Global drug behemoth Pfizer (NYSE: PFE) and partner Medivation (Nasdaq: MDVN) said yesterday that results from the Phase III HORIZON trial of the investigational drug Dimebon (latrepirdine) in patients with Huntington disease did not achieve statistical significance for either of the co-primary endpoints of the study.

Dimebon, which is an old Russian antihistamine approved in that market in 1983, had previously been touted as a blockbuster drug with a sales potential of anything between $1.5 billion and $5 billion in the treatment of Alzheimer’s disease. However, despite positive Phase II trial results, last year it failed to meet co-primary and secondary endpoints in AD in two Phase III studies (The Pharma Letter March 4, 2010).

Development to continue  in Alzheimer’s, says Medivation

“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, and chief executive of Medivation. “We will continue our ongoing 12-month Phase III 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,” he added.

Dimebon was generally well tolerated in the HORIZON trial, consistent with findings from previous trials including over 2,000 patients, the large majority of whom were Alzheimer’s disease patients.

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

HORIZON study design and results

The double-blind, placebo-controlled Phase III HORIZON trial enrolled 403 patients with Huntington disease at 64 sites in North America, Europe and Australia. The trial included patients who had cognitive impairment, based on investigator judgment and verified by MMSE score. Patients were randomized to receive either 20mg of Dimebon three times daily or placebo for six months.

No statistically significant improvements were achieved for the Dimebon group relative to placebo on either of the co-primary endpoints. Dimebon was generally well tolerated in the study. The overall incidence of adverse events was equivalent between the treatment groups: 69% in the Dimebon group and 68% in the placebo arm.

http://www.thepharmaletter.com/file/103545/pfizer-and-medivations-dimebon-also-flops-in-huntington-disease.html

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Dimebon Dimebolin Information Availability

Pfizer Inc (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) announced results from the Phase 3 HORIZON trial of the investigational drug dimebon (latrepirdine*) in patients with Huntington disease. Dimebon 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.”

Dimebon was generally well tolerated in the HORIZON trial, consistent with findings from previous trials including over 2,000 patients, the large majority of whom were Alzheimer’s disease patients.

“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.”

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

HORIZON Study Design and Results
The double-blind, placebo-controlled Phase 3 HORIZON trial enrolled 403 patients with Huntington disease at 64 sites in North America, Europe and Australia. The trial included patients who had cognitive impairment, based on investigator judgment and verified by MMSE score. Patients were randomized to receive either 20 mg of dimebon three times daily or placebo for six months.

No statistically significant improvements were achieved for the dimebon group relative to placebo on either of the co-primary endpoints. Dimebon was generally well tolerated in the study. The overall incidence of adverse events was equivalent between the treatment groups: 69 percent in the dimebon group and 68 percent in the placebo group. Adverse events occurring in at least 5 percent of dimebon treated patients and more frequently than in placebo treated patients were chorea (8 percent vs. 4 percent), headache (6 percent vs 3 percent) and fatigue (5 percent vs 0 percent).

The trial was conducted in collaboration with the Huntington Study Group (HSG) and the European Huntington’s Disease Network (EHDN). The HSG is a non-profit group of experienced clinical trial investigators from medical centers in the United States and abroad dedicated to clinical research of Huntington disease. The EHDN is a non-profit network of professionals providing an infrastructure for large scale Huntington disease clinical trials throughout Europe.

About Dimebon
Dimebon (latrepirdine) is an investigational oral medication being tested as a potential treatment for Alzheimer’s disease. Dimebon is currently being studied in the Phase 3 CONCERT trial, a 12-month study evaluating dimebon in patients with mild-to-moderate Alzheimer’s disease who are taking donepezil, a commonly prescribed Alzheimer’s disease medication.

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. Under the terms of the agreement, the companies work together on the dimebon development program.

http://www.worldpharmanews.com/pfizer/1641-pfizer-and-medivation-announce-results-from-phase-3-horizon-trial-of-dimebon-in-huntington-disease

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Medivation, Inc. – Financial and Strategic Analysis Review

Summary

The “Medivation, Inc. – Financial and Strategic Analysis Review” is an in-depth business, strategic and financial analysis of Medivation, Inc. The report provides a comprehensive insight into the company, including business structure and operations, executive biographies and key competitors. The hallmark of the report is the detailed strategic analysis of the company. This highlights its strengths and weaknesses and the opportunities and threats it faces going forward.

