Medivation, Inc. (NASDAQ: MDVN) and Pfizer Inc. (NYSE: PFE) today announced results from the CONCERT trial, which is a Phase 3 trial that evaluated dimebon (latrepirdine) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer’s disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL), which measures self care and daily function.

“We are disappointed in the CONCERT results and the implications for Alzheimer’s disease patients and their caregivers,” said David Hung, M.D., president and CEO of Medivation. “I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial.”

Dimebon was generally well tolerated in the study. A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.

Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer’s disease. The companies also announce that they will terminate their collaboration to co-develop and market dimebon pursuant to the terms of their Collaboration Agreement.

“We recognize Alzheimer’s is a very complex disease,” said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. “Despite this disappointing result, Pfizer remains committed to advancing the science of Alzheimer’s disease, with the ultimate goal of delivering innovative and meaningful new treatment options to patients.”

The Phase 3 CONCERT trial was a 12-month global randomized, double-blind, placebo-controlled trial that enrolled 1,003 patients with Alzheimer’s disease. Patients on a stable dose of donepezil for at least four months were randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo.

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. Together with its corporate partner Astellas, Medivation currently has its investigational drug MDV3100 in Phase 3 development to treat advanced prostate cancer.

http://www.vadvert.co.uk/health/20918-medivation-and-pfizer-announce-results-from-phase-3-concert-trial-of-dimebon-in-alzheimers-disease.html

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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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When the calendar flips from December to January, many people like to start the year with a clean slate…

They swear off junk food and promise to exercise more. They declare they won’t waste their evenings on reality TV, making a promise to themselves to read more. And finally that they will dump their losing stocks and instead only buy quality names.

Let me give you that little push that you may need. I can’t help much if you’re addicted to Haagen-Dazs and Mob Wives…

But if you own any of the following three stocks, sell them immediately.

“Hung” up on Medivation

San Francisco-based Medivation (Nasdaq: MDVN) has a promising drug for prostate cancer – MDV3100. In Phase III trials, advanced prostate cancer patients lived an average of 18.4 months versus 13.6 for patients on placebo.

The stock is up 200 percent from when the data was released just over a month ago, giving Medivation a market cap of $1.7 billion.

The company should provide more information next year as to the path to regulatory approval. Meanwhile, Medivation and partner Astellas Pharma are currently in an additional Phase III and two Phase II trials.

My problem with Medivation is two-fold:

• Its current market cap is 25-percent greater than Dendreon’s (Nasdaq: DNDN), which already has a prostate cancer drug on the market. Granted, initial sales for Dendreon’s Provenge were disappointing, but there’s a very big difference between weaker than expected sales for a drug that has already been approved versus one that hasn’t been given clearance by the FDA yet.
• The second issue is with Medivation CEO David Hung. I’m very familiar with Hung and Medivation, having covered the company when data for its Alzheimer’s candidate Dimebon was very encouraging. The drug produced stellar Phase II results only to fail miserably in Phase III. Hung is a smooth talker and oozes confidence – a little too much confidence in my opinion. Successful biotech CEOs tend to be cautiously optimistic by nature, not boastful.

When there was tremendous buzz about Dimebon, Hung became a rock star at investing conferences, once telling me, “I’ve made a lot of people (investment managers) heroes.”

Before you think this is sour grapes, you should know that my subscribers took big gains on Medivation during the Dimebon run-up and eventual fall. When the stock took off in anticipation of Phase III results, I recommended selling a sizeable chunk of the position, ensuring gains, even if disaster struck, which it did.

Will history repeat itself with MDV3100? In fairness, it appears to be a better-run study than the Dimebon trial. However, the company’s track record and recent run-up in the stock suggests to me that investors will be better off if they take the money and run.

Black Box Warning

ISIS Pharmaceuticals (Nasdaq: ISIS) – I’ve been banging on this one for a while now. ISIS, along with partner Sanofi-Aventis, plans on filing for FDA approval for cholesterol drug Mipomersen before the end of the year.

