When the calendar flips from December to January, many people like to start the year with a clean slate…

They swear off junk food and promise to exercise more. They declare they won’t waste their evenings on reality TV, making a promise to themselves to read more. And finally that they will dump their losing stocks and instead only buy quality names.

Let me give you that little push that you may need. I can’t help much if you’re addicted to Haagen-Dazs and Mob Wives…

But if you own any of the following three stocks, sell them immediately.

“Hung” up on Medivation

San Francisco-based Medivation (Nasdaq: MDVN) has a promising drug for prostate cancer – MDV3100. In Phase III trials, advanced prostate cancer patients lived an average of 18.4 months versus 13.6 for patients on placebo.

The stock is up 200 percent from when the data was released just over a month ago, giving Medivation a market cap of $1.7 billion.

The company should provide more information next year as to the path to regulatory approval. Meanwhile, Medivation and partner Astellas Pharma are currently in an additional Phase III and two Phase II trials.

My problem with Medivation is two-fold:

• Its current market cap is 25-percent greater than Dendreon’s (Nasdaq: DNDN), which already has a prostate cancer drug on the market. Granted, initial sales for Dendreon’s Provenge were disappointing, but there’s a very big difference between weaker than expected sales for a drug that has already been approved versus one that hasn’t been given clearance by the FDA yet.
• The second issue is with Medivation CEO David Hung. I’m very familiar with Hung and Medivation, having covered the company when data for its Alzheimer’s candidate Dimebon was very encouraging. The drug produced stellar Phase II results only to fail miserably in Phase III. Hung is a smooth talker and oozes confidence – a little too much confidence in my opinion. Successful biotech CEOs tend to be cautiously optimistic by nature, not boastful.

When there was tremendous buzz about Dimebon, Hung became a rock star at investing conferences, once telling me, “I’ve made a lot of people (investment managers) heroes.”

Before you think this is sour grapes, you should know that my subscribers took big gains on Medivation during the Dimebon run-up and eventual fall. When the stock took off in anticipation of Phase III results, I recommended selling a sizeable chunk of the position, ensuring gains, even if disaster struck, which it did.

Will history repeat itself with MDV3100? In fairness, it appears to be a better-run study than the Dimebon trial. However, the company’s track record and recent run-up in the stock suggests to me that investors will be better off if they take the money and run.

Black Box Warning

ISIS Pharmaceuticals (Nasdaq: ISIS) – I’ve been banging on this one for a while now. ISIS, along with partner Sanofi-Aventis, plans on filing for FDA approval for cholesterol drug Mipomersen before the end of the year.

Mipomersen treats a rare genetic form of extremely high cholesterol. The drug works. There’s little controversy about that. The problem is that in every clinical trial, the drug has raised liver enzymes, which is a sign of toxicity.

Supporters say no patients have actually gotten sick on the drug and that the elevated enzymes are no big deal. Detractors argue that patients will have to stay on therapy for life and that the toxicity will become a problem as patients take the Mipomersen over many years.

My prediction is that the FDA either asks for more information (as they have done in the past) or approves it with a black box warning label, which should hurt sales. A black box warning cautions doctors and patients as to the severe side effects that are possible with the medication. ISIS is near its lows, but I don’t think this one is worth the considerable risk.

Come On, Mann…

MannKind (Nasdaq: MNKD) – If you’re in the plumbing supplies business, it’s alright to name your company after yourself. Same thing if you’re opening a law firm. Not so much, though, if you’re starting a biotech company.

Yet that’s what Al Mann did at MannKind. The CEO was nominated by TheStreet.com’s biotech reporter Adam Feuerstein as one of the Worst Biotech CEOs of the year. I’ve seen him speak at investor conferences before. And while he’s charismatic, you get the impression if this was 100 years ago, he’d be selling snake oil instead of inhalable insulin.

Inhalable insulin has so far not been shown to be commercially viable. Nektar Therapeutics’ (Nasdaq: NKTR) and Pfizer’s (NYSE: PFE) Exubera was a commercial disaster. Despite projections of $2 billion in sales, it only generated $12 million in revenue before being pulled from the market. MannKind’s version, called Afrezza, hasn’t even been able to obtain FDA approval, despite several attempts.

