Archive for October, 2009

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Dimebon Clinical Trials

Friday, October 30th, 2009

In regards to Dimebon (Dimbolin) the Medivation firm has announced that it selected the patients for its clinical trial. Does this mean that no other Dimebon will be available for patients until after the trial ends , is published in peer journals and the FDA approves this medication for use in Alzheimer’s Disease ?

Medivation Completes Enrollment in Confirmatory, Pivotal Phase 3 ‘CONNECTION’ Trial of Dimebon in Patients With Alzheimer’s Disease

SAN FRANCISCO, June 11, 2009 /PRNewswire-FirstCall via COMTEX News Network/ — Medivation, Inc. (Nasdaq: MDVN) today announced the completion of patient enrollment in the CONNECTION study, a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug dimebon in patients with mild-to-moderate Alzheimer’s disease.

The international, double-blind, placebo-controlled, pivotal Phase 3 study enrolled 598 patients, exceeding the enrollment target of 525 patients. More than 40 percent of the patients enrolled were in the United States. The six-month study is evaluating the effect of dimebon on the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician’s Interview-Based Impression of Change plus caregiver interview (CIBIC-plus) — the two endpoints have historically been accepted by the U.S. Food and Drug Administration (FDA) to support registration of currently approved drugs for mild-to-moderate Alzheimer’s disease.

“Completion of patient enrollment in this second pivotal trial moves us closer to our goal of submitting a marketing application to the FDA and bringing dimebon to market for the many Alzheimer’s patients suffering from this devastating disease,” said Lynn Seely, M.D., chief medical officer of Medivation. “We are gratified by the strong interest in this trial as indicated by our exceeding the enrollment goal. Together with our partner Pfizer, we are executing a comprehensive clinical plan to support an NDA filing, currently targeted for 2011, with a broad and differentiated label for dimebon in Alzheimer’s disease. We are also conducting a Phase 3 safety study, which will provide us and Pfizer the opportunity to seek marketing approval earlier if results of the CONNECTION study confirm our previously completed first pivotal study, which was published in the Lancet last year.”

About Dimebon

Dimebon is an investigational compound currently in Phase 3 development for the treatment of Alzheimer’s disease and in clinical development for Huntington disease. In preclinical models of Alzheimer’s disease and Huntington disease explored thus far, dimebon has been shown to inhibit brain cell death, potentially by stabilizing and improving mitochondrial function in a way that prevents neuron death and dysfunction. The dimebon mechanism is thought to be distinct from that of currently available Alzheimer’s disease medications.

In addition to CONNECTION, dimebon is being studied in the 12-month Phase 3 CONCERT trial, which is evaluating the efficacy of dimebon when added to ongoing treatment with donepezil (Aricept(R)) in patients with mild-to-moderate Alzheimer’s disease, and in a Phase 3 safety study. Two Phase 3 studies in moderate-to-severe Alzheimer’s disease are also planned to start this year.

In Huntington disease, a Phase 2 study has been completed. Medivation and Pfizer expect to initiate a Phase 3 trial this year to evaluate the potential benefits of dimebon on cognition in patients with Huntington disease.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations.

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. In September 2008, Medivation announced a global agreement with Pfizer Inc to develop and commercialize dimebon for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, the Company is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer’s medications in patients with mild, moderate or severe Alzheimer’s disease. Further development of dimebon in patients with Huntington disease is also planned. In addition, a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer is ongoing, and a Phase 3 trial is expected to begin this year. For more information, please visit us at http://www.medivation.com.

This press release contains forward-looking statements, including statements regarding the timing and potential results of clinical trials, and the anticipated timing of regulatory filings, 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, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation’s clinical trials, partnering of Medivation’s product candidates, manufacturing of Medivation’s product candidates, competition with Medivation’s product candidates should they receive marketing approval, 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, 2009, filed on May 11, 2009, 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.

SOURCE Medivation, Inc.

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http://www.dimebonalzheimers.com

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Tracing amyloid in Alzheimer's

Friday, October 30th, 2009

A diagnostic compound that allows researchers to look into the brains of Alzheimer’s patients will be used for the first time to gauge the effects of an experimental therapy for the disease.

Called florbetaben, the diagnostic could also provide important insights into the role of beta amyloid, a protein that accumulates into plaques in the brains of patients with Alzheimer’s disease and has been shown to be toxic to nerve cells.

