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	<title>Dimebon Dimebolin Information Availability &#187; Aricept</title>
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		<title>Potential Alzheimer&#8217;s Drug Dimebon Fails in Clinical Trials</title>
		<link>http://dimebonalzheimers.com/1202/potential-alzheimers-dimebon-fails/</link>
		<comments>http://dimebonalzheimers.com/1202/potential-alzheimers-dimebon-fails/#comments</comments>
		<pubDate>Sat, 14 Apr 2012 08:06:40 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Alzheimer Disease]]></category>
		<category><![CDATA[Alzheimer S Disease]]></category>
		<category><![CDATA[Alzheimers]]></category>
		<category><![CDATA[Antihistamine]]></category>
		<category><![CDATA[Aricept]]></category>
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		<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[Decades]]></category>
		<category><![CDATA[Dementias]]></category>
		<category><![CDATA[Dimebon]]></category>
		<category><![CDATA[Discontinuation]]></category>
		<category><![CDATA[Draft Document]]></category>
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		<category><![CDATA[Information Availability]]></category>
		<category><![CDATA[Medication]]></category>
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		<guid isPermaLink="false">http://dimebonalzheimers.com/?p=1202</guid>
		<description><![CDATA[<br /><br />Dimebon, a drug that has been in phase three of clinical trials for treatment of Alzheimer&#8217;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&#8217;s in [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>Dimebon, a drug that has been in phase three of <a title="clinical trials" href="http://dimebonalzheimers.com/tag/clinical-trials/">clinical trials</a> for treatment of <a title="Alzheimer" href="">Alzheimer</a>&#8217;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&#8217;s in the United States. Dimebon was never sold or marketed in the United States.</p>
<p>Initially, the drug showed some positive results in patients with Alzheimer&#8217;s, so clinical trials were expanded to study its effects when given with the drug denepazil (<a title="Aricept" href="http://dimebonalzheimers.com/201/aricept/">Aricept</a>), a medication currently used to treat early Alzheimer&#8217;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.</p>
<p>This is disappointing news, especially in light of ournation&#8217;s recent draft document on Alzheimer&#8217;s disease and other related dementias. One goal outlined in this draft is to effectively treat and prevent Alzheimer&#8217;s by 2025. Evidently, the manner in which we do this won&#8217;t include Dimebon.</p>
<p>http://alzheimers.about.com/b/2012/01/22/potential-alzheimers-drug-dimebon-fails-in-clinical-trials.htm</p>
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<p style="text-align: right;"><a href="http://dimebonalzheimers.com/">Dimebon Dimebolin Information Availability</a></p>
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		<title>Dimebon Development for Alzheimer&#8217;s Officially Dead</title>
		<link>http://dimebonalzheimers.com/1168/dimebon-development-alzheimers/</link>
		<comments>http://dimebonalzheimers.com/1168/dimebon-development-alzheimers/#comments</comments>
		<pubDate>Sat, 17 Mar 2012 14:44:32 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Adas]]></category>
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		<category><![CDATA[Antihistamine]]></category>
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		<category><![CDATA[Biopharm]]></category>
		<category><![CDATA[Cognitive Decline]]></category>
		<category><![CDATA[Dimebon]]></category>
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		<category><![CDATA[Huntington S Disease]]></category>
		<category><![CDATA[Lancet]]></category>
		<category><![CDATA[Medivation]]></category>
		<category><![CDATA[Pfizer]]></category>
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		<guid isPermaLink="false">http://dimebonalzheimers.com/?p=1168</guid>
		<description><![CDATA[<br /><br />Medivation and partner Pfizer will cease development of Dimebon (latrepirdine), a now thoroughly defunct antihistamine, &#8220;for all indications and will terminate the ongoing open label extension study in Alzheimer&#8217;s disease.&#8221; 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. [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>Medivation and partner Pfizer will cease development of Dimebon (<a title="latrepirdine" href="http://dimebonalzheimers.com/1104/latrepirdine/">latrepirdine</a>), a <em>now thoroughly</em> defunct antihistamine, &#8220;for all indications and will terminate the ongoing open label extension study in <a title="Alzheimer" href="">Alzheimer</a>&#8217;s disease.&#8221; The small biopharm company announced the official end of Dimebon development yesterday in a press release, and the story was picked up by the <em>WSJ</em>. Dimebon&#8217;s demise is based on flat results in the companies&#8217; CONCERT trial, a phase 3 study in which Dimebon was assessed as add-on treatment to symptomatic treatment <a title="donepezil" href="http://dimebonalzheimers.com/199/donepezil/">donepezil</a> (Aricept) in patients with mild-moderate AD.</p>