Mipomersen treats a rare genetic form of extremely high cholesterol. The drug works. There’s little controversy about that. The problem is that in every clinical trial, the drug has raised liver enzymes, which is a sign of toxicity.

Supporters say no patients have actually gotten sick on the drug and that the elevated enzymes are no big deal. Detractors argue that patients will have to stay on therapy for life and that the toxicity will become a problem as patients take the Mipomersen over many years.

My prediction is that the FDA either asks for more information (as they have done in the past) or approves it with a black box warning label, which should hurt sales. A black box warning cautions doctors and patients as to the severe side effects that are possible with the medication. ISIS is near its lows, but I don’t think this one is worth the considerable risk.

Come On, Mann…

MannKind (Nasdaq: MNKD) – If you’re in the plumbing supplies business, it’s alright to name your company after yourself. Same thing if you’re opening a law firm. Not so much, though, if you’re starting a biotech company.

Yet that’s what Al Mann did at MannKind. The CEO was nominated by TheStreet.com’s biotech reporter Adam Feuerstein as one of the Worst Biotech CEOs of the year. I’ve seen him speak at investor conferences before. And while he’s charismatic, you get the impression if this was 100 years ago, he’d be selling snake oil instead of inhalable insulin.

Inhalable insulin has so far not been shown to be commercially viable. Nektar Therapeutics’ (Nasdaq: NKTR) and Pfizer’s (NYSE: PFE) Exubera was a commercial disaster. Despite projections of $2 billion in sales, it only generated $12 million in revenue before being pulled from the market. MannKind’s version, called Afrezza, hasn’t even been able to obtain FDA approval, despite several attempts.

The company has $224 million in assets, of which $196 million is property, plant and equipment, while it has $210 million in debt. Stockholders’ equity is negative $280 million. Over the past year, it has burned an average of $33 million a quarter. At the end of the September quarter, it has just $22 million in cash.

Somehow the stock still has a market cap of $365 million. If you own the stock, I suggest get out now while there’s still something left to sell.

Although the rewards can be great, investing in small cap biotech stocks can be risky even under the best circumstances. In these three situations, the reward does not justify the enormous risks.

http://www.investmentu.com/2011/December/three-biotech-sell-before-2012.html

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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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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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SAN FRANCISCO, CA — (MARKET WIRE) — 11/09/11 — Medivation, Inc. (NASDAQ: MDVN) today provided a corporate update and reported its financial results for the third quarter ended September 30, 2011.

“The positive interim analysis results that we reported last week from our AFFIRM trial, in which MDV3100 produced a clinically meaningful and statistically significant 4.8-month increase in survival and a 37% reduction in risk of death in post-chemotherapy advanced prostate cancer patients, are an important step toward making this life-extending potential treatment available to the prostate cancer community,” said David Hung, M.D., president and chief executive officer of Medivation. “I am also pleased to announce that just yesterday the FDA granted us Fast Track designation for the post-chemotherapy indication, a designation that is reserved for development programs that the FDA determines to be for life-threatening conditions with unmet medical need. Our AFFIRM interim analysis data are clinically significant in this end-stage patient population, and increase the chance that MDV3100 may potentially demonstrate benefit in the much larger earlier-stage patient populations that we are currently studying in our ongoing clinical trials.”

“Based on the strength of these data, we have elected to exercise our co-promotion option to provide fifty percent of the U.S. sales force under our collaboration with Astellas,” continued Dr. Hung. “We will also provide fifty percent of the U.S. medical affairs support. This decision marks the potential transition of our company from a pure development organization to an integrated commercial organization, and we are actively planning for a successful launch of MDV3100 in post-chemotherapy patients should we receive marketing approval.”

