Posts Tagged ‘Medivation Inc’

« Older Entries

A pill to make you smarter? Drug grows brain cells

Tuesday, August 10th, 2010

Researchers have found a drug that can help the brain grow new cells and said their study may lead to ways to improve experimental Alzheimer’s drugs.

The researchers’ work, done on rodents, builds on findings that all mammals, including humans, make brain cells throughout their lives. Most of these die, but this drug helps more of the baby cells survive and grow to become functioning brain cells.

“We make new neurons every day in our brain,” Andrew Pieper of the University of Texas Southwestern Medical Centre in Dallas who worked on the study, said in a telephone interview. “What our compound does in allow more of them to survive.”

The compound is called P7C3 for now, and the researchers have already started tweaking it to make it more effective. They said it seems safe and appears to work even when taken as a pill.

The compound is similar to Medivation Inc (MDVN.O) and Pfizer Inc’s (PFE.N) experimental Alzheimer’s drug, Dimebon, and may provide ways to improve its effects, Pieper and colleagues reported in the journal Cell.

It is also similar to some compounds owned by Serono, the researchers said.

Dimebon, originally a Russian-made antihistamine also known as latrepirdine, failed in a clinical trial for Alzheimer’s disease in March.

“For the sake of patients suffering from Alzheimer’s disease, it is hoped that the apparently marginal clinical utility of Dimebon might be enhanced by improvements in both its potency and ceiling of proneurogenic, neuroprotective efficacy,” the researchers wrote.

“If so, our work offers concrete assays for the development of improved versions of these neuroprotective drugs.”

Alzheimer’s gradually destroys the brain and affects 26 million people globally. Drugs, such as Pfizer’s Aricept, improve symptoms only minimally.

OLD RATS, NEW TRICKS

The researchers went through 1,000 representative compounds from 300,000 chemicals, pooled them and administered them to mice. They then dissected the brains to see whether any of the mice had made new cells in the hippocampus, a region of the brain associated with learning and memory.

They eventually narrowed the field to P7C3.

When they gave it to old rats for two months, the elderly rodents did far better than other old rats in learning their way around a water maze.

When dissected, the treated rats turned out to have three times the usual number of newborn neurons in a brain region called the dentate gyrus.

They made a derivative of P7C3 called A20 that worked even better.

When the researchers tested Dimebon and the Serono compounds, they found these drugs also stimulated the growth of new brain cells. Being able to target their effects could lead to better drugs to treat Alzheimer’s and perhaps other diseases that destroy brain cells like strokes and amyotrophic lateral sclerosis, also know as ALS or Lou Gehrig’s disease.

“This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease,” said Dr. Thomas Insel, director of the National Institute on Mental Health, which helped pay for the study.

http://www.dimebonalzheimers.com/

Dimebon Over Counter Treatment

One Hour Canada

Furnasman New Homes

Furnasman Winnipeg

  • Share/Bookmark
Blog Traffic Exchange Related Websites

Tags: , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

Medivation Reports First Quarter 2010 Financial Results and Provides Corporate Update

Friday, July 9th, 2010

SAN FRANCISCO, May 10 /PRNewswire-FirstCall/ – Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the first quarter ended March 31, 2010.

“After thorough review of all available dimebon data, including the disappointing CONNECTION results, Medivation remains committed to determining whether dimebon may offer clinical benefit to Alzheimer’s and Huntington disease patients,” said David Hung, MD, president and chief executive officer of Medivation.  ”We will continue to enroll patients in the 12-month Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s patients and the six-month Phase 3 HORIZON study in Huntington disease, and will stop our two ongoing Phase 3 trials in moderate-to-severe Alzheimer’s disease.  In reaching this conclusion, we considered all dimebon data generated thus far, including the negative CONNECTION data, the clinical benefit seen in two prior dimebon trials in mild-to-moderate Alzheimer’s disease and Huntington disease, the excellent safety and tolerability profile in all dimebon trials to date covering more than 2,000 patients, the preclinical data consistently showing that dimebon is pharmacologically active, and the potential risks and returns of continuing development for Alzheimer’s and Huntington diseases.  We believe both the CONCERT and HORIZON studies offer independent pathways to registration, and we will be meeting with the Food and Drug Administration this quarter to discuss the CONNECTION data and obtain guidance on our proposed regulatory path forward.”

