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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Dimebon Dimebolin Information Availability

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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Dimebon Dimebolin Information Availability

SAN FRANCISCO, CA–(Marketwire – Aug 9, 2011) – Medivation, Inc. (NASDAQ: MDVN) today provided a corporate update and reported its financial results for the second quarter ended June 30, 2011.

“We and our partner Astellas continue to work diligently toward our goal of developing MDV3100 across the spectrum of advanced prostate cancer disease states, and are pleased to announce that we expect to report interim analysis data from our post-chemotherapy Phase 3 AFFIRM trial this year,” said David Hung, M.D., president and chief executive officer of Medivation.

“On the corporate front, we continued to build out our management team this past quarter, with the additions of two new vice presidents,” continued Dr. Hung. “Our company’s financial position also remains strong, with more than $182 million in cash at the end of the quarter, including a $3 million milestone payment we received from our partner Astellas in June. Our existing cash is expected to remain adequate to fund our currently budgeted operations into 2013, by which point we expect to have reported data from our ongoing Phase 3 trials in both post-chemotherapy advanced prostate cancer and Alzheimer’s disease.”

Recent Accomplishments and Anticipated Milestones

MDV3100

• On track to conduct an interim analysis of 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 interim analysis will be conducted when 520 events have occurred (80 percent of the 650 total events needed for the final analysis) and must achieve a p-value of 0.024 or better to be successful. Based on the current event rate in the trial, interim analysis results are expected to be reported this year.
• Continued to enroll patients in the Phase 3 PREVAIL trial, which is evaluating the effect of MDV3100 on overall survival and progression-free survival in men with advanced prostate cancer who have not yet received chemotherapy. This trial is expected to enroll approximately 1,700 chemotherapy-naïve patients globally.
• 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 patients with advanced prostate cancer who have progressed following medical castration with LHRH analog therapy or surgical castration.
• Initiated a Phase 2 clinical trial in advanced prostate cancer patients who have not had any previous hormonal therapies. This is the first trial to examine the effects of MDV3100 on prostate-specific antigen (PSA) response in patients without a background of medical or surgical castration. The trial is expected to enroll approximately 60 patients in Europe.
• Announced new data that confirm MDV3100′s anti-tumor effects and tolerability profile seen in the previously reported Phase 1-2 trial and provide further support for the selection of 160 mg per day as the optimal Phase 3 dose. These preliminary results from an ongoing study conducted at MD Anderson Cancer Center in 58 heavily-pretreated patients dosed at 160 mg per day were presented in an oral presentation at the American Society of Clinical Oncology 2011 Annual Meeting.
• Presented results during the 2011 Era of Hope Conference from a preclinical study conducted by researchers at the University of Colorado Denver demonstrating anti-tumor activity of MDV3100 in multiple breast cancer cell lines, including both androgen-driven and estrogen-driven cell lines.

Dimebon (latrepirdine)

• On track to report top-line results from the Phase 3 CONCERT trial in the first half of 2012. This 12-month clinical trial in 1,003 patients with mild-to-moderate Alzheimer’s disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil, the leading approved treatment for mild-to-moderate Alzheimer’s disease.

Corporate

• Appointed Gretchen Burke as vice president, finance and business processes and Stewart Hallett as vice president, clinical operations.
• Received a $3 million milestone payment from our partner Astellas related to the initiation of our ongoing Phase 3 PREVAIL trial of MDV3100 in chemotherapy-naïve advanced prostate cancer patients.

Second Quarter 2011 Financial Results

Revenue for the second quarter of 2011 was $15.8 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 second quarter were $26.2 million, compared with total operating expenses of $23.2 million for the same period in 2010. These figures include non-cash stock-based compensation expense of $3.7 million in the quarter ended June 30, 2011, compared with $3.2 million for the same period in 2010.

For the six months ended June 30, 2011, total operating expenses were $49.9 million, compared with total operating expenses of $56.7 million for the same period in 2010. These figures include non-cash stock-based compensation expense of $7.3 million in the six months ended June 30, 2011, compared with $6.7 million for the same period in 2010.

Medivation reported a net loss for the quarter ended June 30, 2011, of $9.5 million, or $0.27 per share, compared with a net loss of $7.2 million, or $0.21 per share, for the same period in 2010. For the six months ended June 30, 2011, the net loss was $17.9 million, or $0.52 per share, compared with a net loss of $24.7 million, or $0.73 per share, for the same period in 2010.

Cash, cash equivalents and short-term investments at June 30, 2011 totaled $182.4 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.