Recent Accomplishments and Anticipated Milestones

MDV3100

• Announced the results of a pre-specified interim analysis in the Phase 3 AFFIRM trial, which is evaluating the effect of MDV3100 on overall survival in 1,199 men with advanced prostate cancer who have previously been treated with docetaxel-based chemotherapy. The data showed that MDV3100 produced a 4.8-month advantage in median overall survival compared to placebo, with median survival of 18.4 months in the MDV3100 group versus 13.6 months in the placebo group. MDV3100 also provided a 37% reduction in risk of death compared to placebo (hazard ratio = 0.631). The interim analysis results were statistically significant, with a p-value of less than 0.0001. A full analysis of the AFFIRM results, including safety data, will be submitted for presentation at an upcoming scientific congress.
• Based on the above results, the independent data monitoring committee (IDMC) overseeing the AFFIRM trial recommended that the study be stopped early and that all patients be offered MDV3100. The Company and its alliance partner Astellas expect to hold a pre-NDA meeting with the FDA in early 2012 and will provide an update on regulatory timelines for MDV3100 thereafter. Acceptance for filing of the NDA for the post-chemotherapy indication would trigger a $10 million milestone payment under Medivation’s collaboration agreement with Astellas.
• Received Fast Track designation from the FDA for MDV3100 in the post-chemotherapy indication. Receipt of Fast Track designation enables us to request the FDA grant us priority review for our anticipated NDA in post-chemotherapy patients. In considering requests for priority review, the FDA applies the same standard it uses to award Fast Track designation.
• Continued to enroll patients globally in the Phase 3 PREVAIL trial, which is evaluating the effect of MDV3100 on overall survival and progression-free survival in 1,700 men with advanced prostate cancer who have not yet received chemotherapy.
• Continued to enroll patients in the Phase 2 TERRAIN trial, which is comparing the effect of MDV3100 versus bicalutamide, the most commonly used anti-androgen, on progression-free survival in approximately 370 men with advanced prostate cancer who have progressed following medical castration with LHRH analog therapy or surgical castration.
• Continued to enroll patients in an open-label Phase 2 clinical trial designed to evaluate the effect of MDV3100 in 60 men with advanced prostate cancer who have not had any previous hormonal therapies. This trial marks the first step to determine whether MDV3100 can achieve comparable tumor control to LHRH analogs, as measured by prostate-specific antigen (PSA) response, while avoiding the negative quality of life impacts of castration.

Dimebon (latrepirdine)

• Remained on track to announce top-line results from the 12-month Phase 3 CONCERT trial in the first half of 2012. This trial completed enrollment in November 2010 with a total of 1,003 mild-to-moderate Alzheimer’s disease patients and is evaluating dimebon when added to ongoing treatment with donepezil, the leading approved treatment for mild-to-moderate Alzheimer’s disease.

Corporate

• Appointed Cheryl Cohen as chief commercial officer and Stewart Hallett as vice president, clinical operations.
• Exercised its co-promotion option for MDV3100 under the Astellas collaboration agreement. Should MDV3100 receive marketing approval, the Company will provide fifty percent of the sales and medical affairs field forces in support of MDV3100 in the United States.

Third Quarter 2011 Financial Results

Revenue for the third quarter of 2011 was $14.9 million, consisting of partial recognition of the non-refundable up-front and development milestone payments to date from the Company’s corporate partners Astellas and Pfizer. 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 were $26.4 million, compared with total operating expenses of $21.1 million for the same period in 2010. These figures include non-cash stock-based compensation expense of $3.2 million in the quarter ended September 30, 2011, compared with $3.3 million for the same period in 2010.

For the nine months ended September 30, 2011, total operating expenses were $76.4 million, compared with total operating expenses of $77.7 million for the same period in 2010. These figures include non-cash stock-based compensation expense of $10.5 million in the nine months ended September 30, 2011, compared with $10.0 million for the same period in 2010.

Medivation reported a net loss for the quarter ended September 30, 2011 of $10.0 million, or $0.29 per share, compared with a net loss of $5.4 million, or $0.16 per share, for the same period in 2010. For the nine months ended September 30, 2011, the net loss was $28.0 million, or $0.80 per share, compared with a net loss of $30.1 million, or $0.88 per share, for the same period in 2010.

Cash, cash equivalents and short-term investments at September 30, 2011 totaled $163.4 million, compared with $207.8 million at December 31, 2010.