The company has $224 million in assets, of which $196 million is property, plant and equipment, while it has $210 million in debt. Stockholders’ equity is negative $280 million. Over the past year, it has burned an average of $33 million a quarter. At the end of the September quarter, it has just $22 million in cash.

Somehow the stock still has a market cap of $365 million. If you own the stock, I suggest get out now while there’s still something left to sell.

Although the rewards can be great, investing in small cap biotech stocks can be risky even under the best circumstances. In these three situations, the reward does not justify the enormous risks.

http://www.investmentu.com/2011/December/three-biotech-sell-before-2012.html

Puerto Morelos Cheap Rentals

Puerto Morelos Rental Apartments

Dimebon Dimebolin Information Availability

Medivation Inc. (MDVN – Analyst Report) reported a loss of 27 cents per share in the second quarter of 2011, a penny wider than the Zacks Consensus loss Estimate of 26 cents and well above the year-ago loss of 21 cents.

Higher expenses led to the wider loss. Revenues for the quarter were $15.8 million, in-line with the Zacks Consensus Estimate and flat from the year-ago period.

The Quarter in Detail

Revenues consisted of partial recognition of the non-refundable upfront payment of $225 million received from Pfizer (PFE – Analyst Report) 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 12.9% to $26.2 million. Research and development expenses increased 5% to $19.1 million primarily due to an increase in pre-clinical and other expenses. SG&A expenses increased 41% to $7 million primarily due to higher 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. Medivation, which exited 2010 with a cash and equivalents balance of $207.8 million, expects to be able to fund operations into 2013.

Pipeline Update

Medivation provided an update on its pipeline candidates. Medivation and partner Astellas finished enrolling patients for the phase III AFFIRM study (advanced prostate cancer) in Nov 2010. An interim analysis of this study, which is being conducted in post-chemotherapy patients, will be conducted this year.

The companies initiated another phase III study (PREVAIL), which is being conducted in chemotherapy-naïve advanced prostate cancer patients. A head-to-head phase II study (TERRAIN) between MDV3100 and AstraZeneca’s (AZN – Snapshot Report) Casodex (bicalutamide) commenced in March 2011. A phase II study in hormone-naïve patients is also being conducted.

Dimebon is currently in the CONCERT study, which is being conducted with patients suffering from mild-to-moderate Alzheimer’s disease. Results from the CONCERT study are expected in the first half of 2012.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation. We are concerned about partner Pfizer’s commitment towards the dimebon collaboration. With dimebon failing in two phase III studies, we expect investor focus to remain on Medivation’s prostate cancer candidate, MDV3100.

http://www.zacks.com/stock/news/58937/Medivation+Reports+Wider+Loss

Winnipeg Acupuncture Therapy

Dimebon

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

Medivation CEO David Hung is a persuasive individual. He has negotiated some of the most lucrative drug development collaborations in biotechnology. Pfizer’s $225 million upfront for Dimebon remains one of the marquee deals of recent years–if you look strictly at the dollars on the table and not at the disastrous data that followed. To gain global rights to MDV3100 for advanced prostate cancer, Astellas was persuaded to offer $110 million upfront with promises of $655 million more–$355 million ahead of a launch–along with a profit split. Now that Dimebon has flunked back-to-back Phase III studies, the spotlight at Medivation ($MDVN) has shifted squarely to MDV3100. And Hung has used all the persuasiveness he can muster to make a compelling case that the drug has a solid shot at capturing a big chunk of the market for castration

Of course, persuasiveness will only get you so far in biotech. Long-term success relies entirely on the data and regulators’ evaluation of the numbers and trials. In this case, Hung also faces a brisk dispute among the analysts who follow his company, over whether MDV3100 can not only deliver promising data versus a placebo plus standard care, but also come out swinging against abiraterone, which costs $40,000 for eight months of therapy.

One of the bears, Brean Murray Carret & Co analyst Jonathan Aschoff, told Reuters recently that, “it is not our view that MDV-3100 cannot succeed against placebo in vacuum; it is instead our strong view that MDV-3100 can only succeed clinically in a world without abiraterone.”

