Pfizer will stop development of their investigational Alzheimer’s disease drug after it failed to meet the main goals of improving cognition and daily function in a late-stage trial.

The drug companies said Tuesday that while dimebon was generally well tolerated in the study, it did not achieve statistically significant results for either improving cognitive ability or self care and daily function.

The experimental drug also failed an earlier Alzheimer’s disease trial in 2010 and a late-stage study for Huntington’s disease in 2011. Pfizer and Medivation stopped development on dimebon for Huntington’s, a hereditary condition that causes mental deterioration, after that trial failed.

In addition to ending the development of dimebon, the companies will also terminate the ongoing open label extension study in Alzheimer’s disease.

“We recognize Alzheimer’s is a very complex disease,” said Dr. Steven Romano, head of   Pfizer’s medicines development group. Despite the disappointing results, Romano said Pfizer remains committed to advancing the science of the disease.

The Phase III trial took place over a 12-month period with 1,003 Alzheimer’s patients.

Shares of Medivation were down about 2.5% to $54.37 Tuesday morning.

The company’s shares of been hit hard by dimebon’s failures but have gained two-fold over the last two months after its prostate cancer drug, MDV3100, received a positive recommendation from an independent committee.

http://www.foxbusiness.com/industries/2012/01/17/pfizer-medication-end-alzheimers-drug-development/

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]]> http://dimebonalzheimers.com/1231/pfizer-medivation-alzheimers-development/feed/ 0 http://dimebonalzheimers.com/1202/potential-alzheimers-dimebon-fails/ http://dimebonalzheimers.com/1202/potential-alzheimers-dimebon-fails/#comments Sat, 14 Apr 2012 08:06:40 +0000 admin http://dimebonalzheimers.com/?p=1202
Dimebon, a drug that has been in phase three of clinical trials for treatment of Alzheimer’s disease, has recently been discontinued after studies concluded it was ineffective. Dimebon is a drug that was first used in Russia decades ago as an antihistamine, and in the last few years has undergone testing to treat the symptoms of Alzheimer’s in [...]



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Dimebon, a drug that has been in phase three of clinical trials for treatment of Alzheimer’s disease, has recently been discontinued after studies concluded it was ineffective. Dimebon is a drug that was first used in Russia decades ago as an antihistamine, and in the last few years has undergone testing to treat the symptoms of Alzheimer’s in the United States. Dimebon was never sold or marketed in the United States.

Initially, the drug showed some positive results in patients with Alzheimer’s, so clinical trials were expanded to study its effects when given with the drug denepazil (Aricept), a medication currently used to treat early Alzheimer’s. This past week, Pfizer and Medivation, the two drug companies that were conducting the trials, announced the discontinuation of Dimebon after it failed to show benefits for the recipients. In fact, some of the people receiving it declined more than those who received the placebo.

This is disappointing news, especially in light of ournation’s recent draft document on Alzheimer’s disease and other related dementias. One goal outlined in this draft is to effectively treat and prevent Alzheimer’s by 2025. Evidently, the manner in which we do this won’t include Dimebon.

http://alzheimers.about.com/b/2012/01/22/potential-alzheimers-drug-dimebon-fails-in-clinical-trials.htm

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]]> http://dimebonalzheimers.com/1202/potential-alzheimers-dimebon-fails/feed/ 0 http://dimebonalzheimers.com/1197/dimebon-fails-alzheimer%e2%80%99s/ http://dimebonalzheimers.com/1197/dimebon-fails-alzheimer%e2%80%99s/#comments Tue, 10 Apr 2012 06:42:09 +0000 admin http://dimebonalzheimers.com/?p=1197
Topline results of a phase 3 trial of dimebon, also called latrepirdine, on top of ongoing treatment with donepezil has shown no benefit in patients with mild to moderate Alzheimer’s disease (AD). The companies developing dimebon in this indication, Medivation Inc and Pfizer Inc, issued a joint statementnoting that results of the phase 3 CONCERT trial [...]