“We also continue to make progress on our MDV3100 program,” continued Dr. Hung. “This year we and our partner Astellas expect to complete enrollment in the Phase 3 AFFIRM trial in advanced prostate cancer patients and to initiate three new trials in earlier-stage prostate cancer, including a second Phase 3 trial. Our cash position remains strong and, based on current assumptions, we expect our cash to last beyond 2012, without regard to whether Pfizer elects to remain in our dimebon collaboration.  We also expect to have reported top-line data from the CONCERT, HORIZON and AFFIRM trials by the end of 2012.”

Recent Accomplishments and Anticipated Milestones

Dimebon (latrepirdine*)

  • Completed an analysis of data from the Phase 3 CONNECTION trial in patients with mild-to-moderate Alzheimer’s disease, and confirmed that dimebon did not show clinical benefit in this trial. The analysis did not identify any systematic issues with the conduct of the trial or with the drug product that would explain the results.
  • Continued to enroll patients in CONCERT, with the goal of completing 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.
  • Continued to enroll patients in HORIZON, with the goal of completing patient accrual in 2010. This six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating dimebon’s potential benefits on cognition in patients with Huntington disease.
  • Agreed with our partner Pfizer to discontinue the CONSTELLATION and CONTACT Phase 3 trials in patients with moderate-to-severe Alzheimer’s disease. These trials were part of a label expansion strategy for dimebon, which can be revisited at a later time if the results of the ongoing CONCERT trial warrant.

*Latrepirdine is the proposed generic name for dimebon.

MDV3100

  • Announced publication in The Lancet of positive efficacy data from the Phase 1-2 trial of MDV3100 in advanced prostate cancer patients. MDV3100 demonstrated anti-tumor activity as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts.  MDV3100 was generally well-tolerated in this trial at doses up to and including 240 mg/day.
  • Continued to enroll patients in the AFFIRM trial, with the goal of completing 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.
  • Obtained issuance of a U.S. patent claiming MDV3100′s composition of matter.  The term of this patent runs through 2027, and under current law is eligible for up to five years’ patent term extension based on time spent pursuing regulatory approval to market MDV3100.
  • 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; a Phase 2 head-to-head trial comparing MDV3100 with bicalutamide; and a Phase 1 trial in hormone-naive patients. Initiation of the Phase 3 trial would trigger a $10 million milestone payment under our collaboration agreement with Astellas.

Corporate

  • Implemented a 20 percent workforce reduction to focus resources on the prioritized CONCERT and HORIZON dimebon trials and expanded development of MDV3100.

First Quarter 2010 Financial Results

Revenue for the first quarter of 2010 was $15.7 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.

For the three months ended March 31, 2010, total operating expenses were $33.4 million, compared with total operating expenses of $22.1 million for the same period in 2009.  These figures include non-cash stock-based compensation expense of $3.5 million in the quarter ended March 31, 2010, compared with $2.6 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 and the two additional trials in earlier-stage prostate cancer we expect to initiate in 2010, which 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 first quarter of 2010, the net true-up payments payable to Medivation were $4.6 million and $6.1 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 March 31, 2010, of $17.5 million, or $0.51 per share, compared with a net loss of $5.6 million, or $0.19 per share, for the same period in 2009.

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

2010-12 Financial Outlook

Medivation currently expects that total operating expenses for 2010, net of cost-sharing payments from Pfizer and Astellas, will be between $105 and $115 million.  This forecast includes approximately $13.5 million of non-cash stock-based compensation expense.  We also expect to receive a $10 million milestone payment from Astellas in 2010 upon initiation of the second Phase 3 study of MDV3100.

Medivation believes that its existing cash resources are adequate to fund its currently budgeted operations beyond 2012, without regard to whether Pfizer elects to remain in the dimebon collaboration.  By the end of 2012, the Company expects to have reported top-line data from the CONCERT trial in mild-to-moderate Alzheimer’s disease, the HORIZON trial in Huntington disease, and the AFFIRM trial in castration-resistant prostate cancer patients who have failed chemotherapy.

