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Last month the Senate Appropriations Subcommittee on Labor, Health, and Human Services held a hearing to discuss federal budgeting for Alzheimer's Disease research. While much noise has been made about committee members choosing not to attend Seth Rogen's heartfelt testimony, media reports fail to mention the enlightening testimonies of top scientists for which the committee was more engaged. The testimony of NIH Director Dr. Francis Collins, for example, contained some poignant remarks that highlight our still nascent understanding of the disease, and could inform decisions to invest in a cure for Alzheimer's.
That cure will be ever more in demand as the population continues to age, bringing with it a burden on patients, their families, and society. A recent report places Alzheimer's as the third leading cause of death in the US following heart disease and cancer. With that demand in mind, a supplement to the new federal budget allocates $970 million to the NIH earmarked for Alzheimer's research. So if the NIH is investing in a cure, is it time for you to as well?
Barking up the wrong tree
To date, the legacy of Alzheimer's disease research rests heavily on the amyloid-beta hypothesis, which purports that plaques of aggregated amyloid-beta protein underlie cognitive impairment. While many early and mid-stage clinical trials have shown promise in slowing cognitive decline, no magic bullet has yielded durable meaningful relief of disease progression. Eli Lilly (NYSE: LLY ) , Johnson & Johnson, and Pfizer, relying heavily on this hypothesis, developed antibodies aimed at removing amyloid-beta from the brain before it formed plaques. Lilly's solanezumab has arguably been the most notable failure after striking out in Phase 3 trials for patients with mild-moderate Alzheimer's. With the large market for a cure driving its huge investment, the failure leaves Lilly relying heavily on its promising diabetes drug dulaglutide, and a last ditch effort to show that solanezumab works in patients with mild Alzheimer's.
Despite these tribulations calling into question the validity of the amyloid-beta hypothesis, a new approach to preventing plaque formation has gained the attention of well funded development programs. Merck (NYSE: MRK ) and AstraZeneca are two leading players in the race to block the BACE enzyme responsible for a step in the production of amyloid beta, after Lilly and Roche faced separate disappointments with their own BACE inhibitors. Merck has the upper hand in the field, with its MK-8931 in a Phase 2/3 trial for the mild and moderate forms of the disease and a Phase 3 trial for prodromal Alzheimer's. While the Phase 2 interim data suggest that safety is not an issue, the real question will be if the drug can slow cognitive decline more effectively than earlier therapies.
Not to be left out of this Who's Who in health care, Biogen (NASDAQ: BIIB ) has entered the race with a deal to collaborate on Eisai's (NASDAQOTH: ESALY ) E2609. That deal brings together two neurology powerhouses, and I think the partnership is likely to forge the most innovative therapies in the bunch.
The need to refocus efforts
In his testimony, Dr. Collins acknowledged how little we know about the risk factors and causes of Alzheimer's disease, and even went so far as to call drug discovery "pre-competitive". What does that mean, exactly? I think it means that despite the huge investments from drug companies and incremental advances in reducing cognitive decline, it is still too early to confidently (and Foolishly) invest in a cure for Alzheimer's. There are undoubtedly innovative approaches, like Prana's metal-shuttling PBT2, but as a long-term investment the risks associated with its small IMAGINE Phase 2 trial are just too high.
The real problem is a lack of fundamental understanding of the underlying causes of Alzheimer's disease -- a problem which federal funding could go a long way toward addressing. Part of that funding is likely to go toward a search for new genetic risk factors and therapeutic targets, an industry which Illumina (NASDAQ: ILMN ) is primed to dominate. Illumina recently introduced its HiSeq X Ten genome sequencing device, which will enable whole genomes to be decoded quickly and for less than $1,000 each. Next to diabetes, you can bet that Alzheimer's research will be a major beneficiary of an explosion in genomic data. As a leader in both academic and clinical genomics, Illumina should continue to soar on the growing demand for genetic data.
Foolish bottom line
Opportunities to invest in the massive market for an Alzheimer's therapy certainly do exist. In some cases, those investments will grow as drugs make a meaningful impact on the lives of patients. For this Foolish investor, though, we still just don't know enough to manage the risk of investing in a truly disease-modifying treatment for Alzheimer's. I'd be more comfortable encouraging stronger public sector investment in basic research in the hopes that a better understanding of the etiology of the disease can emerge.
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