Both abiraterone and MDV3100 are designed to do the same thing: remove the fuel for the disease from the equation. Abiraterone does that by inhibiting an enzyme needed for the production of testosterone; MDV3100 blocks the androgen receptor to prevent cancer cells from reacting to testosterone. Both drugs would be reserved, at least initially, for patients who are not responding to currently used surgical and therapeutic interventions.

MDV3100 has an impeccable scientific pedigree. It was discovered by a team of scientists led by Charles Sawyer, an investigator with the Howard Hughes Medical Institute based at the prestigious Memorial-Sloan Kettering Cancer Center. Sawyer also discovered ARN-509, an earlier-stage anti-androgen treatment at Aragon Pharmaceuticals, which he sometimes refers to as the Son of Medivation.

Starting with a compound that had already demonstrated an extraordinarily high binding affinity with the androgen receptor, Sawyer recently told Sally Church in a fascinating Q&A posted on her Pharma Strategy Blog that the team looked at more than 200 derivatives before they came across MDV3100.

As Sawyer explains, abiraterone targets the Cyp17 enzyme, which the body relies on to create testosterone. “Abiraterone is looking great,” he told Church, “and showed a survival advantage in the same kind of trial as the Medivation one.” At some point, he added, abiraterone and MDV3100 will probably be matched in a combo drug trial, offering an approach to tackle the disease at two different points.

For now, though, Hung is already well into a Phase III trial, which will wrap early next year with a possible announcement on interim results toward the end of this year. And faced with a competing drug, the CEO’s immediate task is to explain why he thinks MDV3100 is the superior treatment.

Researchers for the company have spelled out a key advantage over bicalutamide, the standard anti-androgen in a pre-abiraterone world, noting that MDV3100 blocks testosterone binding to the androgen receptor, impedes the movement of the androgen receptor to the nucleus of prostate cancer cells and inhibits binding to DNA.

“We believe that redundancy is always a good thing in biology,” says Hung. Comparing MDV3100 to abiraterone, he also zeroes in on the need to use prednisone, a corticosteroid linked to high blood pressure, with J&J’s new drug. Prednisone presents a potentially serious safety issue for the men taking the drug.

MDV3100 “doesn’t affect upstream hormones that cause high blood pressure,” says Hung. “Abiraterone does not have an affect against (androgen receptor) splice variants,” he adds. “3100 did block splice variants, and very effectively.”

Bottom line: “If we had the same survival benefits as abiraterone without the steroids it would be a significant advantage.”

The back-to-back Dimebon failures obviously cast a pall over Medivation. But Hung acknowledges the disappointment while holding on to hope that a final Phase III will come out in its favor. Significantly, he says, this last study involves 12 months of treatment versus six months in the first two, giving Dimebon a better chance to finally beat out a placebo.

“It will only take a few million to complete the study,” he adds, and Pfizer is absorbing 60 percent of all development costs.

http://www.fiercebiotech.com/story/abiraterone-vs-mdv3100-prostate-cancer-drug-showdown/2011-05-18

Winnipeg Alternative Therapies

Furnasmans

Medivation Inc. (MDVN – Analyst Report) reported a loss of 24 cents per share in the first quarter of 2011, a penny wider than the Zacks Consensus Estimate of a loss of 23 cents but well below the year-ago loss of 51 cents. Lower expenses led to the narrower loss. Revenues for the quarter were $14.7 million, well below the Zacks Consensus Estimate of $16 million. Revenues were $15.7 million in the year-ago period.

The Quarter in Detail

Revenues consisted of partial recognition of the non-refundable upfront payment of $225 million received from Pfizer (PFE – Analyst Report) 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 declined 28.7% to $23.8 million. Research and development expenses declined 31.1% to $17.6 million primarily due to a decrease in clinical and preclinical study costs and lower payroll and other related costs due to workforce reduction. Medivation expects its research and development headcount to increase to approximately 80 (from 68) in the next two quarters.

SG&A expenses declined 21.5% to $6.2 million primarily due to the workforce reduction implemented in March 2010.

Maintains 2011 Outlook

Medivation expects operating expenses (after adjusting cost-sharing payments from Pfizer and Astellas) in the range of $100 – $110 million. Medivation, which exited 2010 with a cash and equivalents balance of $207.8 million, expects to be able to fund operations beyond 2012.

