Medivation’s long shot for Alzheimer’s came up short today. The San Francisco-based company (NASDAQ: MDVN) said today its Alzheimer’s drug candidate dimebon failed in a pivotal clinical trial. Medivation and its collaborator, Pfizer, said they plan to quit developing the drug.

The bad news came from a trial known as Concert, which enrolled more than 1,000 patients with mild to moderate symptoms of Alzheimer’s, the neurodegenerative disease that impairs the memory and cognition of millions of elderly people. The drug failed to show a statistically significant benefit on a common cognition score, or a measurement of activities of daily living and self-care.

“We are disappointed in the Concert results and the implications for Alzheimer’s disease patients and their caregivers,” said David Hung, Medivation’s CEO, in a statement.

The Medivation drug, original developed in Russia in the 1980s as an allergy treatment, showed some promise in a smaller study Medivation conducted including more than 180 patients with Alzheimer’s, which was published in 2008. But investors largely gave up on the drug when Medivation and Pfizer failed to reproduce the results in March 2010 in a pivotal trial of about 600 patients, known as Connection. Medivation suffered layoffs after that setback, but it has made a comeback on the strength of a prostate cancer drug called MDV3100, which showed last November that it was able to help men live longer. Details from that trial are expected to come out this year at a medical meeting.

“Given Dimebon’s poor precedence from its Phase III Connection trial in 2010, the failure of Concert should come as no surprise. Investor focus should remain on MDV3100 for prostate cancer,” said Biren Amin of Jefferies & Co., in a note to clients this morning. He notes that the full data from the pivotal study of MDV3100 is expected to be released at the American Society of Clinical Oncology’s Genitourinary symposium, scheduled for February 2-4.

Shares of Medivation fell 1.2 percent to $55.01 shortly after the opening bell.

http://www.xconomy.com/san-francisco/2012/01/17/medivation-fails-alzheimers-trial-pfizer-drops-out-partnership/

Winnipeg Auto Dealers

Winnipeg Wedding Catering

Dimebon Dimebolin Information Availability

Medivation’s dwindling hopes for Dimebon just got even smaller. Once one of the most closely-watched late-stage drugs in neurology, which earned a $225 million upfront deal from Pfizer, Medivation  said this morning that the treatment failed a late-stage study for Huntington’s disease. But with expectations for Dimebon already low, its share price barely nudged down–a far cry from the drubbing it took after Dimebon failed a pivotal trial for Alzheimer’s.

Investigators for Medivation said the treatment failed not only the primary endpoint in its Phase III study for Huntington’s, but all secondary endpoints as well, with no statistically significant improvement on any score over a placebo. The developer promptly scuttled the Huntington’s program, leaving only one remaining Phase III study for Alzheimer’s underway to keep some hope alive that the drug may yet prove to be more effective than a sugar pill.

“Huntington’s is a challenging disease area, and we are also disappointed with the HORIZON results,” said Pfizer’s Steve Romano, M.D., senior vice president, Medicines Development Group head, Primary Care Business Unit. “The results are expected to be presented at an upcoming medical meeting.”

The modest impact on its shares this morning at least in part reflects Medivation CEO Daving Hung’s ability to get investors to look past dimebon and on to MDV3100, its program for prostate cancer. In an industry which specializes in building hope for experimental therapies, Hung is doing his best to keep everyone’s attention on the cancer drug as dimebon goes from failure to failure.

http://www.fiercebiotech.com/story/medivations-dimebon-flunks-ph3-huntingtons-disease/2011-04-11

Winnipeg Alternative Therapy

Pfizer and Medivation’s investigational drug dimebon proved no better than a placebo in achieving statistical significance for either of two co-primary efficacy endpoints in a late stage trial in patients with Huntington’s disease. The endpoints were the Mini-Mental State Examination, which measures cognition, or the Clinician’s Interview-Based Impression of Change, plus caregiver input, which measures global function. Medivation said it would discontinue development of dimebon in Huntington’s disease as a result. Although dimebon has already failed in one late stage trial for Alzheimer’s disease, Medivation will continue a remaining late stage trial in that indication for which it expects to report top-line data in the first half of 2012.