Medivation, Inc. (Medivation) is a biopharmaceutical company engaged in the research and development of small molecule drugs. The company’s pipeline includes two products; Dimebon for Alzheimer’s disease and Huntington’s disease and MDV3100 for Castration-Resistant. It has its operation across the United States. The company is headquartered in California, the US. On July 30, 2009, Pfizer Inc and Medivation, Inc. initiated a Phase 3 trial of the investigational drug dimebon in patients with Huntington disease. In June 2009, the company announced positive results for Phase 1-2 Trial Of MDV3100 for prostate cancer patients.

And More inside the report

Recent Developments

Jul 30, 2009: Pfizer, Medivation Initiate Phase 3 Trial Of Dimebon
Nov 03, 2009: Pfizer, Medivation Commence Two Phase 3 Trials Of Dimebon
Nov 03, 2009: Pfizer, Medivation Initiate Two Phase 3 Trials of Dimebon for Alzheimer’s disease

Scope

- Provides key company information for business intelligence needs
- The company’s strengths and weaknesses and areas of development or decline are analyzed. Financial, strategic and operational factors are considered.
- The opportunities open to the company are considered and its growth potential assessed. Competitive or technological threats are highlighted.
- The report contains critical company information – business structure and operations, the company history, major products and services, key competitors, key employees and executive biographies, different locations and important subsidiaries.
- The report provides detailed financial ratios for the past five years as well as interim ratios for the last four quarters.
- Financial ratios include profitability, margins and returns, liquidity and leverage, financial position and efficiency ratios.

Reasons to buy

- A quick “one-stop-shop” to understand the company.
- Enhance business/sales activities by understanding customers’ businesses better.
- Get detailed information and financial & strategic analysis on companies operating in your industry.
- Identify prospective partners and suppliers – with key data on their businesses and locations.
- Capitalize on competitors’ weaknesses and target the market opportunities available to them.
- Compare your company’s financial trends with those of your peers / competitors.
- Scout for potential acquisition targets, with detailed insight into the companies’ strategic, financial and operational performance.

Medivation, Inc. – Financial and Strategic Analysis Review: http://www.companiesandmarkets.com/r.ashx?id=1M4VHS8TA189857

Dimebon Available Russian Online Internet Pharmacies  ?

http://www.dimebonalzheimers.com/

Pfizer Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) today announced results from two Phase 3 trials of the investigational drug dimebon (latrepirdine*) in patients with Alzheimer’s disease (AD). In the CONNECTION trial, dimebon did not meet its co-primary or secondary efficacy endpoints compared to placebo. Co-primary endpoints were measures of cognition and global function.

“The results from the CONNECTION study are unexpected, and we are disappointed for the Alzheimer’s community,” said Dr. David Hung, president and chief executive officer of Medivation. “We are working with our colleagues at Pfizer to better understand the CONNECTION data and we plan to present these data at an upcoming medical meeting.”

Dimebon was well tolerated in both the CONNECTION study and in a separate Phase 3 safety and tolerability study, which confirmed dimebon’s tolerability when dosed alone or in combination with approved Alzheimer’s disease medicines.

“We are evaluating the CONNECTION data with Medivation. After that review, Pfizer will be in a position to determine appropriate next steps regarding the dimebon program,” said Dr. Briggs W. Morrison, senior vice president, clinical development, Primary Care Business Unit at Pfizer. “We recognize the significant medical need, and we are committed to advancing treatment options for Alzheimer’s disease.”

About the CONNECTION Study

CONNECTION is a Phase 3, multi-national, double-blind, placebo-controlled safety and efficacy trial involving 598 patients with mild-to-moderate AD at 63 sites in North America, Europe, and South America. Patients had a mean age of 74.4 years and a mean score of 17.7 on the Mini-Mental State Examination (MMSE) upon entry into the study. More than 40 percent of the patients enrolled were in the United States. In the study, patients were randomized to one of three treatment groups, receiving dimebon 20 mg three times a day (TID), dimebon 5 mg TID, or placebo TID for six months. The 5 mg arm was included in the study to help define the effective dose range for dimebon treatment.

No statistically significant improvements for the 20 mg TID group relative to placebo were achieved on the co-primary endpoints. One primary endpoint evaluated the effect of dimebon on cognition, as measured by the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog), and showed that dimebon-treated patients achieved a 0.1 point difference from patients receiving placebo (p=0.86). Neither group was significantly changed from baseline. The other primary endpoint evaluated the effect of dimebon on independently-rated global function over the course of the six-month trial, as measured by the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus; p=0.81). According to the CIBIC-plus scale, 64.9 percent of the patients treated with dimebon 20 mg TID showed improvement or no change at Week 26 compared to 65.4 percent of placebo-treated patients. Results for the dimebon 5 mg dose were similar to the dimebon 20 mg and placebo, although they were numerically lower.

The 20 mg TID dimebon-treated patients also showed no statistically significant differences compared to placebo on the secondary efficacy endpoints. After six months of treatment, patients treated with dimebon showed a 0.4 point difference from patients taking placebo on activities of daily living (p=0.61), as measured by the Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL). Neither group was significantly changed from baseline. The dimebon-treated group showed a 1.6 point improvement on behavior compared to placebo (p=0.17), as measured by the Neuropsychiatric Inventory (NPI). Compared to baseline, each group was improved, but this change was only significant for the dimebon group. On the Mini Mental State Examination (MMSE), another measure of cognition, both groups improved significantly over baseline (dimebon 0.7; placebo 1.2). The difference favoring placebo was not significant (p=0.10). Results for the dimebon 5 mg dose were similar to dimebon 20 mg and placebo, although they were numerically lower. Dimebon, 20 mg orally three-times daily, was well tolerated in the study. The number of patients with at least one adverse event was similar in the dimebon 20 mg and placebo groups (72.0% vs. 74.2%, respectively). The most frequently reported adverse events (>5%) in patients in the 20 mg dimebon group occurring more commonly than in the placebo group included somnolence (11.0% vs. 10.1%), dry mouth (8.5% vs. 6.6%), headache (9.5% vs. 5.6%), dizziness (7.5% vs. 5.1%), constipation (5.5% vs. 3.5%), cough (7.5% vs. 3.5%) and depression (6.0% vs. 3.5%). Similar rates of adverse events were observed for the 5 mg TID group. No clinically significant findings were noted in assessment of vital signs, clinical laboratories or on electrocardiography (ECG).

About the Phase 3 Safety and Tolerability Study

In a separate multi-center, placebo-controlled Phase 3 safety and tolerability study, dimebon was well tolerated when given alone or in combination with a variety of other AD medicines, including cholinesterase inhibitors, memantine, or both. Previous studies have confirmed the tolerability of dimebon alone. The Phase 3 safety and tolerability study enrolled 742 patients with mild-to-moderate Alzheimer’s disease in the United States and Canada. In this study, patients were randomized to either dimebon 20 mg three-times daily or placebo and were treated for a period of either three or six months. Approximately 85 percent of patients were taking one or more currently approved Alzheimer’s disease medicines while participating in this study.

Dimebon was well tolerated in the study. The most frequently reported adverse events (>5%) in the dimebon group occurring more commonly than in the placebo group were somnolence (5.1% vs. 1.9%) and fatigue (5.1% vs. 2.4%). No clinically significant findings were noted in assessment of vital signs, clinical laboratories or on electrocardiography (ECG).

About Dimebon

Dimebon (latrepirdine*) is an investigational oral medication being tested as a potential treatment for Alzheimer’s disease and Huntington disease. Dimebon is being studied in four other ongoing randomized, double-blind, placebo-controlled Phase 3 studies, which currently are enrolling. The CONCERT trial is a 12-month study testing dimebon in patients with mild-to-moderate Alzheimer’s disease who are taking donepezil, a commonly prescribed Alzheimer’s disease medication. The CONTACT and CONSTELLATION trials are six-month trials testing dimebon in patients with moderate-to-severe Alzheimer’s disease taking currently approved AD medications. In CONTACT, subjects must also be taking donepezil, while in CONSTELLATION they must also be taking memantine, another commonly prescribed Alzheimer’s disease medication. Dimebon is also being tested in the HORIZON trial, a six-month study evaluating dimebon in patients with Huntington disease.

For 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. Under the terms of the agreement, the companies work together on the dimebon development program.

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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

– Medivation to Receive $110 Million Upfront Cash Payment and Eligible to Receive $655 Million in Milestone Payments, 50 Percent of U.S. Profits and Double-Digit Royalties on Ex-U.S. Sales — – Medivation to Host Conference Call/Webcast Today at 8:30 a.m. Eastern Time –

TOKYO and SAN FRANCISCO, Oct. 27 /PRNewswire-FirstCall/ — Astellas Pharma Inc. (“Astellas”) and Medivation, Inc. (Nasdaq: MDVN) announced today that they have entered into a global agreement to develop and commercialize MDV3100, Medivation’s investigational drug for the treatment of prostate cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.

Under the terms of the agreement, Medivation will receive an up-front cash payment of $110 million. Medivation is also eligible to receive payments of up to $335 million upon the attainment of development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. The companies will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. The companies will share equally all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties on ex-U.S. sales.

“We are pleased to initiate a great partnership with Medivation,” stated Masafumi Nogimori, president and chief executive officer of Astellas. “We believe that MDV3100 has the unique potential to establish a new treatment approach for prostate cancer. Astellas already has the global expertise in urology and the strong commitment to focus on oncology. This partnership is a significant milestone to further expand our business in urology and to establish our franchise in oncology.”

“We are excited to be working with Astellas to develop MDV3100 for a broad spectrum of prostate cancer disease states,” said David Hung, M.D., president and chief executive officer of Medivation. “Astellas is an ideal partner for MDV3100 given its global reach, leading commercial presence in the urology space, and strategic focus on oncology. Astellas is the second major collaboration we have completed in the past year, and we are confident we have the right partners in place for each of our late-stage programs–Astellas for MDV3100 and Pfizer, Inc for dimebon (latrepirdine*).”

According to the American Cancer Society, prostate cancer is the most common non-skin cancer among men in the United States. More than 2 million American men have prostate cancer, and it is the second leading cause of cancer death among men after lung cancer. In 2009, an estimated 192,000 new cases are expected to be diagnosed, and approximately 27,000 men are expected to die from the disease.

MDV3100, a new generation of oral anti-androgen, which shows different pharmacological profiles from current anti-androgens, has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science earlier this year demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

The agreement is not subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and becomes effective immediately. Medivation’s legal and financial advisers on the transaction were Cooley Godward Kronish LLP and Aquilo Partners, L.P. Astellas’ legal adviser on the transaction was Covington & Burling LLP.

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

Conference Call Information
Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 888-280-4443 for domestic callers and 1-719-457-2638 for international callers. In addition, this call is being Webcast and can be accessed at Medivation’s website at www.medivation.com.

About MDV3100′s Clinical Program
In September 2009, Medivation began enrolling patients in a randomized, placebo-controlled, double-blind, multi-national Phase 3 clinical trial known as AFFIRM. This trial is evaluating MDV3100 at a dose of 160 mg taken orally once daily versus placebo in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia and South Africa.

Medivation previously announced interim safety and efficacy results from an ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that MDV3100 was associated with anti-tumor activity in patients who had become resistant to bicalutamide or other standard anti-androgen treatments, including both patients who had failed prior chemotherapy and patients who were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in prostate-specific antigen levels, improvement or stabilization in tumors that had spread to soft tissue or bone, and a decrease in circulating tumor cells, which has been associated in published literature with improved survival in patients with castration-resistant prostate cancer. MDV3100 was generally well tolerated in this trial at doses up to and including 240 mg/day, with fatigue being the most frequently reported adverse event.

About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 14,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology and Inflammatory, Diabetes, CNS/Pain, Infectious diseases (virus) and Cancer. For more information on Astellas Pharma Inc., please visit our website at http://www.astellas.com.

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 (latrepirdine) for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation 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 and severe Alzheimer’s disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy. For more information, please visit us at http://www.medivation.com.

Medivation Forward Looking Statement
This press release contains forward-looking statements, including statements related to future clinical development of and ongoing clinical trials evaluating MDV3100, the therapeutic and commercial potential of MDV3100, and potential future development and regulatory milestone payments, commercial milestone payments and royalty payments under the agreement with Astellas, 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 the progress, timing and results of Medivation’s clinical trials, including the risk that positive results in earlier clinical trials may not be repeated in subsequent clinical trials and the risk that interim results from ongoing clinical trials may not be predictive of the final results of any such trial, enrollment of patients in Medivation’s clinical trials, difficulties or delays in obtaining regulatory approvals, Medivation’s dependence on Astellas for aspects of the development, regulatory approval, manufacturing and commercialization of MDV3100, manufacturing of MDV3100, competition with MDV3100 should it receive marketing approvals, 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 (SEC), including its quarterly report on Form 10-Q for the quarterly period ended June 30, 2009, filed with the SEC on August 5, 2009. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

SOURCE Medivation, Inc.

http://www.earthtimes.org/articles/show/astellas-and-medivation-enter-into,1015012.shtml

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and
Co-Commercialize MDV3100 for the Treatment of Prostate Cancer
– Medivation to Receive $110 Million Upfront Cash Payment and Eligible to
Receive $655 Million in Milestone Payments, 50 Percent of U.S. Profits and
Double-Digit Royalties on Ex-U.S. Sales –

TOKYO and SAN FRANCISCO, Oct. 27 /PRNewswire-FirstCall/ — Astellas Pharma
Inc. (“Astellas”) and Medivation, Inc. (Nasdaq: MDVN) announced today that
they have entered into a global agreement to develop and commercialize
MDV3100, Medivation’s investigational drug for the treatment of prostate
cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical
trial in men with castration-resistant prostate cancer who were previously
treated with docetaxel-based chemotherapy.

Under the terms of the agreement, Medivation will receive an up-front cash
payment of $110 million. Medivation is also eligible to receive payments of
up to $335 million upon the attainment of development and regulatory
milestones plus up to an additional $320 million in commercial milestone
payments. The companies will collaborate on a comprehensive development
program that will include additional studies to develop MDV3100 for both late-
and early-stage prostate cancer. Subject to receipt of regulatory approval,
the companies will jointly commercialize MDV3100 in the U.S. The companies
will share equally all U.S. development costs, commercialization costs, and
profits. Astellas will have responsibility for developing and commercializing
MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties
on ex-U.S. sales.

“We are pleased to initiate a great partnership with Medivation,” stated
Masafumi Nogimori, president and chief executive officer of Astellas. “We
believe that MDV3100 has the unique potential to establish a new treatment
approach for prostate cancer. Astellas already has the global expertise in
urology and the strong commitment to focus on oncology. This partnership is a
significant milestone to further expand our business in urology and to
establish our franchise in oncology.”

“We are excited to be working with Astellas to develop MDV3100 for a broad
spectrum of prostate cancer disease states,” said David Hung, M.D., president
and chief executive officer of Medivation. “Astellas is an ideal partner for
MDV3100 given its global reach, leading commercial presence in the urology
space, and strategic focus on oncology. Astellas is the second major
collaboration we have completed in the past year, and we are confident we have
the right partners in place for each of our late-stage programs–Astellas for
MDV3100 and Pfizer, Inc for dimebon (latrepirdine*).”

According to the American Cancer Society, prostate cancer is the most common
non-skin cancer among men in the United States. More than 2 million American
men have prostate cancer, and it is the second leading cause of cancer death
among men after lung cancer. In 2009, an estimated 192,000 new cases are
expected to be diagnosed, and approximately 27,000 men are expected to die
from the disease.