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Topline results of a phase 3 trial of dimebon, also called latrepirdine, on top of ongoing treatment with donepezil has shown no benefit in patients with mild to moderate Alzheimer’s disease (AD).

The companies developing dimebon in this indication, Medivation Inc and Pfizer Inc, issued a joint statementnoting that results of the phase 3 CONCERT trial showed that the addition of dimebon had no statistically significant benefit on either of the 2 co-primary endpoints, change from baseline in the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) or the activities of daily living subscale (ADAS-ADL).

“Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer’s disease,” the joint company statement notes. The companies also plan to terminate their collaboration to codevelop and market dimebon.

The CONCERT trial was a 12-month global randomized, double-blind, placebo-controlled trial that enrolled 1,003 patients with mild to moderate AD. Patients receiving a stable dose of donepezil for at least 4 months were randomly assigned to 1 of 3 treatment groups: dimebon, 20 mg 3 times per day; dimebon, 5 mg 3 times per day; or placebo.

Although there was no apparent benefit, the drug was generally well tolerated in the study, the companies add. “A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress,” the statement concludes.

Although phase 2 results with this agent were extremely positive in the treatment of AD, previous negative results have been reported with dimebon in phase 3 in the CONNECTION trial, as well as in the treatment of Huntington’s disease in the HORIZON trial.

http://www.medscape.com/viewarticle/757098

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Medivation and partner Pfizer will cease development of Dimebon (latrepirdine), a now thoroughly defunct antihistamine, “for all indications and will terminate the ongoing open label extension study in Alzheimer’s disease.” The small biopharm company announced the official end of Dimebon development yesterday in a press release, and the story was picked up by the WSJ. Dimebon’s demise is based on flat results in the companies’ CONCERT trial, a phase 3 study in which Dimebon was assessed as add-on treatment to symptomatic treatment donepezil (Aricept) in patients with mild-moderate AD.

Previous news on Dimebon (March 2010) was that it failed to improve cognition or global functioning in a placebo-controlled phase 3 study of patients with AD, and Medivation’s share price plummeted 30 points on the dated news. In 2008, Pfizer agreed to pay Medivation $225 million upfront and another $500 million when Dimebon was FDA approved. The agreement—which split development costs and potential profits on a 60-40 basis (Pfizer assumed the larger share)—also conferred licensing rights to Pfizer for use of the drug in Huntington’s disease. But Dimebon also disappointed in this devastating condition.

Pfizer was evidently betting on the chance that Dimebon would sail through US clinical development, given very favorable phase 2 results published in The Lancet in July of 2008.  In a randomized, double-blind, placebo-controlled, multicenter study (N = 183) that was conducted entirely within Russia and funded by Medivation, patients with mild-moderate AD who received Dimebon demonstrated significantly less cognitive decline at 6 months, as measured by the ADAS-cog (mean score difference, 4.0; P < .0001). Although some were scratching their heads as to why an antihistamine would have a disease-delaying or merely symptomatic effect in AD. The ultimate, tired lesson: promising phase 2 results are not a harbinger of anything, except chancy phase 3 study.

Medivation reminds us that it’s also developing an investigational drug (MDV3100) with Astellas for the treatment of advanced prostate cancer. The compound is in the phase 3 stage, and Medivation got a huge bump in its stock price in late October just before news of very favorable survival data was publicly released.

http://bmartinmd.com/2012/01/dimebon-development-for-ad-dead.html

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The last flickering hope that Medivation’s Dimebon could help Alzheimer’s disease patients has just been extinguished. The biotech announced this morning that a 12-month study of the drug failed to register significant improvements for patients, mirroring two shorter Phase III studies in which Dimebon failed to outperform a sugar pill. Pfizer ($PFE) took the opportunity to bow out of its partnership, writing off its $225 million upfront and $500 million milestone program for what proved to be another embarrassing pipeline failure.