The compound is an 18F-radiolabelled tracer that binds specifically to deposits of beta amyloid, and can be measured using positron emission tomography (PET), a nuclear imaging technique which produces a three-dimensional image of functional processes in the body.

In living patients, diagnosis of Alzheimer’s currently relies on a mix of cognitive testing and magnetic resonance imaging (MRI) and computed tomography (CT) scans to exclude other forms of dementia, but is only 70 to 80 per cent reliable.

“A safe diagnosis of Alzheimer’s is currently only possible post-mortem – florbetaben could help differentiate people with Alzheimer’s from healthy individuals”

‘MRI and CT only allow for the imaging of anatomic compositions of the body, such as organs,’ a spokesperson for Bayer Schering Pharma, the company behind the development of florbetaben, told Chemistry World. ‘More recently, PET scans are increasingly being read alongside CT or MRI to allow anatomic and structural or molecular information to be gathered at the same time.’

A definitive diagnosis of Alzheimer’s relies on the presence of beta amyloid plaques and other hallmarks of the disease in brain tissue samples examined under the microscope.

‘A safe diagnosis of [Alzheimer's] is currently only possible post-mortem,’ the spokesperson commented.

Data presented earlier this year from a Phase II trial suggested florbetaben could be used to differentiate people with Alzheimer’s from healthy volunteers of the same age.

In the latest study, florbetaben will be used to see whether a vaccine developed by Swiss company AC Immune, designed to stimulate the immune system to break down amyloid plaques in the brain, is having the expected effect.

The vaccine has already shown it can reduce plaque size and improve memory in animal models of Alzheimer’s disease, according to Dr. Andrea Pfeifer, AC Immune’s chief executive.

‘Visualising the deposition of beta amyloid that is targeted by our vaccine can be an important parameter for dose selection, and will provide useful complementary data,’ she says, adding that developing diagnostics alongside therapeutics is an emerging trend in the pharmaceutical sector.

Meanwhile, florbetaben could also be useful in establishing once and for all the role of beta amyloid in Alzheimer’s disease.

In September, Chemistry World reported the results of a study which found that a compound called dimebolin had a beneficial effect on Alzheimer’s symptoms, despite increasing levels of beta amyloid. That prompted suggestions that other forms of the protein, such as soluble amyloid oligomers, may be more neurotoxic than plaques.

It may be too soon to reject the prevailing ‘amyloid hypothesis’, but tools like florbetaben could be invaluable in establishing the role of the protein once and for all.

‘A good diagnostic assay should help to evaluate the effect of new treatments in clinical trials better, as well as improve correlation of results with existing pathological and memory markers,’ commented the spokesperson.

Phil Taylor

http://www.rsc.org/chemistryworld/News/2009/October/14100901.asp

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Medivation Wins Big Again; Gets $110M Up Front in Astellas Deal

Friday, October 30th, 2009

Assistant Managing Editor

When Medivation Inc. gained clearance in March to start its Phase III trial of MDV3100 in prostate cancer, a company executive told BioWorld Today the firm would consider partnering the drug if the right opportunity came along – as it had for Alzheimer’s disease drug Dimebon, which scored a potential $725 million deal with Pfizer Inc. last year.

For MDV3100, the right deal came along this week.

Astellas Pharma Inc. agreed to pay South San Francisco-based Medivation $110 million up front for rights to the androgen receptor antagonist, with up to another $655 million in potential milestones – $335 million precommercial and $320 million postcommercial – as well as 50 percent of U.S. profits and tiered double-digit royalties on ex-U.S. sales.

On top of that, Astellas takes over two-thirds of the development costs, including funding two-thirds of the ongoing Phase III AFFIRM study, which last month began enrolling patients with castration-resistant prostate cancer who previously were treated with docetaxel, said David Hung, Medivation’s president and CEO.

Not that Medivation needed a partner to move MDV3100 into Phase III. The firm, which had $237.7 million in cash as of June 30, was prepared to launch AFFIRM on its own. But investors clearly had been waiting for a collaboration, and the addition of big pharma muscle means expanding MDV3100 more quickly into broader prostate cancer indications.

The first Phase III is testing the drug in patients following chemotherapy failures.

“As large a market as that is, it’s still not the biggest,” Hung told BioWorld Today. “You have to go after the upstream indications,” hitting first-line and second-line patient populations.

“We mapped out a development program to hit those upstream indications,” he said, adding that additional trials are expected to follow AFFIRM, though Medivation and Astellas have not yet “talked in great detail about what those will be.”

Since the progression of prostate cancer is driven by the testosterone androgen, MDV3100 is designed to work by blocking the binding of testosterone to the androgen receptor, thereby preventing the androgen receptor from invading the cell’s nucleus and promoting further growth.

Prostate cancer is estimated to affect about 1 million men in the U.S.

The castration-resistant form, also known as hormone-refractory prostate cancer, has few treatment options and a median survival of about 12 months.

Hung acknowledged a “healthy interest” among prospective partners for MDV3100, particularly given that the prostate cancer space has been hopping with news this year.

In April, Seattle-based Dendreon Corp. impressed investors with data from its confirmatory Phase III trial showing that cancer vaccine Provenge (sipuleucel-T) improved overall survival in men with metastatic androgen-independent prostate cancer, and a month later Los Angeles-based Cougar Biotechnology Inc., which is in two Phase III trials with abiraterone acetate in previously treated and chemotherapy-naïve patients, was snatched up by Johnson & Johnson in a deal worth nearly $1 billion. (See BioWorld Today, April 15, 2009, and May 26, 2009.)

And prostate cancer led the charge at this year’s American Society of Clinical Oncology meeting, with Bothell, Wash.-based OncoGenex Pharmaceuticals Inc. reporting stellar Phase II survival data with its clusterin-inhibiting antisense drug, OGX-011, in combination with docetaxel in patients with advanced disease. (See BioWorld Today, June 2, 2009.)

“It’s such a large opportunity,” Hung said, so when Medivation looked at potential partners, “we looked at the overall total value of the deal.”

Besides the hefty up-front and milestones – “and there aren’t too many [deals] of this size in oncology for a drug targeting a single cancer,” Hung said – a partnership with Astellas also gives Medivation access to the Tokyo-based pharma’s sales force in urology, “the gatekeepers for prostate cancer treatment.”

Astellas already markets benign prostatic hyperplasia drug Flomax (tamsulosin) and overactive bladder product Vesicare (solefinacin succinate), “so that will give us great entry into the urology market,” Hung added.

Rodman & Renshaw analyst Elemer Piros estimated in a research note that U.S. sales of MDV3100 could hit $700 million seven years after launch, with peak potential of $1.2 billion in 2025.

But some skeptics remain, as well. Analyst Jonathan Aschoff, of Brean Murray Carret & Co., wrote that he was “not encouraged” by the outcome of the ongoing AFFIRM trial, nor the ongoing CONNECTION trial, which is testing the firm’s other late-stage product, Dimebon, in patients with mild to moderate Alzheimer’s.

But like MDV3100, Dimebon (latrepirdine) had produced strong enough data to nab a lucrative pharma deal. Last year, New York-based Pfizer paid a whopping $225 million up front, with up to another $500 million in potential precommercial milestones. Under that deal, the firms agreed to share U.S. development and commercialization costs and profits on a 60/40 basis, with Pfizer holding the larger share. (See BioWorld Today, Sept. 4, 2008.)

Dimebon also is being tested in a 12-month Phase III trial, with results due in the first half of next year. And a 350-patient study recently began in Huntington’s disease. (See BioWorld Today, July 31, 2009.)

Shares of Medivation (NASDAQ:MDVN) fell $1.06 Tuesday, to close at $25.04.

Published  October 28, 2009

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=52506

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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Bullish trader sticks with Medivation-10/19/2009

Friday, October 30th, 2009

Medivation has spent the last 10 months rallying back from the 2008 market crash, and one trader expects it to keep moving higher.

MDVN ChartoptionMONSTER’s Heat Seeker tracking system detected the purchase of 11,111 November 22.50 calls for about $5.40 against open interest of only 123 contracts. The trade came just seconds after the same number of October 20 calls were sold for $7.60 against open interest of 11,141.

MDVN rose 2.45 percent to $27.43 on Friday and is up 88 percent this year. The biotech drug developer leapt to an all-time high over $30 in September 2008 after announcing a partnership with Pfizer to develop and market its Dimebon neurological drug. The shares collapsed along with the rest of the market the following month, but have been fighting their way back since.

In Friday’s options trade, an investor apparently replaced an existing position in the October calls with new ownership in the November strikes. The call-rolling strategy allowed a bullish position in the stock to be extended by one month while recovering $2.20 in premium.

MDVN last reported earnings on Aug. 5 and hasn’t yet indicated its next release date.
Overall options action in the name was 16 times greater than average in the session. Calls outnumbered puts by 72 to 1.

(Chart courtesy of tradeMONSTER)

http://www.nasdaq.com/newscontent/20091019/bullish_trader_sticks_with_medivation_38948.aspx?storyid=38948

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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American Psychiatric Publishing Textbook of Alzheimer Disease and Other Dementias

Friday, October 30th, 2009

Edited by Myron F. Weiner and Anne M. Lipton
4th ed, 557 pp, $125
Washington, DC, American Psychiatric Publishing, 2009
ISBN: 978-1-5856-2278-8

JAMA. 2009;302(15):1707-1708.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

As many as 5.3 million persons in the United States are living with Alzheimer disease, and an additional 10 million US baby boomers are projected to be at risk over their lifetime. Worldwide, with the rapid increase in the older population, Alzheimer disease and related dementias will affect an increasing number of families, with major societal and economic implications. Hence, these are conditions likely to be encountered by a wide range of clinicians. This multiauthored textbook on dementia, coedited by a leading academic geriatric psychiatrist and a practicing neurologist, is a comprehensive, pragmatic, and beautiful synthesis of where clinical care and the search for a cure stand today.

This new edition substantially expands the scope of the editors’ earlier The Dementias: Diagnosis, Treatment, and Research, with nearly twice the number of contributors—all leading clinicians or researchers. The 26 chapters are grouped into 6 sections covering history/epidemiology; evaluation and diagnosis; . . . [Full Text of this Article]

Barry Baumel, MD, Reviewer
Mind Research Network
Albuquerque, New Mexico
barrybaumel@gmail.com

P. Murali Doraiswamy, MD, Reviewer
Duke University
Durham, North Carolina
dorai001@mc.duke.edu

http://jama.ama-assn.org/cgi/content/extract/302/15/1707

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Exelon cholinesterase inhibitor

Thursday, October 29th, 2009

Exelon (Rivastigmine) is a cholinesterase inhibitor used to treat loss of memory and thinking ability associated with Alzheimer‘s Disease.

Dimebon Alzheimer’s Disease

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Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and Co-Commercialize MDV3100 for the Treatment of Prostate Cancer

Thursday, October 29th, 2009

– Medivation to Receive $110 Million Upfront Cash Payment and Eligible to Receive $655 Million in Milestone Payments, 50 Percent of U.S. Profits and Double-Digit Royalties on Ex-U.S. Sales — – Medivation to Host Conference Call/Webcast Today at 8:30 a.m. Eastern Time –

TOKYO and SAN FRANCISCO, Oct. 27 /PRNewswire-FirstCall/ — Astellas Pharma Inc. (“Astellas”) and Medivation, Inc. (Nasdaq: MDVN) announced today that they have entered into a global agreement to develop and commercialize MDV3100, Medivation’s investigational drug for the treatment of prostate cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.

Under the terms of the agreement, Medivation will receive an up-front cash payment of $110 million. Medivation is also eligible to receive payments of up to $335 million upon the attainment of development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. The companies will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. The companies will share equally all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties on ex-U.S. sales.

“We are pleased to initiate a great partnership with Medivation,” stated Masafumi Nogimori, president and chief executive officer of Astellas. “We believe that MDV3100 has the unique potential to establish a new treatment approach for prostate cancer. Astellas already has the global expertise in urology and the strong commitment to focus on oncology. This partnership is a significant milestone to further expand our business in urology and to establish our franchise in oncology.”

“We are excited to be working with Astellas to develop MDV3100 for a broad spectrum of prostate cancer disease states,” said David Hung, M.D., president and chief executive officer of Medivation. “Astellas is an ideal partner for MDV3100 given its global reach, leading commercial presence in the urology space, and strategic focus on oncology. Astellas is the second major collaboration we have completed in the past year, and we are confident we have the right partners in place for each of our late-stage programs–Astellas for MDV3100 and Pfizer, Inc for dimebon (latrepirdine*).”

According to the American Cancer Society, prostate cancer is the most common non-skin cancer among men in the United States. More than 2 million American men have prostate cancer, and it is the second leading cause of cancer death among men after lung cancer. In 2009, an estimated 192,000 new cases are expected to be diagnosed, and approximately 27,000 men are expected to die from the disease.

MDV3100, a new generation of oral anti-androgen, which shows different pharmacological profiles from current anti-androgens, has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science earlier this year demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

The agreement is not subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and becomes effective immediately. Medivation’s legal and financial advisers on the transaction were Cooley Godward Kronish LLP and Aquilo Partners, L.P. Astellas’ legal adviser on the transaction was Covington & Burling LLP.

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

Conference Call Information
Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 888-280-4443 for domestic callers and 1-719-457-2638 for international callers. In addition, this call is being Webcast and can be accessed at Medivation’s website at www.medivation.com.

About MDV3100′s Clinical Program
In September 2009, Medivation began enrolling patients in a randomized, placebo-controlled, double-blind, multi-national Phase 3 clinical trial known as AFFIRM. This trial is evaluating MDV3100 at a dose of 160 mg taken orally once daily versus placebo in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia and South Africa.

Medivation previously announced interim safety and efficacy results from an ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that MDV3100 was associated with anti-tumor activity in patients who had become resistant to bicalutamide or other standard anti-androgen treatments, including both patients who had failed prior chemotherapy and patients who were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in prostate-specific antigen levels, improvement or stabilization in tumors that had spread to soft tissue or bone, and a decrease in circulating tumor cells, which has been associated in published literature with improved survival in patients with castration-resistant prostate cancer. MDV3100 was generally well tolerated in this trial at doses up to and including 240 mg/day, with fatigue being the most frequently reported adverse event.

About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 14,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology and Inflammatory, Diabetes, CNS/Pain, Infectious diseases (virus) and Cancer. For more information on Astellas Pharma Inc., please visit our website at http://www.astellas.com.

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. In September 2008, Medivation announced a global agreement with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer’s medications in patients with mild, moderate and severe Alzheimer’s disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy. For more information, please visit us at http://www.medivation.com.

Medivation Forward Looking Statement
This press release contains forward-looking statements, including statements related to future clinical development of and ongoing clinical trials evaluating MDV3100, the therapeutic and commercial potential of MDV3100, and potential future development and regulatory milestone payments, commercial milestone payments and royalty payments under the agreement with Astellas, 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 the progress, timing and results of Medivation’s clinical trials, including the risk that positive results in earlier clinical trials may not be repeated in subsequent clinical trials and the risk that interim results from ongoing clinical trials may not be predictive of the final results of any such trial, enrollment of patients in Medivation’s clinical trials, difficulties or delays in obtaining regulatory approvals, Medivation’s dependence on Astellas for aspects of the development, regulatory approval, manufacturing and commercialization of MDV3100, manufacturing of MDV3100, competition with MDV3100 should it receive marketing approvals, 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 (SEC), including its quarterly report on Form 10-Q for the quarterly period ended June 30, 2009, filed with the SEC on August 5, 2009. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

SOURCE Medivation, Inc.

http://www.earthtimes.org/articles/show/astellas-and-medivation-enter-into,1015012.shtml

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Medivation Gets Partner for Prostate Drug

Thursday, October 29th, 2009

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

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Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and Co-Commercialize MDV3100 for the Treatment of Prostate Cancer

Thursday, October 29th, 2009

Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and
Co-Commercialize MDV3100 for the Treatment of Prostate Cancer
– Medivation to Receive $110 Million Upfront Cash Payment and Eligible to
Receive $655 Million in Milestone Payments, 50 Percent of U.S. Profits and
Double-Digit Royalties on Ex-U.S. Sales –

TOKYO and SAN FRANCISCO, Oct. 27 /PRNewswire-FirstCall/ — Astellas Pharma
Inc. (“Astellas”) and Medivation, Inc. (Nasdaq: MDVN) announced today that
they have entered into a global agreement to develop and commercialize
MDV3100, Medivation’s investigational drug for the treatment of prostate
cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical
trial in men with castration-resistant prostate cancer who were previously
treated with docetaxel-based chemotherapy.

Under the terms of the agreement, Medivation will receive an up-front cash
payment of $110 million. Medivation is also eligible to receive payments of
up to $335 million upon the attainment of development and regulatory
milestones plus up to an additional $320 million in commercial milestone
payments. The companies will collaborate on a comprehensive development
program that will include additional studies to develop MDV3100 for both late-
and early-stage prostate cancer. Subject to receipt of regulatory approval,
the companies will jointly commercialize MDV3100 in the U.S. The companies
will share equally all U.S. development costs, commercialization costs, and
profits. Astellas will have responsibility for developing and commercializing
MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties
on ex-U.S. sales.

