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Drug company giants compete to find dementia-fighting blockbuster
Monday, December 11, 2000 By Gary Rotstein, Post-Gazette Staff Writer
A decade ago, there was hardly a whiff of excitement in the pharmaceutical industry about potential products or profits tied to Alzheimer's disease.
Few industry leaders were confident the disease could be effectively treated. Investing tens of millions of dollars in trying to solve the late-life puzzle seemed too big a gamble. No one had proven anything could be done to slow, halt or reverse memory loss.
Flash forward to 2000, and the drug giants are in heavy competition to treat, prevent or cure Alzheimer's. Clinical trials are under way for 26 different medications. Aricept, the leading drug already on the market, is on pace to produce a half-billion dollars in U.S. sales this year for Pfizer Inc. and Eisai Ltd.
At least a half-dozen companies making a major investment in Alzheimer's research believe that amount could easily be dwarfed by the next generation of dementia-fighting drugs. The difference in a decade is that some initial drugs have shown the disease can be slowed, and a slew of research from academic institutions has sparked optimism that the underpinnings of the disease can be attacked.
Bristol-Myers Squibb Co. already has spent perhaps $50 million developing a drug that is just now in safety trials on humans, said Dr. Geoffrey Dunbar, the New York company's vice president of neuroscience, clinical research and development. If it proves successful in battling the disease -- a major if -- the overall development costs before it's even marketed could reach $500 million.
"A lot of drug companies with neuroscience interest are exploring this area," Dunbar said. "Clearly, it's a major societal problem and it's increasing, no doubt about that. The chance of having Alzheimer's is proportional to your age, and clearly the population in the [Western hemisphere] is getting older."
That booming market of people with graying hair both in the United States and worldwide is a major factor in pharmaceutical firms' interest. The 4 million cases of Alzheimer's and related dementia presumed among Americans is easily exceeded by the number of patients elsewhere, although worldwide estimates vary widely.
Millions more patients undoubtedly will be diagnosed before any possible cure is identified and in use -- a range in time many experts place at five to 20 years away.
Government-funded studies are seeking to determine whether some effective, low-cost means of at least delaying Alzheimer's is already at hand, in the form of vitamin E, nonsteroidal anti-inflammatory pills and more. At the same time, private firms' laboratories are searching for even more effective future products, which are known only by code numbers in their current development stage.
Three drugs -- Cognex, Aricept and Exelon -- have had government approval since 1993 as drugs that treat some of the initial symptoms of Alzheimer's. For up to a year or more, they can help preserve memory, moderate behavior and postpone the loss of daily functioning that forces people into special-care facilities, although they're not effective on all patients.
The once- or twice-daily pills costing more than $100 a month are likely next year to be joined by Janssen Pharmaceutica's Reminyl, a fourth version of these cholinesterase-inhibiting drugs, which are used to preserve a key neurotransmitter in cognitive functioning. Experts and rival companies don't see those drugs, however, as the long-term answer to Alzheimer's.
Elan Corp. has earned the most attention with a potential vaccine that has proven effective on mice genetically engineered with the brain deposits of plaque that represent a hallmark of the disease in humans. The injection of AN1792, as the synthetic product is named within the Dublin-based company, has proven safe in humans and will probably be tested for its effect on individuals with mild-to-moderate Alzheimer's next year, said company spokesman Max Gershenoff.
"We have the most advanced potential disease modifying agent for Alzheimer's disease today," Gershenoff asserted. "The other products address the symptoms, but not the disease itself, not the underlying cause."
He declined to discuss Elan's investment in the research or to estimate its potential payoff, if the necessary several years of testing yield positive results.
"If AN1792 is successful, it will be a global blockbuster drug," Gershenoff said. "Alzheimer's disease affects so many people around the world, it will have tremendous impact, but you don't speculate" on the company's bottom-line reward.
Dunbar also used the word "blockbuster" to describe the potential payoff for Bristol-Myers and for rival companies working on an alternative to Elan's vaccine. Rather than using antibodies to destroy the harmful plaque buildup, a number of firms are targeting enzymes that may play the key role in creating the plaque. Bristol-Myers is concentrating on inhibiting the gamma secretase enzyme, while other firms believe controlling the beta secretase enzyme will stop plaque.
"There's no guarantee that preventing [plaque] from being deposited will help with Alzheimer's disease," Dunbar acknowledged. "Maybe it's the tangles that are primary, and this is the connecting phenomenon, and we've bet on the wrong horse. When you're on the leading edge of research like this, it involves a lot of risk, a lot of calculated guesses."
If any one drug is successful in curbing Alzheimer's, it doesn't necessarily mean other efforts will be wasted. A number of academic experts believe there could be variations of the disease, and different individual reactions to it, so there's value in the different approaches now in research and development.
At least it's a vast improvement over 1990, when there was comparatively little research, little money to be made, and little hope to offer families.
"If someone could really prevent Alzheimer's disease safely, that would be such an advance that hey, they deserve whatever they can get," said Johns Hopkins Medical Institution researcher Dr. Donald Price.
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