In 2008, Dimebon looked like an odds-on success, with positive data from a Russian study and 10 years of sales experience to underscore its safety. But Medivation ($MDVN) was shaken to the core when its first late-stage study ended in failure, with an additional pratfall for Huntington’s disease to cap the disaster.

In the end, Dimebon’s failure helped tarnish the reputation of Russian drug studies while raising severe doubts about Medivation. But the company and CEO David Hung managed to turn attention to MDV3100 for prostate cancer, with positive data reigniting hope in the biotech’s future and reviving its battered share price. Pfizer, meanwhile, says it won’t give up on Alzheimer’s, which is one of the most difficult fields in drug development.

“We recognize Alzheimer’s is a very complex disease,” said Pfizer’s Dr. Steven J. Romano. “Despite this disappointing result, Pfizer remains committed to advancing the science of Alzheimer’s disease, with the ultimate goal of delivering innovative and meaningful new treatment options to patients.”

Shares of Medivation declined slightly this morning, indicating the market’s near-zero expectations for Dimebon.

President Obama introduced his initiative to speed up the pace of research into viable treatments for Alzheimer’s disease by pledging a total of $156 million in funding over the next two years. The bulk of the money, $130 million, will go to research for drugs to prevent and treat the disease, while another $26 million will be earmarked for caregiver support and public education about the disorder.

Part of the National Alzheimer’s Project Act passed in January of last year, the initiative notes the heavy toll that the disease is taking on an aging U.S. population — over 5 million Americans are estimated to have the disease, and experts fear that number could triple by 2050. Medical costs associated with Alzheimer’s patients’ care looms large, with experts calculating these at about $183 billion last year; totals could reach $1 trillion by 2050.

Since Obama envisions this project as a public-private partnership, some lucky pharmaceutical companies stand to benefit from this new initiative. Reasonably, companies with Alzheimer’s drugs already in the pipeline or ready for testing stand to reap the greatest rewards. The only problem is that it’s a been-there, done-that scenario with Alzheimer’s drug research, with much effort and money producing only a handful of mediocre treatments. Unfortunately, spectacular fails seem to be the norm in this arena.

Many misses, no real hits
Time and again, promising research turned into a collection of almost-useless data as drugs that incited hope in the battle against Alzheimer’s stumbled in clinical trials. Two of the most disappointing were Eli Lilly‘s (NYSE: LLY  ) drug semagacestat, which made it through Phase III clinical trials only to find that it actually worsened the condition; and Dimebon, a Pfizer (NYSE: PFE  ) and Medivation (Nasdaq: MDVN  ) joint venture that eventually was proved ineffective during Phase III. Many lesser drugs have seen their research quietly discontinued, as a list on the Alzheimer’s Research Forum clearly shows.

Alas, the four therapies currently on the market do little to control or postpone the disease for long. Three of the drugs, galantamine, rivastigmine, and donepezil are cholinesterase inhibitors, which help accentuate the effectiveness of waning amounts of acetylcholine in Alzheimer’s patients’ brains. Memantine is a glutamate regulator, since excessive amounts of this chemical can cause brain-cell death.

Meantime, two drugs currently under construction could be on the market by next year, if clinical trials currently finishing up produce the desired results. The drugs, solanezumab, a product of Eli Lilly, and bapineuzumab, made by Pfizer in partnership with Johnson &  Johnson and Elan (NYSE: ELN  ) , show much promise and could conceivably be in use by early 2013 by making use of the accelerated approval process promised by Obama’s Alzheimer’s initiative. Experts feel that the latter drug has the most promise, but either or both could garner their manufacturers a very lucrative payout once they clear all regulatory hurdles. Another drug, Gammagard, is currently in Phase III trials set to end next year. If all goes well, Baxter International (NYSE: BAX  ) , the drug’s maker, could see market share by 2015.

