Alzheimer Failures Elsewhere Don’t Deter Merck: Phase II/III Study Moves Ahead
Although several rivals have recently experienced setbacks with Alzheimer’s compounds, Merck (MRK) disclosed plans to take a pill into a Phase II/III study with patients who suffer from mild-to-moderate stages of the disease. And while one analyst calls the move speculative, the decision underscores an ongoing willingness to place big bets on tackling Alzheimer’s.
Merck will test a beta-amyloid precursor protein site-cleaving enzyme, or BACE, inhibitor, which the drugmaker notes is the first drug with this type of mechanism to advance to this stage of clinical research. The Phase II portion of the new trial will enroll 200 patients and be completed by late 2013. The Phase III segment would then begin with 1,700 patients.
The decision comes after Bristol-Myers Squibb (BMY) halted testing of an Alzheimer’s compound, and Pfizer (PFE) and Johnson & Johnson (JNJ) gave up on their bapineuzumab compound, which failed to meet two Phase III primary endpoints in patients with mild-to-moderate stages of disease (read prior Pharma news). Eli Lilly (LLY), however, is proceeding with its solanezumab compound, which slowed cognitive decline in patients with mild disease, but showed no statistically significant reduction in functional decline (see prior Pharma news).
Merck and other big Pharma companies have had a hard time generating revenue growth, as patents expire on former blockbuster drugs and company labs fail to develop enough new drugs.
With its stock down, Merck's hefty dividend offers an attractive dividend yield these days, but it eats up most of profits.
“Merck is committed to advancing the understanding and treatment of Alzheimer’s disease,” says Darryle Schoepp, a senior vp and head of neuroscience and ophthalmology at Merck Research Laboratories, in a statement. The trial, by the way, will study one of three oral doses of the compound, called MK-8931, which will be administered daily versus a placebo.
The effort underscores that a significant level of interest remains, at least some researchers and executives, to study compounds in later-stage patients, despite the recent setbacks. And Merck notes that its BACE inhibitor recently demonstrated a reduction in cerebral spinal fluid, or CSF, a biomarker, in a Phase I study. But one analysts expresses caution.
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Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily.