Dimebon clinical trials are currently being conducted in both the treatment of Alzheimer’s disease and the treatment of Huntington’s disease. Dimebon clinical trials are in phase III for Alzheimer’s and are phase II for Huntington’s disease.

Phase I clinical trials are the first phase of testing of a drug in humans. In most cases a small group of healthy volunteer subjects (20 – 80) are used in this phase of clinical trials. This phase includes trials designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug.

Phase II clinical trials are performed on larger groups of volunteers (20 – 300). This phase of clinical trials helps to determine the effectiveness of the drug as well as continues the assessment of the safety of the drug from Phase I.

Phase III clinical trials are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current ‘gold standard’ treatment. While not always a requirement, it is common that there be at least two successful Phase III trials, demonstrating a drug’s safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as the FDA (USA), TGA (Australia), EMEA (European Union), and Health Canada.

The phase III Dimebon clinical trial for Alzheimer’s treatment is as of October 20, 2008 in the recruiting phase according to ClinicalTrials.gov. The official title of the Dimebon clinical trial for Alzheimer’s is “A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer’s Disease (CONNECTION)”. This clinical trial study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer’s disease. The target of Dimebon’s mechanism of action are the mitochondria (a cell’s primary source of energy). The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.

The primary outcome measures for this Dimebon clinical trial are to determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the ADAS-cog; and to determine the effect of Dimebon as compared to placebo on the primary measure of global function, the CIBIC-plus.

The secondary outcome measures for this Dimebon clinical trial are to determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the ADCS-ADL; • To determine the effect of Dimebon as compared to placebo on a measure of behavior, the NPI;

There are three arms to this Dimebon clinical trial. The first arm will receive Dimebon 5mg three times daily. The second arm will receive Dimebon 20mg three times daily. And the third arm of the clinical trial will receive placebo three times daily.

The previous Dimebon clinical trials in the treatment of Alzheimer’s have produced great results. We can only hope that this current clinical trial will further confirm the usefulness of Dimebon in the treatment of Alzheimer’s.

http://www.buydimebon.com/Dimebon/Clinical_trials.php

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Dimebon Dimebolin Information Availability

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

We recently downgraded biopharma company Medivation, Inc. ( MDVN ) to Neutral. The stock carries a Zacks #3 Rank (short-term “Hold” rating). Medivation’s shares received a major boost in early November with the company and its partner, Astellas, reporting impressive data on MDV3100 from a pre-specified interim analysis of a phase III study, AFFIRM. The Independent Data Monitoring Committee (IDMC) recommended that MDV3100′s risk-to-benefit ratio was favorable enough to stop the study.

The phase III randomized, double-blind, placebo-controlled study, AFFIRM, was conducted in men with advanced prostate cancer previously treated with docetaxel-based chemotherapy.

Medivation and Astellas intend to conduct a pre-NDA meeting with the FDA in early 2012. We believe the companies will file for regulatory approval of MDV3100 soon thereafter and expect MDV3100 to hit the market in 2013. Based on the data that we have seen so far, we believe MDV3100 has blockbuster potential and will be a game-changer for Medivation.

While we remain positive on the company’s prospects, we are moving back to a Neutral recommendation as we believe most of the positive news is already reflected in the current stock price.

Meanwhile, we have low expectations from Medivation’s other phase III candidate, dimebon, which is being developed in collaboration with Pfizer ( PFE ). Dimebon’s development path has been disappointing with the candidate failing to achieve its primary endpoints in late-stage studies for Huntington disease and Alzheimer’s.

Although Medivation and Pfizer are continuing with the development of dimebon, the companies have decided that they will not develop the candidate for moderate-to-severe Alzheimer’s disease. The companies are now focusing on the development of dimebon for the mild-to-moderate Alzheimer’s disease population. Top-line data from the CONCERT study will be available in the first half of 2012. We have low expectations from this study.

Going forward, we expect investor focus to remain on regulatory and development updates on prostate cancer candidate, MDV3100.

http://community.nasdaq.com/News/2011-11/medivation-back-to-neutral-analyst-blog.aspx?storyid=105019

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Dimebon Dimebolin Information Availability

Medivation Inc. (NASDAQ:MDVN) reported a loss of 29 cents per share in the third quarter of 2011, narrower than the Zacks Consensus loss Estimate of 32 cents but well above the year-ago loss of 16 cents.

Higher expenses led to the higher loss. Revenues for the quarter were $14.9 million, 4.1% above the year-ago period but below the Zacks Consensus Estimate of $16 million.

The Quarter in Detail

Revenues consisted of partial recognition of the non-refundable upfront payment of $225 million received from Pfizer (NYSE:PFE) in October 2008 and $110 million received from Astellas in late 2009. The upfront payments are being recognized on a straight-line basis.

While the Pfizer payment will be recognized through the fourth quarter of 2013, the Astellas payment will be recognized through the fourth quarter of 2014.

Operating expenses increased 25.1% to $26.4 million. Research and development expenses increased 19.7% to $18.7 million primarily due to higher headcount and bonus expense, consulting expenses associated with increased workload on the AFFIRM and PREVAIL trials, and preclinical expenses associated with new programs. This was partially offset by lower clinical expenses due to reduced dimebon development activities.

SG&A expenses increased 41.6% to $7.7 million primarily due to higher payroll-related expenses and legal and other expenses.

Maintains 2011 Outlook

Medivation expects operating expenses (after adjusting cost-sharing payments from Pfizer and Astellas) in the range of $100 – $110 million.

Pipeline Update

Medivation received a huge boost earlier this month when it reported positive survival data on its phase III prostate cancer candidate, MDV3100, which is being developed in collaboration with Astellas Pharma.

The phase III randomized, double-blind, placebo-controlled study, AFFIRM, was conducted in men with advanced prostate cancer previously treated with docetaxel-based chemotherapy. The interim data was impressive with MDV3100 showing a 4.8-month advantage in median overall survival compared to placebo (18.4 months versus 13.6 months).

A 37% reduction in risk of death was observed in the MDV3100 arm compared to placebo. Medivation reported that the US Food and Drug Administration (FDA) recently granted fast track status for the post-chemotherapy indication.

Based on the encouraging interim data, Medivation said that it has decided to exercise its co-promotion option for MDV3100 in the US. Once MDV3100 is approved, Medivation will provide 50% of the US sales and medical affairs field forces for the product.

Medivation and Astellas intend to conduct a pre-NDA meeting with the FDA early next year. We expect to gain more visibility on the regulatory path for the candidate on the conclusion of this meeting. Medivation stands to receive a $10 million milestone payment from Astellas on the acceptance of the NDA for the post-chemotherapy indication.

As far as dimebon is concerned, Medivation remains on track to announce top-line results from the CONCERT study, which is being conducted in patients suffering from mild-to-moderate Alzheimer’s disease. Results will be out the first half of 2012.

http://www.dailymarkets.com/stock/2011/11/14/loss-increases-at-medivation/

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Dimebon Dimebolin Information Availability

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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Dimebon

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, Nov. 5, 2010 /PRNewswire-FirstCall/ — Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the third quarter ended September 30, 2010.

“In the third quarter, we began the expansion of our MDV3100 development program into earlier stage patients with the initiation of the Phase 3 PREVAIL trial, which is enrolling men with advanced prostate cancer who have not yet received chemotherapy.  Additionally, we believe that the positive interim analysis of the abiraterone Phase 3 study is a net positive for MDV3100, as it provides further clinical validation for the importance of the androgen receptor signaling pathway in advanced prostate cancer,” said David Hung, MD, president and chief executive officer of Medivation.  ”Together with our partner Pfizer, we continue to investigate dimebon’s potential clinical benefit in the ongoing Phase 3 HORIZON trial in Huntington disease and the ongoing Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s disease patients who are taking donepezil.  We remain on track to complete enrollment in the CONCERT trial this year and look forward to announcing top-line results from the HORIZON trial in the first half of 2011.”

