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Biogen (BIIB - Free Report) and its Japan-based partner Eisai announced that they received a negative trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to their marketing authorization application for their Alzheimer’s disease (AD) drug, aducanumab, in Europe.
The CHMP’s negative trend vote was based on an oral explanation from Biogen in a meeting held earlier this month. Although the CHMP will provide its formal opinion in December, it is expected that it will maintain its stance and will recommend against the drug’s approval. Meanwhile, Biogen plans to engage in discussions with the EMA and the CHMP for resolving the issues that led to a negative trend vote.
We note that Biogen had a hard time getting approval for the drug in the United States as well. After much controversy, the FDA granted accelerated approval to aducanumab in June, largely based on its ability to remove beta amyloid seen in late-stage studies. However, it is still uncertain whether the reduction in beta amyloid leads to improvement in cognition. The drug is marketd as Aduhelm in the United States. Aduhelm’s FDA approval, despite an FDA advisory committee voting against it, faced a lot of criticism, due to the drug’s mixed efficacy results. The FDA approval is also for patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia but not for patients with earlier or later stages of the disease.
Moreover, the launch uptake of Aduhelm is facing some near-term challenges, including its hefty price tag of $56,000 a year. Sales of the drug fell to $0.3 million in the third quarter from $1.6 million in the second quarter as the launch of the drug has been slower than expected.
Earlier this month, Biogen announced new data from two late-stage clinical studies, which demonstrated that treatment with Aduhelm led to a significant reduction in plasma p-tau181, a biomarker of the hallmark tau tangles in AD. This reduction in plasma p-tau demonstrated a statistically significant correlation with reduced cognitive and function decline in AD patients. This data may help the company to gain support for its drug from the regulators in the United States and Europe as well as gain investors’ confidence. However, the impact remains to be seen.
So far this year, Biogen’s shares have increased 5.5% against the industry’s decrease of 14.4% in the same time frame.
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Apart from Aduehlm, Biogen and partner Eisai are currently seeking approval for another AD candidate, lecanemab. In September, the companies initiated a rolling submission of a biologics license application (BLA) for the candidate, seeking approval as a treatment for early AD under an accelerated pathway.
There are several other pharma and biotech companies, including Eli Lilly (LLY - Free Report) and Cassava Sciences (SAVA - Free Report) that are engaged in developing a treatment for AD. However, AD has always been a highly challenging area and not much progress has been made despite significant investments.
Lilly is developing donanemab for treating AD. The drug works in a similar fashion to Aduhelm by targeting beta amyloid. Lilly initiated the rolling submission of a BLA last month, seeking accelerated approval for the candidate for treating AD later this year.
Data from a mid-stage study demonstrated that Lilly’s donanemab slowed disease progression significantly by 32% compared to placebo in patients with early symptomatic AD.
Cassava is currently developing its AD candidate, simufilam, in an open-label study. Interim data from the study announced in June demonstrated that both cognition and behavior scores of patients improved following six months of treatment with simufilam, with no safety issue observed.
Cassava plans to initiate two pivotal phase III studies to evaluate simufilam for mild-to-moderate AD dementia by the end of 2021. Cassava has successfully completed two mid-stage studies on the candidate. Cassava’s stock declined almost 24% on Nov 17 following reports of a probe by the Securities and Exchange Commission for investigating allegations of manipulation of clinical data on simufilam
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.78 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
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Biogen's (BIIB) Aducanumab Gets CHMP's Negative Trend Vote
Biogen (BIIB - Free Report) and its Japan-based partner Eisai announced that they received a negative trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to their marketing authorization application for their Alzheimer’s disease (AD) drug, aducanumab, in Europe.
The CHMP’s negative trend vote was based on an oral explanation from Biogen in a meeting held earlier this month. Although the CHMP will provide its formal opinion in December, it is expected that it will maintain its stance and will recommend against the drug’s approval. Meanwhile, Biogen plans to engage in discussions with the EMA and the CHMP for resolving the issues that led to a negative trend vote.
We note that Biogen had a hard time getting approval for the drug in the United States as well. After much controversy, the FDA granted accelerated approval to aducanumab in June, largely based on its ability to remove beta amyloid seen in late-stage studies. However, it is still uncertain whether the reduction in beta amyloid leads to improvement in cognition. The drug is marketd as Aduhelm in the United States. Aduhelm’s FDA approval, despite an FDA advisory committee voting against it, faced a lot of criticism, due to the drug’s mixed efficacy results. The FDA approval is also for patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia but not for patients with earlier or later stages of the disease.
Moreover, the launch uptake of Aduhelm is facing some near-term challenges, including its hefty price tag of $56,000 a year. Sales of the drug fell to $0.3 million in the third quarter from $1.6 million in the second quarter as the launch of the drug has been slower than expected.
Earlier this month, Biogen announced new data from two late-stage clinical studies, which demonstrated that treatment with Aduhelm led to a significant reduction in plasma p-tau181, a biomarker of the hallmark tau tangles in AD. This reduction in plasma p-tau demonstrated a statistically significant correlation with reduced cognitive and function decline in AD patients. This data may help the company to gain support for its drug from the regulators in the United States and Europe as well as gain investors’ confidence. However, the impact remains to be seen.
So far this year, Biogen’s shares have increased 5.5% against the industry’s decrease of 14.4% in the same time frame.
Apart from Aduehlm, Biogen and partner Eisai are currently seeking approval for another AD candidate, lecanemab. In September, the companies initiated a rolling submission of a biologics license application (BLA) for the candidate, seeking approval as a treatment for early AD under an accelerated pathway.
There are several other pharma and biotech companies, including Eli Lilly (LLY - Free Report) and Cassava Sciences (SAVA - Free Report) that are engaged in developing a treatment for AD. However, AD has always been a highly challenging area and not much progress has been made despite significant investments.
Lilly is developing donanemab for treating AD. The drug works in a similar fashion to Aduhelm by targeting beta amyloid. Lilly initiated the rolling submission of a BLA last month, seeking accelerated approval for the candidate for treating AD later this year.
Data from a mid-stage study demonstrated that Lilly’s donanemab slowed disease progression significantly by 32% compared to placebo in patients with early symptomatic AD.
Cassava is currently developing its AD candidate, simufilam, in an open-label study. Interim data from the study announced in June demonstrated that both cognition and behavior scores of patients improved following six months of treatment with simufilam, with no safety issue observed.
Cassava plans to initiate two pivotal phase III studies to evaluate simufilam for mild-to-moderate AD dementia by the end of 2021. Cassava has successfully completed two mid-stage studies on the candidate. Cassava’s stock declined almost 24% on Nov 17 following reports of a probe by the Securities and Exchange Commission for investigating allegations of manipulation of clinical data on simufilam
Biogen Inc. Price
Biogen Inc. price | Biogen Inc. Quote
Zacks Rank & Stock to Consider
Biogen currently carries a Zacks Rank #3 (Hold).
Sarepta Therapeutics (SRPT - Free Report) is a better-ranked stock from the same sector, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.78 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.