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 partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimer’s disease. For more information, please visit us at www.medivation.com.

http://www.marketwire.com/press-release/medivation-reports-second-quarter-2011-financial-results-provides-corporate-update-nasdaq-mdvn-1547793.htm

Winnipeg Alternative Therapy

Dimebon

Pfizer Inc (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) announced results from the Phase 3 HORIZON trial of the investigational drug dimebon (latrepirdine*) in patients with Huntington disease. Dimebon did not achieve statistical significance for either of the co-primary endpoints, the Mini-Mental State Examination (MMSE)which measures cognition (p=0.39), or the Clinician’s Interview-Based Impression of Change, plus caregiver input (CIBIC-plus), which measures global function (p=0.84).

“We are disappointed with the results of the HORIZON trial given the high unmet need in this patient population. At this point, we will discontinue development of dimebon in Huntington disease, including the ongoing open-label extension study,” said David Hung, M.D., president and chief executive officer of Medivation. “We will continue our ongoing 12-month Phase 3 CONCERT trial of dimebon and its open-label extension in patients with mild-to-moderate Alzheimer’s disease. We expect to report top-line data from CONCERT in the first half of 2012.”

Dimebon was generally well tolerated in the HORIZON trial, consistent with findings from previous trials including over 2,000 patients, the large majority of whom were Alzheimer’s disease patients.

“Huntington’s is a challenging disease area, and we are also disappointed with the HORIZON results,” said Pfizer’s Steve Romano, M.D., senior vice president, Medicines Development Group head, Primary Care Business Unit. “The results are expected to be presented at an upcoming medical meeting.”

* Latrepirdine is the generic (nonproprietary) name for dimebon.

HORIZON Study Design and Results
The double-blind, placebo-controlled Phase 3 HORIZON trial enrolled 403 patients with Huntington disease at 64 sites in North America, Europe and Australia. The trial included patients who had cognitive impairment, based on investigator judgment and verified by MMSE score. Patients were randomized to receive either 20 mg of dimebon three times daily or placebo for six months.

No statistically significant improvements were achieved for the dimebon group relative to placebo on either of the co-primary endpoints. Dimebon was generally well tolerated in the study. The overall incidence of adverse events was equivalent between the treatment groups: 69 percent in the dimebon group and 68 percent in the placebo group. Adverse events occurring in at least 5 percent of dimebon treated patients and more frequently than in placebo treated patients were chorea (8 percent vs. 4 percent), headache (6 percent vs 3 percent) and fatigue (5 percent vs 0 percent).

The trial was conducted in collaboration with the Huntington Study Group (HSG) and the European Huntington’s Disease Network (EHDN). The HSG is a non-profit group of experienced clinical trial investigators from medical centers in the United States and abroad dedicated to clinical research of Huntington disease. The EHDN is a non-profit network of professionals providing an infrastructure for large scale Huntington disease clinical trials throughout Europe.

About Dimebon
Dimebon (latrepirdine) is an investigational oral medication being tested as a potential treatment for Alzheimer’s disease. Dimebon is currently being studied in the Phase 3 CONCERT trial, a 12-month study evaluating dimebon in patients with mild-to-moderate Alzheimer’s disease who are taking donepezil, a commonly prescribed Alzheimer’s disease medication.

About the Pfizer/Medivation Dimebon Collaboration
Medivation and Pfizer have a global collaboration to develop and commercialize dimebon for the treatment of Alzheimer’s disease and Huntington disease. Under the terms of the agreement, the companies work together on the dimebon development program.

http://www.worldpharmanews.com/pfizer/1641-pfizer-and-medivation-announce-results-from-phase-3-horizon-trial-of-dimebon-in-huntington-disease

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Dimebon

Okay, maybe not quite yet breakfast food for Alzheimer’s disease when added to Aricept (donepezil). But here’s my prediction: CONCERT will publish 1Q2012 and then we should officially be ready to butter dimebon (latrepirdine; Pfizer / Medivation) once and for all.

As for today’s news, results from the Phase 3 HORIZON trial: Dimebon (latrepirdine) in patients with Huntington disease, did not achieve statistical significance for either of the co-primary endpoints, the Mini-Mental State Examination (MMSE), which measures cognition (p=0.39), or the Clinician’s Interview-Based Impression of Change, plus caregiver input (CIBIC-plus), which measures global function (p=0.84). “We are disappointed with the results of the HORIZON trial given the high unmet need in this patient population. At this point, we will discontinue development of dimebon in Huntington disease, including the ongoing open-label extension study,” said David Hung, M.D., president and chief executive officer of Medivation. “We will continue our ongoing 12-month Phase 3 CONCERT trial of dimebon and its open-label extension in patients with mild-to-moderate Alzheimer’s disease. We expect to report top-line data from CONCERT in the first half of 2012.”