Recent Accomplishments and Anticipated Milestones

MDV3100

• Initiated the Phase 3 PREVAIL trial evaluating MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy.  This randomized, double-blind, placebo-controlled, multi-national Phase 3 trial is expected to enroll approximately 1,700 patients globally.
• Continued to enroll patients in the AFFIRM trial and expect to complete patient accrual on November 15, 2010. This randomized, double-blind, placebo-controlled Phase 3 trial is evaluating MDV3100 in men with advanced prostate cancer who have been previously treated with docetaxel-based chemotherapy.
• On track to initiate two new MDV3100 trials in earlier-stage prostate cancer this year: a Phase 2 head-to-head trial comparing MDV3100 with bicalutamide; and a Phase 2 trial in hormone-naive patients.
• The Proceedings of the National Academy of Sciences (PNAS) published a paper showing the preclinical efficacy of MDV3100 against splice variants, which are mutated forms of the androgen receptor that may be associated with the development of prostate cancer resistance to hormone therapy.

Dimebon (latrepirdine)

• On track to report top-line data from HORIZON in the first half of 2011.  This six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating dimebon’s potential benefits on cognition and global function in patients with Huntington disease.

• Continued to enroll patients in CONCERT and expect to complete patient accrual on November 30, 2010.  This 12-month randomized, double-blind, placebo-controlled 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

• Were awarded a $733,000 research and development grant under the Internal Revenue Service’s Therapeutic Discovery Project Credit Program.

Third Quarter 2010 Financial Results

Revenue for the third quarter of 2010 was $14.4 million, consisting of partial recognition of the non-refundable up-front 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.

Total operating expenses for the third quarter of 2010 were $21.1 million, compared with $27.6 million for the same period in 2009.  These figures are net of cost-sharing payments from the Company’s corporate partners of $17.9 million and $4.2 million in the third quarters of 2010 and 2009, respectively, and include non-cash stock-based compensation expense of $3.3 million and $2.5 million, respectively.

For the nine months ended September 30, 2010, total operating expenses were $77.7 million, compared with $73.8 million for the same period in 2009.  These figures are net of cost-sharing payments from the Company’s corporate partners of $41.5 million and $16.2 million in the nine months ended September 30, 2010 and 2009, respectively, and include non-cash stock-based compensation expense of $10.0 million and $7.7 million, respectively.

Income tax benefit for the third quarter of 2010 was $1.5 million, compared with income tax expense of $2.8 million in the comparable period of 2009.  For the nine months ended September 30, 2010, income tax benefit was $1.5 million, compared with income tax expense of $4.5 million in the prior year period.

Medivation reported a net loss for the quarter ended September 30, 2010, of $5.4 million, or $0.16 per share, compared with a net loss of $14.0 million, or $0.42 per share, for the same period in 2009.  For the nine months ended September 30, 2010, the net loss was $30.1 million, or $0.88 per share, compared with a net loss of $28.5 million, or $0.90 per share, for the same period in 2009.

Cash, cash equivalents and short-term investments at September 30, 2010, totaled $211.5 million, compared with $278.2 million at December 31, 2009 and $233.3 million at June 30, 2010.

Financial Outlook

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

http://www.prnewswire.com/news-releases/medivation-reports-third-quarter-2010-financial-results-and-provides-corporate-update-106783688.html

Dimebon

http://www.dimebonalzheimers.com/

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Medivation, Inc. MDVN today provided a corporate update and reported its financial results for the second quarter ended June 30, 2010.

“We have made positive progress in our dimebon program over the past few months,” said David Hung, MD, president and chief executive officer of Medivation.  ”In particular, I am pleased to announce that we have completed enrollment in our Phase 3 HORIZON trial in Huntington disease, exceeding our target of 350 patients by enrolling a total of 403 patients, and we expect to report top-line results from this trial in the first half of 2011.  We also have 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.  We have multiple milestones ahead in the remainder of the year with the planned initiation of three new trials with MDV3100 and the expected completion of enrollment in our Phase 3 Alzheimer’s disease trial, CONCERT and our Phase 3 prostate cancer trial, AFFIRM.  As we move toward these goals, our cash position remains strong and we continue to believe that based on current assumptions, existing cash is adequate to fund our currently planned operations beyond the end of 2012.”