This Fool’s Take
Although any successful Alzheimer’s treatment will raise its parent company’s fortunes, the biggest winners here would be Eli Lilly, who owns solanezumab in its entirely, then Pfizer, who owns half of bapineuzumab. Coming in third would be Johnson & Johnson and Elan, each of whom have a one-quarter stake in bapineuzumab, but Elan is a much smaller company so that 25% stake could actually move the biotech’s shares the most. None of these drugs promise to cure Alzheimer’s, but the hope is that they will be capable of postponing symptoms of moderately-affected individuals for longer than current treatments. But that’s a whole lot of patients that could conceivably be helped by these treatments. If all goes well, these companies may well have the next group of blockbuster drugs on their hands.

http://www.fool.com/investing/high-growth/2012/02/29/obama-accelerates-race-for-alzheimers-cure.aspx

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Ending Dimebon Development: Pfizer and Medivation are ceasing development of Dimebon, an experimental Alzheimer’s treatment, the WSJ reports. It was the second phase 3 trial of the drug to fail. In 2008 Pfizer agreed to pay Medivation $225 million upfront plus up to an additional $500 million if milestones were met for development rights to Dimebon, the paper says.

http://blogs.wsj.com/health/2012/01/18/a-m-vitals-pfizer-medivation-end-dimebon-development/

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Focused on the bottom line

Ian Read
CEO
Pfizer

New Pfizer ($PFE) CEO Ian Read took the top spot in late 2010 with a mandate to make the sluggish drug giant more nimble, if it ever was.

Medivation, Inc. (NASDAQ: MDVN) and Pfizer Inc. (NYSE: PFE) today announced results from the CONCERT trial, which is a Phase 3 trial that evaluated dimebon (latrepirdine) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer’s disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL), which measures self care and daily function.

“We are disappointed in the CONCERT results and the implications for Alzheimer’s disease patients and their caregivers,” said David Hung, M.D., president and CEO of Medivation. “I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial.”

Dimebon was generally well tolerated in the study. A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.

Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer’s disease. The companies also announce that they will terminate their collaboration to co-develop and market dimebon pursuant to the terms of their Collaboration Agreement.

“We recognize Alzheimer’s is a very complex disease,” said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. “Despite this disappointing result, Pfizer remains committed to advancing the science of Alzheimer’s disease, with the ultimate goal of delivering innovative and meaningful new treatment options to patients.”

The Phase 3 CONCERT trial was a 12-month global randomized, double-blind, placebo-controlled trial that enrolled 1,003 patients with Alzheimer’s disease. Patients on a stable dose of donepezil for at least four months were randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo.

About Medivation

Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partner Astellas, Medivation currently has its investigational drug MDV3100 in Phase 3 development to treat advanced prostate cancer.

http://www.vadvert.co.uk/health/20918-medivation-and-pfizer-announce-results-from-phase-3-concert-trial-of-dimebon-in-alzheimers-disease.html

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Pfizer and Medivation ended their collaboration on the experimental drug Dimebon for Alzheimer’s disease after the medicine failed in another late-stage clinical trial.

Dimebon was one of two drugs Pfizer had in its late-stage pipeline to treat the neurodegenerative disease. The other is bapineuzumab, which Pfizer is developing with Johnson & Johnson. The treatments have different mechanisms of action.

Dimebon didn’t show statistically significant results in a study that evaluated the compound when added to a standard treatment in patients with mild to moderate forms of the disease, the companies said Tuesday. The companies will end development of the drug for all uses, and will stop a current study.

San Francisco’s Medivation dropped 3.3 percent to $53.90 at the close in New York. Pfizer, the world’s biggest drugmaker, gained less than 1 percent to $21.94.

Dimebon also failed in a late-stage trial in 2010, sending Medivation shares down 67 percent in one day.

The federal Centers for Disease Control and Prevention in Atlanta estimates that at least 5 million Americans have Alzheimer’s. The disease usually begins affecting people around age 60. There is no known cure.

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