TOKYO and CAMBRIDGE, Mass. - Eisai Co (OTC:ESAIY)., Ltd. and Biogen Inc. (NASDAQ: NASDAQ:BIIB) have received a negative opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorization Approval (MAA) for lecanemab, an Alzheimer's disease treatment. This decision was announced today, following a CHMP meeting that took place from July 22 to July 25.
Lecanemab is a monoclonal antibody targeting amyloid-beta, implicated in the development of Alzheimer's disease (AD). The drug has been approved in the United States, Japan, China, South Korea, Hong Kong, and Israel for mild cognitive impairment due to AD and mild AD dementia. These approvals were based on positive results from the Phase 3 Clarity AD clinical trial, which showed a 27% reduction in clinical decline compared to placebo.
Despite the setback in Europe, Eisai plans to request a re-examination of the CHMP opinion. The company aims to make lecanemab available to patients with early AD in the European Union as soon as possible.
The negative opinion comes as a disappointment to Eisai, Biogen, and the AD community, especially considering the significant unmet need for new treatments targeting the disease's progression.
Alzheimer's disease currently affects approximately 6.9 million people in Europe, a number expected to nearly double by 2050 due to aging populations. The collaboration between Eisai and Biogen on AD treatment development began in 2014, with Eisai leading the regulatory submissions globally. Both companies are co-commercializing and co-promoting lecanemab, with Eisai holding the final decision-making authority.
In addition to lecanemab, Eisai and Biogen's collaboration extends to other ongoing clinical studies for AD, including the Phase 3 AHEAD 3-45 study for preclinical AD and the Tau NexGen clinical study for Dominantly Inherited AD, which includes lecanemab as an anti-amyloid therapy.
This news article is based on a press release statement from Eisai Co., Ltd. and Biogen Inc.
In other recent news, Sage Therapeutics and Biogen have terminated their Phase 2 study of SAGE-324, an investigational drug for essential tremor, after it failed to meet the primary endpoint.
In another development, Biogen completed the acquisition of Human Immunology Biosciences (HI-Bio), integrating HI-Bio's promising late-stage therapeutic candidate, felzartamab, into its immunology pipeline.
Furthermore, the company, in partnership with Eisai Co Ltd , launched their Alzheimer's treatment, Leqembi, in China. Analysts have responded to these developments, with Piper Sandler lowering its price target for Biogen shares to $313 from $335 due to adoption challenges for Leqembi, while maintaining its Overweight rating.
In contrast, RBC Capital maintains a positive outlook on Biogen, keeping a price target of $317.00, linked to the potential success of Leqembi. Lastly, Stifel reaffirmed a Buy rating with a $275.00 price target for Biogen.
InvestingPro Insights
In light of the recent developments regarding Biogen Inc. (NASDAQ: BIIB) and its Alzheimer's disease treatment lecanemab, it's crucial for investors to consider the financial health and market position of the company. According to InvestingPro data, Biogen currently has a market capitalization of $33.11 billion and maintains a P/E ratio of 28.44, which adjusts to 19.9 when looking at the last twelve months as of Q1 2024. This suggests a valuation that factors in the company's earnings potential.
While the revenue has seen a decline of 4.37% in the last twelve months as of Q1 2024, Biogen's gross profit margin stands strong at 75.49%, indicating the company's ability to maintain profitability despite revenue fluctuations. Additionally, Biogen's operating income margin of 20.59% in the same period reflects efficient management and the potential to withstand market adversities.
InvestingPro Tips provide valuable insights for investors considering Biogen's stock. Analysts have revised their earnings upwards for the upcoming period, signaling confidence in the company's future performance. Furthermore, Biogen's stock is known for low price volatility, which may appeal to investors looking for a more stable investment in the biotechnology industry. With 7 additional tips available on InvestingPro, including predictions of profitability for this year and a note on the company's liquid assets exceeding short-term obligations, investors can gain a deeper understanding of Biogen's potential. To access these additional tips and metrics, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
As Biogen and Eisai continue to navigate the regulatory landscape for their Alzheimer's disease treatments, these financial metrics and insights could prove crucial for investors monitoring the situation. The resilience demonstrated by Biogen's financials may provide some assurance amidst the uncertainty surrounding lecanemab's European approval process.
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