“We are pleased to initiate a great partnership with Medivation,” stated
Masafumi Nogimori, president and chief executive officer of Astellas. “We
believe that MDV3100 has the unique potential to establish a new treatment
approach for prostate cancer. Astellas already has the global expertise in
urology and the strong commitment to focus on oncology. This partnership is a
significant milestone to further expand our business in urology and to
establish our franchise in oncology.”

“We are excited to be working with Astellas to develop MDV3100 for a broad
spectrum of prostate cancer disease states,” said David Hung, M.D., president
and chief executive officer of Medivation. “Astellas is an ideal partner for
MDV3100 given its global reach, leading commercial presence in the urology
space, and strategic focus on oncology. Astellas is the second major
collaboration we have completed in the past year, and we are confident we have
the right partners in place for each of our late-stage programs–Astellas for
MDV3100 and Pfizer, Inc for dimebon (latrepirdine*).”

According to the American Cancer Society, prostate cancer is the most common
non-skin cancer among men in the United States. More than 2 million American
men have prostate cancer, and it is the second leading cause of cancer death
among men after lung cancer. In 2009, an estimated 192,000 new cases are
expected to be diagnosed, and approximately 27,000 men are expected to die
from the disease.

MDV3100, a new generation of oral anti-androgen, which shows different
pharmacological profiles from current anti-androgens, has been shown in
preclinical studies to provide more complete suppression of the androgen
receptor pathway than bicalutamide, the most commonly used anti-androgen.
MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers
via three complementary actions – MDV3100 blocks testosterone binding to the
androgen receptor, impedes movement of the androgen receptor to the nucleus of
prostate cancer cells (nuclear translocation), and inhibits binding to DNA.
Preclinical data published in Science earlier this year demonstrated that
MDV3100 is superior to bicalutamide in each of these three actions.

The agreement is not subject to approval under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 and becomes effective immediately. Medivation’s
legal and financial advisers on the transaction were Cooley Godward Kronish
LLP and Aquilo Partners, L.P. Astellas’ legal adviser on the transaction was
Covington & Burling LLP.

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

Conference Call Information
Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30
a.m. Pacific Time) to discuss this announcement. To participate in the
conference call, please dial 888-280-4443 for domestic callers and
1-719-457-2638 for international callers. In addition, this call is being
Webcast and can be accessed at Medivation’s website at www.medivation.com.

About MDV3100′s Clinical Program
In September 2009, Medivation began enrolling patients in a randomized,
placebo-controlled, double-blind, multi-national Phase 3 clinical trial known
as AFFIRM. This trial is evaluating MDV3100 at a dose of 160 mg taken orally
once daily versus placebo in men with castration-resistant prostate cancer who
were previously treated with docetaxel-based chemotherapy. The primary
endpoint of the trial is overall survival; secondary endpoints include
progression-free survival, safety and tolerability. This trial is expected to
enroll approximately 1,200 patients at sites in the United States, Canada,
Europe, South America, Australia and South Africa.

Medivation previously announced interim safety and efficacy results from an
ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that
MDV3100 was associated with anti-tumor activity in patients who had become
resistant to bicalutamide or other standard anti-androgen treatments,
including both patients who had failed prior chemotherapy and patients who
were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in
prostate-specific antigen levels, improvement or stabilization in tumors that
had spread to soft tissue or bone, and a decrease in circulating tumor cells,
which has been associated in published literature with improved survival in
patients with castration-resistant prostate cancer. MDV3100 was generally well
tolerated in this trial at doses up to and including 240 mg/day, with fatigue
being the most frequently reported adverse event.

About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceuticals. Astellas has
approximately 14,000 employees worldwide. The organization is committed to
becoming a global category leader in Urology, Immunology and Inflammatory,
Diabetes, CNS/Pain, Infectious diseases (virus) and Cancer. For more
information on Astellas Pharma Inc., please visit our website at

http://www.astellas.com.

