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

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

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

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

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

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

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

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Pfizer and Medivation ended their collaboration on the experimental drug Dimebon for Alzheimer’s disease after the medicine failed in another late-stage clinical trial.

Dimebon was one of two drugs Pfizer had in its late-stage pipeline to treat the neurodegenerative disease. The other is bapineuzumab, which Pfizer is developing with Johnson & Johnson. The treatments have different mechanisms of action.

Dimebon didn’t show statistically significant results in a study that evaluated the compound when added to a standard treatment in patients with mild to moderate forms of the disease, the companies said Tuesday. The companies will end development of the drug for all uses, and will stop a current study.

San Francisco’s Medivation dropped 3.3 percent to $53.90 at the close in New York. Pfizer, the world’s biggest drugmaker, gained less than 1 percent to $21.94.

Dimebon also failed in a late-stage trial in 2010, sending Medivation shares down 67 percent in one day.

The federal Centers for Disease Control and Prevention in Atlanta estimates that at least 5 million Americans have Alzheimer’s. The disease usually begins affecting people around age 60. There is no known cure.

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Ending Dimebon Development: Pfizer and Medivation are ceasing development of Dimebon, an experimental Alzheimer’s treatment, the WSJ reports. It was the second phase 3 trial of the drug to fail. In 2008 Pfizer agreed to pay Medivation $225 million upfront plus up to an additional $500 million if milestones were met for development rights to Dimebon, the paper says.

Polio Setback: The number of polio cases in Afghanistan tripled to 76 in 2011, alarming public-health experts, the New York Times reports. The Taliban has historically permitted volunteers and workers to move freely and vaccinate people to prevent the disease’s spread; health workers say that has not changed, the paper says. Cases may have spread by travelers from Pakistan, where the disease is also endemic.

Marketing Confusion?: Branding experts aren’t particularly keen on celebrity chef Paula Deen’s partnership with pharma company Novo Nordisk, which makes drugs for type 2 diabetes, the WSJ reports. Deen revealed yesterday that she has had the disease for about three years. Her brand is all about “rich, tasty and decadent eating” but now she is supposed to be about “eating healthy and low fat,” Allen Adamson, managing director of Landor New York, a branding firm owned by WPP, told the WSJ. “It’s a big change to expect consumers to buy into,” he said.

Condom Requirement: The Los Angeles City Council voted 9-1 to approve an ordinance mandating condom use by actors in the pornography industry, the Los Angeles Times reports. The measure was supported by groups including the AIDS Healthcare Foundation but opposed by the porn industry.

http://blogs.wsj.com/health/2012/01/18/a-m-vitals-pfizer-medivation-end-dimebon-development/

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Latrepirdine attracted renewed interest in 2009 after being shown in small preclinical trials to have positive effects on persons suffering from Alzheimer’s disease. Animal studies showing potential beneficial effects on Alzheimer’s disease models were shown in Russian research in 2000. Preliminary results from human trials have also been promising. In an initial six-month phase II trial, results have shown that at 12 months there was significant improvement over placebo. Latrepirdine showed promising results in a Phase III equivalent double blind trial in Russia with mild–moderate stage patients. In April 2009, Pfizer and Medivation initiate a phase III trial (CONCERT study) aiming for FDA approval. In March 2010, Pfizer announced that this clinical trial failed to show any benefit for the treatment of Alzheimer’s disease patients.

Numerous phase III trials for AD were recruiting in 2009.

In July 2009 Pfizer and Medivation announced that latrepirdine will be the proposed international nonproprietary name for latrepirdine for the treatment of Alzheimer’s.

In March 2010 the results of a clinical trial phase III were released. It was announced that the investigational Alzheimer’s disease drug dimebon failed in the pivotal CONNECTION trial of patients with mild-to-moderate disease.