<p>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&#8217;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&#8217;s disease. But Dimebon also disappointed in this devastating condition.</p>
<p>Pfizer was evidently betting on the chance that Dimebon would sail through US clinical development, given very favorable phase 2 results published in <em>The Lancet</em> 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; <em>P</em> &lt; .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.</p>
<p>Medivation reminds us that it&#8217;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.</p>
<p>http://bmartinmd.com/2012/01/dimebon-development-for-ad-dead.html</p>
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		<title>Pfizer, Medivation end development of potential Alzheimer’s treatment Dimebon</title>
		<link>http://dimebonalzheimers.com/1113/pfizer-medivation-development-2/</link>
		<comments>http://dimebonalzheimers.com/1113/pfizer-medivation-development-2/#comments</comments>
		<pubDate>Sat, 21 Jan 2012 12:26:49 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Alzheimer Disease]]></category>
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		<category><![CDATA[Stage Trial]]></category>

		<guid isPermaLink="false">http://dimebonalzheimers.com/?p=1113</guid>
		<description><![CDATA[<br /><br />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 [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><div>
<article>TRENTON, N.J. — In a major setback for patients and doctors, drugmakers Pfizer Inc. and Medivation Inc. have halted development of a potential <a title="Alzheimer" href="">Alzheimer</a>’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.</p>
<p>Pfizer, the world’s largest drugmaker by revenue, and Medivation said on Tuesday 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 <a title="donepezil" href="http://dimebonalzheimers.com/199/donepezil/">donepezil</a>, or Aricept.</p>
</article>
<p>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.</p>
<p>Dimebon, known chemically as <a title="latrepirdine" href="http://dimebonalzheimers.com/1104/latrepirdine/">latrepirdine</a>, 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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>Pfizer still has one Alzheimer’s treatment in late-stage testing, bapineuzamab, which it is jointly developing with Johnson &amp; Johnson. It’s a biologic drug, grown in living cells rather than made by mixing chemicals, and works differently than Dimebon.</p>
<p>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.</p>
<p>The newest drug for Alzheimer’s symptoms, Namenda, was approved back in 2003.</p>
<p>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.</p>
<p>In trading Tuesday, Pfizer shares rose 9 cents to $21.93, while Medivation stock dropped $1.82, or 3.3 percent, to $53.90.</p>
<p>http://www.washingtonpost.com/business/industries/pfizer-medivation-end-development-of-potential-alzheimers-treatment-dimebon/2012/01/17/gIQA91uF5P_story.html</p>
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		<title>Clinical Trial Results Could Promote the Use of Dimebon Throughout the Course of Alzheimer&#8217;s Disease, According to New Findings from Decision Resources</title>
		<link>http://dimebonalzheimers.com/1066/clinical-trial-results-promote/</link>
		<comments>http://dimebonalzheimers.com/1066/clinical-trial-results-promote/#comments</comments>
		<pubDate>Tue, 06 Dec 2011 06:28:08 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<guid isPermaLink="false">http://dimebonalzheimers.com/?p=1066</guid>
		<description><![CDATA[<br /><br />&#160; Decision Resources, one of the world&#8217;s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, if Pfizer/Medivation&#8217;s Dimebon shows efficacy in two ongoing clinical trials in moderate to severe Alzheimer&#8217;s disease that is equivalent to the impressive clinical trial data it has already shown to date in mild to moderate patients, [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>&nbsp;</p>
<p>Decision Resources, one of the world&#8217;s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, if Pfizer/Medivation&#8217;s Dimebon shows efficacy in two ongoing clinical trials in moderate to severe <a title="Alzheimer" href="">Alzheimer</a>&#8217;s disease that is equivalent to the impressive clinical trial data it has already shown to date in mild to moderate patients, these positive data would promote the use of Dimebon throughout the course of the disease. As a result, following its expected launch in 2012, Dimebon will garner peak year sales of $1.5 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.</p>
<p>The Phase III CONTACT clinical trial for patients with moderate-to-severe Alzheimer&#8217;s disease will investigate the effect of Dimebon on neuropsychiatric symptoms and activities of daily living in patients who are already receiving a stable dose of <a title="donepezil" href="http://dimebonalzheimers.com/199/donepezil/">donepezil</a> (Eisai/Pfizer&#8217;s <a title="Aricept" href="http://dimebonalzheimers.com/201/aricept/">Aricept</a>, Bracco&#8217;s Memac). The Phase III CONSTELLATION clinical trial will investigate slightly different end points: the effect of Dimebon on cognition, memory and activities of daily living in patients already receiving a stable dose of memantine (Merz/Grupo Grunenthal&#8217;s Axura/Akatinol, Lundbeck&#8217;s Ebixa, Forest Laboratories&#8217; Namenda).</p>
