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Gaining on Prostate Cancer

admin — Mon, 06 Feb 2012 06:17:29 +0000

Drug Firms Advance Rapidly After Long Drought, but Treatments Are Pricey

Drug companies have scored a string of recent successes against advanced prostate cancer, ending a long drought during which there seemed to be few weapons to combat the disease.

In the latest evidence of progress, researchers reported Tuesday that an experimental drug from San Francisco-based Medivation Inc. extended survival by nearly five months in a 1,199-patient study. A second drug, a radiation-emitter being developed by Bayer AG and Algeta ASA of Norway, targeting prostate cancer that has spread to the bone, improved survival by nearly three months in a 922-patient study.

Results of both trials were released ahead of their presentation at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium being held this week in San Francisco.

If the drugs win approval soon from the Food and Drug Administration, it would mean that after decades of frustration, the pharmaceutical industry will have turned out five new treatments for advanced prostate cancer within just three years.

Those already approved within the past two years include Dendreon Inc.’s Provenge, Jevtana from Sanofi SA, and Zytiga from Johnson & Johnson.

The pharmaceutical industry is increasingly looking for ways to speed development of new drugs—including the realization that closer ties to academic researchers can aid in discovery. Medivation’s compound, called MDV3100, is notable for how it was developed—largely in the research laboratory of Charles Sawyers, a scientist at Memorial Sloan-Kettering Cancer Center with a track record in drug discovery.

Medivation expects to file its application with the FDA this year. Assuming all goes well, the drug could be on a track to win approval about five years after it was first tested in people. “By any standard, that would be considered very, very quick,” said David Hung, Medivation’s chief executive officer.

Also helping progress is a growing understanding of the biology of prostate cancer, a disease fueled largely by the male hormone testosterone.

The new treatments aren’t cures and individually their impact on survival is modest—in clinical trials each added a median of roughly three to five months to patients’ lives. Their high cost is likely to complicate adoption for many patients. Provenge, for instance, costs $93,000 for a course of three treatments while Zytiga’s price is about $5,000 for a monthly supply of pills.

But some researchers believe that the options will lead to new strategies where the drugs are used either sequentially or in combination to significantly extend survival. The new treatments are expected to cause the world-wide market for prostate cancer therapies to surge to $4 billion by 2015, according to Morningstar Inc., up from about $1 billion currently.

“The whole equation for prostate cancer is completely different,” said Christopher J. Logothetis, chief of genitourinary medical oncology at M.D. Anderson Cancer Center, Houston. “It is [now] among the solid tumors that should be considered highly treatable.”

All of this stands in contrast to just a decade or so ago when the disease was considered resistent to almost any treatment. Drug companies would say “nothing has worked in 35 years. Why are we going to throw our [new] drug at that?” said Bruce Roth, professor of medicine and an oncologist at Washington University, St. Louis. “Now we’re starting to see a payoff in the investment in research about the biology of prostate cancer.”

MDV3100 is a case in point. Dr. Sawyers, a Howard Hughes Medical Institute investigator, played important roles in the development of Novartis AG’s breakthrough leukemia drug Gleevec and a second-generation version called Sprycel from Bristol-Myers Squibb Co.

In the mid-1990s, while at University of California at Los Angeles, Dr. Sawyers became interested in why men with prostate cancer relapsed on hormone therapy—the standard treatments, which starve prostate tumors of testosterone, the primary fuel that makes them grow.

Conventional wisdom was that once a patient relapsed, the so-called androgen receptors—structures that protrude from tumor cells like a lock to attract the testosterone “key” that activates them and promotes tumor growth—were no longer driving the disease. Dr. Sawyers was skeptical. In a series of experiments with mice, he and his colleagues found that drug-resistant patients actually had elevated (not lower) levels of androgen receptors. Drugs were now activating them instead of blocking out the testosterone.

“It wasn’t destroying dogma, but it wasn’t what people expected,” Dr. Sawyers said. “It put a spotlight on the androgen receptor as a drug target.”

But he said he wasn’t able to persuade any drug companies to pursue the lead. So he teamed up with a chemist, Michael Jung, at UCLA to design a drug themselves.

Scouring patent databases, Dr. Jung discovered a compound made by the former French drug maker Roussel Uclaf that locked onto the androgen receptor about 100 times more strongly than the commonly used prostate-cancer drug, Casodex.