Pipeline Update

Medivation provided an update on its pipeline candidates. Medivation and partner Astellas finished enrolling patients for the phase III AFFIRM study (advanced prostate cancer) in Nov 2010. An interim analysis of this study, which is being conducted in post-chemotherapy patients, will be conducted in 2011.

The companies initiated another phase III study (PREVAIL), which is being conducted in chemotherapy-naïve advanced prostate cancer patients. A head-to-head phase II study (TERRAIN) between MDV3100 and AstraZeneca’s (AZN – Snapshot Report) Casodex (bicalutamide) commenced in March 2011. A phase II study in hormone-naïve patients is scheduled to commence in the second quarter of 2011.

As far as dimebon is concerned, Medivation and partner, Pfizer, decided to discontinue the development of dimebon for Huntington disease following the release of phase III results (HORIZON study) which showed that dimebon failed to achieve its primary endpoints.

Meanwhile, Medivation continues to evaluate dimebon in the CONCERT study, which is being conducted with patients suffering from mild-to-moderate Alzheimer’s disease. Results from the CONCERT study are expected in the first half of 2012.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation, supported by a Zacks #3 Rank (short-term Hold rating). Given the disappointing track record of dimebon, we are concerned about partner Pfizer’s commitment towards the collaboration. With dimebon failing in two phase III studies, we expect investor focus to shift to the development of MDV3100.

http://www.zacks.com/stock/news/52917/Medivation+Misses+Expectations

Winnipeg Acupuncture

Medivation, Inc. (NASDAQ: MDVN) today announced that it will hold a teleconference and webcast at 8:30 a.m. Eastern Time, Monday, April 11, to discuss the HORIZON Phase 3 trial results for dimebon (latrepirdine) in patients with Huntington disease. A press release will be issued at 7:30 a.m. Eastern Time Monday prior to this call.

Teleconference/Webcast Details

To participate in the live call on Monday, April 11, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time), please dial 866-582-8907 for domestic callers and +1-678-825-8232 for international callers. 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, mild-to-moderate Alzheimer’s disease and Huntington disease.

Winnipeg Alternative Therapy

ORLANDO, Florida (TheStreet) — Medivation(MDVN_) shares are on the rebound as investors cast aside last year’s Alzheimer’s drug failure and focus instead on the company’s efforts to bring a new prostate cancer drug to market.

Medivation on Tuesday evening released long-term follow-up data from a mid-stage study of its prostate cancer drug, known as MDV3100. These new data compare favorably to a similar Johnson & Johnson(JNJ_) prostate cancer drug already under review by U.S. regulators.

Scientists cringe when two competing drugs that have never been formally studied against each other are compared side by side. Wall Street, however, has no qualms about doing just that, which is why MDV3100′s future appears brighter in the eyes of investors Wednesday when stacked up against J&J’s abiraterone.

Medivation shares were up 3.9% to $19.35 Wednesday. In December, Medivation shares were trading at $11. The huge move in the past three months is entirely attributable to excitement and anticipation around MDV3100. Medivation shares tanked below $10 last year after the company’s Alzheimer’s drug Dimebon failed a pivotal phase III study.

Medivation and partner Astellas are conducting two phase III studies of MDV3100 in prostate cancer, with final results from the first, more advanced study expected next year. Medivation has suggested, however, that an interim analysis of this first phase III study might take place earlier. The company is providing scant details but investors have been speculating that this interim analysis could mean positive MDV3100 data in the fourth quarter.

J&J, meanwhile, filed for abiraterone’s approval in December with an FDA approval decision date expected in late June, if not sooner.

Both MDV3100 and abiraterone work similarly by interfering with the way prostate cancer cells feed from testosterone produced in the body.

J&J is seeking initial approval for abiraterone as a treatment for patients with prostate cancer that continues to grow after the use of the chemo drug Taxotere. The approval filing is based on a phase III study in which abiraterone patients reported a median overall survival of 14.8 months compared to 10.9 months for patients treated with a placebo — or a survival advantage of about four months.

http://www.thestreet.com/story/11011436/1/medivation-moves-on-cancer-drug-hopes.html

http://www.dimebonalzheimers.com/

Winnipeg Acupuncture Therapy

Eagle Ridge GM Mobi

Medivation Inc. (MDVN) reported a loss of 16 cents per share in the third quarter of 2010, narrower than the Zacks Consensus Estimate of a loss of 21 cents and the year-ago loss of 42 cents. Lower expenses led to the narrower loss. Revenues for the quarter were $14.4 million, well below the Zacks Consensus Estimate of $16 million. Revenues were $16.3 million in the year-ago period.

