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Medivation and Pfizer Announce Results from Phase 3 Concert Trial of Dimebon in Alzheimer’s Disease

admin — Thu, 02 Feb 2012 08:32:43 +0000

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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Alzheimer’s drug fails for Pfizer, Medivation

admin — Sun, 29 Jan 2012 08:32:11 +0000

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.

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2012/01/17/BUD01MQG0I.DTL

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Pfizer, Medivation end development of potential Alzheimer’s treatment Dimebon

admin — Sat, 21 Jan 2012 12:26:49 +0000

TRENTON, N.J. — In a major setback for patients and doctors, drugmakers Pfizer Inc. and Medivation Inc. have halted development of a potential Alzheimer’s disease treatment after the drug for a second time yielded disappointing results in a late-stage clinical study.Dimebon was furthest along in testing among the experimental Alzheimer’s drugs being developed to try to stop or even reverse the course of the mind-robbing disease. Dimebon would have been the first such drug and specialists just a couple of years ago had hoped it would be on the market this year.

Pfizer, the world’s largest drugmaker by revenue, and Medivation said on Tuesday that Dimebon failed to significantly improve cognitive ability, as well as self-care and daily functions in patients with mild-to-moderate cases of the disease. The study involved about 1,000 patients who had Dimebon added to their ongoing treatment with Pfizer’s former blockbuster Alzheimer’s drug donepezil, or Aricept.

Aricept, jointly marketed by Pfizer and Japan’s Esai Co. Ltd. and once heavily advertised, had about $3.7 billion in sales in 2009. It lost U.S. patent protection in November 2010, and sales have since plunged.

Dimebon, known chemically as latrepirdine, would have been an even bigger blockbuster if it had panned out. The experimental drug looked promising after it kept Alzheimer’s symptoms from worsening for a year in an earlier patient study.

But Dimebon didn’t work as hoped in a late-stage trial in which patients took it for six months. After those results, announced in March 2010, the companies said they were continuing three other studies that could prove Dimebon helped patients in combination with other Alzheimer’s drugs or when used for a longer period.

Then last April Pfizer and Medivation said Dimebon also failed in another late-stage clinical trial, when it did not improve symptoms of the neurologic disorder Huntington’s Disease.

After the latest failure, New York-based Pfizer and Medivation, headquartered in San Francisco, said they are ending development of Dimebon, as well as their agreement to market the potential treatment.

Pfizer still has one Alzheimer’s treatment in late-stage testing, bapineuzamab, which it is jointly developing with Johnson & Johnson. It’s a biologic drug, grown in living cells rather than made by mixing chemicals, and works differently than Dimebon.

Alzheimer’s disease is the most common form of dementia, and drugmakers are trying to find a treatment that does more than temporarily ease the symptoms: memory problems, confusion, aggression and a general decline in ability to function, which together can hasten death. Many drugs have flopped in late-stage testing in recent years, including some that seemed to clear harmful plaque from afflicted brains.

The newest drug for Alzheimer’s symptoms, Namenda, was approved back in 2003.

Cases of Alzheimer’s disease are expected to triple by 2050, to around 106 million people worldwide. The disease strikes nearly a half million new patients a year, mainly as people hit their 70s or 80s.

In trading Tuesday, Pfizer shares rose 9 cents to $21.93, while Medivation stock dropped $1.82, or 3.3 percent, to $53.90.

http://www.washingtonpost.com/business/industries/pfizer-medivation-end-development-of-potential-alzheimers-treatment-dimebon/2012/01/17/gIQA91uF5P_story.html

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Dimebon Clinical Trials

admin — Mon, 09 Jan 2012 01:04:11 +0000

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

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

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

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

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

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

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

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

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

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

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Medivation Back to Neutral – Analyst Blog

admin — Fri, 02 Dec 2011 06:20:37 +0000

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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Hidden Gems In Pfizer’s Annual Report May Reveal The Holy Grail Of Pharmaceuticals

admin — Sun, 27 Nov 2011 00:18:46 +0000

The news is awash these days with well-meaning analysts’ rhetoric of Pfizer’s (PFE) upcoming demise due to expiring patents. But scrutiny of Pfizer’s 2010 Annual Report offers the long-term investor a more balanced perspective. Not only does Pfizer have 24 drug programs in Phase III clinical trials, it also has an additional 354 products under various stages of development. Surely a company known for delivering blockbuster drugs such as Lipitor, which loses its exclusivity this month, and Viagra, which loses its patent protection in 2012, has the scientific capability to continue to deliver breakthrough drugs in the future.

On a side note and interestingly enough, Viagra was targeted by the government as a drug class “erectional dysfunction” that could not be cost-reimbursed through Medicaid or Medicare Part D. Apparently the federal government did not want any potential four-hour porn stars roaming the land. Pfizer cautions that the government could always target other drugs in such a manner for varying reasons.

However, the strong pipeline of new drugs and commitment to R & D bodes well for Pfizer’s future. And two of the drugs under development, or perhaps offshoots thereof such as “Bapineuzumab A beta amyloid inhibitor for the treatment of Alzheimer’s disease being developed in collaboration with Janssen Alzheimer Immunotherapy Research & Development, LLC (Janssen AI), a subsidiary of Johnson & Johnson” and “Dimebon (latrepirdine) A novel mitochondrial protectant and enhancer being developed in collaboration with Medivation, Inc., for the treatment of Alzheimer’s disease and Huntington’s disease” have the potential to become Holy Grail drugs of the 21st Century. Dimebon studies faced a setback during Phase III clinical trials and did not meet expectations for moderate-severe Alzheimer’s. But is now being considered on milder cases. Bapineuzumab is moving forward with international clinical studies. According to Pfizer, most developed nations require their own in-country clinical trials based on local populations prior to receiving the green light for approval.

In an article entitled Alzheimer’s Association Study ‘Generation Alzheimer’s’ Defines Baby Boomers Disease And Urgency To Increase NIH Research, posted on Memoryzine.com, it is noted that:

“In 2011, the oldest Baby Boomers turn 65 -the age when Alzheimer’s disease starts to rise. Thus begins an 18 year process when every 7 seconds another American turns 65- 12,342 people daily ending in 2029 when half of those remaining will be impacted by Alzheimer’s disease.”

As noted in the Sept 10, 2010 Pharmaletter:

“DR’s Pharmacor 2010 findings from the topic titled Alzheimer’s Disease reveal that growth will be driven primarily by the first biologic agents to enter the market – Eli Lilly’s solanezumab and Johnson & Johnson/Pfizer’s bapineuzumab. These anti-beta-amyloid monoclonal antibodies (MAbs), which have the potential to slow the rate of neurodegeneration and cognitive decline, together will earn more than $6.9 billion in the world’s major pharmaceutical markets in 2019.”

Pfizer has restated its commitment to focused research in this and other areas in its annual report:

“We recently announced a focus on fewer disease areas where we believe we can deliver the greatest medical and commercial success.”

“Innovation by our research and development operations is very important to the Company’s success. Our goal is to discover, develop and bring to market innovative products that address major unmet medical needs. We spent $9.4 billion in 2010, $7.8 billion in 2009 and $7.9 billion in 2008 on research and development.”

Pfizer’s 2010 expenditures represent a 20% increase in R&D which is a significant increase considering Pfizer has trimmed back the fat in its research arm since the acquisition of Wyeth Pharmaceuticals. This fact alone indicates that the company is not content to sit on its laurels.

Pfizer’s revenue stream is well diversified:

Not only does Pfizer have a healthy pipeline of new drug programs under development, it also has one of the most diversified revenue streams in the industry:

“Revenues from operations outside the U.S. of $38.8 billion accounted for 57% of our total revenues in 2010. Revenues exceeded $500 million in each of 18 countries outside the U.S. in 2010. The U.S. was the only country to contribute more than 10% of our total revenues, comprising 43% of total revenues in both 2010 and 2009 and 42.3% of total revenues in 2008. Japan is our second?largest national market, with 7.5% of total revenues in 2010, 8.5% of total revenues in 2009 and 7.7% of total revenues in 2008.”

Relating this to the future potential of Alzheimer drugs, let it be noted that over half of all patients live in Asia.

Pfizer is well capitalized:

One might believe that given the daunting task of remaking the EU in the eyes of Ben Bernanke and other central banking “superstars” and possible economic pressures in Asia that Pfizer may have a tougher time ahead of it to obtain operational financing. However, Pfizer believes differently:

“The challenging economic environment has not had, nor do we anticipate it will have, a significant impact on our liquidity. Due to our significant operating cash flow, financial assets, access to capital markets and available lines of credit and revolving credit agreements, we continue to believe that we have the ability to meet our liquidity needs for the foreseeable future.”

Pfizer’s debt issues are also highly rated with Moody’s and S&P , garnering an A1 and an AA Rating with a Stable outlook from both.

Pfizer is a dividend king:

For DRI investors and those looking for a long-term play for retirement, Pfizer looks attractive. It has paid out dividends for the past 289 quarters-and, straight through the U.S. financial crisis so far. Its dividend is currently at .80 or (4.1%) per annum. Pfizer can be found on several Top 10 lists of best companies to purchase using Dividend Reinvest Plan investors.

Pfizer may very well prove to be one of the best companies to own over the next twenty years as they focus their efforts on baby boomer related meds. An interesting idea for investors wishing to profit on the other side of the patent expiration play is Teva Pharmaceuticals (TEVA), an Israeli based firm that is going after the generic Viagra market and also has a large and growing portfolio of generics.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

http://seekingalpha.com/article/309415-hidden-gems-in-pfizer-s-annual-report-may-reveal-the-holy-grail-of-pharmaceuticals

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Why Can’t I Buy Dimebon for Alzheimer’s?

admin — Thu, 17 Nov 2011 06:11:56 +0000

Why can’t, I, WE, buy Dimebon for Alzheimer’s disease?

TERMINATED. That is the word they used when the Dimebon clinical trial that my mother was enrolled in was abruptly canceled on May 7, 2010.

The termination was caused by the failure of the Dimebon Connection Study. My mother was not enrolled in the that study. But, because the study failed to produce the necessary results for potential FDA approval the rug was pulled from under our feet.

We weren’t the only ones. There were more than 2,000 patients enrolled in Dimebon clinical trials. This means at least 1,000 participants received Dimebon. The other participants received a placebo.

The study was not terminated due to any safety findings. Dimebon was well-tolerated in clinical trials.

Safety was not an issue. The problem was efficacy. In other words, the drug did not provide enough benefit to participants. From a statistical standpoint it did not stop memory loss. There was some benefits registered on the behavior scale.

Now to my point.

Dotty did benefit. While on Dimebon, she was more alert and her behavior was dramatically improved over what I had come to expect.

Keep in mind here, Dotty was diagnosed before entering the clinical trial as being in the moderate to severe stage of Alzheimer’s. She scored 14 on the MMSE. She also scored 16 during the trial.

I did ask the personnel at the clinical trial site if they thought that Dotty was showing any improvement. They told me yes. I asked how?

Here is an example. At the outset of the clinical trial they showed Dotty a picture of a fork. Then asked, what do you with this? She could not say or demonstrate how you use a fork. When they put a fork in her hand she could demonstrate what you do with a fork.

Later in the study, they did the same test over. Sure enough, Dotty looked at the picture of the fork and then demonstrated what you do with a fork.

By the way, by the point in the clinical trial I didn’t have to ask anyone anything. I saw with my own eyes, ears, and brains that Dotty was a different person.

How much better?

Hold on tight. Better than she had been in many years. Let me set this straight. I couldn’t tell if there was any improvement in Dotty’s memory, and if you would like to know the truth, I didn’t care.

What I did care about was that Dotty seemed to be more interested in living her life. She was a fuller, better person.

My point. I can accept memory loss. I don’t spend much time thinking about Dotty’s memory, or what she can or can’t remember. What I do care about is the look on Dotty’s face, and how she responds to activity.

Dotty clearly looked more there, and was clearly experiencing “more enjoyment”.

As my close friends know, I was “dancing on the ceiling”.

We are not the only one’s that saw benefits from Dimebon. There are several articles and stories on this website from other caregivers that were enrolled in the Dimebon clinical trials.

I know they want an answer to this question.

Why Can’t We Buy Dimebon in the United States?

The drug is safe. The drug has been used in Russia since 1983.

And, Dimebon was proven to be safe in the clinical trials.

http://www.alzheimersreadingroom.com/2011/11/why-cant-i-buy-dimebon-for-alzheimers.html

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Medivation – Dimebon Launch in 2012?

admin — Tue, 01 Nov 2011 08:02:04 +0000

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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After restructuring, Elan focuses on its R&D priorities

admin — Fri, 28 Oct 2011 07:51:48 +0000

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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Medivation – Dimebon Launch in 2012?

admin — Tue, 23 Aug 2011 13:35:17 +0000

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.

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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