<p>The Pharmacor finding from the topic entitled <em>Alzheimer&#8217;s Disease</em> also reveals that, through 2018, robust 11 percent annual growth in the Alzheimer&#8217;s disease drug market will be driven by the launch and uptake of new anti-amyloid monoclonal antibodies, most notably Johnson &amp; Johnson/Pfizer&#8217;s bapineuzumab and Eli Lilly&#8217;s solanezumab.</p>
<p>&#8220;Although monoclonal antibodies are expected to offer superior efficacy over other drugs in the market, their uptake will be initially slow following their launches, owing to potential safety concerns,&#8221; said Decision Resources Analyst Matthew Winton, Ph.D. &#8220;Nevertheless, bapineuzumab and solanezumab will achieve combined sales of nearly $6 billion in 2018.&#8221;</p>
<p><strong>About Pharmacor</strong></p>
<p>The newly redesigned Pharmacor advisory service offers clients in the biopharmaceutical industry the most up-to-date information available on commercially significant disease topics.</p>
<p><strong>About Decision Resources</strong></p>
<p>Decision Resources ( www.decisionresources.com ) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.</p>
<p><strong>About Decision Resources, Inc.</strong></p>
<p>Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions.</p>
<p><em>All company, brand, or product names contained in this document may be trademarks or</em></p>
<p><em>registered trademarks of their respective holders.</em></p>
<p>http://www.prnewswire.com/news-releases/for-the-treatment-of-alzheimers-disease-pfizermedivations-dimebon-will-garner-peak-year-sales-of-15-billion-81128002.html</p>
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		<title>Pfizer throwing money to buy 700 million experimental drug Dimebon-Pfizer, drug, Dimebon-pharmaceutical industries</title>
		<link>http://dimebonalzheimers.com/1007/pfizer-throwing-money-million/</link>
		<comments>http://dimebonalzheimers.com/1007/pfizer-throwing-money-million/#comments</comments>
		<pubDate>Thu, 20 Oct 2011 09:04:26 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<description><![CDATA[<br /><br />Recently, Pfizer agreed to pay San Francisco-based Medivation Inc. up to 725 million U.S. dollars of funds to be used to treat other developed experimental Alzheimer’s drug Dimebon. This is the world’s largest pharmaceutical companies in deals this year, the ninth operation. Under the agreement, Medivation will receive Pfizer USD 225 million down payment, as [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>Recently, Pfizer agreed to pay San Francisco-based Medivation Inc. up to 725 million U.S. dollars of funds to be used to treat other developed experimental <a title="Alzheimer" href="">Alzheimer</a>’s drug Dimebon. This is the world’s largest <a title="pharmaceutical companies" href="http://dimebonalzheimers.com/tag/pharmaceutical-companies/">pharmaceutical companies</a> in deals this year, the ninth operation. Under the agreement, Medivation will receive Pfizer USD 225 million down payment, as well as drug listing process, linked to up to 5 million milestone payment.</p>
<p>Hot Present, pharmaceutical companies are racing to develop for the treatment of Alzheimer’s disease drug. Analysts believe that 2012, the size of this market could grow to 20 billion U.S. dollars. Although Pfizer has been on sale for Alzheimer’s disease therapy <a title="Aricept" href="http://dimebonalzheimers.com/201/aricept/">Aricept</a>, but in 2010, the drug will face competition from generic drug companies, while the other is developing Alzheimer’s Treatment drugs have not yet entered the final testing stage. Therefore, the transaction may help Pfizer in the treatment of Alzheimer’s disease to achieve a quantum leap in the field, and with the development of such drugs, Lilly, Wyeth and Elan Corporation to compete.</p>
<p>Pfizer has the world’s best-selling drug Lipitor last year, this reduction Cholesterol Drug sales 12.7 billion. However, Lipitor will lose patent protection in 2011 and faces generic competition this end, the hands hold 29,000,000,000 US dollars cash, Pfizer is searching for new drugs to cover sales of Lipitor left empty .</p>
<p>Analyst at Miller Tabak in New York LesFuntleyder that, although Alzheimer’s disease is a difficult to treat disease, but Pfizer, this deal appears to be a positive risk-return opportunities, if Pfizer wants to make up for the next few years will experience significant economic losses, it needs to continue aggressive.</p>
<p>Two companies will share development and marketing in the United States, of which 60% of the cost of Pfizer’s commitment to share in the United States to achieve 60% profit. Pfizer will be responsible for sales outside the United States Dimebon, Medivation Inc. to pay the sales commission. In order to be allowed in the U.S. market, Medivation and Pfizer Inc. are jointly carrying out the work of the last test in order to make good to the U.S. regulatory approval for preparation.</p>