Using that drug as a template, and taking on a task normally performed by drug-industry scientists, Dr. Jung fashioned some 200 slightly different molecules, which the researchers tested against tumor samples in their own version of the drug industry’s high-volume screening technology. They came up with a promising candidate, tweaked it so it would be absorbed in the blood as a pill and then performed the key experiment—testing it in mice to see if it would shrink tumors.

“It did, very dramatically,” Dr. Sawyers said. But academic scientists aren’t positioned to take the drug across the “valley of death”—the chasm between a promising compound discovered in the lab and the work required to test it in humans, said Dr. Sawyers, who as an inventor of MDV3100 is entitled to royalties on any sales.

In 2005, Medivation agreed to license the drug. The company confirmed the researchers’ findings, tested the molecule and altered its formulation to make it suitable for humans, and filed an application with the FDA to start human studies.

Howard Scher, a veteran of prostate-cancer studies and chief of the genitourinary oncology service at Memorial Sloan-Kettering Cancer, agreed to run the research, which began in 2007. Aided by a 13-center research consortium group funded by the Defense Department and the Prostate Cancer Foundation and intended to speed development of medicines for the disease, researchers ultimately and rapidly enrolled 140 patients, with promising results.

In 2009, Medivation, in collaboration with Astellas Pharmaceuticals Inc. of Japan, launched a late-stage trial, the results of which Dr. Scher reported Tuesday.

Dr. Scher reported that the 800 patients treated with the drug had a median survival of 18.4 months compared with 13.6 months for those given a placebo. In addition, 54% of MDV3100 patients—compared to 1.5% of those on placebo—had a greater than 50% reduction in a marker called prostate specific antigen—an indicator of a positive response to the drug. Side effects included fatigue.

During a news conference to announce the findings, Nicholas J. Vogelzang, chairman and medical director of the developmental therapeutics committee of US Oncology, a cancer treatment company, called the results “unprecedented.” He added: “This is definitely going to change the way we take care of patients every day in the office.”

Dr. Scher said the first patient he treated four and a half years ago is still alive and on the drug. “That’s the beauty of a targeted agent,” he said.

For Medivation, the successful study contrasts with news two weeks ago that, along with partner Pfizer Inc., it was pulling the plug on development of an Alzheimer’s drug called dimebon after it failed to show benefit in a late stage, 1003-patient study.

http://online.wsj.com/article/SB10001424052970203920204577195372964538152.html

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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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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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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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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 Reports Third Quarter 2011 Financial Results and Provides Corporate Update

admin — Sun, 13 Nov 2011 06:05:12 +0000

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 surges on prostate cancer drug data

admin — Wed, 09 Nov 2011 00:02:29 +0000

NEW YORK – Medivation Inc. stock more than doubled in value Thursday after the biotechnology company said a clinical trial of its experimental prostate cancer pill is ending earlier than expected because the study showed the drug worked.

Medivation, which does not have any products on the market, said an early analysis from the study showed that men who were treated with MDV3100 had median survival of 18.4 months. That was 4.8 months longer than men who were treated with placebo, and the company said the drug reduced patients’ risk of death by 37 percent. The late-stage clinical trial compared MDV3100 to placebo in 1,199 men with advanced prostate cancer whose disease had progressed despite chemotherapy and hormone treatment.

The company said it will meet with the Food and Drug Administration in early 2012 to discuss the regulatory pathway for the drug. Analysts said MDV3100 could be approved in early 2013 and annual sales could surpass $1 billion.

Shares of Medivation jumped $20.18 to $36.71 in afternoon trading Thursday.

MDV3100 is designed to block the signaling of androgen receptors, which play an important role in the growth of prostate cancer cells. Medivation and its partner, Astellas Pharma Inc. of Japan, are conducting another late-stage trial of the drug on men who have not received chemotherapy. They are running two mid-stage trials of MDV3100, one involving men who have not been helped by hormone treatment and one in men who haven’t received hormone therapy.

If it is approved, MDV3100 would compete with Johnson & Johnson’s prostate cancer pill Zytiga. The FDA approved Zytiga in April and European regulators cleared the drug in September. Rodman & Renshaw analyst Elemer Piros said that if MDV3100 is launched in early 2013, Zytiga will have a two-year head start. He said the two drugs have similar survival benefits, and said peak sales of MDV3100 could reach $1.2 billion a year.

