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  • Writer's pictureMichael Goettler

Alzheimer's Research Perseveres, Providing Hope for Millions of Patients

Updated: Mar 6


alzheimer

What is at Stake?


55 million people live with dementia globally. That number is projected to increase to 139 million by 2050.


What’s New?


On July 6th, the FDA granted full approval to Eisai-Biogen’s lecanemab. It is the first traditionally approved treatment that addresses the underlying biology of Alzheimer's (the most common form of dementia) and may change the course of the disease meaningfully for people in the early stages. Another treatment, aducanumab**, has received accelerated approval. Meanwhile, Eli Lilly’s experimental drug, donanemab, is pending FDA approval.


The drugs are by no means perfect. They modestly slow disease progression, but do not stop it and can have serious side effects. Nevertheless, it is a huge step forward.


Why Does It Matter?


Historically, Alzheimer's disease has been a complex condition, with extensive research yielding very few successes.


Between 1995 and 2021, the cumulative private investment in clinical trials for Alzheimer's disease was $42.5 billion, involving 183,679 study participants. This does not include significant public investments by the NIH or others into basic disease research.


Data

This enormous expense led to only five approved treatments (four cholinesterase inhibitors and one NMDA receptor antagonist, all symptomatic but not disease-modifying agents). Despite enormous investments, no additional treatments received approval between 2003 and 2020. The cumulative failure rate is 95%, and no less than 117 drug candidates have tried and failed to show clinical benefit.


As someone who was a Senior Executive at Wyeth Pharmaceuticals when the company declared "War on Alzheimer's” in the mid-2000s, I witnessed firsthand the significant investments made in vaccine-, biological-, and small-molecule-approaches to tackle the disease. Unfortunately, these efforts, and those of other companies in the industry, ultimately proved unsuccessful.


Where Do We Stand Today?


Aducanumab**, lecanemab, and donanemab are only the tip of the spear of innovation to hopefully come. 187 Phase 1, 2, and 3 clinical trials currently assess 141 unique compounds. 36 drugs are in Phase 3 clinical development, the last phase required before approval.

Click here to see a very helpful overview of the current state of Alzheimer’s drug development, published by the Alzheimer’s Association.


Pharma for Good


No other industry would be willing to take so much risk: spending $42.5 billion with a 95% failure rate and without any success for 17 consecutive years. Still, against all odds, the pharma industry continued to invest and has now finally succeeded in bringing much-needed treatments to patients.


Undoubtedly, the companies that will succeed will be rewarded generously and can expect a very lucrative return on investment. Biogen’s share price jumped almost 40% on the day of the Phase 3 trial announcements, and Eisai’s jumped 58%.


This kind of risk-taking is only possible with the relentless drive and dedication of thousands of pharma researchers backed by management that allows such risky ideas to be realized.


Bottom line: Despite all criticism, the pharma industry continues to be a force of good by taking large risks to push science forward and improve outcomes for millions of patients.


** Disclaimer: Aducanumab has since been discontinued as an Alzheimer’s treatment. For more information, visit here.



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