Conference Call Information

To participate by telephone in today’s live call beginning at 4:30 p.m. Eastern Time, please call 877-303-2523 from the U.S. or +1-253-237-1755 internationally.  In addition, the live conference call is being webcast and can be accessed on the “Events and Presentations” page of the “Investor Relations” section of the Company’s website at www.medivation.com.  A replay also will be available for 30 days following the live call.

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 clinical development program that includes CONCERT, a Phase 3 trial assessing dimebon in patients with mild-to-moderate Alzheimer’s disease, and HORIZON, a Phase 3 trial of dimebon in Huntington disease.  In October 2009, Medivation entered into a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for both early- and late-stage 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.  Additional trials in earlier-stage prostate cancer will begin in 2010.  For more information, please visit us at www.medivation.com.

Mr Furnaces One Hour

Boonstraonehour

Air Quality’s One Hour

Dimebon Online

http://www.dimebonalzheimers.com/

Auto Transport Montreal  and Car Carrier GTA Ontario

  • Share/Bookmark
Blog Traffic Exchange Related Websites

Tags: , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

Job Cuts at Medivation

Friday, June 18th, 2010

Medivation, Inc. (MDVN) recently announced that it intends to reduce its workforce by 20% or 23 people to save costs and focus its resources towards research and developmentmag glass 10x10 Job Cuts at Medivation activities related to dimebon and MDV3100.

Medivation also announced the departure of its senior vice president of clinical development and the vice president of commercial development. The companymag glass 10x10 Job Cuts at Medivation said that it is no longer looking for a new Chief Financial Officer (CFO) as this post will be filled by the current Chief Business Officer (CBO).

Medivation’s workforce reduction announcement comes on the heels of disappointing phase III results reported earlier this month on its lead pipeline candidate, dimebon. Dimebon, which is being developed for Alzheimer’s disease in collaboration with Pfizer, Inc. (PFE), failed to achieve both its primary and secondary endpoints in a phase III study (CONNECTION).

Dimebon was the most advanced pipeline candidate at Medivation, which has no marketed products in its portfolio. The successful development of dimebon would have been a major boost for the company. In addition to the Alzheimer’s indication, Medivation is also studying dimebon for Huntington’s disease.

Going forward, Medivation intends to focus on the further analysis of the CONNECTION data, which will help determine future development plans for the candidate. Dimebon is currently being studied in combination with Pfizer’s Aricept for the treatment of mild-to-moderate Alzheimer’s. Positive results from this study could allow the companies to push for approval of the product as a combination therapy.

Dimebon is also in another study which is being conducted in Huntington disease patients.

We currently have a Neutral recommendation on Medivation. The high profile phase III failure was a major setback for the company. Medivation could suffer another blow if Pfizer decides to pull out from the collaboration agreement for dimebon.

We note that Pfizer already has another Alzheimer’s candidate, bapineuzumab, in its portfolio that is being developed with Elan Corp (ELN) and Johnson & Johnson (JNJ). As such, Pfizer may decide to focus its efforts towards the development of bapineuzumab.

21 Degrees One Hour

Mr Furnaces One Hour

Boonstraonehour

Dimebon Online

http://www.dimebonalzheimers.com/

  • Share/Bookmark
Blog Traffic Exchange Related Websites
  • Google says China partially blocks search service [/caption] BEIJING – A Google search feature was blocked in China on Thursday, the company said as it awaited Beijing's decision on whether to renew its operating license amid tensions...
  • 3 Things to Know About the Most Valuable Silver Coin The most valuable silver dollar is the 1804 Silver Dollar with the Draped Bust. As a side note, this coin is not only the most valuable in the silver coin...
  • Exciting Alzheimer's News Linked to Gene Discovery More exciting Alzheimer's research is in the news.  It seems we are getting closer to better understanding Alzheimer's with  such new discoveries as the four genes now associated with the...
  • Osteoporosis Risk Factors for Women There are a number of ailments that women are actually at risk for developing without actually realizing it. For example, osteoporosis risk factors for women are much more significant than...
  • Global Warming-How It Could Spark World War III by mandiberg Global Warming-How It Could Spark World War III These Days global warming is a very hot topic and little wonder, seeing as the earth grows hotter with each...
  • Intel buys McAfee for $7.7B in push beyond PCs [/caption] SAN FRANCISCO – Talk about a new meaning for "Intel Inside." Intel Corp. wants to be inside your television. And your cell phone. And your car. And pretty much...
  • Is Clean Coal Really Clean? Not Really... Dear EarthTalk: As I understand it, “clean” coal really isn’t—yet the Bush Administration gushed strongly for it. What is Obama’s take on it? Barack Obama and George W. Bush differ...