MDV3100, a new generation of oral anti-androgen, which shows different
pharmacological profiles from current anti-androgens, has been shown in
preclinical studies to provide more complete suppression of the androgen
receptor pathway than bicalutamide, the most commonly used anti-androgen.
MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers
via three complementary actions – MDV3100 blocks testosterone binding to the
androgen receptor, impedes movement of the androgen receptor to the nucleus of
prostate cancer cells (nuclear translocation), and inhibits binding to DNA.
Preclinical data published in Science earlier this year demonstrated that
MDV3100 is superior to bicalutamide in each of these three actions.

The agreement is not subject to approval under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 and becomes effective immediately. Medivation’s
legal and financial advisers on the transaction were Cooley Godward Kronish
LLP and Aquilo Partners, L.P. Astellas’ legal adviser on the transaction was
Covington & Burling LLP.

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

Conference Call Information
Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30
a.m. Pacific Time) to discuss this announcement. To participate in the
conference call, please dial 888-280-4443 for domestic callers and
1-719-457-2638 for international callers. In addition, this call is being
Webcast and can be accessed at Medivation’s website at www.medivation.com.

About MDV3100′s Clinical Program
In September 2009, Medivation began enrolling patients in a randomized,
placebo-controlled, double-blind, multi-national Phase 3 clinical trial known
as AFFIRM. This trial is evaluating MDV3100 at a dose of 160 mg taken orally
once daily versus placebo in men with castration-resistant prostate cancer who
were previously treated with docetaxel-based chemotherapy. The primary
endpoint of the trial is overall survival; secondary endpoints include
progression-free survival, safety and tolerability. This trial is expected to
enroll approximately 1,200 patients at sites in the United States, Canada,
Europe, South America, Australia and South Africa.

Medivation previously announced interim safety and efficacy results from an
ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that
MDV3100 was associated with anti-tumor activity in patients who had become
resistant to bicalutamide or other standard anti-androgen treatments,
including both patients who had failed prior chemotherapy and patients who
were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in
prostate-specific antigen levels, improvement or stabilization in tumors that
had spread to soft tissue or bone, and a decrease in circulating tumor cells,
which has been associated in published literature with improved survival in
patients with castration-resistant prostate cancer. MDV3100 was generally well
tolerated in this trial at doses up to and including 240 mg/day, with fatigue
being the most frequently reported adverse event.

About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceuticals. Astellas has
approximately 14,000 employees worldwide. The organization is committed to
becoming a global category leader in Urology, Immunology and Inflammatory,
Diabetes, CNS/Pain, Infectious diseases (virus) and Cancer. For more
information on Astellas Pharma Inc., please visit our website at

http://www.astellas.com.

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 (latrepirdine) for the
treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation 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
and severe Alzheimer’s disease. The companies are also conducting a Phase 3
trial of dimebon in Huntington disease. In October 2009, Medivation entered a
global agreement with Astellas Pharma Inc. to develop and commercialize
MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100
development program, known as the AFFIRM trial, is under way in patients with
castration-resistant prostate cancer who have previously been treated with
docetaxel-based chemotherapy. For more information, please visit us at

http://www.medivation.com.

Medivation Forward Looking Statement
This press release contains forward-looking statements, including statements
related to future clinical development of and ongoing clinical trials
evaluating MDV3100, the therapeutic and commercial potential of MDV3100, and
potential future development and regulatory milestone payments, commercial
milestone payments and royalty payments under the agreement with Astellas,
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 the progress, timing and results of Medivation’s clinical trials,
including the risk that positive results in earlier clinical trials may not be
repeated in subsequent clinical trials and the risk that interim results from
ongoing clinical trials may not be predictive of the final results of any such
trial, enrollment of patients in Medivation’s clinical trials, difficulties or
delays in obtaining regulatory approvals, Medivation’s dependence on Astellas
for aspects of the development, regulatory approval, manufacturing and
commercialization of MDV3100, manufacturing of MDV3100, competition with
MDV3100 should it receive marketing approvals, 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 (SEC), including its quarterly report on
Form 10-Q for the quarterly period ended June 30, 2009, filed with the SEC on
August 5, 2009. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this press
release. Medivation disclaims any obligation or undertaking to update or
revise any forward-looking statements contained in this press release.

