The Alzheimer’s disease (“AD”) area is in focus once again with Pfizer Inc. PFE saying that it will be dropping its plans to develop treatments for Alzheimer’s and Parkinson’s disease. According to news sources, Pfizer expects its decision to result in the elimination of 300 positions from the neuroscience discovery and early development programs. We expect additional details to be available at the company’s presentation at the 36th Annual JPMorgan Healthcare Conference today.
Pfizer has had a long association with the Alzheimer’s disease research area. In 2015, the company became a part of the Dementia Discovery Fund, which was formed to speed up the development of new treatments for neurological diseases by bringing together major pharma companies, the UK government and Alzheimer’s Research UK. The Fund is involved in the financing of new, early stage drug development projects.
However, Alzheimer’s has always been a highly challenging area with not much progress being made despite the investment of a lot of funds and resources. In fact, Pfizer itself had faced a major setback way back in 2012 in its development efforts for an Alzheimer’s disease treatment. The company and its partner, Johnson & Johnson JNJ, decided to discontinue the development of bapineuzumab IV following a late-stage failure.
Other companies like Eli Lilly and Company LLY and Merck MRK have also stumbled in their efforts to develop treatments for Alzheimer’s. Lilly decided in November 2016 that it would not seek approval for its investigational AD treatment, solanezumab, following disappointing results from a late-stage study. The candidate was being evaluated to see whether it can slow the progression of memory problems associated with amyloid, a protein that forms plaques in the brains of people with Alzheimer’s.
Meanwhile, the evaluation of Merck’s investigational Alzheimer’s disease treatment, verubecestat, was halted in a phase II/III study (EPOCH) in February 2017 based on an interim analysis by an external Data Monitoring Committee (eDMC) that the study might fail. Another study is ongoing with results expected in February 2019.
Biogen also suffered a setback recently when an Independent Data Monitoring Committee said that BAN2401 did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint in the phase II study. The failure to show an early positive result came as a major disappointment for Biogen which is developing the candidate in association with Eisai.
Clinical-stage biopharmaceutical company Axovant Sciences AXON suffered a major setback in September 2017 when its investigational Alzheimer’s disease candidate failed to meet the co-primary efficacy endpoints in a late-stage study. The company decided to discontinue development of the 35 mg dose for the treatment of Alzheimer's disease. Over the last one year, the company’s shares are down 59.7% compared to the 1.7% decline of the industry it belongs to.
According to the Alzheimer's Association, in the 10 years from 2002-2012, 244 drugs were tested for Alzheimer’s in studies registered with clinicaltrials.gov out of which only one succeeded and went on to gain FDA approval.
The Road Ahead
Despite all these setbacks, several companies continue to invest heavily in developing Alzheimer’s disease treatments given the high commercial potential in this market. Success in this area means huge returns considering more than five million Americans are living with Alzheimer’s disease with the numbers expected to triple by 2050 (Data: Alzheimer's Association). It is considered to be one of the biggest burdens of society and is the sixth leading cause of death across all ages in the United States. 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 Alzheimer’s disease treatments include Biogen, Novartis NVS, AstraZeneca, Eisai and Amgen AMGN. Biogen’s aducanumab is one of the most important candidates in the company’s pipeline with the candidate currently in a couple of late-stage studies. Biogen is also working on elenbecestat (E2609), a BACE inhibitor in a phase III program. These candidates are being developed in collaboration with Eisai.
Lilly also has quite a few Alzheimer’s disease candidates in its pipeline including lanabecestat, which is being developed in collaboration with AstraZeneca with data readout expected in 2019. Meanwhile, Novartis and Amgen are collaborating for BACE1 inhibitor, CNP520, which has fast track status in the United Status. Roche is also collaborating with AC Immune for the development of Alzheimer’s disease treatments.
While companies like Pfizer, Lilly and Merck are all Zacks Rank #3 (Hold) stocks, you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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