I will stick closer to home in my size of market thoughts.
The 2b/3 AD trial was comprised of pre-AD mildly cognitively impaired (MCI) patients along with mild AD patients. If blarcamesine gets approved by the EMA and the FDA and goes forward as planned, that's the market -- MCI and mild AD.
In the U.S. we have almost 7 million people with Alzheimer's. Only some fraction of them, perhaps 2 to 3 million, will have mild AD. Others with more advanced disease may try to get it off label, but that group will not benefit and those sales will end. Meanwhile, the mild AD group will begin to grow as the drug slows the progression of their Alzheimer's.
But that's not where I am going with this discussion -- I want to look at the MCI market numbers. There are presently about 12 million people in the U.S. with mild cognitive impairment. About half of them, within a five year period, today progress to mild AD. Some fraction of the others will progress to another dementia. All 12 million will be very interested in this new anti-dementia drug, on label or off label, even the ones who won't get worse but fear they will.
And, if Mayomobile's or my calculations are correct, the 12 million population will also grow significantly as progression to AD (and perhaps similar dementias) is delayed from five years to as many as ten years. The European market should be similar in size.
We are ultimately looking at a European and American blarcamesine market, on label and off label, of perhaps 40 million people. No need for additional trials, either.
Put that in your calculators.
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