<p>High hopes Medivation Inc. was founded in 2003, currently has 40 employees. In the second quarter, Medivation losses amounted to 18.5 million U.S. dollars, compared with last year’s 7.2 million U.S. dollars increased substantially. Medivation’s Dimebon is the main product. 80s of last century, it first as an antihistamine in Russia. To the 90?s, the Russian chemist SergeyBachurin in a variety of laboratory animal tests showed that the drug has the potential to improve the animal’s cognitive abilities. But in the United States, almost no attention to these findings, until the bio-technology entrepreneurs DavidHung discovered in 2003, these studies, the situation began to change. DavidHung visit to Russia in the field heard the results, he decided to set Medivation Inc., began commercial operation of the drug.</p>
<p>Pennsylvania RaymondMyers Emerging Growth Equities analyst, said Pfizer is a great Cooperation Partners, it has tremendous marketing tentacles, especially in the areas of primary health care; Pfizer With Aricept Alzheimer’s disease treatment in a leading position in the field.</p>
<p>According to the British medical journal “Lancet” published in July a study, Dimebon may help Alzheimer’s patients remember the date, understand medication instructions, follow commands, memorize some words and perform simple activities.</p>
<p>http://focusincholesterol.com/pfizer-throwing-money-to-buy-700-million-experimental-drug-dimebon-pfizer-drug-dimebon-pharmaceutical-industries</p>
<p>&nbsp;</p>
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		<title>Pfizer/Medivation Dimebon fails as Huntington disease drug</title>
		<link>http://dimebonalzheimers.com/925/pfizermedivation-dimebon-fails/</link>
		<comments>http://dimebonalzheimers.com/925/pfizermedivation-dimebon-fails/#comments</comments>
		<pubDate>Tue, 02 Aug 2011 14:38:32 +0000</pubDate>
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		<guid isPermaLink="false">http://www.dimebonalzheimers.com/?p=925</guid>
		<description><![CDATA[<br /><br />Pfizer and Medivation&#8217;s Dimebon, which failed as a potential treatment for Alzheimer&#8217;s last year, has now disappointed in a late-stage trial for Huntington disease. The companies have presented results from the 403-patient Phase III HORIZON study of Dimebon (latrepirdine) which show that the drug did not achieve statistical significance for either of the co-primary endpoints [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>Pfizer and Medivation&#8217;s Dimebon, which failed as a potential treatment for <a title="Alzheimer" href="">Alzheimer</a>&#8217;s last year, has now disappointed in a late-stage trial for Huntington disease.</p>
<p>The companies have presented results from the 403-patient Phase III HORIZON study of Dimebon (<a title="latrepirdine" href="http://dimebonalzheimers.com/1104/latrepirdine/">latrepirdine</a>) which show that the drug did not achieve statistical significance for either of the co-primary endpoints of the trial. Full results are expected to be presented at an upcoming medical meeting.</p>
<p>David Hung, Medivation&#8217;s chief executive, said &#8220;we are disappointed with the results of the HORIZON trial given the high unmet need in this patient population&#8221;. He added that &#8220;at this point, we will discontinue development of Dimebon in Huntington disease, including the ongoing open-label extension study&#8221;.</p>
<p>However this may not be the end of the road for Dimebon, which was first sold in Russia as an antihistamine. Dr Hung noted that the firms will continue a 12-month Phase III trial looking at the benefit of adding Dimebon to Eisai/Pfizer&#8217;s Aricept (<a title="donepezil" href="http://dimebonalzheimers.com/199/donepezil/">donepezil</a>) in patients with mild-to-moderate Alzheimer&#8217;s disease. Top-line data from that study is expected in the first half of 2012.</p>
<p>Last March, Dimebon failed in an Alzheimer&#8217;s trial where no statistically significant improvements were achieved on cognition, global function, activities of daily living or behaviour.</p>
<p>Pfizer linked up with Medivation in September 2008 in a deal which saw the latter pocket an upfront cash fee of $225 million with milestone payments of up to $500 million, depending on the success of Dimebon.</p>
<p>http://www.pharmatimes.com/article/11-04-12/Pfizer_Medivation_Dimebon_fails_as_Huntington_disease_drug.aspx</p>
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		<title>Hungry for Breakfast? Dimebon is TOAST</title>
		<link>http://dimebonalzheimers.com/922/hungry-breakfast-dimebon-toast/</link>
		<comments>http://dimebonalzheimers.com/922/hungry-breakfast-dimebon-toast/#comments</comments>
		<pubDate>Fri, 29 Jul 2011 14:32:05 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<guid isPermaLink="false">http://www.dimebonalzheimers.com/?p=922</guid>
		<description><![CDATA[<br /><br />Okay, maybe not quite yet breakfast food for Alzheimer’s disease when added to Aricept (donepezil). But here’s my prediction: CONCERT will publish 1Q2012 and then we should officially be ready to butter dimebon (latrepirdine; Pfizer / Medivation) once and for all. As for today’s news, results from the Phase 3 HORIZON trial: Dimebon (latrepirdine) in [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>Okay, maybe not quite yet breakfast food for <a title="Alzheimer" href="">Alzheimer</a>’s disease when added to Aricept (<a title="donepezil" href="http://dimebonalzheimers.com/199/donepezil/">donepezil</a>). But here’s my prediction: CONCERT will publish 1Q2012 and then we should officially be ready to butter dimebon (<a title="latrepirdine" href="http://dimebonalzheimers.com/1104/latrepirdine/">latrepirdine</a>; Pfizer / Medivation) once and for all.</p>