We believe that when CONCERT (donepezil +/- dimebolin) publishes it will be a negative study. As far as an approvable therapeutic for Alzheimer’s disease we think Dimebon is toast. The basis for this is the changing view of BOLT’s Alzheimer’s Disease Thought Leader panel from 2009 to 2010. In 2009, there was some level of interest in dimebon for AD, as the Russian data had just been published. But by 2010, as our panelists who were involved with the drug once it hit Western clinical sites, had an opportunity to look more closely, their enthusiasm waned. That’s not a good predictive marker! (and that was a pretty poorly constructed sentence. With writing skills like this I should probably stop blogging and get a day job with the Associated Press). Anyway… here are some of the comments from BOLT’s Alzheimer’s Disease Thought Leader panel:

“I have to say I would have put Dimebon on that list. Dimebon might be a good adjunct to donepezil and memantine yet, but I think Dimebon’s day has come and gone. From all the signals I am seeing I don’t know that it has a long-term survival. I am going to take Dimebon off my list”.

“We had Dimebon. I would have mentioned Dimebon but I am not mentioning Dimebon now because it seems to have not done well in the most recent study. Now it seems like they have just continued some of their studies. That has dropped way down now on the list”.

“Dimebon is an interesting story. It was a molecule looking for a mechanism of action, not the other way around and even the company back away from the acetyl cholinesterase inhibition and the NMD antagonists and said we have exciting mechanism of action but we are not sure what it is. They really are moving toward their mitochondrial activity, which would be really terrific if it occurred. I asked them point blank why aren’t you going after mitochondrial myopathies because Dimebon could be a good treatment for mitochondrial myopathies and it is simply business. They said, look, there is a very low market in mitochondrial myopathies and there is a huge market in Alzheimer’s. It still might work in Huntington’s but I am, again, a little cautious about Huntington’s. If the CONCERT study is negative then the drug is dead. Period. And that will publish when? I think they could announce CONCERT data by the summer. The study is done in terms of enrollment. CONCERT was a donepezil adjunct. A lot of people worry on the basis that the CONCERT and CONNECTION is that their treatment periods are short, only six months. I think we are banking on the Russian data to show them a signal. But I think the issue with CONNECTION was that the placebo group did not decline. That is why it was negative. It is more inconclusive than it is negative. That is not going to get Pfizer an indication. I agree”.

Dimebon is viewed as an important addition for patients whose disease has progressed beyond the point of reversibility, who need stabilization or a boost to their functional status. There is more uncertainty that the drug has a clinical effect related to its ability to stabilize mitochondria or affect NMDA.

“The Dimebon I found intriguing. That kind of falls into the same thing as analogous sirtuin-1. I don’t know how it is acting. That really intrigues me and easily could be important. So that seems useful. Why does it matter how it is working if it is working? It doesn’t. It just matters whether you believe it. Phase II trials sometimes even in the phase II sometimes look good and then fail, right. Right. Sure. So people would be just intellectually a little more confident if they knew how it was working but I totally agree with you. I don’t think it matters. Antidepressants, they didn’t know how they acted or antipsychotics for the longest time they didn’t know how they acted but they still were used. So I agree with you it doesn’t matter. And it is very intriguing and the mechanism appeals to me. I had even published something that is a mitochondrial protectant that also looks good so I like that approach. It is just a little bit different. So Dimebon is one that almost made it onto the list. I was debating, but without a mechanism, I just thought that might fail. But I certainly would really believe that it could be very useful”.

“So the landscape is always changing and in a very exciting kind of way. I will say to you right now that the drug that is at the top of the list of the fancy formulary despite the fact that I don’t think it is going to be as robust in the US data as in the Russian data I think the drug that is likely to emerge at the top of the list is Dimebon, strictly as a symptomatic drug. You can parse out all the mitochondrial data and NMDA data you like but at the end of the day I think it will be similar to a cholinesterase inhibitor in terms of its scope and magnitude of effect and will be part of the landscape sooner than later”.

“I think we can do better than what we are doing now. I am not sure whether that is going to be a 5HT drug or some unknown symptomatic mechanism, a Dimebon-like drug. I think we are going to do better than we are doing now. I think Dimebon is likely to succeed. I would probably put that in this category. I hope it is disease-modifying as well but I am certain it is symptomatic and looks better than what we have got. So I just put that on the list because I think we can do better for symptomatic treatments as well”.