SOURCE Medivation, Inc.

Patrick Machado, Chief Financial Officer of Medivation, +1-415-829-4101; or
Corporate Communications of Astellas Pharma Inc., +81-3-3244-3201, Fax:
+81-3-5201-7473

http://www.reuters.com/article/pressRelease/idUS121460+27-Oct-2009+PRN20091027

Donepezil (Aricept)  is a drug derived from components of actual black pepper.  It is the most widely prescribed drug for patients who have Alzheimer’s disease .  It works by preventing the breakdown of the chemical neurotransmitter acetylcholine in the brain.  The tablet is taken once daily , which helps with regular pill taking  ( compliance).  It seems that for all the studies that have been done in an effort to improve the taking of pills and medications on a regular basis – that is compliance – that lack of compliance is generally estimated at a full 50 %.   The only things that seem to enhance and improve compliance levels with medications are 1) to reduce the frequency of dosage and 2) tie in the pill taking to a regime involving a daily habit — 0ften meals.   To make matters perhaps more amusing and even worse it seems that patients often improve their regular pill taking and compliance of medications when they become more ill and are reminded of their symptoms.  The poor health care providers are often at a loss to explain symptoms and side effects that often and usually were not present before and are the direct result of patients now taking their pills and medications on a regular and proper basis. On top of that multi-drug side effects and interactions may now emerge since the patient may well be finally taking the drugs they had forgot to or had chosen not to take before in their treatment plan and plans.

Forteo, Enbrel, Methotrexate, Folic Acid, Donepezil Hcl … – Large, long term drug study: Forteo, Enbrel, Methotrexate, Folic Acid, Donepezil Hcl, Hydrocodone Bitartrate And Acetaminophen, Acetylsalicylic Acid Srt drug interactions and effectivenesses for females and males at all ages (2742948)

Phase 3 study of Dimebon and donepezil combination therapy for … – Pfizer and Medivation, Inc announced the initiation of a 12-month, Phase 3 trial of the investigational drug Dimebon in combination with donepezil HCl for the treatment of mild-to-moderate Alzheimer’s disease (AD).

Alzheimer’s Reading Room: Dimebon Added to Donepezil in Patients … – The study builds on data from a small-scale safety and tolerability trial of Dimebon added to donepezil, which found the combination to be well tolerated. CONCERT is designed to complement previous and ongoing studies by further …

Pfizer and Medivation Initiate Phase 3 Trial of Dimebon Added to … – New 12-month study broadens Phase 3 clinical program to further eval… …NEW YORK and SAN FRANCISCO April 15 /- Pfizer … …,Pfizer,and,Medivation,Initiate,Phase,3,Trial,of,Dimebon,Added,to,Donepezil,in,Patients,with,Alzheimer’s …

Drug interactions analysis of Zyprexa, Venlafaxine Hcl … – Real world drug safety study: Drug interactions analysis of Zyprexa, Venlafaxine Hcl, Risperidone, Quetiapine, Donepezil Hcl (2704001) … Donepezil Hcl. ^Back to Content. 2 related incidents are studied for males aged 75 (±5): …

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Donepezil Hcl side effects and drug interactions analysis (ID … – Drug(s): Donepezil Hcl Date: Aug, 28, 2008 Patient demographics: unspecified year(s) old Male who has Cognitive Disorder.

The Donepezil comes in tablet form.   The typical daily dose id 10 mg. It is generally well tolerated.  Often the dose is started low at 5 mg per a day and then “bumped” up to the 10 mg dose.    Some authorities and practitioners in the field have believed that the drug will only work for a six month time period whereas others have continued treatment with the drug and made substantiated claims that a beneficial effect can be demonstrated in Alzheimer’s patients for several years. Indeed the medication may have  a disease modifying and limited beneficial effect all on its own.

Dimebon Alzheimer?s Disease

http://www.dimebonalzheimers.com