<p>As for today’s news, results from the Phase 3 HORIZON trial: Dimebon (latrepirdine) in patients with Huntington disease, did not achieve statistical significance for either of the co-primary endpoints, the Mini-Mental State Examination (MMSE), which measures cognition (p=0.39), or the Clinician’s Interview-Based Impression of Change, plus caregiver input (CIBIC-plus), which measures global function (p=0.84). “We are disappointed with the results of the HORIZON trial given the high unmet need in this patient population. At this point, we will discontinue development of dimebon in Huntington disease, including the ongoing open-label extension study,” said David Hung, M.D., president and chief executive officer of Medivation. “We will continue our ongoing 12-month Phase 3 CONCERT trial of dimebon and its open-label extension in patients with mild-to-moderate Alzheimer’s disease. We expect to report top-line data from CONCERT in the first half of 2012.”</p>
<p>We believe that when CONCERT (donepezil +/- dimebolin) publishes it will be a negative study. As far as an approvable therapeutic for Alzheimer’s disease we think Dimebon is toast. The basis for this is the changing view of BOLT’s Alzheimer’s Disease Thought Leader panel from 2009 to 2010. In 2009, there was some level of interest in dimebon for AD, as the Russian data had just been published. But by 2010, as our panelists who were involved with the drug once it hit Western clinical sites, had an opportunity to look more closely, their enthusiasm waned. That’s not a good predictive marker! (and that was a pretty poorly constructed sentence. With writing skills like this I should probably stop blogging and get a day job with the Associated Press). Anyway… here are some of the comments from BOLT’s Alzheimer’s Disease Thought Leader panel:</p>
<p>“I have to say I would have put Dimebon on that list. Dimebon might be a good adjunct to donepezil and memantine yet, but I think Dimebon’s day has come and gone. From all the signals I am seeing I don’t know that it has a long-term survival. I am going to take Dimebon off my list”.</p>
<p>“We had Dimebon. I would have mentioned Dimebon but I am not mentioning Dimebon now because it seems to have not done well in the most recent study. Now it seems like they have just continued some of their studies. That has dropped way down now on the list”.</p>
<p>“Dimebon is an interesting story. It was a molecule looking for a mechanism of action, not the other way around and even the company back away from the acetyl cholinesterase inhibition and the NMD antagonists and said we have exciting mechanism of action but we are not sure what it is. They really are moving toward their mitochondrial activity, which would be really terrific if it occurred. I asked them point blank why aren’t you going after mitochondrial myopathies because Dimebon could be a good treatment for mitochondrial myopathies and it is simply business. They said, look, there is a very low market in mitochondrial myopathies and there is a huge market in Alzheimer’s. It still might work in Huntington’s but I am, again, a little cautious about Huntington’s. If the CONCERT study is negative then the drug is dead. Period. And that will publish when? I think they could announce CONCERT data by the summer. The study is done in terms of enrollment. CONCERT was a donepezil adjunct. A lot of people worry on the basis that the CONCERT and CONNECTION is that their treatment periods are short, only six months. I think we are banking on the Russian data to show them a signal. But I think the issue with CONNECTION was that the placebo group did not decline. That is why it was negative. It is more inconclusive than it is negative. That is not going to get Pfizer an indication. I agree”.</p>
<p>Dimebon is viewed as an important addition for patients whose disease has progressed beyond the point of reversibility, who need stabilization or a boost to their functional status. There is more uncertainty that the drug has a clinical effect related to its ability to stabilize mitochondria or affect NMDA.</p>
<p>“The Dimebon I found intriguing. That kind of falls into the same thing as analogous sirtuin-1. I don’t know how it is acting. That really intrigues me and easily could be important. So that seems useful. Why does it matter how it is working if it is working? It doesn’t. It just matters whether you believe it. Phase II trials sometimes even in the phase II sometimes look good and then fail, right. Right. Sure. So people would be just intellectually a little more confident if they knew how it was working but I totally agree with you. I don’t think it matters. Antidepressants, they didn’t know how they acted or antipsychotics for the longest time they didn’t know how they acted but they still were used. So I agree with you it doesn’t matter. And it is very intriguing and the mechanism appeals to me. I had even published something that is a mitochondrial protectant that also looks good so I like that approach. It is just a little bit different. So Dimebon is one that almost made it onto the list. I was debating, but without a mechanism, I just thought that might fail. But I certainly would really believe that it could be very useful”.</p>