“I don’t have anything against Dimebon. It is very attractive but without knowing its mechanism of action or without seeing more in the way of long-term clinical outcomes, it is hard for me to think that this is more than another symptomatic therapy. If it turns to that it is complimentary then that would be attractive. I think without some reason to think that it was really a disease-modifying therapy it would be hard to get too enthusiastic about just adding yet another symptomatic therapy to cholinesterase inhibitors and to Namenda. So that is why it didn’t make my list. Now I understand the evidence refutes the possibilities that this is a cholinesterase inhibitors or an NMDA antagonist. So I am comfortable it is not just another version of the existing therapies. But I don’t think there are any great evidences to what the actual mechanism of action is”.

“Then I would still like to have a symptomatic treatment. Is there anything that I would pick better than a cholinesterase inhibitor? I’m not sure if Dimebon really works? So the next one would be from the group of cholinesterase inhibitor or Dimebon or Memantine kinds of symptomatic treatment because I would not want to be limited to a formulary that didn’t have that safety net for the people that came to you late”.

http://www.boltinternational.com/2011/04/hungry-for-breakfast-dimebon-is-toast/

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Dimebon

Pfizer Inc. (PFE)’s plans to shed two businesses boosts the potential payoff for three experimental drugs moving toward regulatory review later this year.

Pfizer, the world’s biggest drugmaker, yesterday said it plans to sell or spin off its animal health and baby food divisions. The units may command a price of $22 billion, said Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston. Pfizer Chief Executive Officer Ian Read has said he plans to use the proceeds to buy back shares and develop new drugs.

Read is giving new products led by the apixaban blood thinner, the lung cancer drug crizotinib and tofacitinib for rheumatoid arthritis added prominence within Pfizer’s revenue portfolio. Divesting the units — which generate $5.5 billion in annual sales, or 8 percent of the New York-based company’s revenue — also lets Pfizer sharpen its focus on developing the three drugs, which analysts surveyed by Bloomberg estimate may reach $3 billion in annual sales by 2015.

“In the next 3 to 6 months, there’s going to be a lot of pipeline news, and as Pfizer gets smaller the pipeline becomes more important,” said David Maris, an analyst with CLSA in New York. “This is a management team that is following through on what they said they would do, which is take a fresh look at the business and decide what is important and what is not.”

Pfizer declined 7 cents to $20.16 at 4 p.m. in New York stock exchange composite trading. The shares have climbed 36 percent in the past 12 months.
Sales to Fall

Pfizer loses patent exclusivity in November for its biggest product, the Lipitor cholesterol pill with $10.7 billion in sales last year. The drugmaker forecasts sales may fall as much as 8.3 percent in two years as the company’s new medicines fail to offset lower sales of Lipitor.

Crizotinib was accepted for priority review by the U.S. Food and Drug Administration, and the company expects clearance by year’s end, said Chris Loder, a spokesman. The drugmaker plans to seek approval of tofacitinib and apixaban by the end of the year, he said. Pfizer partners with New York-based Bristol- Myers Squibb Co. on apixaban.

“Pfizer’s late-stage pipeline is as well positioned as at any time in recent history,” said Christopher Schott, a New York-based analyst for JPMorgan Chase & Co., in a note to clients.
Wanting More

On Feb. 1, Read said he would review whether to divest four business areas that aren’t involved in developing new drugs, including the two now being shopped. Pfizer fell 2.7 percent yesterday, after the company said it will keep its established products and consumer health units with $12.9 billion in yearly sales. Some investors wanted the units sold to focus on higher- profit drug development.

Erik Gordon, a University of Michigan business professor in Ann Arbor, isn’t convinced Pfizer’s pipeline will pay off.

“Should Pfizer double its dependence on what it does worst: Get new drugs out the door?” Gordon, who studies the biomedical industry, said in an e-mail.

In 2006, Pfizer halted development of its torcetrapib cholesterol pill, a product designed to succeed Lipitor, after it failed to benefit patients in a late-stage study.
Development Failures

Last year, the drugmaker said its experimental Alzheimer’s drug Dimebon failed to help patients in a late-stage test. Analysts had predicted the product would generate $5 billion in annual sales. That same month, Sutent, approved for kidney and stomach cancers, failed in two studies to shrink breast tumors, and the experimental drug figitumumab didn’t help lung cancer patients.

Read, head of global pharmaceutical operations from 2006 until his appointment as CEO last December, said Pfizer needed to fix its “innovative core.” Fifteen research programs have been discontinued since last September and the budget to develop new medicines will be cut by as much as $3 billion in the next two years from $9.4 billion in 2010 to target experimental drugs with a greater chance of success, he said.

