Biogen Inc. BIIB and its Japan-based partner Eisai presented mixed new data from the ENGAGE and EMERGE phase III studies on its Alzheimer’s candidate, aducanumab at the Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego
Biogen’s shares were up 3.4% on Thursday after the news was announced. However, Biogen’s shares have declined 0.5% this year so far against the industry’s increase of 6.2% in the same time frame.
In October, Biogen revealed controversial plans to pursue U.S. regulatory approval of aducanumab based on positive results of a new analysis of larger dataset from the discontinued ENGAGE and EMERGE studies, which became available after the studies were ceased.
In March, Biogen and Eisai had discontinued ENGAGE and EMERGE following a futility analysis, which relied on an earlier and smaller dataset. Biogen in October said that a new analysis of the larger dataset showed a different outcome than the one predicted at the time of the futility analysis.
The EMERGE study met the primary endpoint, showing that patients treated with high dose (10mg/kg) of aducanumab experienced a statistically significant reduction in clinical decline of Alzheimer’s disease. At the CTAI, detailed data from EMERGE showed that the higher of the two tested doses ((10mg/kg and 6mg/kg) led to 22% less cognitive decline in patients with early Alzheimer’s disease after 78 weeks than placebo based on a standard scale called the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Also, key secondary endpoints were met, which demonstrated improvements in cognition and function.
The ENGAGE study, however, did not meet the primary endpoint. However, Biogen said that data from a post-hoc analysis, from a subset of patients in the ENGAGE study who received higher dose of aducanumab, support the findings from EMERGE study. Biogen is confident that the totality of these data supports a regulatory filing. Biogen plans to submit a biologics license application (BLA) seeking approval of aducanumab to the FDA in early 2020.
A group of analysts believe that the promising new data from two failed studies on aducanumab have revived hopes for approval of this almost-written off experimental Alzheimer’s therapy. However, another group believes that the FDA may not approve aducanumab, particularly with mixed outcome results across the two studies. Also, the FDA may require additional studies to be conducted to confirm the candidate’s benefits.
Alzheimer’s, a fatal condition that causes progressive decline in memory, has always been a highly challenging area, and not much progress has been made despite significant investments (both funds and resources). The drugs presently available just treat the symptoms of the disease. Several companies have failed to develop safe and effective treatment options to treat this deadly brain disease. Other than Biogen, several large pharma companies, including Roche RHHBY, Amgen AMGN, Novartis NVS, Merck, Pfizer, Lilly and AstraZeneca stopped development of their AD candidates in 2019/2018 either due to low possibility of success or safety concerns.
Despite the setbacks, companies continue to invest heavily in developing AD treatments, given the high commercial potential in this market. Success in this area means huge returns. This is because more than 5 million Americans are living with AD with the numbers expected to triple by 2050 (Data: Alzheimer's Association). The market has immense commercial potential and companies coming out with new treatments could rake in billions of dollars in sales.
No doubt, Biogen is leaving no stone unturned to resurrect aducanumab because if it is approved by the FDA it will become the first medicine to treat Alzheimer’s disease.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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