US biotech firm Medivation (Nasdaq: MDVN) says that patient enrollment was completed at end November in the CONCERT study, a 12-month, Phase III clinical trial in patients with mild-to-moderate Alzheimer’s disease evaluating the potential efficacy of Dimebon (latrepirdine) when added to ongoing treatment with donepezil.

Medivation is conducting this study under its collaboration agreement with drug behemoth Pfizer (NYSE: PFE) which acquired rights the product in 2008 in a deal worth a potential $725 million ($225 million upfront) to the former company.

Dimebon – an old Russian antihistamine approved in that market in 1983 – had once been touted as a blockbuster drug for AD, with potential for anything between $1.5 billion and $5 billion annual sales. However, earlier this year, the majority of observers wrote it off after – somewhat unexpectedly – it failed to meet co-primary or secondary efficacy endpoints compared to placebo in two Phase III trials (The Pharma Letter March 4). After the disastrous results, Medivation’s shares cratered and have yet to recover from the beating they received.

Has received FDA feedback

“Completing patient enrollment in CONCERT is an important step forward for our Dimebon development program in Alzheimer’s disease,” said Lynn Seely, chief medical officer of Medivation. “Now that enrollment is complete, we expect to report top-line results from the CONCERT trial in the first half of 2012. We have previously received feedback from the FDA [Food and Drug Administration] confirming that we can use our Phase III CONCERT trial to complete our registration package for mild-to-moderate Alzheimer’s disease, provided that the results are robustly positive,” she added.

The international, randomized, double-blind, placebo-controlled Phase III CONCERT trial  enrolled 1,003 patients with mild-to-moderate AD at approximately 100 sites in the USA, Australia, New Zealand and Western Europe. Patients on a stable dose of donepezil were randomized to one of three treatment groups: Dimebon 20mg three times per day, Dimebon 5mg three times per day or placebo. Patients were required to be on treatment with donepezil for at least six months and at a stable dose of 10mg daily for at least four months prior to enrollment in the study. The primary endpoints are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) – a measure of self-care and daily function.

http://www.thepharmaletter.com/file/100475/medivation-persists-with-dimebon-research-in-alzheimers-despite-earlier-failures.html

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Dimebon Dimebolin Information Availability

SAN FRANCISCO — Medivation, Inc. (Nasdaq: MDVN) today announced that patient enrollment was completed on November 30, 2010 in the CONCERT study, a 12-month, Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD) evaluating the potential efficacy of dimebon (latrepirdine*) when added to ongoing treatment with donepezil.

Medivation is conducting this study under its collaboration agreement with Pfizer Inc.

“Completing patient enrollment in CONCERT is an important step forward for our dimebon development program in Alzheimer’s disease,” said Lynn Seely, M.D., chief medical officer of Medivation. “Now that enrollment is complete, we expect to report top-line results from the CONCERT trial in the first half of 2012. We have previously received feedback from the FDA confirming that we can use our Phase 3 CONCERT trial to complete our registration package for mild-to-moderate Alzheimer’s disease, provided that the results are robustly positive.”

The international, randomized, double-blind, placebo-controlled Phase 3 CONCERT trial enrolled 1,003 patients with mild-to-moderate AD at approximately 100 sites in the United States, Australia, New Zealand and Western Europe. Patients on a stable dose of donepezil were randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo. Patients were required to be on treatment with donepezil for at least six months and at a stable dose of 10 mg daily for at least four months prior to enrollment in the study. The primary endpoints are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) – a measure of self-care and daily function.

About Dimebon

Dimebon (latrepirdine*) is an investigational oral medication being tested as a potential treatment for Alzheimer’s disease and Huntington disease. In addition to the CONCERT trial, dimebon is also being tested in the HORIZON trial, a six-month Phase 3 study evaluating dimebon in patients with Huntington disease. Medivation expects to report top-line results from the HORIZON trial in the first half of 2011. For further information on dimebon clinical trials, please visit www.dimebontrials.com or www.clinicaltrials.gov.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as delusions, hallucinations, anxiety and agitation.

About the Pfizer/Medivation Dimebon Collaboration

Medivation and Pfizer have a global collaboration to develop and commercialize dimebon for the treatment of Alzheimer’s disease and Huntington disease. For more information about Medivation, visit www.Medivation.com.

*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.

http://checkorphan.getreelhealth.com/grid/news/treatment/medivation-completes-enrollment-in-phase-3-concert-trial-of-dimebon-added-to-donepezil-in-patients-with-alzheimer-s-disease

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SAN FRANCISCO, CA–(Marketwire – March 16, 2011) – Medivation, Inc. (NASDAQ: MDVN) today provided a corporate update and reported its financial results for the year ended December 31, 2010.

