TRENTON, N.J. — In a major setback for patients and doctors, drugmakers Pfizer Inc. and Medivation Inc. have halted development of a potential Alzheimer’s disease treatment after the drug for a second time yielded disappointing results in a late-stage clinical study.
Dimebon was furthest along in testing among the experimental Alzheimer’s drugs being developed to try to stop or even reverse the course of the mind-robbing disease. Dimebon would have been the first such drug and specialists just a couple of years ago had hoped it would be on the market this year.
Pfizer, the world’s largest drugmaker by revenue, and Medivation said earlier this week that Dimebon failed to significantly improve cognitive ability, as well as self-care and daily functions in patients with mild-to-moderate cases of the disease. The study involved about 1,000 patients who had Dimebon added to their ongoing treatment with Pfizer’s former blockbuster Alzheimer’s drug donepezil, or Aricept.
Aricept, jointly marketed by Pfizer and Japan’s Esai Co. Ltd. and once heavily advertised, had about $3.7 billion in sales in 2009. It lost U.S. patent protection in November 2010, and sales have since plunged.
Dimebon, known chemically as latrepirdine, would have been an even bigger blockbuster if it had panned out. The experimental drug looked promising after it kept Alzheimer’s symptoms from worsening for a year in an earlier patient study.
But Dimebon didn’t work as hoped in a late-stage trial in which patients took it for six months. After those results, announced in March 2010, the companies said they were continuing three other studies that could prove Dimebon helped patients in combination with other Alzheimer’s drugs or when used for a longer period.
Then last April Pfizer and Medivation said Dimebon also failed in another late-stage clinical trial, when it did not improve symptoms of the neurologic disorder Huntington’s Disease.
After the latest failure, New York-based Pfizer and Medivation, headquartered in San Francisco, said they are ending development of Dimebon, as well as their agreement to market the potential treatment.
Pfizer still has one Alzheimer’s treatment in late-stage testing, bapineuzamab, which it is jointly developing with Johnson & Johnson. It’s a biologic drug, grown in living cells rather than made by mixing chemicals, and works differently than Dimebon.
Alzheimer’s disease is the most common form of dementia, and drugmakers are trying to find a treatment that does more than temporarily ease the symptoms: memory problems, confusion, aggression and a general decline in ability to function, which together can hasten death. Many drugs have flopped in late-stage testing in recent years, including some that seemed to clear harmful plaque from afflicted brains.
The newest drug for Alzheimer’s symptoms, Namenda, was approved back in 2003.
Cases of Alzheimer’s disease are expected to triple by 2050, to around 106 million people worldwide. The disease strikes nearly a half million new patients a year, mainly as people hit their 70s or 80s.
In trading Tuesday, Pfizer shares rose 9 cents to $21.93, while Medivation stock dropped $1.82, or 3.3 percent, to $53.90.
Too bad – Alzheimer’s is a nasty disease and it would be nice to find a way to kill it.
My SIL was diagnosed with early onset Alzheimer and was given a prescription for Aricept. This was before she got on SSI and received Medicaid. The cost was so high that I looked into ordering it from Canada and Mexico. It would have cost pennies on the dollar. Later she was given Namenda along with it. Sad to say neither was effective in her particular case. We got licensed by the state and took care of her for the last 3 1/2 years of her life.
I learned one thing from this ordeal and that is our patent laws are way behind the times when it comes to medicine. I found that we are the ONLY country that lets the demand dictate the costs of any medicine that is designed to help a particular disease. If you buy a prescription from Canada or Mexico you are told by US authorities that it isn’t made to the same standards as if it were made here. Supposedly they have more leeway in how much of the needed ingredient is to be used. It can vary as much as 15% and as such can be dangerous for any patient that needs a set amount n their system.
I have to wonder why they tell us this. Most of the doctors in other countries prescribe the same medicines as we do here and we don’t hear if their patients are suffering more from this anomaly.
No matter what happens in the future of finding a cure, I do know this. As in anything else, it will not be cheap. No one in congress is willing to buck the lobbyist for the drug companies patent laws so that we could receive a break. It is all about the Benjamin’s.
It is sad that you have to get licensed by the state to care for kin.
http://www.webmd.com/alzheimers/news/20061006/marijuana-may-slow-alzheimers
…from the lab of Kim Janda, PhD, director of the Worm Institute of Research and Medicine at Scripps Research Institute.
“..these findings offer convincing evidence that THC possesses remarkable
inhibitory qualities, especially when compared to [Alzheimer’s drugs]
currently available to patients,” Janda says in a news release.
“Although our study is far from final, it does show that there is
a previously unrecognized molecular mechanism through which THC may
directly affect the progression of Alzheimer’s disease.”
Janda’s team found that THC blocks an enzyme called
acetylcholinesterase, which speeds the formation of amyloid plaque in
the brains of people with Alzheimer’s disease.
The Alzheimer’s drugs Aricept and Cognex
work by blocking acetylcholinesterase. When tested at double the
concentration of THC, Aricept blocked plaque formation only 22% as well
as THC, and Cognex blocked plaque formation only 7% as well as THC.
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Cannabis remains the most widespread drug in use worldwide. Cannabis will probably remain the most widely used drug because the crop is easily grown in many different climates and requires no processing for use as drugs.
That is textbook knowlegde:
http://www.gale.cengage.com/pdf/samples/sp65756X.pdf
Legalize.
There is no reason Aunt Sally shouldn’t be able to grow marijuana in her garden for Grandma’s Alzheimer’s Disease or Uncle Bob’s glaucoma or her niece’s menstrual cramps!
You can’t “OD” on weed, and there are dozens of ways other than smoking to consume it.
Why do so many deny its usefulness?