However, Jefferies & Co. analyst Biren Amin said MDV3100 could have an advantage in survival. Patients treated with Zytiga had median survival of 4.6 months compared to placebo at the end of late-stage testing, but he noted that median survival was 3.9 months after an early analysis like the one Medivation and Astellas reported Thursday. Amin said patients treated with MDV3100 could also have greater survival when a final analysis is complete.

Medivation said full results from the study will be presented at a future scientific meeting.

Amin said he now expects annual sales of MDV3100 to reach $1.48 billion, while analyst Lucy Lu of Citi Investment Research said those sales could be more than $2 billion per year.

Shares of the San Francisco company peaked at $38.48 in morning trading. The stock had traded between $10.96 and $25.50 in the last 12 months. Shares were trading around $40 in late 2009 and early 2010, but the stock plunged in March 2010 after its other key drug candidate, an Alzheimer’s disease and Huntington disease drug called Dimebon, failed in a late-stage trial. Medivation is developing Dimebon through a partnership with Pfizer Inc., and the companies are continuing to test the drug.

http://www.cnbc.com/id/45152458

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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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Pfizer throwing money to buy 700 million experimental drug Dimebon-Pfizer, drug, Dimebon-pharmaceutical industries

admin — Thu, 20 Oct 2011 09:04:26 +0000

Recently, Pfizer agreed to pay San Francisco-based Medivation Inc. up to 725 million U.S. dollars of funds to be used to treat other developed experimental Alzheimer’s drug Dimebon. This is the world’s largest pharmaceutical companies in deals this year, the ninth operation. Under the agreement, Medivation will receive Pfizer USD 225 million down payment, as well as drug listing process, linked to up to 5 million milestone payment.

Hot Present, pharmaceutical companies are racing to develop for the treatment of Alzheimer’s disease drug. Analysts believe that 2012, the size of this market could grow to 20 billion U.S. dollars. Although Pfizer has been on sale for Alzheimer’s disease therapy Aricept, but in 2010, the drug will face competition from generic drug companies, while the other is developing Alzheimer’s Treatment drugs have not yet entered the final testing stage. Therefore, the transaction may help Pfizer in the treatment of Alzheimer’s disease to achieve a quantum leap in the field, and with the development of such drugs, Lilly, Wyeth and Elan Corporation to compete.

Pfizer has the world’s best-selling drug Lipitor last year, this reduction Cholesterol Drug sales 12.7 billion. However, Lipitor will lose patent protection in 2011 and faces generic competition this end, the hands hold 29,000,000,000 US dollars cash, Pfizer is searching for new drugs to cover sales of Lipitor left empty .

Analyst at Miller Tabak in New York LesFuntleyder that, although Alzheimer’s disease is a difficult to treat disease, but Pfizer, this deal appears to be a positive risk-return opportunities, if Pfizer wants to make up for the next few years will experience significant economic losses, it needs to continue aggressive.

Two companies will share development and marketing in the United States, of which 60% of the cost of Pfizer’s commitment to share in the United States to achieve 60% profit. Pfizer will be responsible for sales outside the United States Dimebon, Medivation Inc. to pay the sales commission. In order to be allowed in the U.S. market, Medivation and Pfizer Inc. are jointly carrying out the work of the last test in order to make good to the U.S. regulatory approval for preparation.

High hopes Medivation Inc. was founded in 2003, currently has 40 employees. In the second quarter, Medivation losses amounted to 18.5 million U.S. dollars, compared with last year’s 7.2 million U.S. dollars increased substantially. Medivation’s Dimebon is the main product. 80s of last century, it first as an antihistamine in Russia. To the 90?s, the Russian chemist SergeyBachurin in a variety of laboratory animal tests showed that the drug has the potential to improve the animal’s cognitive abilities. But in the United States, almost no attention to these findings, until the bio-technology entrepreneurs DavidHung discovered in 2003, these studies, the situation began to change. DavidHung visit to Russia in the field heard the results, he decided to set Medivation Inc., began commercial operation of the drug.

Pennsylvania RaymondMyers Emerging Growth Equities analyst, said Pfizer is a great Cooperation Partners, it has tremendous marketing tentacles, especially in the areas of primary health care; Pfizer With Aricept Alzheimer’s disease treatment in a leading position in the field.

According to the British medical journal “Lancet” published in July a study, Dimebon may help Alzheimer’s patients remember the date, understand medication instructions, follow commands, memorize some words and perform simple activities.

http://focusincholesterol.com/pfizer-throwing-money-to-buy-700-million-experimental-drug-dimebon-pfizer-drug-dimebon-pharmaceutical-industries

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