2011 Financial Outlook

Medivation continues to expect total operating expenses for 2011, net of cost-sharing payments from Astellas and Pfizer, to be between $100.0 and $110.0 million. This forecast includes approximately $14.0 million of non-cash stock-based compensation expense.

http://investors.medivation.com/releasedetail.cfm?ReleaseID=622443

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Medivation Inc. (MDVN – Analyst Report) reported first quarter 2009 financial results following the market close on May 11, 2009. Revenue came in at $16.34 million, exactly where we had it modeled. Revenue consisted solely of collaboration revenue from Pfizer. EPS was ($0.19), significantly ahead of our forecast of ($0.34), due to substantially lower-than-expected operating expenses.

Pfizer makes quarterly true-up payments to Medivation as reimbursement for a significant portion of Dimebon-related development and commercialization expenses. In the first quarter 2009, Pfizer made a $5.8 million true-up payment to MDVN, which is reflected as a reduction in operating expenses – approximately $5.4 million of the true-up payment hit the R&D expense line-item.

In October 2008 Medivation received $225 million in collaboration revenue from Pfizer, which will be recognized on a straight-line basis through the first quarter of 2012. The company will likely not generate any other revenue or receive any development milestone payments in 2009.

We expect operating expenses to spike to near $120 million in 2009 (from $77 million in 2008), as the company funds larger clinical trials of both Dimebon and MDV3100. We model $65.4 million in collaboration revenue and EPS of ($1.65) in 2009.

An NDA filing for Dimebon for the treatment of Alzheimer’s is possible in 2010, depending on the success of the CONNECTION and safety studies. We more conservatively model a Dimebon Alzheimer’s filing in 2011, supported from all 5 of the phase III Alzheimer’s studies. We believe Dimebon could launch with a broad label, including for the treatment of mild-through-severe Alzheimer’s as a monotherapy as well as a combination therapy. We model a Dimebon launch in 2012 for both the Alzheimer’s and Huntington’s indications.

We view MDV3100 as more of a wild-card, but with significant upside depending on the outcome of phase III trials. Safety, most notably seizures, are a concern but appear to be possibly dose-related or related to background medication, and occurred in patients treated at doses greater than 240mg. The phase III trial will exclusively use the 240mg dose.

We also believe Medivation could be looking to partner MDV3100 in the near-term, potentially before phase III testing begins later this year. A partnership would reduce Medivations’ development costs, dilute the risk of failure of MDV3100 and potentially bolster the company’s cash position.

With cash-burn rates materially increasing in 2009 and 2010, a partnering deal for MDV3100 would also significantly reduce the need to raise additional capital before Dimebon launches.

We expect the company to remain unprofitable through at least 2010 and currently model EPS of $0.11 in 2011 as development milestones push the company towards positive earnings. We think this grows to $0.32 in 2012 on the heels of the Dimebon launch. EPS upside to our forecast could materialize with an earlier-than-expected NDA filing for Dimebon and/or a partnering deal for MDV3100.

Medivation shares currently trade at $22.41. We recommend that investors hold at the current price, and forecast an EPS loss of $1.65 in 2009. Our price target is $25.

http://www.zacks.com/stock/news/21612/Medivation

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]]> http://dimebonalzheimers.com/1017/medivation-dimebon-launch-2/feed/ 0 http://dimebonalzheimers.com/1010/pfizer-medivation%e2%80%99s-dimebon/ http://dimebonalzheimers.com/1010/pfizer-medivation%e2%80%99s-dimebon/#comments Mon, 24 Oct 2011 09:11:14 +0000 admin http://dimebonalzheimers.com/?p=1010
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 [...]



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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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BOSTON  — This week’s Biotech Stock Mailbag opens with good news.

Sepgeninvestor writes, “Adam, I value your skepticism about biotechs in general. You saved me more times than I can count, but I wish you’d write more about the biotech stocks that you like. Are there any positive stocks you want to highlight for the end of the year?”

Valid criticism. Guilty as charged. I’m a glass-half-empty guy so focusing more on what’s wrong in biotech is irresistible to me. In my defense, I will say that my early August call recommending Celgene(CELG) and Alexion Pharmaceuticals(ALXN) as a safer haven for biotech investors amid an ugly stock market turned out prescient and profitable.