The units Pfizer is seeking to divest may be sold outright, or spun off as independent companies. Spinoffs evade a 35 percent capital gains tax and sometimes provide the best return for investors, said Adam Berger, head of mergers and acquisitions at Leerink Swann, in a telephone interview.

Still, the remaining parent company wouldn’t benefit from the added proceeds the way it would in a sale, he said.
Value to Shareholder

“It’s like a dividend; the value goes to the shareholder,” Berger said. “But Pfizer has been extraordinarily acquisitive, and sometimes if you’re a very large business it’s hard to grow from that base.”

Another option might be a sponsored spinoff in which investors buy a stake in the company, typically 20 percent, when the deal is announced, Berger said. That allows the parent company to share in proceeds from the divestiture, he said.

Pfizer acquired its nutrition unit in the 2009 purchase of Wyeth. The unit sells food replacement and supplement products in more than 80 countries, according to the company’s website.

Mead Johnson Nutrition Co. (MJN), the baby-formula maker that Bristol-Myers took public in February 2009, had sales of $3.14 billion last year, led by the Enfamil infant formula. The Glenview, Illinois-based company trades at 27 times earnings, almost three times the valuation of Pfizer, after a 188 percent surge through yesterday that beat the Standard & Poor’s 500 Index’s 63 percent rise, according to Bloomberg data.
Valuing Nutritionals

Applying Mead Johnson’s profit margins and share price valuation of 31 times net income to Pfizer’s unit, which had $1.87 billion in sales last year, would give Pfizer nutritionals a market value of about $8.4 billion, according to data compiled by Bloomberg.

Leerink’s Fernandez put the figure at about $10 billion for the nutritionals and said “demand would be high.”

Pfizer may fare better with an initial public offering for the animal health unit, which could value the unit at $10 billion to $12 billion, Fernandez said. He cited a “conversation with Pfizer” that suggested nutritionals would be sold and the animal health division may be spun off.

Pfizer had 28 divestitures completed in the last five years, with an average deal size of $1.8 billion, according to data compiled by Bloomberg. The biggest was the $16.6 billion sale of its consumer products business to Johnson & Johnson in June 2006. Pfizer sold Capsugel, a hard-capsules manufacturing business, to KKR & Co. in April for $2.38 billion.

Pfizer said it doesn’t anticipate making more announcements about the alternatives for the two units until sometime in 2012, and that any transaction may take as many as 24 months to complete.

http://www.bloomberg.com/news/2011-07-08/pfizer-unit-sales-add-payoff-to-pipeline-drugs-in-deal-seen-at-22-billion.html

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Dimebon

Company Announces It Will Conduct Interim Analysis of Phase 3 MDV3100 AFFIRM Trial in Post-Chemotherapy Prostate Cancer Patients; Conference Call Today at 4:30 p.m. Eastern Time

SAN FRANCISCO, CA–(Marketwire – May 6, 2011) – Medivation, Inc. (NASDAQ: MDVN) today provided a corporate update and reported its financial results for the first quarter ended March 31, 2011.

“We and our partner Astellas continue to make substantial progress with our MDV3100 program. We now have multiple MDV3100 trials ongoing evaluating a broad spectrum of advanced prostate cancer patients, and we have jointly reached a decision to conduct an interim analysis of our Phase 3 AFFIRM trial in the post-chemotherapy patient population,” said David Hung, M.D., president and chief executive officer of Medivation. “On the corporate side, we reiterate our financial guidance for 2011 and continue to believe that our existing cash is adequate to fund our operations beyond the end of 2012, which we expect to be more than sufficient time to complete and report data from our ongoing Phase 3 trials in post-chemotherapy advanced prostate cancer and in Alzheimer’s disease.”

Recent Accomplishments and Anticipated Milestones

MDV3100

• Confirmed intent to conduct an interim analysis of 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. Depending on the survival rates of patients in the AFFIRM trial, data from the interim analysis could potentially be available in 2011.
• Continued to enroll patients in the Phase 3 PREVAIL trial, which is evaluating the effect of MDV3100 on overall survival and progression-free survival in men with advanced prostate cancer who have not yet received chemotherapy. This trial is expected to enroll approximately 1,700 chemotherapy-naïve patients globally.
• Initiated 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 patients with advanced prostate cancer who have progressed following medical castration with LHRH analog therapy or surgical castration.
• On track to initiate a Phase 2 trial in the second quarter of 2011 in patients who have not yet received any hormonal therapy. This will be the first trial to evaluate MDV3100 in advanced prostate patients who have not yet undergone medical or surgical castration.