Tags: , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

Biotech Implosion: Medivation, Alzheimer’s Beats Drug (MDVN, PFE)

Friday, June 11th, 2010

Medivation, Inc. (NASDAQ: MDVN) is the next biotech implosion.  The company’s highly awaited Phase III study on its Alzheimer drug called Dimebon did not meet expectations. It failed to meet primary and secondary endpoints. The problem is that this was hitting 52-week highs yesterday.

The company did note that a separate Phase 3 safety study demonstrated Dimebon’s tolerability when used alone or in combination with approved Alzheimer’s Disease medicines.  Just one more problem… if it doesn’t work it doesn’t matter how tolerable it is.  In some cases the placebo group even did better on the sugar pill, which is perhaps the worst endorsement a company can get.

Furnasman Winnipeg

21 Degrees One Hour

Mr Furnaces One Hour

Dimebon Online

http://www.dimebonalzheimers.com/

  • Share/Bookmark
Blog Traffic Exchange Related Websites

Tags: , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

Dimebon Clinical Trials

Friday, October 30th, 2009

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

  • Share/Bookmark
Blog Traffic Exchange Related Websites

Tags: , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

Medivation Wins Big Again; Gets $110M Up Front in Astellas Deal

Friday, October 30th, 2009

Assistant Managing Editor

When Medivation Inc. gained clearance in March to start its Phase III trial of MDV3100 in prostate cancer, a company executive told BioWorld Today the firm would consider partnering the drug if the right opportunity came along – as it had for Alzheimer’s disease drug Dimebon, which scored a potential $725 million deal with Pfizer Inc. last year.

For MDV3100, the right deal came along this week.

Astellas Pharma Inc. agreed to pay South San Francisco-based Medivation $110 million up front for rights to the androgen receptor antagonist, with up to another $655 million in potential milestones – $335 million precommercial and $320 million postcommercial – as well as 50 percent of U.S. profits and tiered double-digit royalties on ex-U.S. sales.

On top of that, Astellas takes over two-thirds of the development costs, including funding two-thirds of the ongoing Phase III AFFIRM study, which last month began enrolling patients with castration-resistant prostate cancer who previously were treated with docetaxel, said David Hung, Medivation’s president and CEO.

Not that Medivation needed a partner to move MDV3100 into Phase III. The firm, which had $237.7 million in cash as of June 30, was prepared to launch AFFIRM on its own. But investors clearly had been waiting for a collaboration, and the addition of big pharma muscle means expanding MDV3100 more quickly into broader prostate cancer indications.

The first Phase III is testing the drug in patients following chemotherapy failures.

“As large a market as that is, it’s still not the biggest,” Hung told BioWorld Today. “You have to go after the upstream indications,” hitting first-line and second-line patient populations.

“We mapped out a development program to hit those upstream indications,” he said, adding that additional trials are expected to follow AFFIRM, though Medivation and Astellas have not yet “talked in great detail about what those will be.”

Since the progression of prostate cancer is driven by the testosterone androgen, MDV3100 is designed to work by blocking the binding of testosterone to the androgen receptor, thereby preventing the androgen receptor from invading the cell’s nucleus and promoting further growth.

Prostate cancer is estimated to affect about 1 million men in the U.S.

The castration-resistant form, also known as hormone-refractory prostate cancer, has few treatment options and a median survival of about 12 months.

Hung acknowledged a “healthy interest” among prospective partners for MDV3100, particularly given that the prostate cancer space has been hopping with news this year.