<p>“So the landscape is always changing and in a very exciting kind of way. I will say to you right now that the drug that is at the top of the list of the fancy formulary despite the fact that I don’t think it is going to be as robust in the US data as in the Russian data I think the drug that is likely to emerge at the top of the list is Dimebon, strictly as a symptomatic drug. You can parse out all the mitochondrial data and NMDA data you like but at the end of the day I think it will be similar to a cholinesterase inhibitor in terms of its scope and magnitude of effect and will be part of the landscape sooner than later”.</p>
<p>“I think we can do better than what we are doing now. I am not sure whether that is going to be a 5HT drug or some unknown symptomatic mechanism, a Dimebon-like drug. I think we are going to do better than we are doing now. I think Dimebon is likely to succeed. I would probably put that in this category. I hope it is disease-modifying as well but I am certain it is symptomatic and looks better than what we have got. So I just put that on the list because I think we can do better for symptomatic treatments as well”.</p>
<p>“I don’t have anything against Dimebon. It is very attractive but without knowing its mechanism of action or without seeing more in the way of long-term clinical outcomes, it is hard for me to think that this is more than another symptomatic therapy. If it turns to that it is complimentary then that would be attractive. I think without some reason to think that it was really a disease-modifying therapy it would be hard to get too enthusiastic about just adding yet another symptomatic therapy to cholinesterase inhibitors and to Namenda. So that is why it didn’t make my list. Now I understand the evidence refutes the possibilities that this is a cholinesterase inhibitors or an NMDA antagonist. So I am comfortable it is not just another version of the existing therapies. But I don’t think there are any great evidences to what the actual mechanism of action is”.</p>
<p>“Then I would still like to have a symptomatic treatment. Is there anything that I would pick better than a cholinesterase inhibitor? I’m not sure if Dimebon really works? So the next one would be from the group of cholinesterase inhibitor or Dimebon or Memantine kinds of symptomatic treatment because I would not want to be limited to a formulary that didn’t have that safety net for the people that came to you late”.</p>
<p>http://www.boltinternational.com/2011/04/hungry-for-breakfast-dimebon-is-toast/</p>
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		<title>Pfizer throwing money to buy 700 million experimental drug Dimebon-Pfizer, drug, Dimebon-pharmaceutical industries</title>
		<link>http://dimebonalzheimers.com/902/pfizer-throwing-money-buy-700/</link>
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		<pubDate>Tue, 19 Jul 2011 13:32:33 +0000</pubDate>
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		<description><![CDATA[<br /><br />Recently, Pfizer agreed to pay San Francisco-based Medivation Inc. up to 725 million U.S. dollars of funds to be used to treat other developed experimental Alzheimer’s drug Dimebon. This is the world’s largest pharmaceutical companies in deals this year, the ninth operation. Under the agreement, Medivation will receive Pfizer USD 225 million down payment, as [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>Recently, Pfizer agreed to pay San Francisco-based Medivation Inc. up to 725 million U.S. dollars of funds to be used to treat other developed experimental <a title="Alzheimer" href="">Alzheimer</a>’s drug Dimebon. This is the world’s largest <a title="pharmaceutical companies" href="http://dimebonalzheimers.com/tag/pharmaceutical-companies/">pharmaceutical companies</a> in deals this year, the ninth operation. Under the agreement, Medivation will receive Pfizer USD 225 million down payment, as well as drug listing process, linked to up to 5 million milestone payment.</p>
<p>Hot Present, pharmaceutical companies are racing to develop for the treatment of Alzheimer’s disease drug. Analysts believe that 2012, the size of this market could grow to 20 billion U.S. dollars. Although Pfizer has been on sale for Alzheimer’s disease therapy <a title="Aricept" href="http://dimebonalzheimers.com/201/aricept/">Aricept</a>, but in 2010, the drug will face competition from generic drug companies, while the other is developing Alzheimer’s Treatment drugs have not yet entered the final testing stage. Therefore, the transaction may help Pfizer in the treatment of Alzheimer’s disease to achieve a quantum leap in the field, and with the development of such drugs, Lilly, Wyeth and Elan Corporation to compete.</p>