Dimebon (latrepirdine)

• Announced top-line results from the Phase 3 placebo-controlled HORIZON trial in patients with Huntington disease showing that dimebon was generally well tolerated but did not achieve statistical significance on any of the co-primary or secondary efficacy endpoints. Based on these results, we have discontinued the dimebon program in Huntington disease.
• On track to report top-line results from the Phase 3 CONCERT trial in the first half of 2012. This 12-month clinical trial in 1,003 patients with mild-to-moderate Alzheimer’s disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil, the leading approved treatment for mild-to-moderate Alzheimer’s disease.

First Quarter 2011 Financial Results

Revenue for the first quarter of 2011 was $14.7 million, consisting of partial recognition of the non-refundable up-front and development milestone payments to date from the Company’s corporate partners Pfizer and Astellas. 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.

For the three months ended March 31, 2011, total operating expenses were $23.8 million, compared with total operating expenses of $33.4 million for the same period in 2010. These figures include non-cash stock-based compensation expense of $3.6 million in the quarter ended March 31, 2011, compared with $3.5 million for the same period in 2010.

Medivation reported a net loss for the quarter ended March 31, 2011, of $8.5 million, or $0.24 per share, compared with a net loss of $17.5 million, or $0.51 per share, for the same period in 2010.

Cash, cash equivalents and short-term investments at March 31, 2011, totaled $195.0 million, compared with $207.8 million at December 31, 2010.

2011 Financial Outlook

Medivation reaffirms its guidance that total operating expenses for 2011, net of cost-sharing payments from Astellas and Pfizer, will be between $100.0 and $110.0 million. This forecast includes approximately $12.0 million of non-cash stock-based compensation expense.

Conference Call Information

To participate by telephone in today’s live call beginning at 4:30 p.m. Eastern Time, please call 877-303-2523 from the U.S. or +1-253-237-1755 internationally. In addition, the live conference call is being webcast and can be accessed on the “Events and Presentations” page of the “Investor Relations” section of the Company’s website at www.medivation.com. A replay also will be available for 30 days following the live call.

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 partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimer’s disease. For more information, please visit us at www.medivation.com.

This press release contains forward-looking statements, including statements regarding the continued clinical development of Medivation’s product candidates and potential future progress related thereto, the therapeutic potential of Medivation’s product candidates, the potential completion of patient enrollment in ongoing clinical trials, the planned initiation of additional clinical trials, the planned interim analysis in the AFFIRM study, the anticipated timing of announcement of top-line data from ongoing clinical trials and other statements with respect to future clinical trial events or results, the continued effectiveness of, and continuing collaborative activities and benefits under, Medivation’s collaboration agreements with Pfizer and Astellas, and Medivation’s anticipated future financial results, including the potential sufficiency of Medivation’s cash resources, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation’s actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation’s clinical trials, including the risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of Medivation’s product development activities and the risk that positive results seen in our prior clinical trials may not be predictive of the results of our ongoing or planned clinical trials, difficulties or delays in enrolling and retaining patients in Medivation’s clinical trials, including as a result of the availability of competing treatments or clinical trials of competing drugs for the same indication, partnering of Medivation’s product candidates, including Medivation’s dependence on the efforts of and funding by Astellas and Pfizer for the development of MDV3100 and dimebon, respectively, the achievement of development, regulatory and commercial milestones under Medivation’s collaboration agreements, the manufacturing of Medivation’s product candidates, the adequacy of Medivation’s financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation’s filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended March 31, 2011, filed today with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

http://www.marketwire.com/press-release/medivation-reports-first-quarter-2011-financial-results-provides-corporate-update-nasdaq-mdvn-1511312.htm

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SAN FRANCISCO, CA–(Marketwire – March 16, 2011) – Medivation, Inc. (NASDAQ: MDVN) today provided a corporate update and reported its financial results for the year ended December 31, 2010.

“We are pleased with the progress we made with our MDV3100 and dimebon programs in 2010, and we look forward to reporting Phase 3 data from each of these programs in the near-term. With regard to dimebon, we expect to report top-line data from our Phase 3 Huntington disease trial in the first half of this year, with top-line data from our Phase 3 mild-to-moderate Alzheimer’s disease trial expected to follow in the first half of 2012. And with MDV3100, we expect to report top-line data from our Phase 3 AFFIRM trial in advanced prostate cancer in 2012, although those data could come in 2011 if an interim analysis is conducted,” said David Hung, MD, president and chief executive officer of Medivation. “Our company also remains in a strong financial position, with more than $200 million in cash at December 31, 2010 and strong corporate partnerships for each of our programs that provide substantial cost-sharing benefits. Based on our current budget, we believe our existing cash is adequate to fund our currently planned operations beyond the end of 2012, by which time we expect to have completed and reported top-line data from all three of our Phase 3 programs.”