In April, Seattle-based Dendreon Corp. impressed investors with data from its confirmatory Phase III trial showing that cancer vaccine Provenge (sipuleucel-T) improved overall survival in men with metastatic androgen-independent prostate cancer, and a month later Los Angeles-based Cougar Biotechnology Inc., which is in two Phase III trials with abiraterone acetate in previously treated and chemotherapy-naïve patients, was snatched up by Johnson & Johnson in a deal worth nearly $1 billion. (See BioWorld Today, April 15, 2009, and May 26, 2009.)

And prostate cancer led the charge at this year’s American Society of Clinical Oncology meeting, with Bothell, Wash.-based OncoGenex Pharmaceuticals Inc. reporting stellar Phase II survival data with its clusterin-inhibiting antisense drug, OGX-011, in combination with docetaxel in patients with advanced disease. (See BioWorld Today, June 2, 2009.)

“It’s such a large opportunity,” Hung said, so when Medivation looked at potential partners, “we looked at the overall total value of the deal.”

Besides the hefty up-front and milestones – “and there aren’t too many [deals] of this size in oncology for a drug targeting a single cancer,” Hung said – a partnership with Astellas also gives Medivation access to the Tokyo-based pharma’s sales force in urology, “the gatekeepers for prostate cancer treatment.”

Astellas already markets benign prostatic hyperplasia drug Flomax (tamsulosin) and overactive bladder product Vesicare (solefinacin succinate), “so that will give us great entry into the urology market,” Hung added.

Rodman & Renshaw analyst Elemer Piros estimated in a research note that U.S. sales of MDV3100 could hit $700 million seven years after launch, with peak potential of $1.2 billion in 2025.

But some skeptics remain, as well. Analyst Jonathan Aschoff, of Brean Murray Carret & Co., wrote that he was “not encouraged” by the outcome of the ongoing AFFIRM trial, nor the ongoing CONNECTION trial, which is testing the firm’s other late-stage product, Dimebon, in patients with mild to moderate Alzheimer’s.

But like MDV3100, Dimebon (latrepirdine) had produced strong enough data to nab a lucrative pharma deal. Last year, New York-based Pfizer paid a whopping $225 million up front, with up to another $500 million in potential precommercial milestones. Under that deal, the firms agreed to share U.S. development and commercialization costs and profits on a 60/40 basis, with Pfizer holding the larger share. (See BioWorld Today, Sept. 4, 2008.)

Dimebon also is being tested in a 12-month Phase III trial, with results due in the first half of next year. And a 350-patient study recently began in Huntington’s disease. (See BioWorld Today, July 31, 2009.)

Shares of Medivation (NASDAQ:MDVN) fell $1.06 Tuesday, to close at $25.04.

Published  October 28, 2009

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=52506

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

  • Share/Bookmark
Blog Traffic Exchange Related Websites
  • Farmers Market Produce (part 2 of a series) We are told to eat a rainbow of different fruits and vegetables, but nobody really ever explains why. Why is it so vitally important for us to eat fruits and...
  • Macau News September 2007 ADB report says Macau in top five Macau was recently listed as one of Asia's top five economies by the Asian Development Bank (ADB). Hong Kong, Taipei, Singapore and Brunei...
  • Cancer Cure? Sunshine! People pay thousands or even millions of dollars just to get their sickness cured. More so with cancer. Money is not an object when your life is at stake. But...
  • Thanksgiving Fun Facts With Thanksgiving coming up next Thursday in the U.S., I thought it would be fun to share some interesting facts about this historical holiday. Note: You can always turn these...
  • Nanotech Robots Developed to Fight Cancer [/caption] On Sunday, March 21, 2010, a group of United States researchers released their findings in the journal Nature. The study offers early proof that a new treatment approach of...
  • How Corporate Executives Should Be Paid Yesterday, The Weakonomist introduced you to how executives are paid.  Today, that same brilliant mind will explain his two ideas on how executives should be paid.  They should be paid...

