Lilly digs deeper into Alzheimer's
Lilly, which is simultaneously expanding its diabetes presence, is in a unique place among its peers in the Alzheimer's field. Whereas Pfizer and Johnson & Johnson ditched their low-expectations Alzheimer's treatment bapineuzumab last August, and Sanofi told the crowds at the San Diego PhRMA conference it was avoiding the field altogether, Lilly has been standing fast. Like bapineuzumab, Lilly's contender, solanezumab, failed to wow physicians or analysts as clinical trial results rolled in last year. The company spun the results as marking a decent, if modest, advance, and they did not harm company reputation on Wall Street, but only because analysts had not included the drugs in their financial models for Lilly. The "OK" framing was possible when the company uncoupled results for global and cognitive function and presented the results independently. The drawback at the time was that it meant resetting the endpoints, in addition to sidestepping FDA requirements that Alzheimer's medications show progress on both fronts. Solanezumab acts on beta-amyloid proteins.
The FDA's position on the two-for-one results has since shifted, and the regulator issued draft guidance in February outlining the sort of changes it was considering. FDA's head of neurology, Russell Katz, even went so far as to explain the proposed revisions in a Perspectives piece that ran in the New England Journal of Medicine in March. In addition to noting the slew of failures, Katz wrote that studies are increasingly focused on early-stage patients, when cognitive and or global function impairment may not be in synch and “it might be feasible to approve a drug through the FDA's accelerated approval pathway on the basis of assessment of cognitive outcome alone.”
When Lilly released its disappointing results in August it noted that if it pooled results from two studies and focused only on cognitive function that the treatment did slow the decline among patients with mild forms of Alzheimer's.
Part of the urgency behind the field's research is the impact the disease is going to have. Alzheimer's is currently cited as the cause of one in every 6 US deaths, and the Alzheimer's Association projects that 7.1 million people 65 and older will have Alzheimer's in 10 years. That's a 40% increase from the 5.1 million who now have the disease and it's expected to jump to between 14 million and 16 million by 2050 -- a 180% increase from current levels. On the financial side, the Association noted that caregivers, who provide aid such as getting into and out of bed, feeding, dressing, bathing and managing incontinence, provided $216.4 billion in unpaid care in 2012. The association's report indicates that $203 billion will be spent on paid care this year, for services including healthcare, long-term care, and hospice, and expects this number to hit $1.2 trillion in current dollars in the next 12 years.