Recent Accomplishments and Anticipated Milestones

MDV3100 
• Completed patient enrollment in the Phase 3 AFFIRM trial in November 2010. This trial is evaluating MDV3100 in men with advanced prostate cancer who have previously been treated with docetaxel-based chemotherapy. Top-line data are expected in 2012, although they could be reported in 2011 if an interim analysis is conducted.
• Announced positive, new, long-term follow-up data from the Phase 1-2 trial of MDV3100 in patients with advanced prostate cancer showing that MDV3100 continues to demonstrate durable antitumor activity as evaluated by median times to prostate-specific antigen (PSA) progression and radiographic progression. These findings confirm the initial Phase 1-2 results published in The Lancet, in which MDV3100 consistently demonstrated anti-tumor activity in both chemotherapy-naïve and post-chemotherapy patients across endpoints, as evaluated by PSA levels, radiographic findings and circulating tumor cell (CTC) counts.
• Continued to enroll patients in the Phase 3 PREVAIL trial of MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy. The trial is expected to enroll approximately 1,700 patients globally.
• On track to initiate two new Phase 2 trials to explore the potential benefit of MDV3100 in earlier-stage patient populations — a Phase 2 trial comparing MDV3100 with bicalutamide, a commonly used anti-androgen, in the treatment of advanced prostate cancer patients who have progressed following medical or surgical castration; and a Phase 2 monotherapy trial in advanced prostate cancer patients who have not yet been treated with any hormonal therapy.
• Began clinical development of MDV3100 in Japan, with the initiation of patient dosing in a Phase 1-2 clinical study.

Dimebon (latrepirdine) 
• On track to report top-line results from the HORIZON trial in the first half of 2011. This six-month Phase 3 trial is evaluating the potential benefits of dimebon on cognition and global function in patients with Huntington disease.
• Completed patient enrollment in the CONCERT trial in November 2010; on track to report top-line results in the first half of 2012. This 12-month Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil.

Corporate 
• Received a $10 million milestone payment from Astellas in the fourth quarter of 2010 for the initiation of our Phase 3 PREVAIL trial of MDV3100 in chemotherapy-naïve advanced prostate cancer patients.

Fourth Quarter and Year-End 2010 Financial Results

Revenue for the year ended December 31, 2010, was $62.5 million, consisting of partial recognition of the non-refundable up-front and development milestone payments to date from the Company’s corporate partners Pfizer and Astellas. 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.

For the quarter and year ended December 31, 2010, total operating expenses were $17.5 million and $95.2 million, respectively, compared with total operating expenses of $42.9 million and $116.7 million, respectively, for the same periods in 2009. The year-end figures include non-cash stock-based compensation expense of $13.5 million in 2010 compared with $10.7 million in 2009.

Medivation reported a net loss for the quarter ended December 31, 2010, of $3.9 million, or $0.11 per share, compared with a net loss of $26.2 million, or $0.78 per share, for the same period in 2009. For the year ended December 31, 2010, the net loss was $34.0 million, or $0.99 per share, compared with a net loss of $54.8 million, or $1.71 per share, for the same period in 2009.

Cash, cash equivalents and short-term investments at December 31, 2010, totaled $207.8 million, compared with $278.2 million at December 31, 2009.

2011 Financial Outlook

Medivation currently expects total operating expenses for 2011, net of cost-sharing payments from Pfizer and Astellas, to be between $100.0 and $110.0 million. This forecast includes approximately $12.0 million of non-cash stock-based compensation expense.

Medivation expects that its existing cash resources are adequate to fund currently planned operations beyond the end of 2012. By the end of 2012, the Company expects to have completed and reported top-line data from the Phase 3 AFFIRM trial of MDV3100 in advanced prostate cancer patients who have failed chemotherapy, the Phase 3 HORIZON trial of dimebon in Huntington disease, and the Phase 3 CONCERT trial of dimebon in mild-to-moderate Alzheimer’s disease.

http://www.marketwire.com/press-release/Medivation-Reports-Fourth-Quarter-Year-End-2010-Financial-Results-Provides-Corporate-NASDAQ-MDVN-1412885.htm

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SAN FRANCISCO, Nov. 5, 2010 /PRNewswire-FirstCall/ — Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the third quarter ended September 30, 2010.