Hopes for Teva Pharmacuetical’s experimental multiple sclerosis pill laquinimod were dimmed after a results from a pivotal trial showed it reduced the disease’s relapse rate less than hoped, reported Reuters. Teva announced a 23 percent annualized relapse rate over a placebo, less than the hoped for 25 percent. Teva is up against Novartis’ recently approved Gilenya, which showed a 54 percent reduction in relapse rates. In a second measure, disability progression, laquinimod compared favorably with Gilenya as measured by the expanded disability status scale which, at 36 percent, was ahead of Gilenya. Dan Bar-Zohar, Teva’s global medical director, told Reuters he was “very happy” with the overall results.

Canadian researchers have found a link between Roche’s diet drug Xenical (orlistat) and an increase in kidney injuries, reports Reuters Health. The new study is based on 953 new users of orlistat and is published in the Archives of Internal Medicine. In an overview of Ontario’s healthcare databases, researchers found that 0.5 percent of new orlistat users were hospitalized for kidney problems in the year before starting on the drug. Over the next year, that number jumped to 2 percent. In an email, Researcher Matthew Weir said that the study should be interpreted cautiously because it is just observational and doesn’t prove causality. The study comes after U.S. health officials warned last year of rare cases of liver damage in people using Xenical or GlaxoSmithKline’s Alli, an over-the-counter version. Orlistat, the active ingredient, inhibits gut absorption of fat. A few days later, GSK announced that it plans to sell Alli along with several other over-the-counter brands. Although once seen as a potential blockbuster, sales of Alli never grew as expected.

European regulators are recommending changes to the product label on GlaxoSmithKline’s pandemic flu vaccine Pandemrix in an effort to draw attention to a potential risk of narcolepsy in children or adolescents associated with the vaccine, Reuters reports. The EU decision is based on preliminary results of studies from Finland, Sweden, and France that suggest a possible link. A final regulatory decision is pending a review expected to conclude in July. GSK believes further information is needed on the causal relationship between Pandemrix and narcopolepsy before coming to any conclusion. Although not administered in the United States, more than 31 million doses of Pandemrix were given to people in 47 countries. GSK said it had been notified of 247 cases of narcolepsy in those vaccinated as of April 5, according to Reuters.

Medical device maker ReGen Biologics filed voluntary petitions for Chapter 11 bankruptcy protection with the U.S. Bankruptcy Court for the District of Delaware, reports MassDevice. The bankruptcy petition includes ReGen’s subsidiary RBio but not its Swiss subsidiary ReGen Biologics AG. ReGen has had an ongoing battle with the U.S. Food and Drug Administration over its Menaflex device, a bio-absorbable mesh knee implant designed to encourage regrowth of damaged knee cartilage. The FDA rescinded ReGen’s 2008 510(k) clearance last week until it can meet the FDA’s standards for safety and effectiveness. ReGen CEO Gerald Bisbee says the company has spent $30 million to meet FDA requirements and feels the FDA’s rescission is unfair, according to MassDevice.

The Justice Department has sentenced W. Scott Harkonen, former CEO of Intermune, to six months of home confinement and fined him $20,000 for his role in disseminating misleading information about the drug Actimmune for the treatment of lung disease, reports Bloomberg. He was convicted of wire fraud in September 2009 for issuing a deceptive press release in 2002 to boost sales of Actimmune, which said the drug reduced deaths by 70 percent in patients with mild to moderate idiopathic pulmonary fibrosis, a fatal lung disease—a false and misleading statement. Although approved to treat rare bone and immune disorders, Actimmune was not approved for idiopathic pulmonary fibrosis. Harkonen plans to appeal his conviction. In 2006 Intermune agreed to pay $36.9 million to settle U.S. claims for illegally marketing the drug for unapproved uses.

http://www.burrillreport.com/article-dimebon_fails_in_late_stage_huntingtons_disease_trial.html

http://www.dimebonalzheimers.com/

Winnipeg Acupuncture Therapy

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