StreetTalk: Memory Drugs: "Viagra for the Brain"

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BioPharm International, BioPharm International-11-01-2005, Volume 18, Issue 11

According to a 2005 study by the American Academy of Neurology, donepezil may improve the memory of Alzheimers patients and those suffering with multiple sclerosis.

If the 1990s were the vanguard of the sexual stimulant revolution, will the 2000s go down in history as the age of the memory-enhancing drug?

Brian O'Connell

An impressive line-up of biopharmaceutical firms think so. Companies like Memory Pharmaceuticals, Sention, Saegis Pharmaceuticals, and Cortex Pharmaceuticals all have memory-enhancing programs in the pipeline.

Imagine, as The Washington Post put it recently, a pill that not only banishes the senior moments of aging baby boomers, but drugs that could improve the SAT scores of your high school teenager by 200 points or more.

The life sciences industry is tantalizingly close to pulling it off. And if they do, the stock of companies like the ones listed above will go through the roof, just as the makers of Viagra and Levitra did (Pfizer and GlaxoSmith Kline, respectively).

Is it time to get in to the memory drug market now? Hard to say. But it is growing increasingly clear that clinical researchers are beginning to crack the code surrounding the molecular details of how memory works.

NEW GENERATION OF DRUGS TO COMBAT MEMORY LOSS

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According to a recent article on Forbes.com, much of the hard work in decoding memory neurons has already been completed. "(Life sciences firms) have taken a crucial first step: identifying the genes and proteins inside brain cells that regulate memory formation," says the article. "They are tantalizingly close to creating a kind of Viagra for the brain: a chemical that reinvigorates an organ that has faded with age. This new generation of drugs could mend memory loss in the seriously ill or the merely absentminded."

According to Eric Kandel, the founder of Memory Pharmaceuticals who has been working on memory-enhancing drugs since the 1950s, the end is in sight for a solution.

"My friends keep asking when the little red pill is coming," he tells Forbes.com. "If we continue making the kind of progress we are now, we will have drugs for age-related memory loss in five to ten years," he says. And it could come sooner. Researchers at New York-based Helicon Therapeutics say they hope to launch human trials for memory improvement drugs by 2007.

The list of markets for memory-enhancing drugs is long and lucrative enough to make the most cynical Wall Street trader drool. Imagine the four million Americans suffering from Alzheimers disease steadily getting their memories back? Or about head trauma sufferers or stroke patients who couple memory drugs with cognitive therapies to regain their memories and recognize their loved ones once again?

According to the website FuturePundit.com, roughly one third of all people age 60 and over suffer from memory and recall woes. And the good news that more Americans are living longer has an unpleasant side effect — about one quarter of people age 85 and over are afflicted with dementia, which the site defines as "the loss of memory and cognitive function and an inability to understand words, carry out motor activities, and recognize or identify objects."

Then there is the mother lode. Memory drugs could be manna from heaven for those 76 million baby boomers who would welcome a drug that forestalls the onslaught of memory loss and the onset of one of aging's most nefarious side effects – if only to remember where they left their Viagra.

James McGaugh, a neuroscientist at the University of California, Irvine tells Forbes.com, "Drug companies won't tell you this, but they are really gunning for the market of unimpaired people — the 44-year-old salesman trying to remember the names of his customers."

AMPED UP

So far, research scientists are focusing on a new class of drugs called ampakines, where evidence shows that it could increase the flow of acetylcholine to the brain and heighten the mind's ability to process information better and even create new memories. For years, spiritualists have touted the beneficial effects of ginseng (an extract from the leaves of the 200-million-year-old ginkgo tree). Some studies have claimed that ginseng improves the flow of oxygen to the brain and helps Alzheimers sufferers, for example, stave off the onset of dementia.

But clinical data are beginning to show that ampakines could wind up making ginseng look like a piker. From a recent study by New Scientist magazine, research shows that ampakine – tested under the clinical name CX717 at the University of Surrey in the UK — significantly improved the memories of 16 male study participants between the ages of 18 and 45.

Study researchers, using an ampakine pill developed by California-based Cortex, found that even small doses of the drug improved study participants' memories even after being kept up all night. The more ampakine the study subjects ingested, the better their memories tested with study researchers.

Another (May 2004) study, this one by scientists from Wake Forest University Baptist Medical Center, demonstrated in a unique primate model that the CX717 pill from Cortex improved cognitive performance and also reversed the deleterious effects of sleep deprivation. The research at Wake Forest provided the basis for conducting a Phase II sleep deprivation study in humans, which confirmed CX717 improved wakefulness, memory, cognition, and attention without causing systemic stimulation in subjects that were sleep deprived.

Another memory-enhancement drug, donepezil, is showing both scientific and commercial promise as well. According to a 2005 study by the American Academy of Neurology, the drug may improve the memory of Alzheimers patients and those suffering with multiple sclerosis (MS).

The study involved 69 people with MS and mild cognitive problems. One-half of the participants took the donepezil for 24 weeks and the other half took a placebo. The participants were tested for memory and other cognitive functions at the beginning and end of the study.

At the study's conclusion those taking donepezil improved by an average of 14 percent on the memory test, compared to a 3-percent improvement for those taking the placebo. And 66 percent of those taking the drug felt that their memory had improved, compared to 32 percent of those taking the placebo.

"The possibility that memory and cognitive impairment in MS could benefit from drug treatment is of major importance to patients and their families," said study author and neurologist Lauren Krupp, MD, of Stony Brook University Hospital in New York. "Any treatment that would enhance their ability to meet the mental challenges of their daily lives would be helpful."

REMEMBERING THE FUTURE

Promising clinical studies are one thing, actual commercial usage on a widespread basis is another. Nothing out there in the marketplace currently does what memory drug makers claim their products can do — namely cure or halt the disease in which brain cells deteriorate and die, robbing people of their memory. Drug maker Pharmos knows the feeling. It's efforts to help the 85,000 Americans who suffer from traumatic brain injury fell short last year with its clinical trial of dexanabinol, which failed to show statistically significant improvement in a critical late-stage testing program. Investors weren't happy. The drug had been under development since the mid-1990s at a cost of $50 million. The day after the failed trial, shares of Pharmos fell 66% to $1.18.

PRESENT DAY DATA

But that was then and this is now. Notably, the pool of potential memory drugs is widening. According to the analyst firm Datamonitor, there were more than 40 drugs in mid- or late- stage clinical trials and another 100 more in early stages of development at the beginning of 2005. The firm also reports that future successes may not even come from biopharm behemoths like Merck or Eli Lilly. Smaller companies like Cortex, Neurochemand, and Axonyx are making the fastest inroads.

So let's recap. The market — remember those 76 million baby boomers? — is most definitely there. The pipeline is filling up. And the technology is getting better.

On Wall Street total recall is an absolute necessity. If the biopharmaceutical industry can give Main Street a memory drug that will do what Viagra did for the boomers, believe me, investors will have a long memory.

Celebrity author and business/finance commentator for CNN and Fox News, Brian O’Connell has written for The Wall Street Journal and Newsweek, 79 Radcliffe Drive, Doylestown, PA 18901, 267.880.3144, fax 267.880.1939, brian.oco@verizon.net