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. In September 2008, Medivation announced a global agreement
with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the
treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation is
conducting a broad dimebon clinical development program that includes several
Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in
combination with other Alzheimer’s medications in patients with mild, moderate
and severe Alzheimer’s disease. The companies are also conducting a Phase 3
trial of dimebon in Huntington disease. In October 2009, Medivation entered a
global agreement with Astellas Pharma Inc. to develop and commercialize
MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100
development program, known as the AFFIRM trial, is under way in patients with
castration-resistant prostate cancer who have previously been treated with
docetaxel-based chemotherapy. For more information, please visit us at

http://www.medivation.com.

Medivation Forward Looking Statement
This press release contains forward-looking statements, including statements
related to future clinical development of and ongoing clinical trials
evaluating MDV3100, the therapeutic and commercial potential of MDV3100, and
potential future development and regulatory milestone payments, commercial
milestone payments and royalty payments under the agreement with Astellas,
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 the progress, timing and results of Medivation’s clinical trials,
including the risk that positive results in earlier clinical trials may not be
repeated in subsequent clinical trials and the risk that interim results from
ongoing clinical trials may not be predictive of the final results of any such
trial, enrollment of patients in Medivation’s clinical trials, difficulties or
delays in obtaining regulatory approvals, Medivation’s dependence on Astellas
for aspects of the development, regulatory approval, manufacturing and
commercialization of MDV3100, manufacturing of MDV3100, competition with
MDV3100 should it receive marketing approvals, 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 (SEC), including its quarterly report on
Form 10-Q for the quarterly period ended June 30, 2009, filed with the SEC on
August 5, 2009. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this press
release. Medivation disclaims any obligation or undertaking to update or
revise any forward-looking statements contained in this press release.

SOURCE Medivation, Inc.

Patrick Machado, Chief Financial Officer of Medivation, +1-415-829-4101; or
Corporate Communications of Astellas Pharma Inc., +81-3-3244-3201, Fax:
+81-3-5201-7473

http://www.reuters.com/article/pressRelease/idUS121460+27-Oct-2009+PRN20091027

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Medivation Names Hank Mansbach, M.D., Vice President of Medical Affairs

Thursday, October 29th, 2009

SAN FRANCISCO, Oct. 23 CA-Medivation-VP

SAN FRANCISCO, Oct. 23 /PRNewswire-FirstCall/ — Medivation, Inc. (Nasdaq: MDVN) today announced the appointment of Hank Mansbach, M.D., as vice president of medical affairs. Dr. Mansbach will lead Medivation’s medical affairs activities for dimebon (latrepirdine*), the company’s Phase 3 candidate for the treatment of Alzheimer’s and Huntington diseases, and MDV3100, which is in Phase 3 clinical development for the treatment of advanced prostate cancer.

“Hank brings a vast array of experience in a broad range of CNS therapeutic areas, and we are delighted to have him join the Medivation team,” said Rohan Palekar, chief commercial officer of Medivation. “With multiple Phase 3 trials ongoing with both dimebon and MDV3100, this is an excellent time for Hank to help deepen our relationships with the medical community and expand the visibility of our programs as we move towards commercialization.”

Dr. Mansbach is a neurologist with more than 10 years of strategic and operational drug development experience across all phases of development and multiple therapeutic areas. Prior to joining Medivation, he was senior vice president and head of global drug development at Valeant Pharmaceuticals, a specialty pharmaceutical company. At Valeant, among other programs, he led the development of retigabine, a novel epilepsy therapy which successfully completed Phase 3 trials in 2008 and was subsequently licensed to GlaxoSmithKline (GSK). From 2004 to 2006, Dr. Mansbach was chief medical officer and vice president for clinical development at Cortex Pharmaceuticals, an emerging biotechnology company developing novel CNS therapeutics. Dr. Mansbach began his industry career in the U.S. medical affairs department at GlaxoWellcome supporting the commercialization of Imitrex®/Imigran® and Lamictal® before taking on leadership roles in the GSK Neurosciences clinical development organization. While at GSK he worked on programs in migraine, stroke, epilepsy, multiple sclerosis, pain and Alzheimer’s disease.

Dr. Mansbach earned a medical degree from Duke University and a bachelor’s degree cum laude in philosophy from Yale University.

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

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. In September 2008, Medivation announced a global agreement with Pfizer Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer’s medications in patients with mild, moderate and severe Alzheimer’s disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. A Phase 3 clinical trial of MDV3100 in patients with castration-resistant prostate cancer is under way. For more information, please visit us at http://www.medivation.com.

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