Quarter in Detail

Revenues consisted of partial recognition of the non-refundable upfront payment of $225 million received from Pfizer (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 declined 23.6% to $21.1 million. Research and development expenses declined 27.4% to $15.6 million primarily due to decreased clinical activity in the Dimebon program. This was partially offset by increased clinical trial activities in the MDV3100 program.

SG&A expenses declined 9.6% to $5.5 million primarily due to the 20% workforce reduction implemented in March 2010, the termination of office leases, and lower intellectual property expenses related to Dimebon. Medivation expects its cash balance to be sufficient to finance operations beyond 2012.

Pipeline Update

Medivation provided an update on its pipeline candidates. The company expects to report top-line results from its phase III HORIZON study in the first half of 2011. The study is being conducted with Dimebon for the treatment of Huntington disease. Medivation will request a pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) if results are positive.

Meanwhile, Medivation continues to evaluate Dimebon in the CONCERT study, which is being conducted with patients suffering from mild-to-moderate Alzheimer’s. Robust results from this study along with data from an earlier study could be enough to support Dimebon’s approval for mild-to-moderate Alzheimer’s disease.

Medivation and partner Astellas are looking to complete enrolment for the phase III AFFIRM study (advanced prostate cancer) by mid-Nov 2010. The companies initiated another phase III study (PREVAIL), which is being conducted in chemotherapy-naïve advanced prostate cancer patients.

The companies also intend to commence two new studies with MDV3100. While one trial will be a head-to-head phase II study between MDV3100 and AstraZeneca‘s (AZN) Casodex (bicalutamide), the other study (phase II) will be conducted in hormone-naïve patients. Top-line results from CONCERT and AFFIRM should be out by 2012.

We expect investor focus to remain on the HORIZON study results, which are expected in the first half of 2011.

http://www.benzinga.com/10/11/602409/narrower-loss-at-medivation-analyst-blog

Dimebon

http://www.dimebonalzheimers.com/

Mazda  Edmonton

Winnipeg Mainstay

SAN FRANCISCO, Calif. (TheStreet) — Medivation(MDVN Quote) CEO David Hung has delivered another drug partnership, this time for the company’s prostate cancer drug MDV-3100.

Japanese drug maker Astellas said Tuesday that it will pay an upfront fee of $110 million in cash to Medivation in exchange for worldwide marketing rights to MDV-3100, which recently began a pivotal phase III study.

Medivation is also eligible to receive from Astellas another $335 million in cash milestone payments tied to MDV-3100 meeting future development and regulatory goals, plus an added $320 million in commercial milestone payments.

Astellas and Medivation will jointly market MDV-3100 in the U.S. and share costs and profits equally. Astellas will sell the drug outside the U.S. and pay Medivation a double-digit royalty based on sales. A phase III study of MDV-3100 enrolled its first prostate cancer patient on Sept. 23. The study compares MDV-3100 againt a placebo in 1,200 patients with advanced prostate cancer who have already received first-line treatment with the chemotherapy drug Taxotere. The primary goal of the study is to demonstrate that MDV-3100 can prolong survival in these patients.

In September 2008, Medivation’s Hung negotiated one of the biggest partnership deals of that year when Pfizer(PFE Quote) bought worldwide commercial rights to Dimebon, Medivation’s Alzheimer’s drug.

More recently, Johnson & Johnson(JNJ Quote) paid roughly $900 million in May to acquire Cougar Biotechnology, which is developing a prostate cancer drug very similar to Medivation’s MDV-3100.
Medivation shares closed Monday at $26.10.

– Reported by Adam Feuerstein in Boston

http://www.thestreet.com/story/10617222/1/medivation-lands-partner-for-prostate-cancer-drug.html?cm_ven=GOOGLEFI

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com