<p>Pfizer has the world’s best-selling drug Lipitor last year, this reduction Cholesterol Drug sales 12.7 billion. However, Lipitor will lose patent protection in 2011 and faces generic competition this end, the hands hold 29,000,000,000 US dollars cash, Pfizer is searching for new drugs to cover sales of Lipitor left empty .</p>
<p>Analyst at Miller Tabak in New York LesFuntleyder that, although Alzheimer’s disease is a difficult to treat disease, but Pfizer, this deal appears to be a positive risk-return opportunities, if Pfizer wants to make up for the next few years will experience significant economic losses, it needs to continue aggressive.</p>
<p>Two companies will share development and marketing in the United States, of which 60% of the cost of Pfizer’s commitment to share in the United States to achieve 60% profit. Pfizer will be responsible for sales outside the United States Dimebon, Medivation Inc. to pay the sales commission. In order to be allowed in the U.S. market, Medivation and Pfizer Inc. are jointly carrying out the work of the last test in order to make good to the U.S. regulatory approval for preparation.</p>
<p>High hopes Medivation Inc. was founded in 2003, currently has 40 employees. In the second quarter, Medivation losses amounted to 18.5 million U.S. dollars, compared with last year’s 7.2 million U.S. dollars increased substantially. Medivation’s Dimebon is the main product. 80s of last century, it first as an antihistamine in Russia. To the 90?s, the Russian chemist SergeyBachurin in a variety of laboratory animal tests showed that the drug has the potential to improve the animal’s cognitive abilities. But in the United States, almost no attention to these findings, until the bio-technology entrepreneurs DavidHung discovered in 2003, these studies, the situation began to change. DavidHung visit to Russia in the field heard the results, he decided to set Medivation Inc., began commercial operation of the drug.</p>
<p>Pennsylvania RaymondMyers Emerging Growth Equities analyst, said Pfizer is a great Cooperation Partners, it has tremendous marketing tentacles, especially in the areas of primary health care; Pfizer With Aricept Alzheimer’s disease treatment in a leading position in the field.</p>
<p>According to the British medical journal “Lancet” published in July a study, Dimebon may help Alzheimer’s patients remember the date, understand medication instructions, follow commands, memorize some words and perform simple activities.</p>
<p>http://focusincholesterol.com/pfizer-throwing-money-to-buy-700-million-experimental-drug-dimebon-pfizer-drug-dimebon-pharmaceutical-industries</p>
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		<title>Dimebon a No-Go for Huntington’s Disease</title>
		<link>http://dimebonalzheimers.com/875/dimebon-nogo-huntingtons-disease-2/</link>
		<comments>http://dimebonalzheimers.com/875/dimebon-nogo-huntingtons-disease-2/#comments</comments>
		<pubDate>Thu, 23 Jun 2011 13:03:39 +0000</pubDate>
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		<description><![CDATA[<br /><br />Dimebon, the old Russian cold medicine that held promise as a treatment for Alzheimer’s and potentially other brain diseases, is looking more and more like a dud. In a late-stage trial in 403 patients with Huntington’s disease, a genetic progressive brain disorder, the drug didn’t significantly improve cognition or global functioning, Pfizer and Medivation announced [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>Dimebon, the old Russian cold medicine that held promise as a  treatment for <a title="Alzheimer" href="">Alzheimer</a>’s and potentially other brain diseases, is  looking more and more like a dud.</p>
<p>In a late-stage trial in 403 patients with Huntington’s disease, a  genetic progressive brain disorder, the drug didn’t significantly  improve cognition or global functioning, Pfizer and Medivation announced today. The full results will be presented later this year at a scientific conference.</p>
<p>“Huntington’s is a challenging disease area, and we are also  disappointed with the HORIZON results,” Steve Romano, head of Pfizer’s  Medicines Development Group, said in a statement.</p>
<p>Last year, the companies announced negative results in phase III trials in the treatment of Alzheimer’s as well. But, a 12-month, late-stage trial of Dimebon called CONCERT will continue, the companies said. That trial examines the benefit of  adding Dimebon to <a title="donepezil" href="http://dimebonalzheimers.com/199/donepezil/">donepezil</a> (brand name: <a title="Aricept" href="http://dimebonalzheimers.com/201/aricept/">Aricept</a>), approved for mild,   moderate and severe Alzheimer’s.</p>
<p>Dimebon had been the focus of much industry excitement after a small  study on Alzheimer’s patients conducted in Russia had shown the drug had  some benefit, though many experts urged caution because of the many differences between the patient population in  Russia and those in many Western countries. In 2008, Pfizer shelled out  $225 million to Medivation to develop and co-market the drug.</p>
<p>The Huntington trial results are “disappointing but not unexpected,” P. Murali Doraiswamy, a professor at Duke University and an investigator on the CONCERT study, tells the Health Blog.</p>
