Merck, GE team up for new Alzheimer's treatment
With the help of an imaging agent, the pharma is pursuing what it hopes will be a blockbuster drug.
By Barry S. Cohen, Stock Traders Daily
Is Merck's (MRK) pursuit of late-stage Alzheimer's patients the case of a fool rushing in where angels have chosen not to tread? The N.J. pharmaceutical giant obviously doesn't think so. Furthermore, Merck believes it may have an ace in the hole as it pursues development of what it hopes will be an Alzheimer's blockbuster.
Merck is counting on an imaging agent from General Electric (GE) Health Care to work in tandem with its investigational drug MK-8931 to determine if the medicine is successfully obstructing an enzyme that can cut back the development of beta amyloid.
Although the exact cause of Alzheimer's disease remains a mystery, many experts believe that that it results from the accumulation of beta amyloid proteins in the brain.
The GE imaging agent, called flutemetamol, is injected into patients before positron emission tomography (PET) scans to detect beta amyloid deposits in the brain. Although the agent is still in development, it showed promising results in a late-stage study.
Merck's plan is to use flutemetamol to identify study candidates to treat with MK-8931 and then track their progress to learn if the drug is having the desired effect.
Of course, the opportunity is huge for any pharmaceutical company that can come up with an effective Alzheimer's treatment. AD is the most common cause of dementia, accounting for approximately 50% to 75% of the estimated 35 million dementia cases globally. About 5.4 million people in the U.S. are currently living with AD and there are currently no disease-modifying treatments available. Current treatments are limited to providing symptomatic improvements with only modest and short-term effects.
Some in the industry wonder whether Merck is barking up the wrong tree. They think the company would be better off going after members of the Alzheimer's population in the early rather than late stage of the disease, pointing out that both Lilly (LLY) and Bristol-Myers Squibb (BMY) threw in the towel on their drugs after they failed to produce results in late-phase AD patients.
In Merck's defense, its drug works differently than the Lilly and Bristol medications. Evidence suggests that it decreases the production of beta amyloid and may therefore reduce amyloid plaque formation and modify disease progression. And Merck has its ace in the hole -- flutemetamol.
As to flutemetamol, GE plans to file for FDA and EU approvals later this year. But the company faces competition in the search for next-generation imaging for Alzheimer's. Navidea (NAVB), based in Dublin, Ohio, is studying an agent that also targets beta amyloid. Lilly, meanwhile, is trying to get Amyvid, its diagnostics agent, indicated for Alzheimer’s imaging.
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