“We are pleased with the progress we made with our MDV3100 and dimebon programs in 2010, and we look forward to reporting Phase 3 data from each of these programs in the near-term. With regard to dimebon, we expect to report top-line data from our Phase 3 Huntington disease trial in the first half of this year, with top-line data from our Phase 3 mild-to-moderate Alzheimer’s disease trial expected to follow in the first half of 2012. And with MDV3100, we expect to report top-line data from our Phase 3 AFFIRM trial in advanced prostate cancer in 2012, although those data could come in 2011 if an interim analysis is conducted,” said David Hung, MD, president and chief executive officer of Medivation. “Our company also remains in a strong financial position, with more than $200 million in cash at December 31, 2010 and strong corporate partnerships for each of our programs that provide substantial cost-sharing benefits. Based on our current budget, we believe our existing cash is adequate to fund our currently planned operations beyond the end of 2012, by which time we expect to have completed and reported top-line data from all three of our Phase 3 programs.”

Recent Accomplishments and Anticipated Milestones

MDV3100 
• Completed patient enrollment in the Phase 3 AFFIRM trial in November 2010. This trial is evaluating MDV3100 in men with advanced prostate cancer who have previously been treated with docetaxel-based chemotherapy. Top-line data are expected in 2012, although they could be reported in 2011 if an interim analysis is conducted.
• Announced positive, new, long-term follow-up data from the Phase 1-2 trial of MDV3100 in patients with advanced prostate cancer showing that MDV3100 continues to demonstrate durable antitumor activity as evaluated by median times to prostate-specific antigen (PSA) progression and radiographic progression. These findings confirm the initial Phase 1-2 results published in The Lancet, in which MDV3100 consistently demonstrated anti-tumor activity in both chemotherapy-naïve and post-chemotherapy patients across endpoints, as evaluated by PSA levels, radiographic findings and circulating tumor cell (CTC) counts.
• Continued to enroll patients in the Phase 3 PREVAIL trial of MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy. The trial is expected to enroll approximately 1,700 patients globally.
• On track to initiate two new Phase 2 trials to explore the potential benefit of MDV3100 in earlier-stage patient populations — a Phase 2 trial comparing MDV3100 with bicalutamide, a commonly used anti-androgen, in the treatment of advanced prostate cancer patients who have progressed following medical or surgical castration; and a Phase 2 monotherapy trial in advanced prostate cancer patients who have not yet been treated with any hormonal therapy.
• Began clinical development of MDV3100 in Japan, with the initiation of patient dosing in a Phase 1-2 clinical study.

Dimebon (latrepirdine) 
• On track to report top-line results from the HORIZON trial in the first half of 2011. This six-month Phase 3 trial is evaluating the potential benefits of dimebon on cognition and global function in patients with Huntington disease.
• Completed patient enrollment in the CONCERT trial in November 2010; on track to report top-line results in the first half of 2012. This 12-month Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil.

Corporate 
• Received a $10 million milestone payment from Astellas in the fourth quarter of 2010 for the initiation of our Phase 3 PREVAIL trial of MDV3100 in chemotherapy-naïve advanced prostate cancer patients.

Fourth Quarter and Year-End 2010 Financial Results

Revenue for the year ended December 31, 2010, was $62.5 million, consisting of partial recognition of the non-refundable up-front and development milestone payments to date from the Company’s corporate partners Pfizer and Astellas. These payments were recorded as deferred revenue upon receipt and are being recognized as revenue on a straight-line basis over the estimated performance period of the Company’s obligations under the applicable collaboration agreement.

For the quarter and year ended December 31, 2010, total operating expenses were $17.5 million and $95.2 million, respectively, compared with total operating expenses of $42.9 million and $116.7 million, respectively, for the same periods in 2009. The year-end figures include non-cash stock-based compensation expense of $13.5 million in 2010 compared with $10.7 million in 2009.

Medivation reported a net loss for the quarter ended December 31, 2010, of $3.9 million, or $0.11 per share, compared with a net loss of $26.2 million, or $0.78 per share, for the same period in 2009. For the year ended December 31, 2010, the net loss was $34.0 million, or $0.99 per share, compared with a net loss of $54.8 million, or $1.71 per share, for the same period in 2009.

Cash, cash equivalents and short-term investments at December 31, 2010, totaled $207.8 million, compared with $278.2 million at December 31, 2009.

2011 Financial Outlook

Medivation currently expects total operating expenses for 2011, net of cost-sharing payments from Pfizer and Astellas, to be between $100.0 and $110.0 million. This forecast includes approximately $12.0 million of non-cash stock-based compensation expense.

