease more than 260,000 square feet at multiple locations in Massachusetts as it looks to cut $1 billion in costs, The Boston Globe reported.

Across from its Cambridge, Massachusetts, headquarters, the company plans to sublease more than 183,000 square feet in its 300 Binney Street space, while it has also made plans to sublease two floors comprising 80,000 square feet at one of two properties at 133 Boston Pond Road in Weston, Massachusetts, The Globe report said.

The Globe report credited the Boston Business Journal with first reporting the sublease news, while also saying that Biogen has “long subleased” one of its two Weston buildings to Monster, the job search website.

Biogen’s cost-cutting efforts will…

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Biogen halts observational post-marketing study of aducanumab

Biogen (Nasdaq:BIIB) has terminated a study of the controversial Alzheimer’s disease drug Aduhelm (aducanumab) as a result of limited national policy for coverage.

In a listing on clinicaltrials.gov, the company notes that it anticipates there will limited prescriptions of the drug in routine clinical practice, which would provide limited enrollment for the planned ICARE AD study.

The study would have been a prospective, single-arm, multicenter study of aducanumab with up to 5 years of follow-up. The study would have collected data via routine visits every 6 to 12 months, but after opening up recruitment in November, only 29 volunteers had enrolled, according to data posted on clinicaltrials.gov.

Biogen and its partner Eisai (TYO:4523) announced their plans to launch the observational study in a presentation at the July 2021 Alzheimer’s Association International Conference. The drug had won FDA approval a month earlier.

Biogen still has a Phase 4 …

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Zuranolone could offer rapid relief from postpartum depression 

Postpartum depression is one of the most common psychological conditions after childbirth, affecting roughly one in eight new mothers.

“Postpartum depression is one of the most common — often underdiagnosed complications of childbirth,” said Dr. Samantha E. Meltzer-Brody, director of the University of North Carolina Center for Women’s Mood Disorders. The pandemic has likely only made the situation worse.

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq:BIIB) are optimistic about the prospects of zuranolone, a drug candidate for postpartum depression, that met primary and key secondary endpoints in the Phase 3 SKYLARK study. If approved, the drug would be the first oral therapy for postpartum depression.

The treatment response in the placebo-controlled study was “robust,” Meltzer-Brody said.

Patients two received a 50 mg daily dose of zuranolone, a neuroactive steroid, had a 15.6 reduction in the 17-item Hamilton Rating Scale for Depression (HAM-…

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