“In the third quarter, we began the expansion of our MDV3100 development program into earlier stage patients with the initiation of the Phase 3 PREVAIL trial, which is enrolling men with advanced prostate cancer who have not yet received chemotherapy.  Additionally, we believe that the positive interim analysis of the abiraterone Phase 3 study is a net positive for MDV3100, as it provides further clinical validation for the importance of the androgen receptor signaling pathway in advanced prostate cancer,” said David Hung, MD, president and chief executive officer of Medivation.  ”Together with our partner Pfizer, we continue to investigate dimebon’s potential clinical benefit in the ongoing Phase 3 HORIZON trial in Huntington disease and the ongoing Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s disease patients who are taking donepezil.  We remain on track to complete enrollment in the CONCERT trial this year and look forward to announcing top-line results from the HORIZON trial in the first half of 2011.”

Recent Accomplishments and Anticipated Milestones

MDV3100

• Initiated the Phase 3 PREVAIL trial evaluating MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy.  This randomized, double-blind, placebo-controlled, multi-national Phase 3 trial is expected to enroll approximately 1,700 patients globally.
• Continued to enroll patients in the AFFIRM trial and expect to complete patient accrual on November 15, 2010. This randomized, double-blind, placebo-controlled Phase 3 trial is evaluating MDV3100 in men with advanced prostate cancer who have been previously treated with docetaxel-based chemotherapy.
• On track to initiate two new MDV3100 trials in earlier-stage prostate cancer this year: a Phase 2 head-to-head trial comparing MDV3100 with bicalutamide; and a Phase 2 trial in hormone-naive patients.
• The Proceedings of the National Academy of Sciences (PNAS) published a paper showing the preclinical efficacy of MDV3100 against splice variants, which are mutated forms of the androgen receptor that may be associated with the development of prostate cancer resistance to hormone therapy.

Dimebon (latrepirdine)

• On track to report top-line data from HORIZON in the first half of 2011.  This six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating dimebon’s potential benefits on cognition and global function in patients with Huntington disease.

• Continued to enroll patients in CONCERT and expect to complete patient accrual on November 30, 2010.  This 12-month randomized, double-blind, placebo-controlled Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil.

Corporate

• Were awarded a $733,000 research and development grant under the Internal Revenue Service’s Therapeutic Discovery Project Credit Program.

Third Quarter 2010 Financial Results

Revenue for the third quarter of 2010 was $14.4 million, consisting of partial recognition of the non-refundable up-front payments to date from the Company’s corporate partners Pfizer and Astellas.  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 of 2010 were $21.1 million, compared with $27.6 million for the same period in 2009.  These figures are net of cost-sharing payments from the Company’s corporate partners of $17.9 million and $4.2 million in the third quarters of 2010 and 2009, respectively, and include non-cash stock-based compensation expense of $3.3 million and $2.5 million, respectively.

For the nine months ended September 30, 2010, total operating expenses were $77.7 million, compared with $73.8 million for the same period in 2009.  These figures are net of cost-sharing payments from the Company’s corporate partners of $41.5 million and $16.2 million in the nine months ended September 30, 2010 and 2009, respectively, and include non-cash stock-based compensation expense of $10.0 million and $7.7 million, respectively.

Income tax benefit for the third quarter of 2010 was $1.5 million, compared with income tax expense of $2.8 million in the comparable period of 2009.  For the nine months ended September 30, 2010, income tax benefit was $1.5 million, compared with income tax expense of $4.5 million in the prior year period.

Medivation reported a net loss for the quarter ended September 30, 2010, of $5.4 million, or $0.16 per share, compared with a net loss of $14.0 million, or $0.42 per share, for the same period in 2009.  For the nine months ended September 30, 2010, the net loss was $30.1 million, or $0.88 per share, compared with a net loss of $28.5 million, or $0.90 per share, for the same period in 2009.

Cash, cash equivalents and short-term investments at September 30, 2010, totaled $211.5 million, compared with $278.2 million at December 31, 2009 and $233.3 million at June 30, 2010.

Financial Outlook

Medivation expects that its existing cash resources are adequate to fund its currently budgeted operations beyond 2012.  By the end of 2012, the Company expects to have reported top-line data from the Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s disease, the Phase 3 HORIZON trial in Huntington disease and the Phase 3 AFFIRM trial in advanced prostate cancer patients who have failed chemotherapy..

http://www.prnewswire.com/news-releases/medivation-reports-third-quarter-2010-financial-results-and-provides-corporate-update-106783688.html

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