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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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Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, if Pfizer/Medivation’s Dimebon shows efficacy in two ongoing clinical trials in moderate to severe Alzheimer’s disease that is equivalent to the impressive clinical trial data it has already shown to date in mild to moderate patients, these positive data would promote the use of Dimebon throughout the course of the disease. As a result, following its expected launch in 2012, Dimebon will garner peak year sales of $1.5 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

The Phase III CONTACT clinical trial for patients with moderate-to-severe Alzheimer’s disease will investigate the effect of Dimebon on neuropsychiatric symptoms and activities of daily living in patients who are already receiving a stable dose of donepezil (Eisai/Pfizer’s Aricept, Bracco’s Memac). The Phase III CONSTELLATION clinical trial will investigate slightly different end points: the effect of Dimebon on cognition, memory and activities of daily living in patients already receiving a stable dose of memantine (Merz/Grupo Grunenthal’s Axura/Akatinol, Lundbeck’s Ebixa, Forest Laboratories’ Namenda).

The Pharmacor finding from the topic entitled Alzheimer’s Disease also reveals that, through 2018, robust 11 percent annual growth in the Alzheimer’s disease drug market will be driven by the launch and uptake of new anti-amyloid monoclonal antibodies, most notably Johnson & Johnson/Pfizer’s bapineuzumab and Eli Lilly’s solanezumab.

“Although monoclonal antibodies are expected to offer superior efficacy over other drugs in the market, their uptake will be initially slow following their launches, owing to potential safety concerns,” said Decision Resources Analyst Matthew Winton, Ph.D. “Nevertheless, bapineuzumab and solanezumab will achieve combined sales of nearly $6 billion in 2018.”

About Pharmacor

The newly redesigned Pharmacor advisory service offers clients in the biopharmaceutical industry the most up-to-date information available on commercially significant disease topics.

About Decision Resources

Decision Resources ( www.decisionresources.com ) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions.

All company, brand, or product names contained in this document may be trademarks or

registered trademarks of their respective holders.

http://www.prnewswire.com/news-releases/for-the-treatment-of-alzheimers-disease-pfizermedivations-dimebon-will-garner-peak-year-sales-of-15-billion-81128002.html

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For years Elan has struggled to deliver for its investors–with little success. It spent quite some time talking about restructuring without actually accomplishing much. It had to deal with a severe safety issue with Tysabri, its drug for multiple sclerosis. And its stock has suffered so badly that using a private jet for executive trips earned catcalls from analysts and shareholders alike. Back in 2008, The Street‘s Adam Feuerstein named CEO Kelly Martin the worst chief executive in biotech.

Now Martin is planning to step down after focusing the company on a narrow set of research goals. The delivery tech side of the business was finally bought out by a savvy group at Alkermes and Elan is focused on building its Tysabri franchise, depending on its revenue from sales to fund some new drugs in the pipeline while it scouts for fresh partnerships.

Bloomberg‘s “Exhibit A” in the pipeline: Bapineuzumab, the Alzheimer’s drug being advanced by J&J ($JNJ) and Pfizer ($PFE). Elan still has rights to some of the revenue from the treatment, a late-stage program angling to become the first new Alzheimer’s med to get approved since 2004. Alzheimer’s remains one of the most complex unmet medical needs in the business. Any new drug that can warrant an approval could earn a sizeable amount from a huge patient population. In this case some analysts are looking at mega-blockbuster returns, but Alzheimer’s remains a wild card in the drug development business, as Pfizer learned with its big upfront deal for the disappointing Medivation drug Dimebon. And Elan learned long ago that over-promising on this Alzheimer’s program has a big down side.

“You can buy Elan stock right now and still grab the upside of Tysabri, with bapineuzumab being the lottery ticket,” Jefferies’ Corey Davis tells the business news service.

In an interview with Bloomberg, Elan’s CEO also highlighted early-stage for ELND002, its next-gen successor to Tysabri that is fully owned by Elan. And Martin made it clear that his $20 million development deal with Proteostasis is a model for future pacts.

http://www.fiercebiotech.com/story/after-restructuring-elan-focuses-its-rd-priorities/2011-10-19

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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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