Lecanemab shows sustained benefits in early Alzheimer's

PHILADELPHIA - Eisai Co (OTC:ESAIY)., Ltd. and Biogen Inc. (NASDAQ:BIIB) have presented new clinical data on lecanemab, a treatment for early Alzheimer's disease (AD), at the Alzheimer's Association International Conference (AAIC) 2024. The study reveals that lecanemab, also known by its U.S. brand name LEQEMBI®, offers continuous benefits over three years for patients with early AD, particularly those with no or low tau protein accumulation in their brains.

The Clarity AD study, a global Phase 3 trial, included an optional tau PET substudy to identify patients at an early stage of AD. Results showed that after three years of lecanemab treatment, more than half of these patients demonstrated improvement or no decline in cognition and function. Specifically, 51% of patients with no or low tau showed improvement on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale from baseline.

In addition, the study indicates that Alzheimer's disease continues to progress even after amyloid beta (Aβ) plaque clearance when treatment is stopped. Lecanemab's dual mechanism of action not only targets amyloid plaques but also the highly toxic protofibrils, which continue to cause neuronal injury. Continuous treatment with lecanemab was found to slow the spread of tau protein across all brain regions, suggesting its potential as a long-term treatment for this chronic disease.

No new safety findings have emerged with continued lecanemab treatment over three years. Most amyloid-related imaging abnormalities (ARIA) occurred within the first six months, with rates similar to placebo thereafter. The findings suggest that ARIA was not associated with accelerated long-term progression.

Eisai, headquartered in Tokyo, leads the development and regulatory submissions for lecanemab globally, with both Eisai and Biogen co-commercializing and co-promoting the product. Biogen, headquartered in Cambridge, Massachusetts, states that lecanemab is the only early AD treatment widely available that supports neuronal function by clearing toxic protofibrils and amyloid plaques.

The presented data at AAIC 2024 is based on a press release statement from Eisai Co., Ltd. and Biogen Inc. LEQEMBI® is currently indicated for the treatment of Alzheimer's disease and is administered to patients with mild cognitive impairment or mild dementia stage of the disease, the population in which treatment was initiated in clinical trials.

In other recent news, Biogen Inc., Beckman Coulter Inc., and Fujirebio have collaborated to develop blood-based biomarkers for Alzheimer's disease. The partnership aims to create and commercialize new tests that could stratify patients and monitor treatment responses. Biogen's Alzheimer's drug, Leqembi, faced a setback as the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a negative recommendation due to safety concerns.

This decision prompted Baird to adjust its price target for Biogen shares from $316.00 to $294.00 while maintaining an Outperform rating. Piper Sandler and RBC Capital also revised their price targets to $307 and $282 respectively, but kept their positive ratings. Despite these challenges, Goldman Sachs reiterated its Buy rating and $342.00 price target on Biogen. These recent developments also include Biogen's recent completion of the acquisition of Human Immunology Biosciences, integrating its late-stage therapeutic candidate, felzartamab, into its immunology pipeline. Additionally, Biogen and Eisai launched Leqembi in China, marking a significant step for the company in the international market.

InvestingPro Insights

As Biogen Inc. (NASDAQ:BIIB) continues to make strides in the development of treatments for Alzheimer's disease, investors and stakeholders are closely monitoring the company's financial health and market performance. According to real-time data from InvestingPro, Biogen's market capitalization stands at a robust $30.9 billion, reflecting the company's significant presence in the biotechnology industry. The latest metrics show a price-to-earnings (P/E) ratio of 18.52 when adjusted for the last twelve months as of Q1 2024, indicating how much investors are willing to pay for a dollar of earnings, with a lower number suggesting a potentially undervalued stock relative to its earnings.

The company's revenue over the same period was reported at $9.663 billion, despite a slight revenue decline of 4.37%. Nevertheless, Biogen's gross profit margin remains high at 75.49%, a testament to the company's efficiency in managing its production costs and maintaining profitability. This financial stability is further underscored by two key InvestingPro Tips: Biogen has been profitable over the last twelve months, and analysts predict the company will continue to be profitable this year.

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With the promising clinical data on lecanemab and a strong financial standing, Biogen remains a prominent player in the biotechnology industry, poised to make a significant impact on the treatment of Alzheimer's disease and offering potential opportunities for investors.

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