Medivation expects that its existing cash resources are adequate to fund currently planned operations beyond the end of 2012. By the end of 2012, the Company expects to have completed and reported top-line data from the Phase 3 AFFIRM trial of MDV3100 in advanced prostate cancer patients who have failed chemotherapy, the Phase 3 HORIZON trial of dimebon in Huntington disease, and the Phase 3 CONCERT trial of dimebon in mild-to-moderate Alzheimer’s disease.

http://www.marketwire.com/press-release/Medivation-Reports-Fourth-Quarter-Year-End-2010-Financial-Results-Provides-Corporate-NASDAQ-MDVN-1412885.htm

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In regards to Dimebon (Dimbolin) the Medivation firm has announced that it selected the patients for its clinical trial. Does this mean that no other Dimebon will be available for patients until after the trial ends , is published in peer journals and the FDA approves this medication for use in Alzheimer’s Disease ?

Medivation Completes Enrollment in Confirmatory, Pivotal Phase 3 ‘CONNECTION’ Trial of Dimebon in Patients With Alzheimer’s Disease

SAN FRANCISCO, June 11, 2009 /PRNewswire-FirstCall via COMTEX News Network/ — Medivation, Inc. (Nasdaq: MDVN) today announced the completion of patient enrollment in the CONNECTION study, a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug dimebon in patients with mild-to-moderate Alzheimer’s disease.

The international, double-blind, placebo-controlled, pivotal Phase 3 study enrolled 598 patients, exceeding the enrollment target of 525 patients. More than 40 percent of the patients enrolled were in the United States. The six-month study is evaluating the effect of dimebon on the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician’s Interview-Based Impression of Change plus caregiver interview (CIBIC-plus) — the two endpoints have historically been accepted by the U.S. Food and Drug Administration (FDA) to support registration of currently approved drugs for mild-to-moderate Alzheimer’s disease.

“Completion of patient enrollment in this second pivotal trial moves us closer to our goal of submitting a marketing application to the FDA and bringing dimebon to market for the many Alzheimer’s patients suffering from this devastating disease,” said Lynn Seely, M.D., chief medical officer of Medivation. “We are gratified by the strong interest in this trial as indicated by our exceeding the enrollment goal. Together with our partner Pfizer, we are executing a comprehensive clinical plan to support an NDA filing, currently targeted for 2011, with a broad and differentiated label for dimebon in Alzheimer’s disease. We are also conducting a Phase 3 safety study, which will provide us and Pfizer the opportunity to seek marketing approval earlier if results of the CONNECTION study confirm our previously completed first pivotal study, which was published in the Lancet last year.”

About Dimebon

Dimebon is an investigational compound currently in Phase 3 development for the treatment of Alzheimer’s disease and in clinical development for Huntington disease. In preclinical models of Alzheimer’s disease and Huntington disease explored thus far, dimebon has been shown to inhibit brain cell death, potentially by stabilizing and improving mitochondrial function in a way that prevents neuron death and dysfunction. The dimebon mechanism is thought to be distinct from that of currently available Alzheimer’s disease medications.

In addition to CONNECTION, dimebon is being studied in the 12-month Phase 3 CONCERT trial, which is evaluating the efficacy of dimebon when added to ongoing treatment with donepezil (Aricept(R)) in patients with mild-to-moderate Alzheimer’s disease, and in a Phase 3 safety study. Two Phase 3 studies in moderate-to-severe Alzheimer’s disease are also planned to start this year.

In Huntington disease, a Phase 2 study has been completed. Medivation and Pfizer expect to initiate a Phase 3 trial this year to evaluate the potential benefits of dimebon on cognition in patients with Huntington disease.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations.

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. In September 2008, Medivation announced a global agreement with Pfizer Inc to develop and commercialize dimebon for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, the Company is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer’s medications in patients with mild, moderate or severe Alzheimer’s disease. Further development of dimebon in patients with Huntington disease is also planned. In addition, a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer is ongoing, and a Phase 3 trial is expected to begin this year. For more information, please visit us at http://www.medivation.com.

This press release contains forward-looking statements, including statements regarding the timing and potential results of clinical trials, and the anticipated timing of regulatory filings, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation’s actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation’s clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation’s clinical trials, partnering of Medivation’s product candidates, manufacturing of Medivation’s product candidates, competition with Medivation’s product candidates should they receive marketing approval, the adequacy of Medivation’s financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation’s filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended March 31, 2009, filed on May 11, 2009, with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

SOURCE Medivation, Inc.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com