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Posted: September 09, 2008

Pfizer Eyes Old Russian Drug with Alzheimer?s Promise; New Generic OK?d


Fresh on the heels of the pharmaceutical industry’s disappointment surrounding two hope-for new Alzheimer’s drugs, industry giant Pfizer is focusing on a decades-old Russian antihistamine which fared well in a small trial of Alzheimer’s patients, while the FDA has approved a generic version of a long-time Alzheimer’s medication.


The flurry of pharmaceutical industry activity tracks with the medical community’s urgency to find a cure for Alzheimer’s as well as develop new and better drugs to treat the fatal disease, which is currently estimated to afflict more than 5 million Americans and is currently the sixth-leading cause of death in the United States.


Scientists worldwide are working to find a cure for the mind-robbing disease, and drug development is growing on several fronts to slow the progression or even reverse the condition’s effects. But not all roads lead to success: in June, Myriad Genetics found out its Flurizan had no effect whatsoever in a big trial, and in July, drug makers Elan and Wyeth released weaker than anticipated initial trial results for a widely-discussed antibody to fight brain plaques thought to be a culprit in Alzheimer’s development.


With that backdrop, Pfizer, which markets the well-know Alzheimer’s drug Aricept, announced it would team with a West Coast biotech company, Medivation, to intensify the study of an obscure Russian antihistamine called Dimebon, which turned up promising results in a very small test published this summer.


According to Forbes magazine, the stakes are huge as Pfizer has agreed to pay Medivation $225 million now plus $500 million more if Dimebon is approved by the FDA as a treatment for Alzheimer’s. In addition, Medivation would get a 40% share of US profits.


Industry observers said Pfizer’s “bet” was logical, since its patent on Aricept expires in two years and successful testing and development of Dimebon could reap large financial benefits, while aiding in the cause of fighting the age-related memory disease. Dimebon is already in final-stage trial in over 500 patients through Medivation.


"It [Dimebon] looks to be a very effective symptomatic therapy -- at least as good if not better than current [drugs]," Pfizer Vice President Steve Romano told Forbes. He said Pfizer is interested in Dimebon because it seems work through a different mechanism than Aricept, even though exactly how it works is not yet clear.


The previously reported trial of 183 Russian Alzheimer's patients showed that those who got Dimebon for six months were four points better on a commonly used 70-point cognitive rating scale than those who got placebo. This compares with a two- or three-point boost that’s typically seen with existing drugs over the half-year test period.


A subset of patients who continued on the drug for a second six months held their initial level of function over the whole year, according to results published in the British medical journal Lancet in July.


Dimebon, which was first marketed in Russia more than 30 years ago as an antihistamine, is now undergoing a final-stage US and European trial comparing its effects with placebo. Medivation has said it is testing whether Dimebon can be safely combined with Aricept, and if so, the combination could be scheduled for another efficacy trial in the future, Forbes said.


Meanwhile, the FDA has approved plans to manufacture and market a generic version of Razadyne (galantamine hydrobromide), which was formerly known as Reminyl and is used to treat mild to moderate Alzheimer’s disease.


Barr Pharmaceuticals, Inc., of Montvale, New Jersey, said it will immediately begin production of the generic tablets in 4, 8 and 12 milligram dosages. In addition, Mylan, Inc., of Pittsburgh, also said it would launch a generic version of Razadyne. Barr and Milan are among a group of companies that will share a 180-day marketing exclusivity grant from the FDA on the generic form of Razadyne.


The original Razadyne drug is made by Ortho-McNeil Neurologics, a unit of Johnson & Johnson.

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