<p>Doraiswamy, who also served in the past as an advisor to Pfizer and  Medivation, says he thinks the Huntington’s results don’t bode well for  the drug’s effectiveness in Alzheimer’s. “I  think this is bad news both  for the drug and their postulated mechanism  of action.” He said the  companies haven’t informed him of any changes to the trial with which he  is involved.</p>
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		<title>Alzheimer’s Panel Calls for Large-Scale Study to Find Disease Risk Targets</title>
		<link>http://dimebonalzheimers.com/857/alzheimers-panel-calls-largescale-study-find-disease-risk-targets/</link>
		<comments>http://dimebonalzheimers.com/857/alzheimers-panel-calls-largescale-study-find-disease-risk-targets/#comments</comments>
		<pubDate>Tue, 24 May 2011 00:49:01 +0000</pubDate>
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		<description><![CDATA[<br /><br />More extensive, and expensive, studies that follow large groups of people over generations are needed to combat Alzheimer’s, researchers said today in a report that cited the lack of progress in slowing the disease. There isn’t enough evidence to prove anything can be done to prevent or delay the malady, which is expected to grow [...]<br /><br /><br /><br />]]></description>
			<content:encoded><![CDATA[<p></p><p>More extensive, and expensive, studies that follow large groups of people over generations are needed to combat <a title="Alzheimer" href="">Alzheimer</a>’s, researchers said today in a report that cited the lack of progress in slowing the disease.</p>
<p>There isn’t enough evidence to prove anything can be done to prevent or delay the malady, which is expected to grow threefold and strike 16 million Americans by 2050, the researchers wrote today in the Archives of Neurology.</p>
<p>The report documented findings of a panel charged with compiling evidence on Alzheimer’s risk factors and preventive measures. Researchers cited the Framingham Heart Study, started in 1948 and spanning three generations, as the kind of trial needed to pinpoint who gets Alzheimer’s and why. The Framingham study identified elevated cholesterol and blood pressure, as well as cigarette smoking, as contributors to heart disease.</p>
<p>“Maybe we are going to prove that indeed there are associations, but for that we need more studies of good quality,” Martha Daviglus, one of the report’s authors and a professor of preventive medicine at Northwestern University, said in a telephone interview.</p>
<p>While <a title="Forest Laboratories Inc" href="http://dimebonalzheimers.com/tag/forest-laboratories-inc/">Forest Laboratories Inc</a>. (FRX)’s Namenda, and Pfizer Inc. (PFE) and Eisai Co.’s <a title="Aricept" href="http://dimebonalzheimers.com/201/aricept/">Aricept</a> address symptoms, there is no way to slow or cure a disease that affects about 5.4 million Americans, the report concluded.</p>
<p>The message of the report isn’t that nothing works to reduce Alzheimer’s risk, Daviglus said. Rather, it’s that we don’t yet know what will.</p>
<h2>Risk Factors</h2>
<p>“We need to start the studies earlier not only because of environmental and lifestyle factors,” Daviglus said. “We need to find what their baseline was, when the adults were healthy. It’s the only way to know what risk factors are associated with the disease.”</p>
<p>Such research is pricey, said Bill Thies, the chief medical and scientific officer for the Alzheimer’s Association, a Chicago-based advocacy group. The Framingham study cost about $120 million, he said. The Alzheimer’s Disease Neuroimaging Initiative, meant to define the progression of the disease through brain scans, blood tests and cerebral-spinal fluid will cost about $140 million, Thies said.</p>
<p>The current yearly federal budget for Alzheimer’s disease is “a little less than $500 million,” he said.</p>
<p>The report notes that some studies suggest physical activity reduces Alzheimer’s risk, as does a vegetable-rich diet, and controlling diabetes and blood pressure, Thies said.</p>
<p>“We know those are good things to do,” he said. “There’s no possibility that more physical activity does harm; there’s a net benefit and maybe it will also reduce the risk of Alzheimer’s disease.”</p>
<h2>Clinical Trials</h2>
<p>As of March 2011, there are six ongoing, late-stage clinical trials in Alzheimer’s disease, according to data from the Alzheimer’s Association. Those drugs include Baxter International Inc. (BAX)’s intravenous immunoglobulin; Pfizer and Johnson &amp; Johnson (JNJ)’s bapineuzumab; Eli Lilly &amp; Co. (LLY)’s solanezumab; Pfizer’s and Medivation Inc. (MDVN)’s Dimebon; a supplementary dose of resveratrol, the compound found in red wine; and a trail of Namenda in combination with vitamin E.</p>
<p>Also in today’s Archives of Neurology, researchers found that people who had a gene alteration associated with Alzheimer’s disease had fewer connections in certain parts of the brain. Those changes in brain structure suggest that alterations in connectivity may serve as an early biomarker for the disease.</p>
<p>A separate study found that two cerebrospinal fluid markers of Alzheimer’s disease did well at identifying people with Alzheimer’s pathology. However, the two tests identified different absolute values for the amount of Alzheimer’s-related proteins in the brain.</p>
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