Amgen, Inc.AMGN and Novartis NVS have announced that they are discontinuing two pivotal phase II/III studies evaluating their BACE1 inhibitor CNP520 to prevent or delay the symptoms of Alzheimer's disease (AD) in a high-risk population.
The two studies were being conducted under the Alzheimer's Prevention Initiative Generation Program, and were sponsored by Amgen and Novartis in collaboration with Banner Alzheimer's Institute.
A review of clinical data from the study showed that some patients in the studies experienced worsening in cognitive function. This led the sponsors of the Generation Program to conclude that the potential benefit for participants in the studies failed to outweigh the risks.
Amgen’s shares were down 2.3% while that of Novartis declined 1.15% on Wednesday in response to the news. So far this year, Amgen shares have declined 9.6% compared with 5.7% decrease registered by the industry during this period.
Alzheimer’s, a fatal condition that causes progressive decline in memory, has always been a highly challenging, and not much progress has been made despite significant investments (both funds and resources). Several companies have failed to develop safe and effective treatment options for this deadly brain disease.
In March 2019, Biogen BIIB/Eisai announced the discontinuation of ENGAGE and EMERGE phase III studies on their pipeline candidate aducanumab in early AD. A futility analysis conducted by an independent data monitoring committee (“IDMC”) showed that the studies were unlikely to meet their primary endpoints.
In January 2019, Roche RHHBY discontinued two late-stage studies evaluating its AD candidate, crenezumab as it was unlikely to meet primary endpoints of the studies as assessed by an IDMC.
In 2018, several large pharma companies, including Merck, Pfizer and Lilly/AstraZeneca stopped development of their AD candidates 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.
Companies that are currently working on AD treatments include Biogen, Novartis, AstraZeneca, Eisai and Amgen.
Amgen 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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