Tags: , , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and Co-Commercialize MDV3100 for the Treatment of Prostate Cancer

Thursday, October 29th, 2009

– 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

  • Share/Bookmark
Blog Traffic Exchange Related Websites

Tags: , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and Co-Commercialize MDV3100 for the Treatment of Prostate Cancer

Thursday, October 29th, 2009

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

  • Share/Bookmark
Blog Traffic Exchange Related Websites

Tags: , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

Medivation Names Hank Mansbach, M.D., Vice President of Medical Affairs

Thursday, October 29th, 2009

SAN FRANCISCO, Oct. 23 CA-Medivation-VP

SAN FRANCISCO, Oct. 23 /PRNewswire-FirstCall/ — Medivation, Inc. (Nasdaq: MDVN) today announced the appointment of Hank Mansbach, M.D., as vice president of medical affairs. Dr. Mansbach will lead Medivation’s medical affairs activities for dimebon (latrepirdine*), the company’s Phase 3 candidate for the treatment of Alzheimer’s and Huntington diseases, and MDV3100, which is in Phase 3 clinical development for the treatment of advanced prostate cancer.

“Hank brings a vast array of experience in a broad range of CNS therapeutic areas, and we are delighted to have him join the Medivation team,” said Rohan Palekar, chief commercial officer of Medivation. “With multiple Phase 3 trials ongoing with both dimebon and MDV3100, this is an excellent time for Hank to help deepen our relationships with the medical community and expand the visibility of our programs as we move towards commercialization.”

Dr. Mansbach is a neurologist with more than 10 years of strategic and operational drug development experience across all phases of development and multiple therapeutic areas. Prior to joining Medivation, he was senior vice president and head of global drug development at Valeant Pharmaceuticals, a specialty pharmaceutical company. At Valeant, among other programs, he led the development of retigabine, a novel epilepsy therapy which successfully completed Phase 3 trials in 2008 and was subsequently licensed to GlaxoSmithKline (GSK). From 2004 to 2006, Dr. Mansbach was chief medical officer and vice president for clinical development at Cortex Pharmaceuticals, an emerging biotechnology company developing novel CNS therapeutics. Dr. Mansbach began his industry career in the U.S. medical affairs department at GlaxoWellcome supporting the commercialization of Imitrex®/Imigran® and Lamictal® before taking on leadership roles in the GSK Neurosciences clinical development organization. While at GSK he worked on programs in migraine, stroke, epilepsy, multiple sclerosis, pain and Alzheimer’s disease.

Dr. Mansbach earned a medical degree from Duke University and a bachelor’s degree cum laude in philosophy from Yale University.

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

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. A Phase 3 clinical trial of MDV3100 in patients with castration-resistant prostate cancer is under way. For more information, please visit us at http://www.medivation.com.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

  • Share/Bookmark
Blog Traffic Exchange Related Websites
  • Natural Cures for Migraines No one likes a migraine headache! To say they're extremely painful is an understatement! However, if you dislike the thought of taking medications, experiencing their side effects, or spending the...
  • Alzheimer's test touted Researcher Deborah Barnes of the University of California, San Francisco, thinks she has a tool for discovering who among the over-65 set is at risk for developing Alzheimer's Disease within...
  • St. Jude Medical (STJ) - Will Fourth Quarter Predictions Ring True? St. Jude Medical is a company dedicated to making medical tools and providing the services needed to give doctors better control in helping patients suffering from cardiovascular disease, neurological disease,...
  • WORLD - Stem Cells: International Guidelines Published Image via Wikipedia First and foremost, the new international guidelines on stem cells, with four Italians among the authors, need to be clear, eliminating false illusions, incredible exaggerations, and confusion...
  • Is a Niche Blog Right For You? If you’ve been considering starting a corporate blog, but you’re not quite sure that your company is ready yet, there is still a way that you can get your feet...

Tags: , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

New Additional Alzheimer’s Patients Wanted – Medivation Dimebon Clinical Trial Study July 09

Sunday, July 5th, 2009

It appears that there has almost been a midnight hour last minute reprieve for Alzheimer’s patients and their families wishing to participate or at least to obtain Dimebon for patients and loved ones via the clinical trial route”A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer’s Disease”  is recruiting candidates and is underway

“This study is currently recruiting participants.”

This was only announced recently at Clinical Trials.gov and just verified by Pfizer itself

(Pfizer and Medivation had announced an agreement to co-develop and market Dimebon for treatment of Alzheimer’s Disease.
A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer’s Disease
This study is currently recruiting participants.
Verified by Pfizer, June 2009
First Received: February 5, 2009   Last Updated: June 25, 2009   History of Changes
Sponsors and Collaborators:     Pfizer
Medivation, Inc.
Information provided by:     Pfizer
ClinicalTrials.gov Identifier:     NCT00838110

triangle New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 Purpose

This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer’s disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.