Recent Accomplishments and Anticipated Milestones

Dimebon(latrepirdine)

• Completed patient accrual in HORIZON, with a total of 403 patients enrolled versus our targeted enrollment of 350 patients.  This six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating dimebon’s potential benefits on cognition and global function in patients with Huntington disease.  Top-line data from this trial are expected in the first half of 2011.
• Continued to enroll patients in CONCERT and remain on track to complete patient accrual in 2010. This 12-month randomized, double-blind, placebo-controlled 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.
• Presented the negative data from the Phase 3 CONNECTION trial to the Food and Drug Administration and received feedback that our prior Alzheimer’s disease trial published in the Lancet plus CONCERT would be adequate to support approval for mild-to-moderate Alzheimer’s disease, provided that the CONCERT results are robustly positive.

MDV3100

• Continued to enroll patients in the AFFIRM trial and remain on track to complete patient accrual in 2010. This randomized, double-blind, placebo-controlled Phase 3 survival trial is evaluating 160 mg/day of MDV3100 in men with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
• On track to initiate three new MDV3100 trials in earlier-stage prostate cancer this year: a Phase 3 trial in men with chemotherapy-naive castration-resistant prostate cancer, which will be called PREVAIL; a Phase 2 head-to-head trial comparing MDV3100 with bicalutamide; and a Phase 2 trial in hormone-naïve patients. Initiation of the Phase 3 PREVAIL trial would trigger a milestone payment under the collaboration agreement with Astellas.

Second Quarter 2010 Financial Results

Revenue for the second quarter of 2010 was $15.8 million, consisting of partial recognition of the non-refundable up-front payments of $225.0 million received from Pfizer in the fourth quarter of 2008 and $110.0 million received from Astellas in the fourth quarter of 2009. Both up-front payments were recorded as deferred revenue upon receipt and are being recognized on a straight-line basis over the estimated performance period of the Company’s obligations under the applicable collaboration agreement, which the Company presently expects to complete in the second quarter of 2013 for the Pfizer collaboration and in the fourth quarter of 2014 for the Astellas collaboration.

Total operating expenses for the second quarter were $23.2 million, compared with total operating expenses of $24.2 million for the same period in 2009.  These figures included non-cash stock-based compensation expense of $3.2 million in the quarter ended June 30, 2010, compared with $2.5 million for the same period in 2009.

For the six months ended June 30, 2010, total operating expenses were $56.7 million, compared with total operating expenses of $46.2 million for the same period in 2009. These figures include non-cash stock-based compensation expense of $6.7 million in the six months ended June 30, 2010, compared with $5.1 million for the same period in 2009.

Beginning in October 2008, Pfizer became responsible for 60 percent of all dimebon-related development and commercialization costs in the U.S., and 100 percent of such costs outside the U.S. Beginning in October 2009, Astellas became responsible for 50 percent of all MDV3100-related development and commercialization costs in the U.S. (other than costs for clinical trials supporting development in both the U.S. and either Europe or Japan, including the ongoing Phase 3 AFFIRM trial, the upcoming planned Phase 3 PREVAIL trial and the two additional trials in earlier-stage prostate cancer we expect to initiate in 2010, which costs are borne two-thirds by Astellas and one-third by Medivation) and 100 percent of such costs outside the U.S. The parties make quarterly true-up payments as necessary to ensure that each bears its applicable share of costs. For the second quarter of 2010, the net true-up payments payable to Medivation were $6.0 million and $7.0 million under the Pfizer and Astellas collaborations, respectively. Medivation presents these cost-sharing true-up payments in the applicable expense line of its consolidated statement of operations.

Medivation reported a net loss for the quarter ended June 30, 2010, of $7.2 million, or $0.21 per share, compared with a net loss of $8.9 million, or $0.29 per share, for the same period in 2009.  For the six months ended June 30, 2010, the net loss was $24.7 million, or $0.73 per share, compared with a net loss of $14.5 million, or $0.47 per share, for the same period in 2009.

Cash, cash equivalents and short-term investments at June 30, 2010, totaled $233.3 million, compared with $278.2 million at December 31, 2009, and $255.5 million at March 31, 2010.

Updated 2010 Financial Outlook

Medivation currently expects that total operating expenses for 2010, net of cost-sharing payments from Pfizer and Astellas, will be between $95 and $105 million, down from prior guidance of between $105 and $115 million.  The revised forecast includes approximately $13.0 million of non-cash stock-based compensation expense.

Dimebon

http://www.dimebonalzheimers.com/

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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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