Looking ahead, I’m most excited and optimistic about the prospects for Medivation(MDVN) and Targacept(TRGT) as each stock nears make-or-break releases of data from pivotal late-stage clinical trials.

Medivation’s BIG EVENT is the fourth-quarter interim analysis of the phase III “Affirm” study of MDV3100 in advanced prostate cancer patients who have progressed after chemotherapy.

Positive results from the MDV3100 study propels Medivation’s stock price into the high $20s or even $30s (depending on how good the data are.) Failure sends Medivation shares plummeting to around cash, call it $5-$6 a share. [I'm offering these guesses on stock moves with the assumption that a global recession doesn't completely obliterate the equity markets. Wishful thinking, perhaps.]

The primary endpoint of the MDV3100 study is overall survival compared to a placebo, the gold standard for cancer drug stocks. Medivation designed the study to show an approximate 20% reduction in the risk of death favoring MDV3100, or about a three-month median survival advantage.

Another important benchmark for success, particularly as it relates to Medivation’s stock price, is the 3.9-month survival advantage in the same prostate cancer patient population demonstrated by Johnson & Johnson’s(JNJ) Zytiga.

Zytiga and MDV3100 will compete for the same prostate cancer patients, so investors will want to see similar efficacy between the drugs. Zytiga must be administered with a steroid that can cause side effects. That’s a potential advantage for MDV3100, which doesn’t require steroid co-administration.

A win in the MDV3100 study will also be a nice resurrection story for Medivation and its CEO David Hung following the Dimebon — Dimebomb — Alzheimer’s blow-up. Hung has proven himself to be one of the best dealmakers in biotech, negotiating huge partnerships with Pfizer(PFE) and Astellas, but he needs a drug development victory to gild his reputation.

Targacept is waiting for its partner AstraZeneca(AZN) to take the wraps off results from the first of four phase III studies of TC-5214 in depression augmentation. [TC-5214, if approved, would be prescribed as an add-on therapy for patients who respond poorly to commonly used anti-depressants.]

http://www.thestreet.com/story/11257078/1/biotech-stock-mailbag-medivation-targacept.html?cm_ven=GOOGLEN

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We recently reiterated a Neutral recommendation on biopharmaceutical company Medivation Inc. (MDVN – Analyst Report). Medivation, which currently does not have any marketed product in its portfolio, focuses on the development of novel small molecule drugs for the treatment of serious diseases for which there are limited treatment options.

Medivation currently has two lead candidates in its pipeline — dimebon (latrepirdine), which is being developed for the treatment of Alzheimer’s disease, and MDV3100, which is being developed for the treatment of castration-resistant prostate cancer. While dimebon is partnered with Pfizer Inc. (PFE – Analyst Report), the prostate cancer program is partnered with Astellas Pharma. Both dimebon and MDV3100 are in phase III development.

However, Medivation suffered major development setbacks with dimebon, which failed to achieve its primary endpoints in phase III studies for Alzheimer’s and Huntington disease. The results were a huge disappointment for Medivation. Although dimebon is in a phase III study (CONCERT) for mild to moderate Alzheimer’s disease, we have low expectations from this study.

Moreover, we are concerned that partner Pfizer could opt out from the dimebon collaboration. We note that Pfizer already has another Alzheimer’s candidate, bapineuzumab, in its portfolio that is being developed with Johnson & Johnson (JNJ – Analyst Report). Considering the development setbacks with dimebon, Pfizer could decide to focus its efforts towards the development of bapineuzumab.

Meanwhile, MDV3100 is currently in several studies including a phase III study (AFFIRM) in men with castration-resistant prostate cancer who were previously treated with Sanofi-Aventis’ (SNY – Analyst Report) Taxotere (docetaxel)-based chemotherapy. We expect investor focus to remain on an interim analysis of this study scheduled for later this year.

http://www.zacks.com/stock/news/60625/Medivation+Remains+Neutral

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