SAN FRANCISCO -- Dr. Eric Kandel shared last year's Nobel Prize in medicine for figuring out what makes sea slugs remember. He's hoping the same technology can help aging baby boomers fight memory loss.
Kandel is co-founder and scientific advisory board chairman of 3-year-old Memory Pharmaceuticals Corp., which has 20 scientists in Montvale, N.J., developing drugs based mostly on research Kandel began in the 1960s.
Aside from the research challenges, however, Memory Pharmaceuticals faces a considerable regulatory hurdle: The Food and Drug Administration has been reluctant to approve drugs that simply target normal memory problems -- drugs it considers lifestyle enhancers rather than disease fighters.
"Aging isn't a disease," FDA spokeswoman Laura Bradbard said.
Dozens of companies are racing alongside Memory Pharmaceuticals to develop drugs to enhance memory, betting the FDA will ultimately approve therapies for relatively minor memory problems.
"The fact that this is the FDA's belief now doesn't mean it won't change later," said Wally Gilbert, a former Harvard professor who co-founded Memory Pharmaceuticals and shared a Nobel Prize in 1982 for contributions concerning the makeup of DNA.
'This isn't cosmetic'
Meanwhile, Memory Pharmaceuticals is also pursuing treatments for Alzheimer's, Parkinson's and other serious illnesses.
Americans spend about $1 billion a year on gingko biloba, a clinically unproven herbal memory enhancer. Another $1 billion is spent each year on the four available prescription Alzheimer's drugs, each of which have shown only limited effectiveness in the 4 million U.S. sufferers. These drugs only slow the progression of Alzheimer's.
Still, its primary target is improving the typically failing memories of the elderly -- a problem that affects about half of all seniors, said Axel Unterbeck, the company's chief scientific officer.
"This isn't cosmetic," said Kandel, who continues his research at Columbia University. "This is a real medical problem."
Bradbard said, however, that in order to win FDA approval, any drug that improves memory will also probably need to prove helpful with a major brain disorder such as Alzheimer's.
After lobbying from a number of companies and academics, an FDA advisory committee did recommend in June that companies should be allowed to target drugs specifically for mild cognitive impairment, defined as a decline in memory function beyond what is expected in people for their age.
That memory loss disorder affects four million Americans, some of whom will go on to develop Alzheimer's disease.
Any company that can successfully produce FDA-approved drugs for mild cognitive impairment will find a huge market, worth at least $1 billion a year, according to Harry Tracy, publisher of the stock picking newsletter NeuroInvestment.
"Alzheimer's is definitely one of the last great paydays for pharma," said Bill Thies of the Alzheimer's Association. As baby boomers age, Alzheimer's sufferers could number 14 million in 10 years, he said.
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