Condition     Intervention     Phase
Alzheimer’s Disease     Drug: Dimebon
Drug: Placebo     Phase III
Study Type:     Interventional
Study Design:     Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
Official Title:     A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer’s Disease

Resource links provided by NLM:
Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer’s Disease

Drug Information available for: Dimebolin
U.S. FDA Resources

Further study details as provided by Pfizer:
Primary Outcome Measures:

* Adverse events [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
* ECG’s [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
* Vital Signs [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
* Clinical Chemistry / Hematology [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:     750
Study Start Date:     February 2009
Estimated Study Completion Date:     March 2010
Estimated Primary Completion Date:     March 2010 (Final data collection date for primary outcome measure)

Arms     Assigned Interventions
Dimebon 20 mg TID (Cohort 1): Experimental     Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 26
Placebo TID (Cohort 1): Placebo Comparator     Drug: Placebo
10 mg TID for week 1 followed by 20 mg TID through Week 26
Dimebon 20 mg TID (Cohort 2): Experimental     Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 12
Placebo TID (Cohort 2): Placebo Comparator     Drug: Placebo
20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12

triangle New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 Eligibility
Ages Eligible for Study:     50 Years and older
Genders Eligible for Study:     Both
Accepts Healthy Volunteers:     No
Criteria

Inclusion Criteria:

* Diagnosis of Alzheimer’s Disease.
* MMSE 12-26 inclusive.
* If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
* If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Exclusion Criteria:

* Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).
* Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient’s ability to comply with study procedures and abide by study restrictions.
* Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
* Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.

triangle New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838110

Contacts
Contact: Pfizer CT.gov Call Center     cb transparent l New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09us New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09arrow New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 091-800-718-1021cb transparent r New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09

plus New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 Show 111 Study Locations
Sponsors and Collaborators
Pfizer
Medivation, Inc.

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer

triangle New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 More Information
Additional Information:
To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided
Responsible Party:     Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:     B1451027
Study First Received:     February 5, 2009
Last Updated:     June 25, 2009
ClinicalTrials.gov Identifier:     NCT00838110 History of Changes
Health Authority:     United States: Food and Drug Administration

Keywords provided by Pfizer:
Alzheimer’s Disease, Dimebon, Safety, Tolerability

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases     Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases     Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on June 30, 2009

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

  • Share/Bookmark
Blog Traffic Exchange Related Websites
  • Heart Attack Victim Healed in Stem Cell Research Study Image via Wikipedia In a stem cell research study at the University of Miami, Barry Brown has had his heart attack healed after receiving therapy using his own Adult Stem...
  • Tips for Fire Safety If you want to practice good fire safety, then you are going to need to have a plan in place. If your home or workshop should ever happen to catch...
  • What are your risks of getting Alzheimer's? Your risk of contracting Alzheimer's disease will most likely increase if  both your parents have it.During a recent study researchers found a larger percentage of children whose parents were diagnosed with Alzheimer's,...
  • Health Insurance: Two Percent Profit Sunday Paper - November 1st, 2009 Now the figures are in.  The evil greedy immoral health insurance industry has the audacity to post an average profit of 2 percent!  And...
  • Safety call over stem cell trips Image via Wikipedia A clampdown on unproven and potentially unsafe stem cell research is being called for by an expert group. Bionet, a group of expert Chinese and European doctors,...
  • Stem Cell Therapeutics Corp. Announces Completion of Enrollment Stem Cell Therapeutics Corp. or the  wishes to announce the acceptance and publication of the paper entitled "The Beta-hCG + Erythropoietin in Acute Stroke (BETAS) Study" by the journal "Stroke",...
  • 5 Tips to Landing a King Salmon If you are up for a challenge, there is nothing like the feeling of being able to land a king salmon. These fish have an incredible amount of fight in...

Tags: , , , , , , , , , , , , , , , , , , ,
Posted in Uncategorized | No Comments »

« Older Entries