Breaking down barriers in the quest to cure Alzheimer’s

Written by David Ricks on 23 September 2019 in Opinion Plus
Opinion Plus

Innovation can change the maths of Alzheimer’s disease. But to do that, governments need to change the maths for innovators, says David Ricks.

Photo credit: Eli Lilly and Company


The estimated annual global cost of care for people with Alzheimer’s and other forms of dementia is $1tn (€900bn), similar to total global spending on all pharmaceuticals. In Europe, the societal and economic cost of Alzheimer’s Disease is estimated to increase by 43 percent to over €250bn between 2008 and 2030, the equivalent to the GDP of Finland.

In a recent survey run by Eli Lilly and Company, Europeans surveyed said they consider Alzheimer’s Disease/dementia to be the second most important illnesses for the EU to prioritise over the next five years, after cancer. But current intellectual property laws discourage companies from investing in drugs that treat slow-progressing, difficult diseases such as Alzheimer’s. It is the only disease among the top 10 global causes of death that lacks a treatment to slow it down. Failure rates have been higher in Alzheimer’s drug development than in almost any other disease. In cancer, one in five drugs completes testing successfully; in Alzheimer’s, it is one in 200.


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Pharmaceutical companies are studying more than 20 times as many drugs for cancer than for Alzheimer’s, even though the societal costs of each disease are about the same. One reason is the difficulty of finding clinical trial participants. At least half of dementia patients are not clinically diagnosed — far higher than for other diseases. It has also been difficult to identify patients soon enough for a treatment to be effective. Alzheimer’s tell-tale clumps of amyloid beta protein appear in the brain 10 to 20 years before patients experience any change in thinking or memory. Scientists have developed new tests that can diagnose Alzheimer’s before symptoms appear. But these tests are not widely available and none can yet be the endpoint of a clinical trial, which would shorten the time needed to determine whether potential treatments work.

"In cancer, one in five drugs completes testing successfully; in Alzheimer’s, it is one in 200"

Shorter clinical trials are key to encouraging private investment, which helps fund more than 70 percent of Alzheimer’s studies. While patents disallow copycat versions of a new medicine for 20 years, that clock typically starts before clinical trials begin and years before a medicine is available for patients. The longer the trials, the less time the company has to get a return on investment. But innovative companies can be encouraged to put more money into diseases with longer development times. Governments can grant periods of “data exclusivity” during which competition cannot introduce a copycat medicine without conducting their own clinical studies.

Data exclusivity begins when a new medicine is approved. For drugs developed quickly, the period of data exclusivity overlaps substantially with the patent term, offering little additional benefit. But for drugs that take longer, it offsets the time lost to extended clinical trials. Right now, governments offer a range of data exclusivity protections, from 12 years to none. The European law provides 10 years. Provision of an appropriate and sufficiently long period of data exclusivity is central to spur investment into difficult and slow-progressing diseases such as Alzheimer’s.

Some people argue the way to cut healthcare costs is to reduce intellectual property protections. But a strong IP system produces breakthroughs today and bargains tomorrow. An effective Alzheimer’s medicine would, after a typical post-approval patent life of 13 years, go on delivering value for decades. Nothing in healthcare and social care is more productive.

 

The article has been adapted from the original published in the Financial Times.

Find out more at: www.lillypad.eu

About the author

David Ricks is chairman and chief executive officer of Eli Lilly and Company, and president of the International Federation of Pharmaceutical Manufacturers & Associations.

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