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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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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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Loss Increases At Medivation

admin — Wed, 23 Nov 2011 00:17:50 +0000

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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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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Morgan Joseph Analysts Initiate Coverage on Medivation Inc (MDVN)

admin — Sat, 24 Sep 2011 04:08:06 +0000

Analysts at Morgan Joseph initiated coverage on shares of Medivation Inc (NASDAQ: MDVN) in a research note on Wednesday. The analysts set a “buy” rating and a $30.00 price target on the stock.

Medivation, Inc. is a biopharmaceutical company. The Company focuses on the development of small molecule drugs to treat serious diseases. The Company’s product candidates in clinical development are dimebon (latrepirdine), which is in Phase III development for the treatment of Alzheimer’s disease and Huntington disease, and MDV3100, which is in Phase III development for the treatment of castration-resistant prostate cancer. Its dimebon program is partnered with Pfizer Inc. (Pfizer) and its MDV3100 program is partnered with Astellas Pharma Inc. (Astellas).Shares of Medivation Inc opened at 18.74 on Thursday. Medivation Inc has a 52 week low of $9.86 and a 52 week high of $25.50. The stock’s 50-day moving average is $17.97 and its 200-day moving average is $19.98. The company has a market cap of $654.2 million.

http://www.newsystocks.com/News/4107368/morgan-joseph-analysts-initiate-coverage-on-medivation-inc-mdvn

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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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Dimebon fails in late-stage human HD clinical trial

admin — Fri, 19 Aug 2011 13:34:45 +0000

Dimebon fails to improve symptoms in HD patients in the HORIZON trial

Dimebon, an experimental drug marketed by Medivation, fails to improve the symptoms of Huntington’s disease patients in the HORIZON trial. This is the end of the road for developing this drug for HD.

What is Dimebon?

Dimebon is an old drug, actually developed as an allergy medicine in Russia. Based on improvements in the mental or ‘cognitive’ symptoms in some Alzheimer’s disease patients taking the drug, it was developed by Medivation and Pfizer as a potential treatment for both Alzheimer’s and Huntington’s disease.

What’s been done before?

In the early phases of drug development, clinical trials are aimed at showing that the drug is not harmful, in small numbers of healthy volunteers or patients. The earlier DIMOND trial looked at the effect of Dimebon on 90 HD patients taking either Dimebon or a placebo. That trial showed that Dimebon was safe, and suggested there might be some benefit in the mental problems associated with HD.

A larger “phase III” trial was therefore conceived. Called HORIZON, this trial involved several hundred HD patients in Europe and the USA, with the goal of definitively proving that Dimebon helped with the cognitive symptoms of HD.

Phase III trials are the final stage before a drug company applies to the regulatory agencies for approval for a drug. Success or failure at the phase III level is what ultimately controls what drugs are available to patients.

Worryingly, in the meantime, Dimebon had failed to improve symptoms in a large phase III study of hundreds of Alzheimer’s disease patients. The failure of that larger trial raised concerns about the drug. Nevertheless, because of the positive results from the DIMOND trial, the HORIZON trial in HD patients continued.

What are the results?

The HORIZON trial focused on two measures — a short mental quiz called the ‘mini-mental state examination’ and another score (called the ‘CIBIC-plus’), which is based on a physician’s impression of a patient’s symptoms.

Both of these measures failed to improve in the patients taking Dimebon, compared to those taking placebo. The numbers were not close — it was a clear failure on both measures.

Now what?

According to a press release issued by Medivation, David Hung (president and CEO) has said “we will discontinue development of Dimebon in Huntington disease, including the ongoing open-label extension study” — the end of the road for Dimebon in Huntington’s Disease.

Silver linings?

There’s usually an up-side to bad news in science. One way to look at this disappointing announcement is that the results were very clearly negative, with no room for doubt. That means it’s now clear that studying Dimebon further in Huntington’s disease isn’t worthwhile — so patients and researchers can spend precious time and resources developing other treatments — and, as our other HDBuzz articles will hopefully demonstrate, there are plenty of those in the pipeline.

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Pfizer/Medivation Dimebon fails as Huntington disease drug

admin — Tue, 02 Aug 2011 14:38:32 +0000

Pfizer and Medivation’s Dimebon, which failed as a potential treatment for Alzheimer’s last year, has now disappointed in a late-stage trial for Huntington disease.

The companies have presented results from the 403-patient Phase III HORIZON study of Dimebon (latrepirdine) which show that the drug did not achieve statistical significance for either of the co-primary endpoints of the trial. Full results are expected to be presented at an upcoming medical meeting.

David Hung, Medivation’s chief executive, said “we are disappointed with the results of the HORIZON trial given the high unmet need in this patient population”. He added that “at this point, we will discontinue development of Dimebon in Huntington disease, including the ongoing open-label extension study”.

However this may not be the end of the road for Dimebon, which was first sold in Russia as an antihistamine. Dr Hung noted that the firms will continue a 12-month Phase III trial looking at the benefit of adding Dimebon to Eisai/Pfizer’s Aricept (donepezil) in patients with mild-to-moderate Alzheimer’s disease. Top-line data from that study is expected in the first half of 2012.

Last March, Dimebon failed in an Alzheimer’s trial where no statistically significant improvements were achieved on cognition, global function, activities of daily living or behaviour.

Pfizer linked up with Medivation in September 2008 in a deal which saw the latter pocket an upfront cash fee of $225 million with milestone payments of up to $500 million, depending on the success of Dimebon.

http://www.pharmatimes.com/article/11-04-12/Pfizer_Medivation_Dimebon_fails_as_Huntington_disease_drug.aspx

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